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EX-32 - CERTIFICATION - Medifirst Solutions, Inc.f10k2016ex32_medifirst.htm
EX-31.2 - CERTIFICATION - Medifirst Solutions, Inc.f10k2016ex31ii_medifirst.htm
EX-31.1 - CERTIFICATION - Medifirst Solutions, Inc.f10k2016ex31i_medifirst.htm

 

 

UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-K

 

(Mark One)

☒  ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the fiscal year ended: December 31, 2016

 

☐  TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from [             ] to [             ]

 

Commission file number 000-55465

 

Medifirst Solutions, Inc.

(Name of small business issuer in its charter)

 

NEVADA   27-3888260

(State or other jurisdiction of
incorporation or organization)

 

(IRS Employer
Identification Number)

     
4400 Route 9 South. Suite 1000, Freehold NJ 07728
(Address of Principal Executive Offices)

 

Issuer’s telephone number: (732) 786-8044

 

Securities registered pursuant to Section 12(b) of the Act:
None
 
Securities registered pursuant to Section 12(g) of the Act:
Common Stock, Par Value $0.0001

 

Indicate by check mark if registrant is a well-known seasoned issuer, as defined under Rule 405 of the Securities Act  Yes ☐  No ☒

 

Indicate by check mark if registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.  Yes ☐  No ☒

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act during the preceding 12 months (or for such shorter period that the issuer was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.   Yes ☒  No ☐

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).  Yes ☒  No ☐

 

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§ 229.405 of this chapter) is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.  

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer.        ☐ Accelerated filer.

Non-accelerated filer.          ☐

(Do not check if a smaller reporting company)

Smaller reporting company.

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).  Yes ☐  No ☒

 

The aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at which the common equity was last sold, or the average bid and ask price of such common equity, as of the last business day of the registrant’s most recently completed second fiscal quarter, June 30, 2016: $366,556.

 

As of March 31, 2017, there were 390,395,684 shares of the issuer’s common stock, par value $0.0001 per share, issued and outstanding.

 

Documents incorporated by reference: None

 

 

 

 

 

 

TABLE OF CONTENTS

 

 

        Page
Part I        
Item 1   Business   1
Item 1A   Risk Factors   10
Item 1B   Unresolved Staff Comments   17
Item 2   Properties   17
Item 3   Legal Proceedings   17
Item 4   Mine Safety Disclosures   17
Part II        
Item 5   Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities   18
Item 6   Selected Financial Data   21
Item 7   Management’s Discussion and Analysis of Financial Condition and Results of Operation   21
Item 7A   Quantitative and Qualitative Disclosures about Market Risk   24
Item 8   Financial Statements and Supplementary Data   24
Item 9   Changes in and Disagreements with Accountants on Accounting and Financial Disclosure   26
Item 9A   Controls and Procedures   26
Item 9B   Other Information   27
Part III        
Item 10   Directors and Executive Officers and Corporate Governance   28
Item 11   Executive Compensation   29
Item 12   Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters   31
Item 13   Certain Relationships and Related Transactions, and Director Independence   31
Item 14   Principal Accountant Fees and Services   32
Part IV        
Item 15   Exhibits, Financial Statement Schedules   34
    Signatures   36

 

i

 

 

In this report, unless the context indicates otherwise, the terms "Medifirst," "Company," "we," "us," and "our" refer to Medifirst Solutions, Inc., a Nevada corporation.

 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, or the "Securities Act," and Section 21E of the Securities Exchange Act of 1934 or the "Exchange Act." These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from historical results or anticipated results.

 

In some cases, you can identify forward-looking statements by terms such as "may," "intend," "might," "will," "should," "could," "would," "expect," "believe," "anticipate," "estimate," "predict," "potential," or the negative of these terms. These terms and similar expressions are intended to identify forward-looking statements. The forward-looking statements in this report are based upon management's current expectations and beliefs, which management believes are reasonable. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor or combination of factors, or factors we are aware of, may cause actual results to differ materially from those contained in any forward-looking statements. You are cautioned not to place undue reliance on any forward-looking statements. These statements represent our estimates and assumptions only as of the date of this report. Except to the extent required by federal securities laws, we undertake no obligation to update any forward-looking statement to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

 

You should be aware that our actual results could differ materially from those contained in the forward-looking statements due to a number of factors, including:

 

  new competitors are likely to emerge and new technologies may further increase competition;
  our operating costs may increase beyond our current expectations and we may be unable to fully implement our current business plan;
  our ability to obtain future financing or funds when needed;
  our ability to successfully obtain and maintain our diverse customer base;
  our ability to protect our intellectual property through patents, trademarks, copyrights and confidentiality agreements;
  our ability to attract and retain a qualified employee base;
  our ability to respond to new developments in technology and new applications of existing technology before our competitors;
  acquisitions, business combinations, strategic partnerships, divestures, and other significant transactions may involve additional uncertainties; and
  our ability to maintain and execute a successful business strategy.

 

Other risks and uncertainties include such factors, among others, as market acceptance and market demand for our products and services, pricing, the changing regulatory environment, the effect of our accounting policies, potential seasonality, industry trends, adequacy of our financial resources to execute our business plan, our ability to attract, retain and motivate key technical, marketing and management personnel, and other risks described from time to time in periodic and current reports we file with the United States Securities and Exchange Commission, or the "SEC." You should consider carefully the statements under "Item 1A. Risk Factors" and other sections of this report, which address additional factors that could cause our actual results to differ from those set forth in the forward-looking statements and could materially and adversely affect our business, operating results and financial condition. All subsequent written and oral forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by the applicable cautionary statements.

 

ii

 

 

PART I

 

ITEM 1. BUSINESS

 

Corporate History

 

Medifirst Solutions, Inc. (“Medifirst” and the “Company”) was incorporated in Nevada in November 2010. Our principal executive office is located at 4400 U.S. 9 South, Suite 1000, Freehold NJ, 07726, and our telephone number is (732) 786-8044. Our website address is www.medifirstsolutions.com. The Company began as a development stage company focused on developing products within the healthcare market for both consumer and professional applications. In 2013, Medifirst began developing its own line of disposable electronic cigarettes (“e-cigs”) but the e-cig industry subsequently encountered significant government push-back to try to heavily regulate their use and production, including a ban on e-cigs. In order to avoid the uncertainties and costs of the regulated e-cig industry, Medifirst entered into an agreement with Panacea Photonics Corporation that allowed Medifirst to exclusively market and distribute a series of Botanical LED Light Therapy Systems, including skin care and pain relief products. Under the terms of the marketing and distribution agreement, Medifirst became the exclusive distributor of the light therapy products in both New York and New Jersey. In 2014, in addition to the LED light therapy division, the Company became a dealer for Atmospheric Water Solutions, a Florida based company that sells water generators that makes drinking water from air. In 2015, the Company made a strategic decision to add laser technology to its health and wellness division and discontinue its efforts with its light therapy and water generator products. Management believed that it was in the best interest of the Company and its shareholders to narrow its focus and business to developing its laser technology, which lasers are expected to target professionals that treat pain and inflammation, as well as cosmetic and skincare related conditions. In connection with the changed focus, the Company began to develop a product that if successfully cleared by the U.S. Food and Drug Administration ("FDA"), would be the first in a series of proprietary medical devices for the Company. The Company entered into an exclusive manufacturing agreement to produce what is now its hand-held mobile laser system known as “The Time Machine Program” for which the Company purchased the registered trademark. Furthermore, the Company purchased inventory from the developer of the lasers.

 

Additionally, Medifirst, through its wholly-owned subsidiary Medical Laser Manufacturer, Inc., entered into a Product and Know-How License Agreement (the “License Agreement”) with Laser Lab Corp to license the use of various intellectual property in connection with seeking regulatory approval for and marketing, distributing and selling The Time Machine Series Lasers (“TTM Series”). The License Agreement grants a license to the Company to use various technology, trade secrets, invention records, research records, reports and data, test results, clinical studies, engineering and technical data, designs, production specifications, processes, methods, procedures, facilities and know-how related to the inventions identified in the License Agreement, which inventions include the infrared laser in the TTM Series for which the Company previously filed a Premarket Notification 510(k) submission with the FDA. Although the License is not exclusive, Laser Lab Corp may not license the know-how or inventions to a third party and may only directly, or through its wholly-owned subsidiary, use the know-how and inventions. In addition to the license granted to the Company, the License Agreement provides for an option to license other fields of use of the infrared laser in the TTM Series, as well as additional wavelengths and colors, allowing the Company to develop a broader range of product offerings in the future. Furthermore, Laser Lab Corp granted the Company a right of first refusal to consider matching any bona fide offer to license other technologies of Laser Lab Corp.

 

After having received clearance to market the infrared laser in the TTM Series, the Company has completed its internal controls and procedures as required by the FDA and has initiated its sales division, which has begun soliciting sales in both the U.S. and overseas.

 

The Time Machine Series Laser

 

FDA 510(k) Clearance

 

During fiscal year 2015, we submitted to the FDA a Premarket Notification (510(k)) for two of our lasers in the TTM Series. The two lasers that were the subject of the 510(k) submissions have target indications for treating specific skin conditions, including Vascular and Pigmented Lesions, as well as relief of muscle and joint pain, muscle spasms and inflammation.

 

 1 

 

 

On July 8, 2016, we received clearance from the FDA to market its infrared Time Machine TTML-8102000 Laser Thermal Therapeutic Device. Indication for use: The Time Machine Series Lasers Model TTML-8102000 - 810/830nm is intended for use in temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions.

 

Applications

 

Our infrared laser was cleared by the FDA for the following applications: temporary relief of minor muscle and joint pain, muscle spasms, temporary increase in local blood circulation and temporary relaxation of muscles.

 

In 2017 we expect to seek clearance on our Green Laser, for which we intend to re-file a previously withdrawn 510(k) submission, for the following applications: treatment of vascular lesions and pigmented lesions.

 

Specifications

 

The Time Machine Infrared Laser 810/830nm operates in continuous wave mode set at a fixed frequency. The Infrared laser operates at a 810/830nm wavelength and at 2000mw, as set forth in our 510(k) submission. The Laser is hand-held and mobile. It works on rechargeable batteries, has 6,000 hours of usage against average treatments of 8 minutes and had specifications that are often found on larger more expense laser machines.

  

Manufacturing Agreement

 

Medifirst has entered into an exclusive manufacturing agreement allowing us to exclusively purchase various lasers in the TTM Series having a range of wavelengths and colors, including Infrared, Green, Red, Violet, Ultra-Violet and Blue. We believe that our present manufacturing capacity at these facilities is sufficient to meet foreseeable demand for our products. We have established a quality control program, including a set of standard manufacturing and documentation procedures intended to ensure that, where required, our products are manufactured in accordance with applicable FDA regulations and the comparable requirements of the European community and other countries.

 

Business Plan

 

We plan to sell our TTM Series lasers in the U.S. and international marketplace and have initiated the Company sales division. The current strategy to rolling out the products will be multifaceted, starting with direct sales and partnering with medical device distributors. Medifirst has implemented internal controls and procedures as mandated by the FDA, including checks and balances to be implemented prior to sale in the Company’s office, which procedures will also be put in place at the Company’s manufacturer. The Company continues to actively engage additional sales and distribution affiliates to offer our lasers in the US market. Furthermore, we expect to engage various product marketing teams to introduce our brand and products to direct and indirect customers of the TTM Series.

 

We have contracted a Sales Director for international sales and started our sales initiatives from our new office space for FDA controls and procedures and for training. We are actively interviewing sales and marketing professionals on an ongoing basis to introduce the Time Machine technology to international markets. As part of our sales strategy, we will highlight to the medical communities our belief that the Time Machine hand-held mobile laser unit offers a very unique, effective and affordable alternative to the extremely costly and bulky laser machines current being offered in the marketplace.

 

The Company has presented the Time Machine Lasers to distributors and healthcare professionals in Morocco, Dubai and Paris and continues to follow up to initiate sales. In the U.S. market, the Company has enlisted sales representatives in New Jersey, Florida and New York City. Currently the Company is introducing, demonstrating and conducting training for the Lasers at the offices of its Medical Directors in New York City and Boca Raton, Florida, as well as in the corporate office in New Jersey.

 

 2 

 

 

The healthcare professionals that we believe will benefit from incorporating the TTM Series Lasers into their practices include medical doctors, chiropractors, pain specialists, dentists, cosmetic professional as well as hospitals and surgical centers. We also believe that our lasers will be useful to medi-spas, massage therapists, electrolysis providers, physical therapists and any professional that treats pain, inflammation and scarring. Because laser regulations vary from state-to-state, healthcare professionals will need to research their state-specific compliance requirements regarding their authorized usage.

 

The Time Machine Laser Series and Program (“TMP”) will be affordable and priced very competitively, as compared to other lasers in the industry which can typically cost tens of thousands of dollars. The Company currently offers financing through a third party for as little as just over two hundred dollars a month, or to purchase the laser outright for approximately $9,995. Other lasers in the marketplace are typically financed for up to several thousands per month. We believe the benefits to healthcare professionals which include our treatment protocols as well as the additional benefit of additional revenue will make us highly competitive and in high demand in the medical laser industry. For example, although each practitioner can set the rates patients pay for laser treatments, which typically can range from $1,200 to $2,400 for a six treatment package. Just one package sold can cover at least 6 months financing payments. We believe that the potential revenue generation for treatment centers or healthcare professionals can easily justify the cost to finance or purchase our laser units. The Company does offer financing through a third party financing company.

 

Benefits of the The Time Machine Program (TMP):

 

  ●   Offers practitioners a lucrative opportunity to generate new revenues or enhance existing revenue sources with a low-cost device that provided what we believe to be an effective laser medical technology.
  ●   Allows businesses to expand their treatment offerings and increase their clientele using what our studies have shown are effective outcomes from treatment.
  ●   Allows businesses the possibility of recouping their initial investment within the first months, thereby creating a positive cash flow stream utilizing the recommended business model.
  ●   Promotes and advertises the doctors locations via The Time Machine Program’s social media updates which continues to bring in new patients.
  Laser has pinpoint accuracy.
  Easy to use and operate.
  No incision, no redness, no swelling, no burning, no pain and no downtime.
  Consistent “results-pleased” patients.
  Increased referrals from patients.
  ●   Helps patients with various pain issues: JOINT, NECK & BACK, MUSCLE & BODY, TMJ & JAW, SPORTS INJURIES, NERVE PAIN, NEUROPATHY, ARTHRITIS, CARPAL TUNNEL and SCAR REDUCTION.

 

Brand Awareness

 

The Company plans to aggressively develop a social media, internet and advertising presence to target medical professionals, as well as their perspective patients. In addition, our Sales Directors will implement and oversees a sales team to increase our exposure to patients and healthcare providers. A major component of the business roll-out includes attending major industry trade shows, where we believe we will be able to reach a high number of professionals and distribution partners. These conferences will include those in the medical industry, the beauty and spa industry, as well as alternative healthcare practices. On the international front we will actively negotiating for sales and distribution in Africa, Europe and the Mid-East.

 

Medifirst plans to file for FDA 510K clearance for its Green Laser. This Laser will be used and marketed for the aesthetics market which will include non-invasive and minimally-invasive cosmetic procedures for anti-aging, wrinkles, hyper-pigmentation, skin spots, acnes and various skin related concerns. Minimally-invasive and non-invasive treatments within the cosmetic procedures industry have been, in our belief, a booming area within the laser healthcare market. The Green Laser is perfectly positioned, in our judgement, as a Laser that will be in demand especially for healthcare professionals looking for an affordable entry point into the laser market. Many of our target clients’ patients are willing to pay out-of-pocket for what we believe are highly effective, affordable and shorter-recovery-time treatments. Although we believe some applications of our future lasers may be covered by some health insurance plans, and have reimbursable provider codes, our Laser will appeal to those healthcare professionals that typically charge their patients directly for services rendered.

 

 3 

 

 

The Market

 

Laser Systems

 

According to Global Industry Analysts Inc., the global market for medical laser systems is forecast to reach US$10 billion by 2020, driven by the aging population’s shift towards minimally invasive procedures, and growing awareness over the safety of laser-based procedures. Other factors driving growth in the market include rise in age related illnesses, increasing consumer spending on non-invasive cosmetic surgeries, developments in Diode Lasers & Fiber Lasers, and expanding applications in cardiology. The United States represents the largest market worldwide.

 

Medical laser systems refer to devices that emit monochromatic light beam in a highly concentrated form for excision of tissues. Lasers are being extensively used for diagnosis and treatment of a number of diseases that were previously difficult to treat or were known to lead to significant complications using traditional procedures. Most common applications of medical laser systems include ophthalmology, oncology, cosmetic surgery, cardiology, dentistry, gynecology, dermatology, gastroenterology, diagnostics and urology. Major factors driving growth in the market include aging population, increasing focus on aesthetics, and growing awareness over the benefits of laser procedures. Rising disposable incomes particularly in developing markets and growing adoption of laser-based treatments are also factors driving growth in the market.

 

Surgical lasers represent the largest product market, supported by developments in diode lasers and fiber lasers, and well-established applications in cardiology. Growing prevalence of cardiovascular diseases is therefore expected to provide sturdy opportunities for growth in the coming years. Growing focus on aesthetics, rise in obesity, and preference for non-surgical cosmetic procedures are fueling demand for aesthetic lasers. Advancements in laser technology are resulting in lesser pain and higher surgical accuracy thereby encouraging volume growth in laser procedures. Dedicated lasers with varying active media have been developed to meet specific needs of each procedure. These advancements enable physicians to provide more favorable and noticeable results to patients, with the added benefit of quicker post surgery recovery. Non-invasive methods of body contouring and fat reduction are also gaining popularity, supported by advancements such as Transdermal Focused Ultrasound, Monopolar RF, Low level laser, High Intensity Focused Ultrasound (HIFU) and Cryolipolysis.

  

Laser and Light-Based Aesthetic Treatments

 

A laser is a device that creates and amplifies a coherent beam of light generally of one wavelength or a narrow band of wavelengths. Lasers have been used for medical and aesthetic applications since the 1960s. Intense pulsed light technology was introduced in the 1990s and uses flash lamps, rather than lasers, to generate incoherent light of multiple wavelengths, often referred to as a broadband of wavelengths. Both lasers and intense pulsed light devices can emit high energy light over varying pulse durations or time intervals.

 

By producing intense bursts of concentrated light, lasers and other light-based technologies selectively target melanin in hair follicles and pigmented lesions, hemoglobin in blood vessels and vascular lesions, water surrounding collagen in or below the dermis, ink in tattoos or fat tissue below the dermis. When the target absorbs sufficient energy, it becomes heated and/or mechanically disrupted to cause a biological reaction useful for treatment. The degree to which energy is absorbed in the skin depends upon the skin structure targeted—e.g., hair follicle or blood vessel—and the skin type—e.g., light or dark. Different types of lasers and other light-based technologies are needed to effectively treat the spectrum of skin types and conditions. As a result, an active aesthetic practice may require multiple laser or other light-based systems in order to offer treatments to its entire client base.

 

 4 

 

 

Different types of lasers are currently used for a wide range of aesthetic treatments. Each type of laser operates at its own wavelength, measured in nanometers, which corresponds to a particular emission and color in the light spectrum. The most common lasers used for non-invasive aesthetic treatments are:

 

  Pulse dye lasers—may produce light of various wavelengths.
  Alexandrite lasers—produce a near infrared invisible light that functions with high power at a deep penetration depth.
  CO2 lasers—produce infrared invisible light that creates a deep ablation region.
  Diode lasers—may produce light of various wavelengths.
  Erbium: glass lasers—produce a near infrared invisible light that functions at a deep penetration depth.
  Er:YAG lasers—produce a near infrared invisible light that creates a shallow ablation region.
  Nd:YAG lasers—produce a near infrared invisible light that functions over a wide range of penetration depths or when frequency doubled produce a green light that functions at a shallow penetration depth.

 

In addition to selecting the appropriate wavelength for a particular application, laser and other light-based treatments require an appropriate balance among three other parameters to optimize safety and effectiveness for aesthetic treatments:

 

  Energy level—the amount of light emitted to heat the target;
  Pulse duration—the time interval over which the energy is delivered; and
  Spot size—the diameter of the energy beam.

 

Aesthetic Market

 

Medical Insight, an independent industry research and analysis firm, stated that in 2015 total sales of products in the professional aesthetic product market exceeded $7.6 billion and predicted that the sales would expand by 11.0% per year to $12.8 billion through 2020.

 

Key factors affecting growth rates in the markets for aesthetic treatment procedures and aesthetic laser equipment include:

 

  improvements in overall economic conditions and an expanding physician base;
  the aging population of industrialized countries and the amount of discretionary income of the “baby boomer” demographic segment;
  greater anticipated growth in Asian markets;
  the desire of many individuals to improve their appearance;
  the development of technology that allows for safe and effective aesthetic treatment procedures as well as advances in treatable conditions;
  the impact of managed care and reimbursement on physician economics, which has motivated physicians to establish or seek to expand their elective aesthetic practices with procedures that are paid for directly by patients; and
  reductions in cost per procedure, which has attracted a broader base of clients and patients for aesthetic treatment procedures.

 

 5 

 

 

Non-Traditional Physician Customers

 

Aesthetic treatment procedures that use lasers and other light-based equipment have traditionally been performed by dermatologists and plastic surgeons. Based on published membership information from professional medical organizations, there are approximately 6,000 dermatologists and plastic surgeons in the United States. A broader group of physicians in the United States, including primary care physicians, obstetricians and gynecologists, have incorporated aesthetic treatment procedures into their practices. These non-traditional physician customers are largely motivated to offer aesthetic procedures by the potential for a reliable revenue stream that is unaffected by managed care and government-payor reimbursement economics. We believe that there are a significant number of these potential non-traditional physician customers in the United States, representing a market opportunity to be addressed by laser developers, manufacturers and suppliers like Medifirst. Medical Insight has even reported that some physicians are electing to open medical spas, often adjacent to their conventional office space, where they perform aesthetic procedures in an environment designed to feel less like a health care facility.

 

Competition

 

Many laser devices and procedures currently used are invasive, which results in the potential of side effects and/or down time (redness, puffiness, swelling) after the laser treatments. Additionally, many of these procedures are very expensive for both the health care professionals that must purchase the expensive laser technology and for the patients paying for procedure costs of the laser treatments. The purchase price of such lasers range from $15,000 to $100,000 per unit and the laser units are typically big, bulky machines.

 

Because we anticipate the price range of The Time Machine Lasers to be approximately $9,995 or less, each healthcare professional will be paying less than traditionally spend on laser units and will have the flexibility to pass along the lower cost of the machinery onto their patients.

 

We believe, the Time Machine Lasers will be very well received in the Laser Industry as we are not aware of other handheld laser devices for pain that have the capabilities of our TTM Series lasers.

 

The industry is subject to intense competition for minimally-invasive and non-invasive aesthetic procedures. We compete against products and procedures using laser, light-based, RF, ultrasound, and other aesthetic energy modalities for skin resurfacing and rejuvenation, skin tightening, body contouring, and acne treatment from companies such as Alma Laser, Clarisonic, Cutera, Cynosure, Erchonia, Lumenis, Lutronic, Palomar, PhotoMedex, MedixSysteme, Real Aesthetics, Sciton, Sybaritic, Syneron, Tria Beauty, Ulthera, Ultrashape, Zeltiq and Zeno.

  

In addition, we compete against existing and emerging treatment alternatives such as cosmetic surgery, chemical peels, microdermabrasion, Botox®, dermal fillers, collagen injections and both prescription and over the counter acne medications. Some of these alternative procedures require a lower initial capital investment by a practitioner and, in the area of acne, consumers have a wide variety of treatment choices. Some of our competitors are also publicly-traded companies and others have longer operating histories than we do. Many of them may enjoy several competitive advantages, including: greater name recognition, more extensive intellectual property protection, established relationships with practitioners and other health care professionals, established domestic and international distribution networks, broader product lines and existing treatment systems, and the ability to offer rebates or bundle products to offer higher discounts or incentives, greater experience in conducting research and development, manufacturing, clinical trials, obtaining regulatory approval for products and marketing approved products, greater financial resources for product development, sales and marketing and patent litigation. Competition among providers of laser, light-based, ultrasound, and other energy devices for the aesthetic market is characterized by intensive sales and marketing activities.

 

 6 

 

 

Government Regulation

 

Our products are medical devices that are subject to extensive regulation by government authorities in the United States and in other countries and jurisdictions, including the European Union, or EU. These governmental authorities regulate the marketing and distribution of medical devices in their respective jurisdictions. The regulations cover the entire life cycle of the product, including the research, development, testing, manufacture, quality control, packaging, storage, labeling, advertising and promotion of the devices. In addition, post-approval monitoring and reporting, as well as import and export of medical devices, are subject to various regulatory requirements. The processes for obtaining regulatory approvals or clearances in the United States and in foreign countries and jurisdictions, including the EU, along with subsequent compliance with applicable statutes and regulations, require the expenditure of substantial time and financial resources.

 

Regulations Relating to Products and Manufacturing

 

Our products and research and development activities are regulated by numerous governmental authorities, principally the FDA and corresponding state and foreign regulatory agencies. Any medical device or cosmetic we manufacture and/or distribute will be subject to pervasive and continuing regulation by the FDA. The FDCA, and other federal and state laws and regulations govern the pre-clinical and clinical testing, design, manufacture, use, labeling and promotion of medical devices. Product development and approval for medical devices within this regulatory framework takes a number of years and involves the expenditure of substantial resources.

   

Failure to comply with applicable regulatory requirements can result in fines, injunctions, civil penalties, recalls or seizures of products, total or partial suspensions of production, refusals by the U.S and foreign governments to permit product sales and criminal prosecution.

 

Review and Clearance of Medical Devices in the United States

 

The FDA strictly regulates medical devices in the United States. Under the Federal Food, Drug and Cosmetic Act, or FDCA, a medical device is defined as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory, which is, among other things: intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals; or intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes. Unless an exemption applies, a new medical device may not be marketed in the United States unless it has been cleared by the FDA through filing of a 510(k) premarket notification, or 510(k), or approved by the FDA pursuant to a premarket approval application, or PMA. Both premarket notifications and premarket approval applications, when submitted to the FDA, must be accompanied by a user fee, unless exempt.

 

The information that must be submitted to the FDA in order to obtain clearance or approval to market a new medical device varies depending on how the medical device is classified by the FDA. Medical devices are classified into one of three classes depending on the level of control necessary to assure the safety and effectiveness of the device. Class I devices have the lowest level or risk associated with them, and are subject to general controls, including labeling, premarket notification and adherence to the QSR. Class II devices are subject to general controls and special controls, including performance standards. Class III devices, which have the highest level of risk associated with them, are subject to most of the aforementioned requirements as well as to premarket approval. Most Class I devices and some Class II devices are exempt from the 510(k) requirement, although manufacturers of these devices are still subject to registration, listing, labeling and QSR requirements.

 

510(k) Premarket Notification

 

A 510(k) is a premarket submission made to the FDA to demonstrate that the proposed device to be marketed is at least as safe and effective (i.e., substantially equivalent) to another legally marketed device, or predicate device, that did not require premarket approval. In evaluating a 510(k), the FDA will determine whether the device has the same intended use as the predicate device, and (a) has the same technological characteristics as the predicate device, or (b) has different technological characteristics, and (1) the data supporting substantial equivalence contains information, including appropriate clinical or scientific data, if deemed necessary by the FDA, that demonstrates that the device is as safe and as effective as a legally marketed device, and (2) does not raise different questions of safety and effectiveness than the predicate device. Most 510(k)s do not require clinical data for clearance, but the FDA may request such data.

 

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The FDA seeks to review and act on a 510(k) within 90 days of submission, but it may take longer if the agency finds that it requires more information to review the 510(k). If the FDA concludes that a new device is not substantially equivalent to a predicate device, the new device will be classified in Class III and the manufacturer will be required to submit a PMA to market the product. With the enactment of the Food and Drug Administration Safety and Innovation Act, or the FDASIA, a de novo pathway is directly available for certain low to moderate risk devices that do not qualify for the 510(k) pathway due to the absence of a predicate device.

 

Healthcare Law and Regulation

 

Healthcare providers, physicians and third-party payors may play a role in the recommendation and selection of medical devices for patients. Arrangements with providers, consultants, third-party payors and customers are subject to broadly applicable fraud and abuse, anti-kickback, false claims laws, reporting of payments to physicians and teaching physicians and patient privacy laws and regulations and other healthcare laws and regulations that may constrain business and/or financial arrangements. Restrictions under applicable federal and state healthcare laws and regulations, include the following:

 

  The federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, paying, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made, in whole or in part, under a federal healthcare program such as Medicare and Medicaid;
  The federal civil and criminal false claims laws, including the Civil False Claims Act, and civil monetary penalties laws, which prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false, fictitious or fraudulent or knowingly making, using or causing to made or used a false record or statement to avoid, decrease or conceal an obligation to pay money to the federal government.
  The federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created additional federal criminal laws that prohibit, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;
  HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and their respective implementing regulations, including the Final Omnibus Rule published in January 2013, which impose obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;
  The federal false statements statute, which prohibits knowingly and willfully falsifying, concealing ·or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services;
  The federal transparency requirements known as the federal Physician Payments Sunshine Act, under the Patient Protection and Affordable Care Act, as amended by the Health Care Education Reconciliation Act, or the Affordable Care Act, which requires certain manufacturers of drugs, devices, biologics and medical supplies to report annually to the Centers for Medicare & Medicaid Services, or CMS, within the U.S. Department of Health and Human Services, information related to payments and other transfers of value made by that entity to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members; and
  Analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to healthcare items or services that are reimbursed by non-governmental third-party payors, including private insurers.

 

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State and foreign laws also govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

 

Review and Approval of Medical Devices in the European Union

 

The European Union, or EU, consists of 28 member states and has a coordinated system for the authorization of medical devices. The EU Medical Devices Directive (Council Directive 93/42/EEC, as amended) sets out the basic regulatory framework for medical devices in the European Union. In the EU our medical devices must comply with the Essential Requirements in Annex I to the EU Medical Devices Directive, which we refer to as the Essential Requirements. Compliance with these requirements is a prerequisite to be able to affix the Certificate of Conformity mark, or CE Mark, to our medical devices, without which they cannot be marketed or sold in the European Economic Area, or EEA. To demonstrate compliance with the Essential Requirements we must undergo a conformity assessment procedure, which varies according to the type of medical device and its classification. Except for low risk medical devices (Class I with no measuring function and which are not sterile), where the manufacturer can issue a CE Declaration of Conformity based on a self-assessment of the conformity of its products with the Essential Requirements, a conformity assessment procedure requires the intervention of a third-party organization designated by competent authorities of an EU country to conduct conformity assessments, which is referred to as a Notified Body. The Notified Body would typically audit and examine products’ technical file and the quality system for the manufacture, design and final inspection of the devices before issuing a CE Certificate of Conformity demonstrating compliance with the relevant Essential Requirements.

 

The method of assessing conformity varies depending on the type and class of the product, but normally involves a combination of self-assessment by the manufacturer and a third party assessment by a Notified Body, an independent and neutral institution appointed by a country to conduct the conformity assessment. This third party assessment may consist of an audit of the manufacturer’s quality system and specific testing of the manufacturer’s device. An assessment by a Notified Body in one member state of the European Union or the European Free Trade Association is required in order for a manufacturer to distribute the product commercially throughout these countries.

 

On September 26, 2012, the European Commission adopted a package of legislative proposals designed to replace the existing regulatory framework for medical devices in the EU. These proposals provide for a revision of the current regulatory framework for medical devices in the EU to strengthen patient safety, transparency and product traceability. The proposals, for instance, include reinforced rules governing clinical evaluation throughout the life of the device, improved traceability of devices in the supply chain, including a phased and risk-based introduction of unique device identification, or UDI, improved market surveillance and vigilance, as well as better co-ordination between national regulators, increased powers for Notified Bodies to undertake unannounced inspections and strengthened supervision of Notified Bodies by member states. The European Commission’s proposals may undergo significant amendments as they are reviewed by the European Council and European Parliament as part of the EU legislative process.

 

On June 14, 2016, the European lawmakers and regulators have published the draft versions of the new Medical Device Regulations (“MDR”) and In Vitro Diagnostic Regulations (“IVDR”). If and when adopted, the new legislation may prevent or delay the EU approval or clearance of our products under development or may impact our ability to modify our currently EU approved or cleared products on a timely basis and impose additional costs relating to clinical evaluation, vigilance and product traceability. It is expected there will be a transition period before the new MDR and IVDR come into effect.

 

Intellectual Property

 

Patents, Proprietary Technology and Trademarks

 

Our success depends in part on our ability to obtain and maintain proprietary protection for our products, technology and know-how, to operate without infringing the proprietary rights of others and to prevent others from infringing our proprietary rights. Our policy is to seek to protect our proprietary position by, among other methods, filing U.S. and foreign trademark applications, and, when it becomes applicable, patent applications related to our proprietary technology, inventions and improvements that are important to the development of our business. However, currently, our rights to our proprietary technology are in-licensed rights and not a technology that we could directly patent. We also rely on trademarks, trade secret and copyright laws and contractual restrictions to protect our proprietary technology. These legal protections afford only limited protection for our technology. We currently own the trademark for “The Time Machine Program”. 

 

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ITEM 1A. RISK FACTORS

  

In addition to the other information contained in this Annual Report and the exhibits hereto, the following risk factors should be considered carefully in evaluating our business. Our business, financial condition, cash flows or results of operations could be materially adversely affected by any of these risks. Additional risks not presently known to us or that we currently deem immaterial may also adversely affect our business, financial condition, cash flows or results of operations. The following discussion of risk factors contains forward-looking statements as discussed in the section entitled “Information Regarding Forward Looking Statements.” Our business routinely encounters and addresses risks, some of which may cause our future results to be different – sometimes materially different – than we presently anticipate.

 

RISKS RELATING TO OUR BUSINESS

 

We have a limited operating history and a history of operating losses, and expect to incur significant additional operating losses.

 

We were organized on November 8, 2010, and we have had a limited operating history. Therefore, there is limited historical financial information upon which to base an evaluation of our performance. Our prospects must be considered in light of the uncertainties, risks, expenses, and difficulties frequently encountered by companies in their early stages of operations. We have generated net losses since we began operations. We expect to incur substantial additional net expenses in the foreseeable future as our research, development, and commercial activities increase. The amount of future losses and when, if ever, we will achieve profitability are uncertain. Our ability to generate revenue and achieve profitability will depend on, among other things, receiving 510(k) clearance from the FDA for our various medical devices and similar international regulatory agencies; successful manufacturing; sales and marketing arrangements; and raising sufficient funds to finance our activities. If we are unsuccessful at some or all of these undertakings, our business, prospects, and results of operations may be materially adversely affected.

 

We may need to secure additional financing.

 

We anticipate that we will incur operating losses for the foreseeable future. As of December 31, 2016, we had cash in the amount of $165,017. Based on our current resources, we will not be able to continue to operate without additional immediate funding. If we are not successful in securing additional financing, we may be required to delay significantly, reduce the scope of or eliminate one or more of our development programs, downsize our general and administrative infrastructure, or seek alternative measures to avoid insolvency, including arrangements with collaborative partners or others that may require us to relinquish rights to certain of our technologies, assets, rights or products.

 

Our auditors have expressed substantial doubt about our ability to continue as a going concern.

 

Our auditor’s report on our December 31, 2016 financial statements expresses an opinion that substantial doubt exists as to whether we can continue as a going concern. Although we have obtained the FDA clearance on our infrared laser, we have only begun to market and sell our infrared product in select markets. We expect to commence our national products and services campaign to generate revenue for our Time Machine TTML-8102000 Laser Thermal Therapeutic Device as soon as the funds for such a strategy are available. If we are unable to develop sufficient additional customers for our products and services, we will not generate enough revenue to sustain our business, and the Company may fail.

 

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Our success is dependent on our officers and director to properly manage the Company and the loss or unavailability of their services could cause the business to fail.

 

Currently, we have one Officer and Director, Bruce Schoengood, who has assumed responsibility for all planning, development and operational duties, and will continue to do so throughout the beginning stages of the Company. We are heavily dependent on the personal efforts and abilities of Mr. Schoengood.  He has, and expects to continue, to commit full-time to the development of our business plan in the next twelve months. In addition, we have recently contracted a Sales Director to implement and oversee our sales and marketing operations. The Company has added additional sales representatives as independent contractors in Florida, New York and New Jersey and will continue to try to add sales persons throughout the country. In August 2016, the Company announced the appointment of Richard J. Berman to its Advisory Board. Mr. Berman, an experienced officer and director to over a dozen public and private companies, including extensive experience with pharmaceutical, healthcare, biotechnology and life sciences companies. In addition, the Company added Bill White and Blain Riley to its Advisor Board. Both have extensive experience working with public companies and developing and working with start-up technology companies. Mr. White is currently Chief Financial Officer, Treasurer and Board Secretary of Intellicheck Mobilisa Mr. Riley is the Founder, President and Managing Partner of International Monetary (IM).

 

The loss or unavailability of services of any of the four individuals would have a materially adverse effect on our business prospects and potential earning capacity. We do not currently carry any insurance to compensate for any such loss.

 

Changing and unpredictable market conditions may impact the demand for our products and services.

 

There can be no guarantee that there will be a demand for our products or services. There are several other companies that are currently marketing lasers for pain and although they are different from the Time Machine Laser, if these companies are successful in the marketplace, our products and services may face more competition, which can adversely affect our operations.

 

We may have difficulty managing growth in our business, which could have a material adverse effect on our business, financial condition and results of operations and our ability to execute our business plan in a timely fashion.

 

Because of our small size, growth in accordance with our business plans, if achieved, will place a significant strain on our financial, technical, operational and management resources. As we expand our activities, and increase the number of divisions within the company, we are evaluating or in which we participate, there will be additional demands on our financial, technical and management resources. The failure to continue to upgrade our technical, administrative, operating and financial control systems or the occurrence of unexpected expansion difficulties, including the inability to recruit and retain experienced personnel, could have a material adverse effect on our business, financial condition and results of operations and our ability to execute our business plan in a timely fashion.

  

There may be deficiencies with our internal controls that require improvements, and we will be exposed to potential risks from legislation requiring companies to evaluate controls under Section 404 of the Sarbanes-Oxley Act of 2002.

 

As a result of becoming a reporting issuer under the federal securities laws and the rules and regulations of the SEC thereunder, we will be required to establish and maintain a system of internal controls and procedures. Because Bruce Schoengood is presently and for the foreseeable future, our sole executive officer and director, our internal controls and procedures may not be effective to assure timely and adequate disclosures.

 

There may not be a viable market for our products.

 

We believe that there will be many different applications for our products. We also believe that the anticipated market for our products and the marketplace will continue to expand. These assumptions may prove to be incorrect for a variety of reasons, including competition from other products and the degree of our products’ commercial viability.

 

We may not be successful in selling and marketing our new products.

 

The commercial success of our products and technologies we develop will depend upon the acceptance of these products by physicians and various healthcare professionals and their patients. It is difficult for us to predict how successful the products we are currently developing will be over the long term. If the products we develop do not gain market acceptance, our revenues and operating results will suffer. In addition, we expect to face significant competition, in some cases from companies that are more established, market more widely known products and have greater resources than we do. We may not be able to differentiate our new products sufficiently from our competitors’ products to achieve significant market penetration. As a result of these factors, we may incur significant sales and marketing expenses for our new products without achieving commercial success, which could harm our business and our competitive position.

 

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The failure of our systems to meet patient expectations or the occurrence of unpleasant side effects from the procedures for which our products are used could impair our financial performance.

 

Our future success depends upon patients having a positive experience with the procedures for which our products are used in order to increase physician demand for our products, as a result of both individual patients’ repeat business and as a result of word-of-mouth referrals. We believe that patients may be dissatisfied with these procedures if they find them to be not effective for the conditions they are being treated for.

 

If there is not sufficient consumer demand for the procedures performed with our products, practitioners may not demand for our products, which would adversely affect our operating results.

 

The aesthetic laser and light-based treatment system industry in which we expect to operate is particularly vulnerable to economic trends. Most procedures we expect to be performed using our aesthetic and pain treatment systems are elective procedures that are not reimbursable through government or private health insurance. The cost of these elective procedures must be borne by the patient. As a result, the decision to undergo a procedure that utilizes our products may be influenced by the cost.

 

Consumer demand, and therefore our business, is sensitive to a number of factors that affect consumer spending, including political and macroeconomic conditions, health of credit markets, disposable consumer income levels, consumer debt levels, interest rates, consumer confidence and other factors.  If there is not sufficient consumer demand for the procedures we expect to be performed with our products, practitioner demand for our products my not exist and our business would suffer.

 

We may be exposed to potential product liability.

 

Our anticipated business can expose us to potential product liability risks, which are inherent in the testing, manufacturing, marketing and sale of medical devices. Medical devices involve an inherent risk of product liability claims and associated adverse publicity. While we will continue to take precautions we deem appropriate, there can be no assurance that we will be able to avoid significant product liability exposure. We do not currently maintain liability insurance coverage as such insurance is expensive and difficult to obtain. We plan to obtain liability insurance coverage in the jurisdictions applicable to our sales activity for the products cleared with the FDA. However, when we seek such insurance, it may not be available on acceptable terms, if at all. A product liability claim brought against us in could have a material adverse effect upon us and our financial condition. Should the insurance coverage be insufficient in amount or scope to address multiple and diverse claims, liabilities not covered by insurance could represent a significant financial liability for us.

 

We do offer training for users of our products, and we will sell these products only to healthcare professionals, there still exists an increased potential for misuse of these products, which could harm our reputation and our business.

 

With 510(k) clearance, our products may be purchased or operated by healthcare professionals with varying levels of training and, in some states, by non-physicians, including nurse practitioners, chiropractors and technicians. Outside the United States, many jurisdictions do not require specific qualifications or training for purchasers or operators of our prospective products. We will not supervise the procedures performed with our products, nor will we require that direct medical supervision occur. Purchasers need to check with their state or country regulations for laser usage. We will offer product training sessions, but we may not require purchasers or operators of our non-invasive products to attend training sessions. The lack of required training and the purchase and use of our non-invasive products by purchasers may result in product misuse and adverse treatment outcomes, which could harm our reputation and expose us to costly product liability litigation.

 

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We may be involved in intellectual property litigation, which could be costly and time consuming, and may impact our future business and financial performance.

 

Litigation related to infringement and other intellectual property claims, with or without merit, is unpredictable, can be expensive, time-consuming, could divert management’s attention from planned business and could be asserted even before we begin our manufacturing or sales efforts. If we lose this kind of litigation, a court could require us to pay substantial damages, and prohibit us from using technologies essential to our products, any of which would have a material adverse effect on our business, results of operations and financial condition. We do not know whether necessary licenses would be available to us on satisfactory terms, or whether we could redesign our products or processes to avoid infringement. If our products or methods are found to infringe, we could be prevented from marketing or continuing to market the product series we expect to offer. In addition, we do not know whether our competitors or potential competitors have applied for, or will apply for or obtain, patents that will prevent, limit or interfere with our ability to make, use, sell, import or export our products. Competing products may also appear in other countries. If we lose a foreign patent lawsuit, we could be prevented from marketing our products in such countries.

  

In addition, we may hereafter become involved in litigation to protect our trademark rights associated with our company name or the names used with our products. Names used with our products and procedures may be claimed to infringe names held by others or to be ineligible for proprietary protection. If we have to change the name of our company or products, we may experience a loss in goodwill associated with our brand name, customer confusion and a loss of sales.

 

RISKS RELATED TO REGULATORY MATTERS

 

If we fail to obtain and maintain necessary FDA clearances for our systems and indications, if clearances for future products and indications are delayed, not issued or rescinded or if there are federal or state level regulatory changes, our commercial operations would be harmed.

 

Our systems are medical devices that are subject to extensive regulation in the United States by the FDA for manufacturing, labeling, sale, promotion, distribution and shipping. Before a new medical device, or a new use of or claim for an existing product, can be marketed in the United States, it must first receive either 510(k) clearance or premarket approval from the FDA, unless an exemption applies. Either process can be expensive and lengthy. The FDA’s 510(k) clearance process usually takes from three to six months from the time the application is filed with the FDA, but it can take significantly longer. The process of obtaining premarket approval is much more costly and uncertain than the 510(k) clearance process, and it generally takes from one to three years, or even longer, from the time the application is filed with the FDA.

 

Medical devices may be marketed only for the indications for which they are approved or cleared. We have obtained the 510(k) clearance to market its infrared Time Machine TTML-8102000 Laser Thermal Therapeutic Device. In addition, 510(k) clearance has been applied for but put on hold various indications of our green TTM Series laser. We are unable to predict if or when we would obtain such clearance and, even if we do obtain clearance, it can be revoked if safety or effectiveness problems develop. After the 510(k) clearance, we are also subject to Medical Device Reporting regulations, which require us to report to the FDA if our product causes or contributes to a death or serious injury, or malfunctions in a way that would likely cause or contribute to a death or serious injury if the malfunction were to recur. Our products are also subject to state regulations which are, in many instances, in flux. Changes in state regulations may impede sales. For example, federal regulations allow our systems to be sold to, or on the order of, “licensed practitioners,” as determined on a state-by-state basis. As a result, in some states, non-physicians may legally purchase and operate our systems. However, a state could change its regulations at any time, disallowing sales to particular types of end users. We cannot predict the impact or effect of future legislation or regulations at the federal or state levels.

 

The FDA and state authorities have broad enforcement powers. Our failure to comply with applicable regulatory requirements could result in enforcement action by the FDA or state agencies, which may include any of the following sanctions:

 

  warning letters, fines, injunctions, consent decrees and civil penalties;
  repair, replacement, refunds, recall or seizure of our products;
  operating restrictions or partial suspension or total shutdown of production;
  refusing our requests for 510(k) clearance or premarket approval of new products, new intended uses or modifications to our existing products;
  withdrawing 510(k) clearance or premarket approvals that have already been granted; and
  criminal prosecution.

 

If any of these events were to occur, our business could be harmed.

 

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If we modify our FDA-cleared devices, we may need to seek and obtain new clearances, which, if not granted, would prevent us from selling our modified product or require us to redesign our product.

 

If we decide to make any modification to an FDA-cleared device that would significantly affect its safety or effectiveness or that would constitute a change in its intended use, we would be required to submit a new 510(k) clearance or possibly a premarket approval. We may not be able to obtain any 510(k) clearances or premarket approvals for modifications to, or additional indications for, our existing products, if any, in a timely fashion, or at all. Delays in obtaining clearances on modifications to our current products for which we have a 510(k) clearance or submission would adversely affect our planned business and ability to introduce future products in a timely manner, which in turn would harm our revenue and potential future profitability.

 

If we or our suppliers and subcontractors fail to comply with the QSR, our business would suffer.

 

When we begin to manufacture and sell our FDA cleared products, we and our suppliers and subcontractors will be required to demonstrate and maintain compliance with the QSR. The QSR is a complex regulatory scheme that covers the methods and documentation of the design, testing, control, manufacturing, labeling, quality assurance, packaging, storage and shipping of our products. The FDA enforces the QSR through periodic inspections. We anticipate that we and our suppliers will be subject to such inspections in the future. Our failure, or the failure of our suppliers and subcontractors, to take satisfactory corrective action in response to an adverse QSR inspection could result in enforcement actions, including a public warning letter, a shutdown of our manufacturing operations, a recall of our products, civil or criminal penalties or other sanctions, which would cause our sales and business to suffer.

 

RISKS RELATED TO OUR COMMON STOCK

 

Our current officer and director owns a substantial amount of our common stock, which gives him significant control.

Our current sole officer, sole director and principal founding stockholder, Bruce Schoengood, beneficially owns approximately 1.6% of the outstanding shares of our common stock and 100% of our Series A Preferred shares which carry super voting rights, which, when combined with his common stock holdings, constitutes approximately 21.65% of the voting rights of the Company. So long as this control is concentrated in the hands of Mr. Schoengood, he will continue to have the ability to elect our directors and determine the outcome of votes by our stockholders on corporate matters, including mergers, sales of all or substantially all of our assets, charter amendments and other matters requiring stockholder approval. This controlling interest may have a negative impact on the market price of our common stock by discouraging third-party investors. In addition, such control by Mr. Schoengood will allow him to establish his own compensation and other benefits and perquisites in an amount and manner that would have a negative impact on our net income which in turn could negatively impact the market price, if any, of our common stock.

   

We may need to obtain additional capital, which additional funding may dilute our existing stockholders.

 

We may need additional funding to carry out all of our development plans. If we are unable to obtain sufficient capital on a timely basis, the development of our current or any future product candidates is likely to be delayed, and we could be forced to reduce the scope of our projects or otherwise limit or terminate our operations altogether.

 

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We have not identified the sources for the additional financing that we will require, and we do not have commitments from any third parties to provide this financing. Certain investors may be unwilling to invest in our securities since we are traded on the OTCQB and not on a national securities exchange, particularly if there is only limited trading in our common stock on the OTCQB at the time we seek financing. The volume and frequency of such trading has been limited to date. Sufficient funding through a financing may not be available to us at acceptable terms or at all. Any additional funding that we obtain in a financing is likely to reduce the percentage ownership of us held by our existing security holders. The amount of this dilution may be substantially increased if the trading price of our common stock has declined at the time of any financing from its current levels.

 

Our articles of incorporation allow for our board to create a new series of preferred stock without further approval by our stockholders, which could adversely affect the rights of the holders of our Common Stock.

 

Our Board of Directors has the authority to fix and determine the relative rights and preferences of preferred stock. Our Board of Directors have the authority to issue up to 1,000,000 shares of our preferred stock terms of which may be determined by the Board without further stockholder approval. As a result, our Board of Directors could authorize the issuance of a series of preferred stock that would grant to holders the preferred right to our assets upon liquidation, the right to receive dividend payments before dividends are distributed to the holders of Common Stock and the right to the redemption of the shares, together with a premium, prior to the redemption of our Common Stock. In addition, our Board of Directors could authorize the issuance of a series of preferred stock that has greater voting power than our Common Stock, as it has with the Company’s Series A Preferred Stock or that is convertible into our Common Stock, as it has with the Company’s Series B Preferred Stock, which could decrease the relative voting power of our Common Stock or result in dilution to our existing stockholders.

 

You may experience dilution of your ownership interests because of the future issuance of additional shares of common stock.

 

In the future, we may issue additional authorized but previously unissued equity securities, resulting in the dilution of the ownership interests of our shareholders. We may also issue additional shares of our securities that are convertible into or exercisable for Common Stock, as the case may be, in connection with hiring or retaining employees, future acquisitions, future sales of its securities for capital raising purposes, or for other business purposes. The future issuance of any such additional shares of Common Stock may create downward pressure on the value of our securities. There can be no assurance that we will not be required to issue additional shares of Common Stock, warrants or other convertible securities in the future in conjunction with any capital raising efforts, including at a price (or exercise prices) below the price at which our shares may be valued or are trading in a public market.

 

There is currently limited market for our common stock, but if a sufficient market for our common stock does develop, our stock price may be volatile.

 

Our common stock currently trades on a limited basis on the OTCQB. Trading of our stock through the OTCQB is frequently thin and highly volatile. There is no assurance that a sufficient market will develop in our stock, in which case it could be difficult for stockholders to sell their stock. The market price of our common stock could fluctuate substantially due to a variety of factors, including:

 

  our actual or anticipated operating and financial performance;
  quarterly variations in the rate of growth of our financial indicators, such as net income per share, net income and cash flows, or those of companies that are perceived to be similar to us;
  changes in revenue, cash flows or earnings estimates or publication of reports by equity research analysts;
  speculation in the press or investment community;
  public reaction to our press releases, announcements and filings with the SEC;
  the limited amount of our freely tradable common stock available in the public marketplace;

 

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  general financial market conditions;
  the realization of any of the risk factors presented in this annual report;
  the recruitment or departure of key personnel;
  changes in market valuations of companies similar to ours; and
  domestic and international economic, legal and regulatory factors unrelated to our performance.

 

In addition, future sales of our common stock by our stockholders could cause our stock price to decline and we cannot predict the effect, if any, that market sales of shares of the our common stock or the availability of shares for sale will have on the market price prevailing from time to time.

 

We do not expect to pay dividends for the foreseeable future.

 

For the foreseeable future, it is anticipated that earnings, if any, that may be generated from our operations will be used to finance our operations and that cash dividends will not be paid to holders of our common stock.

 

We will incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives.

 

As a public company, we are incurring significant legal, accounting and other expenses. As of July 8, 2015, the date we filed a Form 8-A for registration of our common stock, we are subject to the filing requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934 (the “Exchange Act”), as amended. Accordingly we are required to file reports with the Securities and Exchange Commission, including annual, quarterly and current reports with respect to our business and financial condition. We are also required to establish and maintain effective disclosure and financial controls and corporate governance practices. Compliance with the Exchange Act and the rules and regulations under the Exchange Act have substantially increased our legal and financial compliance costs and made some activities more time-consuming and costly. Our management and other personnel devote a substantial amount of time to these compliance initiatives. For example, we expect that these rules and regulations may make it more difficult and more expensive for us to obtain director and officer liability insurance. We estimate that we will incur significant expenses in response to these requirements and will require additional funding to cover such costs.

 

There are legal restrictions on the resale of our shares of common stock offered, including penny stock regulations under the U.S. federal securities laws. These restrictions may adversely affect the ability of investors to resell their shares.

 

We anticipate that our common stock will continue to be subject to the penny stock rules under the Securities Exchange Act of 1934, as amended. These rules regulate broker/dealer practices for transactions in “penny stocks.”  Penny stocks are generally equity securities with a price of less than $5.00. The penny stock rules require broker/dealers to deliver a standardized risk disclosure document that provides information about penny stocks and the nature and level of risks in the penny stock market. The broker/dealer must also provide the customer with current bid and offer quotations for the penny stock, the compensation of the broker/dealer and its salesperson and monthly account statements showing the market value of each penny stock held in the customer's account. The bid and offer quotations and the broker/dealer and salesperson compensation information must be given to the customer orally or in writing prior to completing the transaction and must be given to the customer in writing before or with the customer's confirmation. In addition, the penny stock rules require that prior to a transaction, the broker and/or dealer must make a special written determination that the penny stock is a suitable investment for the purchaser and receive the purchaser's written agreement to the transaction. The transaction costs associated with penny stocks are high, reducing the number of broker-dealers who may be willing to engage in the trading of our shares. These additional penny stock disclosure requirements are burdensome and may reduce all of the trading activity in the market for our common stock. As long as the common stock is subject to the penny stock rules, holders of our common stock may find it more difficult to sell their shares.

 

Under the JOBS Act, we have elected to use the extended transition period for complying with new or revised accounting standards.

 

Pursuant to Section 107(b) of the JOBS Act, we have elected to use the extended transition period for complying with new or revised accounting standards for an “emerging growth company.” This election will permit us to delay the adoption of new or revised accounting standards that will have difference effective dates for public and private companies until such time as those standards apply to private companies. Consequently, our financial statements may not be comparable to companies that comply with public company effective dates.

 

Some of our stockholders may have rescission rights with respect to their original purchases of our common stock.

 

If one of our stockholders were to allege that the original offering of our common stock was not made in compliance with applicable federal and/or states securities laws and regulations, and if a court were to agree with such an allegation, the stockholders may have the right to rescind their purchase of our common stock. In such an event, we would be required to offer to refund the original purchases made by the stockholders. Because we have only limited funds, such a refund could have an adverse impact on our financial situation. Furthermore, our involvement with any claim by a stockholder of revision rights may divert the attention of our management and force us to expend resources to defend against such claims.

 

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INFORMATION REGARDING FORWARD-LOOKING STATEMENTS

 

Statements contained in this Annual Report on Form 10-K may be “forward-looking statements.” Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions. These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may, and are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors, including those described above and those risks discussed from time to time in this Annual Report on Form 10-K, including the risks described under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” in this Annual Report on Form 10-K and in other documents which we file with the Securities and Exchange Commission. In addition, such statements could be affected by risks and uncertainties related to:

 

☐      our ability to raise funds for general corporate purposes and operations, including our clinical trials;

☐      the commercial feasibility and success of our technology;

☐      our ability to recruit qualified management and technical personnel;

☐      the success of our clinical trials;

☐      our ability to obtain and maintain required regulatory approvals for our products; and

☐      the other factors discussed in the “Risk Factors” section and elsewhere in this Annual Report on Form 10-K.

 

Any forward-looking statements speak only as of the date on which they are made, and except as may be required under applicable securities laws, we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of this current report.

 

ITEM 1B. UNRESOLVED STAFF COMMENTS

 

There are no unresolved staff comments.

 

ITEM 2. PROPERTIES

 

Our corporate office is located at 4400 Route 9 South, Suite, Freehold NJ 07728 and our telephone number is (732) 786-8044. Our administrative office is located at 9 South Main Street, Suite 9, Marlboro NJ 07746. The office space is leased at a monthly cost of approximately $750. There are currently no proposed programs for the renovation, improvement or development of the facilities currently used. We intend to renew the current lease for one year prior to its termination date on September 14th, 2017. We believe these existing facilities are adequate for the foreseeable future.

 

ITEM 3. LEGAL PROCEEDINGS

 

We are not currently a party to any legal or administrative proceedings. Our current sole officer and director has not been convicted in a criminal proceeding nor has he been permanently or temporarily enjoined, barred, suspended or otherwise limited from involvement in any type of business, securities or banking activities.

 

ITEM 4. MINE SAFETY DISCLOSURES

 

Not Applicable.

 

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PART II

 

ITEM 5. MARKET FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

 

Our common stock is currently traded under the symbol “MFST” on the OTCQB. Our common stock began trading on the OTC Bulletin Board on September 14, 2012. The following table sets forth the quarterly high and low sales prices of our common stock since we began trading. Such prices are inter-dealer quotations without retail mark-ups, mark-downs or commissions, and may not represent actual transactions.

 

Fiscal Year Ending December 31, 2017        
Quarter Ended  High $   Low $ 
March 31, 2017   0.0125    0.0027 

 

Fiscal Year Ending December 31, 2016        
Quarter Ended  High $   Low $ 
December 31, 2016   0.007    0.0045 
September 30, 2016   0.0178    0.0067 
June 30, 2016   0.01    0.0071 
March 31, 2016   0.0156    0.0089 

 

Fiscal Year Ending December 31, 2015        
Quarter Ended  High $   Low $ 
December 31, 2015   0.00126    0.0056 
September 30, 2015   0.0175    0.0143 
June 30, 2015   0.0166    0.0102 
March 31, 2015   0.041    0.0166 

 

Our common stock is subject to Rule 15g-9 of the Exchange Act, known as the Penny Stock Rule which imposes requirements on broker/dealers who sell securities subject to the rule to persons other than established customers and accredited investors. For transactions covered by the rule, brokers/dealers must make a special suitability determination for purchasers of the securities and receive the purchaser's written agreement to the transaction prior to sale. The SEC also has rules that regulate broker/dealer practices in connection with transactions in "penny stocks." Penny stocks generally are equity securities with a price of less than $5.00, other than securities registered on certain national securities exchanges or quoted on the NASDAQ system, provided that current price and volume information with respect to transactions in that security is provided by the exchange or system. The Penny Stock Rules requires a broker/dealer, prior to a transaction in a penny stock not otherwise exempt from the rules, to deliver a standardized risk disclosure document prepared by the SEC that provides information about penny stocks and the nature and level of risks in the penny stock market. The broker/dealer also must provide the customer with current bid and offer quotations for the penny stock, the compensation of the broker/dealer and its salesperson in the transaction, and monthly account statements showing the market value of each penny stock held in the customer's account. The bid and offer quotations, and the broker/dealer and salesperson compensation information, must be given to the customer orally or in writing prior to effecting the transaction and must be given to the customer in writing before or with the customer's confirmation. These disclosure requirements have the effect of reducing the level of trading activity in the secondary market for our common stock. As a result of these rules, investors may find it difficult to sell their shares.

 

 18 

 

 

As of March 31, 2017, we had 390,395,684 shares of common stock issued and outstanding and 47 stockholders of record.

  

Dividend Policy

 

We have not paid any cash dividends on our common stock. It is anticipated that our future earnings will be retained to finance our continuing development. The payment of any future dividends will be at the discretion of our board of directors and will depend upon, among other things, future earnings, any contractual restrictions, success of business activities, regulatory and corporate law requirements and our general financial condition.

 

Recent Sales of Unregistered Securities

 

During the period covered by this report, we issued and sold the following securities without registration under the Securities Act.

 

Common Stock:

 

During the fiscal year ended December 31, 2015, the Company issued an aggregate of 7,900,000 shares of Common Stock at $0.0005 per share upon conversions of convertible promissory notes of an aggregate principal amount equal to $3,950.

 

During the fiscal year ended December 31, 2016, the Company issued 71,667,558 shares of Common Stock upon conversions of an aggregate principal amount equal to approximately $163,712 outstanding convertible promissory notes.

 

During the fiscal year ended December 31, 2016, the Company issued an aggregate of 10,450,000 shares of Common Stock upon conversion of an aggregate of 20,900 shares of Series B Preferred.

 

During the fiscal year ended December 31, 2016, the Company issued an aggregate of 10,300,000 shares of restricted Common Stock for consulting services. 

 

Subsequent to the fiscal year ended December 31, 2016, the Company issued an aggregate of 13,900,000 shares of restricted Common Stock for consulting services.

 

Subsequent to the fiscal year ended December 31, 2016, the Company issued 112,497,708 shares of Common Stock upon conversions of an aggregate principal amount equal to approximately $141,573 outstanding convertible promissory notes.

 

Subsequent to the fiscal year ended December 31, 2016, the Company issued an aggregate of 9,050,000 shares of Common Stock upon conversion of an aggregate of 18,100 shares of Series B Preferred.

 

Promissory Notes:

 

In April 2015, the Company issued a promissory note to a stockholder in the amount of $3,000. Principal and interest were due and payable on October 2015. In October 2016, this note was assigned to a new holder. As of the date of this Report, there remains no balance on this note.

 

October 12, 2015, the Company closed on a private funding transaction and issued its Convertible Promissory Note in the principal amount of $31,000.00 dated October 8, 2015 to a private institutional investor. The maturity date is October 8, 2016, at which time the outstanding principal and interest balance is due and payable. The promissory note provides, among other things, that the holder cannot exercise the right of conversion prior the expiration of six (6) months and the conversion price will be equal to 58% of the lowest trading price of the Company’s common stock for the twenty (20) days prior to the date of conversion. As of the date of this Report, there remains no balance on this note.

 

 19 

 

 
Effective October 27, 2015, the Company closed on a private funding transaction and issued its 5% Convertible Promissory Note in the principal amount of $35,000.00 dated October 12, 2015 to a private institutional investor. The maturity date is October 12, 2016, at which time the outstanding principal and interest balance is due and payable. The promissory note provides, among other things, that the holder cannot exercise the right of conversion prior the expiration of six (6) months and the conversion price will be equal to 55% of the lowest trading price of the Company’s common stock for the ten (10) trading days prior to the date of conversion. As of the date of this Report, there remains no balance on this note.

 

Effective July 8, 2015, the Company closed on a private funding transaction and issued its 8% Convertible Promissory Note in the principal amount of $59,000.00 dated June 25 2015 to a private institutional investor. The maturity date is March 30, 2016, at which time the outstanding principal and interest balance is due and payable. The promissory note provides, among other things, that the holder cannot exercise the right of conversion prior the expiration of six (6) months and the conversion price will be equal to 45% of the average of the three lowest trading price of the Company’s common stock for the ten (10) trading days prior to the date of conversion. On January 2016, this note was assigned to a new holder. As of the date of this Report, there remains no balance on this note.

 

Effective September 8, 2015, the Company closed on a private funding transaction and issued its 8% Convertible Promissory Note in the principal amount of $38,000.00 dated August 31, 2015 to a private institutional investor. The maturity date is June 3, 2016, at which time the outstanding principal and interest balance is due and payable. The promissory note provides, among other things, that the holder cannot exercise the right of conversion prior the expiration of six (6) months and the conversion price will be equal to 45% of the average of the three lowest trading price of the Company’s common stock for the ten (10) trading days prior to the date of conversion. On January 2016, this note was assigned to a new holder. As of the date of this Report, there remains no balance on this note.

 

On January 7, 2016, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with an accredited investor (the “Investor”) for the sale of convertible redeemable notes in aggregate principal amount of $251,803. On January 7, 2016, the Company and the Investor conducted the first closing under the Purchase Agreement, pursuant to which the Company issued to the Investor (i) a convertible redeemable note in principal amount of $105,000 containing an original issue discount of $20,000 (the “$105K Note”); and (ii) a convertible redeemable note in principal amount of $50,000 (the “$50K Note” and together with the $105K Note, the “Notes”). In consideration for the issuance of the $105K Note, on January 13, 2016, the Company received net proceeds (after deducting the original issue discount and legal fees) in the amount of $75,696.69. In consideration for the issuance of the $50K Note, the Investor issued to the Company a $50,000 fully-collateralized secured promissory note (the “Investor Note”), pursuant to which the Investor agreed to pay the Company $50,000 on or before April 30, 2016, which was paid in full in May 2016. Under the Purchase Agreement, on March 15, 2016, the Company and the Investor conducted an additional closing for the sale and purchase of additional notes having the same terms as the Notes in principal amounts equal to $50,000 (the “$50K March Note”) and $46,803 (the “$46K March Note”), respectively. In consideration for the issuance of the $46K March Note, the Investor issued to the Company a $46,803 fully-collateralized secured promissory note, pursuant to which the Investor agreed to pay the Company $46,803 on or before June 15, 2016, which was paid in full in June 2016. All notes issued pursuant to the Purchase Agreement bear interest at the rate of 8% per annum. Subject to a beneficial ownership limitation equal to 9.99%, principal and interest on all the notes issued pursuant to the Purchase Agreement convertible into shares of the Company’s common stock at a conversion price equal to 55% of the lowest trading price of Common Stock during the 20 trading day period prior to conversion. As of the date of this Report, there remains no balance on the $105K Note and the principal balances of the $50K Note, the $50K March Note and the $46K March Note remain $50,000, $50,000 and $46,803, respectively,

  

On October 11, 2016, the Company issued to an accredited investor a 9% convertible promissory note in the principal amount of $157,895, which included an original issue discount of $7,895, resulting in proceeds of $150,000 to the Company. On the same day, the Company issued to the investor a convertible redeemable replacement note in principal amount of $50,000 (the “Replacement Note”). The issuance of the Replacement Note was made in connection with the investor’s partial purchase of $45,000 in principal and accrued interest thereon (valued at $5,000) of a $100,000 convertible promissory note that was originally issued by the Company on June 12, 2015 (the “Original Note”). The $50,000 principal amount of the Replacement Note reflected the principal and accrued interest under the Original Note. Subject to a beneficial ownership limitation equal to 4.99%, principal and interest on the Replacement Note is convertible into shares of Common Stock at a conversion price equal to 50% of the lowest trading price of Common Stock during the 20 trading day period prior to conversion, representing the same conversion terms as those included in the Original Note. The current principal balance of the note remains $157,895.

 

 20 

 

 

Series B Preferred Stock:

 

On March 8, 2016, the Company, through its wholly-owned subsidiary, Medical Laser Manufacturer, Inc., memorialized in a Product and Know-How License Agreement with Medical Lasers Manufacturer, Inc., a Florida corporation doing business as Laser Lab Corp., an agreement to license the use of various intellectual property in connection with seeking regulatory approval for and marketing, distributing and selling The Time Machine Series Lasers. In connection with the Company’s agreement with Laser Lab, which agreement was memorialized in the License Agreement, on September 24, 2015, the Company filed with the Secretary of State of the State of Nevada a Certificate of Designation of Rights, Preferences and Privileges (the “Certificate of Designation”), of the Company’s Series B Convertible Preferred Stock (“Series B Preferred”). Pursuant to the Certificate of Designation, the Company designated 50,000 shares of Series B Preferred. The Series B Preferred does not hold any rights to receive dividends or any rights to vote. The Company, at its sole discretion, may redeem at any time, in whole or in part, outstanding shares of Series B Preferred for a price per share equal to the consideration paid or deemed to have been paid for such shares. The Series B Preferred may be converted, sixty days after their respective issuance, each share into the Company’s common stock at a conversion ratio equal to one (1) share of Series B Preferred for five hundred (500) shares of Common Stock.

 

Pursuant to the License Agreement, the Company agreed to issue to Laser Lab 25,000 shares of Series B Preferred and a promissory note (the “Promissory Note”) in principal amount of $150,000 and bearing interest at 10% per annum. The principal and interest due under the Promissory Note is payable 18-months from the date of issuance.

 

On May 15, 2016, the Company issued 4,000 shares of its Series B Preferred Stock in satisfaction of the obligation to issue such shares to the seller of a trademark the Company purchased in August 2015.

 

All of the previously described issuances of securities were made pursuant to the exemption from registration at Section 4(a)(2) and/or Rule 506 of Regulation D and/or Section 4(6) under the Securities Act for either transactions not involving a public offering or for transactions with an “accredited investor” as defined under the Securities Act. Common Stock issued upon the exercise of conversion rights were made pursuant to Section 3(a)(9) of the Securities Act for securities exchanged by an issuer with its existing security holders exclusively.

 

Purchases of Equity Securities by the Issuer and Affiliated Purchasers

 

We did not purchase any of our shares of common stock or other securities during our fiscal year ended December 31, 2015 and 2016.

 

Equity Compensation Plan Information

 

We have two stock-based compensation plans, the 2016 Equity Incentive Plan and the MFST Equity Incentive Plan, together referred to herein as the “Stock Plans.” As of March 31, 2017, there were no share available for issuance under the Stock Plans.

 

ITEM 6. SELECTED FINANCIAL DATA

 

We are a smaller reporting company, as defined by Rule 229.10(f)(1) and therefore are not required to provide the information required by this Item.

 

ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OR PLAN OF OPERATION

 

This section must be read in conjunction with the Audited Financial Statements included in this Prospectus.

 

 21 

 

 

Plan of Operation

 

Medifirst Solutions, Inc. (“Medifirst” and the “Company”) was incorporated in Nevada in November 2010. Our principal executive office is located at 4400 U.S. 9 South, Suite 1000, Freehold NJ, 07726, and our telephone number is (732) 786-8044. Our website address is www.medifirstsolutions.com. The Company began as a development stage company focused on developing products within the healthcare market for both consumer and professional applications. In 2013, Medifirst began developing its own line of disposable electronic cigarettes (“e-cigs”) but the e-cig industry subsequently encountered significant government push-back to try to heavily regulate their use and production, including a ban on e-cigs. In order to avoid the uncertainties and costs of the regulated e-cig industry, Medifirst entered into an agreement with Panacea Photonics Corporation that allowed Medifirst to exclusively market and distribute a series of Botanical LED Light Therapy Systems, including skin care and pain relief products. Under the terms of the marketing and distribution agreement, Medifirst became the exclusive distributor of the light therapy products in both New York and New Jersey. In 2014, in addition to the LED light therapy division, the Company became a dealer for Atmospheric Water Solutions, a Florida based company that sells water generators that makes drinking water from air. In 2015, the Company made a strategic decision to add laser technology to its health and wellness division and discontinue its efforts with its light therapy and water generator products. Management believed that it was in the best interest of the Company and its shareholders to narrow its focus and business to developing its laser technology, which lasers are expected to target professionals that treat pain and inflammation, as well as cosmetic and skincare related conditions. In connection with the changed focus, the Company began to develop a product that if successfully cleared by the U.S. Food and Drug Administration, would be the first in a series of proprietary medical devices for the Company. The Company entered into an exclusive manufacturing agreement to produce what is now its hand-held mobile laser system known as “The Time Machine Program” for which the Company purchased the registered trademark. Furthermore, the Company purchased inventory from the developer of the lasers.

 

Additionally, Medifirst, through its wholly-owned subsidiary Medical Laser Manufacturer, Inc., entered into a Product and Know-How License Agreement (the “License Agreement”) with Laser Lab Corp to license the use of various intellectual property in connection with seeking regulatory approval for and marketing, distributing and selling The Time Machine Series Lasers (“TTM Series”). The License Agreement grants a license to the Company to use various technology, trade secrets, invention records, research records, reports and data, test results, clinical studies, engineering and technical data, designs, production specifications, processes, methods, procedures, facilities and know-how related to the inventions identified in the License Agreement, which inventions include the infrared laser in the TTM Series for which the Company previously filed a Premarket Notification 510(k) submission with the FDA. Although the License is not exclusive, Laser Lab Corp may not license the know-how or inventions to a third party and may only directly, or through its wholly-owned subsidiary, use the know-how and inventions. In addition to the license granted to the Company, the License Agreement provides for an option to license other fields of use of the infrared laser in the TTM Series, as well as additional wavelengths and colors, allowing the Company to develop a broader range of product offerings in the future. Furthermore, Laser Lab Corp granted the Company a right of first refusal to consider matching any bona fide offer to license other technologies of Laser Lab Corp.

 

After having received clearance to market the infrared laser in the TTM Series, the Company has completed its internal controls and procedures as required by the FDA and has initiated its sales division, which has begun soliciting sales in both the U.S. and overseas.

 

During fiscal year 2015, we submitted to the FDA a Premarket Notification 510(k) for two of our lasers in the TTM Series, which submission noted the intended use of the lasers to treat specific skin conditions, including Vascular and Pigmented Lesions, as well as relief of muscle and joint pain, muscle spasms and inflammation. On July 8, 2016, we received clearance from the FDA to market its infrared Time Machine TTML-8102000 Laser Thermal Therapeutic Device.

 

Our auditors have issued a going concern opinion. This means that our auditors believe there is substantial doubt that we can continue as an on-going business for the next twelve (12) months. Our auditors’ opinion is based on the uncertainty of our ability to establish profitable operations. The opinion results from the fact that we have not generated significant revenues.  Accordingly, we must raise cash from operations or from investments by others in the Company to continue our operations.

 

Our sole officer and director is responsible for our managerial and organizational structure, which will include preparation of disclosure and accounting controls under the Sarbanes Oxley Act of 2002. When these controls are implemented, he will be responsible for the administration of the controls. Should he not have sufficient experience, he may be incapable of creating and implementing the controls which may cause us to be subject to sanctions and fines by the SEC which ultimately could cause you to lose your investment.

 

 22 

 

 

Results of Operations

 

Fiscal Year Ended December 31, 2016

 

Revenues 

 

During the year ended December 31, 2016 and 2015, we generated $-0- and $1,858 in revenues, respectively. The company is still in developmental stage and does not generate significant revenue.

 

We no longer are a dealer for Atmospheric Waters Solutions and sell water generators.

 

Expenses

 

For the year ended December 31, 2016 and 2015, expenses were $733,746 and $244,262, respectively. The reason for the increase in expenses was primarily due to substantial increases in: advertising and promotions costs, consulting fees, professional fees, and subscriptions, and research and development lab testing. These increases are in-line with the Company’s mission as they start to plan to enter the market with product. 

 

Legal and Accounting

 

For the year ended December 31, 2016 and 2015, professional fees were $143,531 and $59,086, respectively.

 

We had increased costs in these professional services due to hiring new audit firm as well as FDA filing concerns. The substantial increases were due to additional accounting, consulting and professional fees incurred in the connection with accounting for derivatives, SEC compliance, legal services for an increased number of conversions and contracts, and general bookkeeping and financial statement preparation

 

Other Income/(Expense)

 

For the year ended December 31, 2016 and 2015, other expenses were ($403,938) and ($96,570), respectively consisting of interest expense. These changes are all due to the changes in fair value of derivatives for the quarter and interest expense on debt, amortization of original issue discount, amortization of deferred financing costs, loss on the extinguishment of debt and derivative discount amortization.

 

Net Income/(Loss)

 

For the year ended December 31, 2016 and 2015 the company had a net loss of ($1,137,684) and ($344,124).

 

Liquidity and Capital Resources

 

Since incorporation, we have financed our operations through the private placement of our common stock to selected accredited investors and periodic borrowings from investors. At December 31, 2016 and 2015, our principal sources of liquidity included cash and cash equivalents of $165,017 and $156,958, respectively.

 

As of December 31, 2016, we did not have any significant commitments for capital expenditures.

 

If we do not generate sufficient cash flow to support our operations over the next twelve (12) months, in order to continue as a going concern we may need to raise additional capital by issuing capital stock in exchange for cash.  There are no formal or informal agreements to attain such financing.  The Company’s ability to obtain additional capital on acceptable terms is subject to a variety of uncertainties, including: investors’ perception of, and demand for, securities of companies in our industry; conditions of the U.S. and other capital markets in which we may seek to raise funds; future results of operations, financial condition and cash flow. Therefore, the Company’s management cannot assure that financing will be available in amounts or on terms acceptable to the Company, or if at all. Any failure by the Company’s management to raise additional funds on terms favorable to the Company could have a material adverse effect on the Company’s liquidity and financial condition.

 

 23 

 

 

Critical Accounting Policies

 

Our significant accounting policies are summarized in Note 1 of our consolidated financial statements. While all these significant accounting policies impact our financial condition and results of operations, we view certain of these policies as critical. Policies determined to be critical are those policies that have the most significant impact on our financial statements and require management to use a greater degree of judgment and estimates. Actual results may differ from those estimates. Our management believes that given current facts and circumstances, it is unlikely that applying any other reasonable judgments or estimate methodologies would cause an effect on our consolidated results of operations, financial position or liquidity for the periods presented in this report.

 

Off Balance Sheet Arrangements

 

The Company has no off-balance sheet arrangements.

 

Recently Adopted Accounting Pronouncements

 

Please see Note 1 of our consolidated financial statements that describe the impact, if any, from the adoption of Recent Accounting Pronouncements.

 

ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

We are a smaller reporting company, as defined by Rule 229.10(f)(1) and are not required to provide the information required by this Item.

 

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

 

The Company’s consolidated financial statements are stated in United States dollars and are prepared in accordance with United States generally accepted accounting principles.

 

It is the opinion of management that the audited consolidated financial statements for the calendar year ended December 31, 2016 include all adjustments necessary in order to ensure that the audited consolidated financial statements are not misleading.

 

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MEDIFIRST SOLUTIONS, INC.

 

CONSOLIDATED FINANCIAL STATEMENTS

 

DECEMBER 31, 2016 and 2015

 

 

 

 

 

 

 

 

 

 

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TABLE OF CONTENTS

 

Financial Statements  
   
Report of Independent Registered Public Accounting Firm F-2
   
Consolidated Balance Sheets F-3
   
Consolidated Statements of Operations F-4
   
Consolidated Statements of Stockholders' Equity F-5
   
Consolidated Statements of Cash Flows F-6
   
Notes to Consolidated Financial Statements F-7 - F-33

 

 F-1 

 

 

802 N. Washington St.
Spokane, WA 99201

 

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

To the Board of Directors and
Stockholders of Medifirst Solutions, Inc.

 

We have audited the accompanying consolidated balance sheets of Medifirst Solutions, Inc. as of December 31, 2016 and 2015, and the related consolidated statements of operations, stockholders’ equity, and cash flows for each of the years in the two-year period ended December 31, 2016. Medifirst Solutions Inc.’s management is responsible for these consolidated financial statements. Our responsibility is to express an opinion on these consolidated financial statements based on our audits.

 

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement. The company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audit included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

 

In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of Medifirst Solutions, Inc. as of December 31, 2016 and 2015, and the results of its operations and its cash flows for each of the years in the two-year period ended December 31, 2016, in conformity with accounting principles generally accepted in the United States of America.

 

The accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern. As discussed in Note 11 to the financial statements, the Company has not generated positive operating cash flows since inception and requires significant outside funding to continue operations. This raises substantial doubt about the Company’s ability to continue as a going concern. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

   

Fruci & Associates II, PLLC

Spokane, WA

   
April 5, 2017  

 

 F-2 

 

 

Medifirst Solutions, Inc.

Consolidated Balance Sheets

December 31, 2016 and December 31, 2015

 

ASSETS
   December 31, 2016   December 31, 2015 
Current Assets:        
Cash  $165,017   $156,958 
Inventory   14,023    50,000 
Prepaid items   15,720    - 
Total current assets   194,760    206,958 
           
Property, Plant and Equipment, net   1,871    2,159 
           
Other Assets          
Security Deposit   650    - 
Intangible Asset -License Agreement, net   137,502    - 
Total other assets   138,152    - 
           
Total Assets  $334,783   $209,117 
           
LIABILITIES AND STOCKHOLDERS' EQUITY
           
Liabilities          
Accounts payable and accrued expenses  $75,368   $123,648 
Accrued expenses - officer's compensation   405,197    370,000 
Due to related party   8,921    8,921 
Loans payable - stockholders   10,555    24,449 
Note Payable for license agreement   150,000    - 
Convertible notes payable   391,653    180,393 
Derivative Liabilities   144,792    157,617 
Total current liabilities   1,186,486    865,028 
           
Commitments & Contingencies (Note 8)   -    - 
           
Stockholders' Equity:          
Series A preferred stock, $0.0001 par value; 1,000,000 shares authorized, 50,000 and 50,000 shares issued and outstanding, respectively   5    5 
Series B convertible preferred stock, $0.0001 par value; 50,000 shares authorized, 26,100 and -0- shares issued and outstanding, respectively   3    - 
Common stock, $0.0001 par value; 1,500,000,000 shares authorized, 225,847,976 and 35,101,750 shares issued and outstanding, respectively   22,586    3,510 
Additional paid in capital   1,232,996    310,183 
Accumulated deficit   (2,107,293)   (969,609)
Total Stockholders' Equity   (851,703)   (655,911)
           
Total Liabilities & Stockholders' Equity  $334,783   $209,117 

 

The accompanying notes are an integral part of these financial statements. 

 

 F-3 

 

 

Medifirst Solutions, Inc.

Consolidated Statements of Operations

Years Ended December 31, 2016 and 2015

 

   2016   2015 
         
Consulting fee revenue  $-   $1,858 
Product sales, net   -    - 
    -    1,858 
Cost of goods sold   -    5,150 
Gross income   -    (3,292)
           
Expenses:          
Officer's compensation   100,000    100,000 
Impairment loss-trademark   -    20,000 
Impairment loss-inventory   45,475    - 
Advertising and promotion   48,694    4,990 
Computer and internet   978    2,085 
Consulting fees   295,764    30,175 
Professional fees   143,531    59,086 
Provision for bad debts   -    2,255 
Rent   9,536    6,483 
Travel   3,959    - 
Lab testing   32,449    - 
Dues and subscriptions   11,402    - 
Other   41,958    19,188 
    733,746    244,262 
           
Net loss from Operations before other income, expenses   (733,746)   (247,554)
           
Other income and (expense)          
Interest expense   (641,812)   (92,515)
Interest income   1    - 
Loss on extinguishment of debt   (4,733)   - 
Change in fair value -derivatives   242,606    (4,055)
           
Net loss before provision for income tax  $(1,137,684)  $(344,124)
           
Provision for income taxes   -    - 
           
Net Loss  $(1,137,684)  $(344,124)
           
Loss per common share - Basic and fully diluted  $(0.014)  $(0.012)
           
Weighted average number of shares outstanding - Basic and fully diluted   80,655,915    28,596,216 

 

The accompanying notes are an integral part of these financial statements.

 

 F-4 

 

 

Medifirst Solutions, Inc.

Consolidated Statement of Stockholders' Equity

For the Period from January 1, 2015 to December 31, 2016

 

               Additional       Total 
   Common Stock   Preferred Class A   Preferred Class B   Paid in   Accumulated   Stockholders' 
   Shares   Amount   Shares   Amount   Shares   Amount   Capital   Deficit   Equity 
Balance - January 1, 2015   22,481,750    2,248    50,000    5              258,755    (625,485)   (364,477)
Issuance of common shares upon partial  conversion of note at $0.0001 per share   2,000,000    200    -    -              1,800    -    2,000 
Cancellation of common shares   (500,000)   (50)   -    -              50    -    - 
Issuance of common shares upon partial  conversion of note at $0.0005 per share   800,000    80    -    -              320    -    400 
Contribution to additional paid in capital   -    -    -    -              1,050    -    1,050 
Issuance of common shares upon partial conversion of note at $0.0005 per share   300,000    30    -    -              120    -    150 
Issuance of common shares upon partial conversion of note at $0.0005 per share   1,000,000    100    -    -              400    -    500 
Issuance of common shares upon partial conversion of note at $0.0005 per share   1,000,000    100    -    -              400    -    500 
Contribution to additional paid in capital   -    -    -    -              1,575    -    1,575 
Issuance of common shares upon partial conversion of note at $0.0005 per share   3,800,000    380    -    -              1,520    -    1,900 
Issuance of common shares to acquire subsidiary at $0.015 per share   20,000    2    -    -              18    -    20 
Issuance of common shares for services  $0.01 per share   3,500,000    350                        34,650    -    35,000 
Contribution to additional paid in capital   -    -    -    -              1,575    -    1,575 
Issuance of common shares to investor $0.01 per share   200,000    20    -    -              -    -    20 
Issuance of common shares for services  $0.01 per share   500,000    50    -    -              4,950         5,000 
Additional paid in capital on  debt discount related to the intrinsic beneficial conversion feature   -    -    -    -              3,000    -    3,000 
Net loss   -    -    -    -              -    (344,124)   (344,124)
Balance December 31, 2015   35,101,750    3,510    50,000    5    -    -    310,183    (969,609)   (655,911)
Issuance of common shares upon partial conversion of note at $0.00275 per share   1,095,036    110                        2,901         3,011 
Issuance of common shares upon partial conversion of note at $0.00275 per share   1,285,560    129                        3,406         3,535 
Issuance of common shares upon partial conversion of note at $0.003355 per share   906,533    91                        2,950         3,041 
Issuance of common shares upon partial conversion of note at $0.00275 per share   1,500,000    150                        600         750 
Issuance of Series B Preferred shares as part consideration for license agreement                       25,000    3              3 
Issuance of common shares upon conversion of 3,400 shares of Series B Preferred Stock   1,700,000    170         -    (3,400)   (1)   (170)        (1)
Additional paid in capital from derivative liability on debt conversion        -         -              10,152    -    10,152 
Issuance of Series B Preferred shares as   -    -    -    -              -         - 
payment for inventory                       10,000    1    49,999         50,000 
Issuance of common shares upon conversion of 3,400 shares of Series B Preferred Stock   1,700,000   $170              (3,400)  $0   $(170)        0 
Issuance of common shares upon partial conversion of note at $.0033 per share   1,584,873   $158                       $5,072         5,230 
Issuance of common shares upon partial conversion of note at $.0033 per share   2,194,200   $219                       $7,021         7,240 
Issuance of common shares upon partial conversion of note at $.0044 per share   2,000,000   $200                       $8,600         8,800 
Issuance of common shares upon conversion of 3,900 shares of Series B Preferred Stock   1,950,000   $195              (3,900)  $(0)  $(195)        (0)
Issuance of common shares to extend due date  of a note payable at par value per share   300,000   $30                                  30 
Issuance of Series B Preferred shares as consideration for trademark purchase                       4,000   $0   $19,999         19,999 
Issuance of common shares upon partial conversion of note at $.0029 per share   2,500,000   $250                       $7,038         7,288 
Issuance of common shares upon partial conversion of note at $.0038 per share   783,062   $78                       $2,980         3,058 
Issuance of common shares upon conversion of 2,200 shares of Series B Preferred Stock   1,100,000   $110              (2,200)  $(0)  $(110)        (0)
Issuance of common shares upon partial conversion of note at $.0036 per share   768,026   $77                       $2,723         2,800 
Issuance of common shares upon partial conversion of note at $.0028 per share   853,643   $85                       $2,315         2,400 
Issuance of common shares for services  $0.01 per share   500,000   $50                       $4,950         5,000 
Additional paid in capital from derivative liability on debt conversion                                $42,092         42,092 
Issuance of common shares upon partial conversion of note at $.002915 per share   1,356,747    136                        3,664         3,800 
Issuance of common shares upon partial conversion of note at $..002915 per share   2,500,000    250                        7,038         7,288 
Issuance of common shares upon partial conversion of note at $.0029 per share   2,213,714    221                        6,199         6,420 
Issuance of common shares upon partial conversion of note at $..002915 per share   3,193,941    319                        8,621         8,940 
Issuance of common shares upon partial conversion of note at $..002915 per share   3,180,000    318                        8,952         9,270 
Issuance of common shares upon partial   conversion of note at $.0029 per share   2,995,816    300                        8,388         8,688 
Issuance of common shares upon partial  conversion of note at $.002915 per share   3,352,874    335                        9,040         9,375 
Issuance of common shares upon partial  conversion of note at $..002915 per share   1,194,500    119                        3,360         3,480 
Issuance of common shares upon partial  conversion of note at $..00352 per share   3,333,073    333                        10,902         11,235 
Issuance of common shares upon partial  conversion of note at $.0039 per share   2,693,624    269                        10,181         10,450 
Issuance of common shares upon partial  conversion of note at $.003465 per share   2,886,003    289                        9,711         10,000 
Issuance of common shares upon partial  conversion of note at $.0029 per share   2,226,772    223                        5,777         6,000 
Issuance of common shares upon conversion of note payable at $.0005 per share   2,400,000    240                        960         1,200 
Issuance of common shares for services  $.0092 per share   4,000,000    400                        36,400         36,800 
Issuance of common shares for services $.0092 per share   3,000,000    300                        27,300         27,600 
Issuance of common shares for services  $.0083 per share   2,000,000    200                        16,400         16,600 
Issuance of common shares for services $.00083 per share   2,000,000    200                        16,400         16,600 
Issuance of common shares for services $.0078 per share   500,000    50                        3,850         3,900 
Issuance of common shares for services $.0065 per share   2,000,000    200                        12,800         13,000 
Issuance of common shares upon conversion of note payable at $.001 per share   3,000,000    300                        2,700         3,000 
Issuance of common shares upon conversion of note payable at $.0028 per share   2,516,666    251                        6,997         7,248 
Additional paid in capital from derivative  liability on debt conversion                                 99,387         99,387 
Issuance of common shares upon partial  conversion of note at $.0025   5,000,000    500                        12,000         12,500 
Issuance of common shares upon partial  conversion of note at $.0033   3,696,081    370                        12,130         12,500 
Issuance of common shares upon partial conversion of note at $.0022   5,705,841    571                        11,929         12,500 
Issuance of common shares upon partial conversion of note at $.002   5,750,000    575                        10,925         11,500 
Issuance of common shares upon partial conversion of note at $.0018   5,251,122    525                        9,032         9,557 
Issuance of common shares upon partial  conversion of note at $.0015   6,666,667    667                        9,333         10,000 
Issuance of common shares upon partial  conversion of note at $.0016   6,436,527    644                        9,356         10,000 
Issuance of common shares upon partial  conversion of note at $.0017   6,679,822    668                        10,354         11,022 
Issuance of common shares upon partial  conversion of note at $.0015   8,000,000    800                        11,200         12,000 
Issuance of common shares upon partial  conversion of note at $.0017   7,955,721    796                        12,331         13,127 
Issuance of common shares upon partial  conversion of note at $.0016   6,451,139    645                        9,355         10,000 
Issuance of common shares upon partial conversion of note at $.0012   3,231,334    323                        3,677         4,000 
Issuance of common shares for services $.0052 per share   2,000,000    200                        10,200         10,400 
Issuance of common shares for services $.0045 per share   3,500,000    350                        15,400         15,750 
Issuance of common shares for services $.0054 per share   3,000,000    300                        15,900         16,200 
Issuance of common shares for services  $.0035 per share   2,000,000    200                        6,800         7,000 
Issuance of common shares for services $.0035 per share   1,000,000    100                        3,400         3,500 
Issuance of common shares for services $.0036 per share   7,900,000    790                        27,650         28,440 
Issuance of common shares for services $.0052 per share   2,000,000    200                        10,200         10,400 
Issuance of common shares for services $.005 per share   4,000,000    400                        19,600         20,000 
Issuance of common shares for services $.0036 per share   5,000,000    500                        17,500         18,000 
Issuance of common shares for services $.0032 per share   6,500,000    650                        20,150         20,800 
Issuance of common shares upon final conversion of note at $.0013   7,757,309    776                        9,224         10,000 
Additional paid in capital from derivative liability on debt conversion                                 155,150         155,150 
Additional paid in capital from conversion of accrued interest on notes                                 2,836         2,836 
Net Loss                                      (1,137,684)   (1,137,684)
Balance - December 31, 2016   225,847,976    22,586    50,000    5    26,100    3    1,232,996    (2,107,293)   (851,703)

 

The accompanying notes are an integral part of these financial statements.

 

 F-5 

 

 

Medifirst Solutions, Inc.

Consolidated Statement of Cash Flows

Years Ended December 31, 2016 and 2015

 

   2016   2015 
         
Cash flows from operating activities:        
Net loss  $(1,137,684)  $(344,124)
Adjustments to reconcile net loss to net cash used by operating activities:          
Depreciation & amortization expense   13,430    1,663 
Provision for doubtful accounts   -    2,255 
Stock Based Compensation   270,020    40,000 
Interest/excess of fair value of shares to repay loan        5,450 
Change in assets and liabilities          
Accrued Interest Receivable   -    - 
Accounts payable and accrued expenses   63,798    174,243 
Security deposit   (650)   1,065 
Due to related party   -    2,984 
Gain on fair market value of derivatives   (242,606)     
Amortization of debt discount & other financing costs   665,385    157,617 
Stockholder's loan   (13,894)   (17,761)
Prepaid expenses   (15,720)   1,125 
Inventory   35,977    (45,000)
Net cash used by operating activities   (361,944)   (20,483)
           
Cash flows from investing activities:          
Purchase of equipment   (642)   - 
Net cash used by investing activities   (642)   - 
           
Cash flows from financing activities:          
Repayment of bank overdraft   -    (4,748)
Proceeds from issuance of common stock   -    20 
Contribution of additional paid in capital   -    7,200 
Proceeds from related party advances   -    - 
Repayment of stockholders' loan   -    - 
Proceeds from sale of Convertible notes payable   370,645    174,418 
Net cash provided by financing activities   370,645    176,890 
           
Net increase (decrease) in cash   8,059    156,407 
Cash at beginning of period   156,958    551 
Cash at end of period  $165,017   $156,958 
           
Supplemental cash flow information:          
Cash paid during the period for:          
Interest  $-   $759 
Income taxes  $1,014   $550 
           
Non-cash investing and financing activities:          
Shares issued upon acquisition of Subsidiary  $-   $20 
Cancellation of shares  $-   $50 
Shares issued upon settlement of debt  $-   $5,450 
Common stock issued for note interest and note conversions  $636,711   $- 
Preferred stock issued for debt settlement and license agreement  $70,001   $- 

 

The accompanying notes are an integral part of these financial statements.

 

 F-6 

 

 

Medifirst Solutions, Inc.

Notes to Consolidated Financial Statements

December 31, 2016

 

Note 1. NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

Organization

 

Medifirst Solutions, Inc. ("MSI" or the "Company") was incorporated in Nevada in November 2010. The Company has not generated significant sales to date. The Company intends to have a diverse product line of consumer products. Since inception, the Company has been engaged in business planning activities, including researching the industry, identifying target markets for the Company's products, developing the Company's models and financial forecasts, performing due diligence regarding potential geographic locations most suitable for establishing the Company's offices and identifying future sources of capital. At the present time, the Company is building products and affiliations in and related to the cosmetic healthcare industry.

 

In July 2016, Medifirst, in response to its Premarket Notification 510(k) submission for “The Time Machine” Series Laser, received clearance from the U.S. Food and Drug Administration (“FDA”) to market its infrared Time Machine TTML-8102000 Laser Thermal Therapeutic Device.The Company is actively putting together a sales and distribution team to offer our lasers in the US market.

 

Pursuant to a sale and purchase agreement dated August 19, 2015 between the Company and the Company's president, the Company acquired 100% of the equity interests in Medical Lasers Manufacturer, Inc. ("MLM") with the total purchase price of 20,000 shares of the Company's common stock at $0.001 per share. The fair value of the acquired entity was $20.

 

The transaction was considered as a business acquisition and accordingly the acquisition method of accounting has been applied. MLM had no assets at the date of the business combination.


The Consolidated financial statements include the accounts of MSI and its only wholly owned subsidiary, MLM. All material intercompany balances and transactions have been eliminated in consolidation.

 

The Company’s activities are subject to significant risks and uncertainties, including failing to secure additional funding to operationalize the Company’s current technology.

 

 F-7 

 

 

Medifirst Solutions, Inc.

Notes to Consolidated Financial Statements

December 31, 2016

 

Basis of Presentation

 

The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America ("GAAP"). In the opinion of management, all adjustments considered necessary for a fair presentation have been included. All such adjustments are of a normal recurring nature.

 

Some items in the prior year financial statements were reclassified to conform to the current presentation. Reclassifications had no effect on prior year net income or shareholders’ equity.

 

Revenue Recognition

 

In general, the Company records revenue when persuasive evidence of an arrangement exists, services have been rendered or product delivery has occurred, the sales price to the customer is fixed or determinable, and collectability is reasonably assured. The following policies reflect specific criteria for the various revenues streams of the Company:

 

Revenue is recognized at the time the product is delivered or services are performed. Provision for sales returns are estimated based on the Company's historical return experience. Revenue is presented net of returns.

 

Accounts Receivable

 

The Company extends credit to its customers in the normal course of business and performs ongoing credit evaluations of its customers, maintaining an allowance for potential credit losses. Accounts receivable is reported net of the allowance for doubtful accounts. The allowance is based on management's estimate of the amount of receivables that will actually be collected. The Company has not recorded an allowance for doubtful accounts as of December 31, 2016 or December 31, 2015.

 

Inventory

 

Inventory consists of finished goods and is stated at the lower of cost (first-in, first-out) or market value. Finished goods inventory includes hand held laser devices and their carrying cases. During the year ended December 31, 2016, the Company determined that the current market value of it's inventory was significantly lower than it's cost. This resulted from initial inventory purchases having a significantly higher cost during the earlier phase of product development. In accordance with FASB codification topic 330-10-35-1, the company has written-down its inventory to the lower of it's cost or market value which resulted in a charge of $45,475 which is presented as "Impairment loss -inventory" on the Company's statement of operations for the year ended December 31, 2016..

 

Equipment

 

Equipment, consisting of computer equipment, is stated at cost less accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets, of five years.

 

Long-Lived Assets

 

The Company reviews long-lived assets, such as equipment, for impairment whenever events or changes in circumstances indicate the carrying amount may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds the estimated future cash flows, an impairment loss will be recorded by the amount the carrying value exceeds the fair value of the asset.

 

 F-8 

 

 

Medifirst Solutions, Inc.

Notes to Consolidated Financial Statements

December 31, 2016

 

In August 2015, the Company's wholly-owned subsidiary MLM, acquired a trademark for $20,000. Due to the uncertainty of future cash flows from the trademark, management has deemed it to be impaired and recorded an impairment expense of $20,000 in 2015.

 

Intangible Asset- Licensing Agreement

 

On March 8th 2016, the company, through it's sole wholly-owned subsidiary ("Licensee"), entered into a Product and Know-How License Agreement ("Agreement") with a Florida Corporation ("Licensor") which is owned by a related party - the son of the Company's CEO. The license provides with respect to the Technology, Licensor hereby grants to Licensee an irrevocable, nontransferable, royalty-bearing license, with a right of sublicense (the “License”), throughout the Territory in the Field of Use, whether or not under the Licensed Patent, to:

 

-use or submit or deliver the Technology and/or any Product to any regulatory body throughout the Territory for purposes of obtaining approval to make, Sell, offer for Sale, import, export and distribute the Technology or Products; and

 

- use or copy the Technology and/or any Product; and

 

- market, make, have made, Sell, offer for Sale, import and distribute Products; and

 

- sublicense the Technology; and

 

- prepare, or have prepared on its behalf, modifications, enhancements and/or derivative works of the Technology.

 

In connection with the license granted, Licensor hereby grants to Licensee a license to the Licensed Patents, whether now existing or hereafter acquired.

 

The consideration for the licensing agreement consisted of the issuance of 25,000 Series B Preferred stock shares to the Licensor (at par) plus a $150,000 promissory note issued by the Company to the licensor. The promissory note is payable 18 months from the date of issuance and bears interest at the rate of 10% per annum. The last part of the consideration in this license agreement is the royalty payments which have not taken effect yet as they are based on sales for which the company has none.

 

The licensing agreement is for a ten year period effective from March 8th 2016. The cost of the licensing agreement is being amortized over it's ten-year period and charged to income on a straight-line basis.

 

 F-9 

 

 

Medifirst Solutions, Inc.

Notes to Consolidated Financial Statements

December 31, 2016

 

Debt Issues Costs and Debt Discount

 

The Company may pay debt issue costs, and record debt discounts in connection with raising funds through the issuance of convertible debt. These costs are amortized over the life of the debt to interest expense. If a conversion of the underlying debt occurs, a proportionate share of the unamortized amounts are immediately expensed. Beginning in 2015, the Company early-adopted ASU 2015-03: Simplifying the Presentation of Debt Issuance Costs and has reflected the deferred financing costs as a direct reduction of the related debt (See table included in Note 5 to Consolidated Financial Statements).

 

Original Issue Discount

 

For certain convertible debt issued, the Company provides the debt holder with an original issue discount. The original issue discount is recorded to debt discount, reducing the face amount of the note and is amortized to interest expense over the life of the debt.

 

Derivative Liabilities

 

Fair value accounting requires bifurcation of embedded derivative instruments such as conversion features in convertible debt or equity instruments, and measurement of their fair value for accounting purposes. The Company assessed its securities for purposes of determining the proper accounting treatment and valuation as set forth in the Statement of Financial Accounting Standard ASC 820–10–35–37 Fair Value in Financial Instruments; Statement of Financial Accounting Standard ASC 815 Accounting for Derivative Instruments and Hedging Activities; and Emerging Issues Task Force (“EITF”) Issue No. 00–19 and EITF 07–05.

 

In assessing the convertible debt instruments, management determines if the convertible debt host instrument is conventional convertible debt and further if there is a beneficial conversion feature requiring measurement. If the instrument is not considered conventional convertible debt, the Company will continue its evaluation process of these instruments as derivative financial instruments.

 

Once the derivative liabilities are determined, they are adjusted to reflect fair value at each reporting period end, with any increase or decrease in the fair value being recorded in results of operations as an adjustment to fair value of derivatives.

 

Use of Estimates

 

The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the dates of the condensed consolidated balance sheets and the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from those estimates.

 

Financial Instruments

 

The carrying amounts reported in the balance sheets for cash, accounts receivable, accounts payable, and other accrued liabilities approximate their fair values.

 

Segment Information

 

The Company follows Accounting Standards Codification ("ASC") 280, "Segment Reporting". The Company currently operates in a single segment and will evaluate additional segment disclosure requirements as it expands its operations.

 

 F-10 

 

 

Medifirst Solutions, Inc.

Notes to Consolidated Financial Statements

December 31, 2016

 

Net Income (Loss) Per Common Share

 

The Company calculates net income (loss) per share based on the authoritative guidance. Basic earnings (loss) per share is calculated by dividing net income (loss) by the weighted average number of common shares outstanding for the period. Diluted earnings (loss) per share is calculated by dividing net income (loss) by the weighted average number of common shares and dilutive common stock equivalents outstanding. During periods in which the Company incurs losses, common stock equivalents, if any, are not considered, as their effect would be anti-dilutive.

 

Income Taxes

 

The Company utilizes the accrual method of accounting for income taxes. Under the accrual method, deferred tax assets and liabilities are determined based on the differences between the financial reporting basis and the tax basis of the assets and liabilities, and are measured using enacted tax rates and laws that will be in effect when the differences are expected to reverse. An allowance against deferred tax assets is recognized, when it is more likely than not, that such tax benefits will not be realized.

 

The Company recognizes the financial statement benefit of an uncertain tax position only after considering the probability that a tax authority would sustain the position in an examination. For tax positions meeting a “more-likely-than-not” threshold, the amount recognized in the financial statements is the benefit expected to be realized upon settlement with the tax authority. For tax positions not meeting the threshold, no financial statement benefit is recognized. The Company recognizes interest and penalties, if any, related to uncertain tax positions in income tax expense. The Company did not have any unrecognized tax benefits as of December 31, 2016, and does not expect this to change significantly over the next 12 months.

 

 F-11 

 

 

Medifirst Solutions, Inc.

Notes to Consolidated Financial Statements

December 31, 2016

 

Stock-Based Compensation

 

The Company accounts for equity instruments issued to employees in accordance with ASC 718, Compensation - Stock Compensation. ASC 718 requires all share-based compensation payments to be recognized in the financial statements based on the fair value on the issuance date.

 

Equity instruments granted to non-employees are accounted for in accordance with ASC 505, Equity. The final measurement date for the fair value of equity instruments with performance criteria is the date that each performance commitment for such equity instrument is satisfied or there is a significant disincentive for non-performance.

 

Cash and Cash Equivalents

 

The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents. At December 31, 2016, the Company had $165,017 in cash equivalents and $156,958 in cash equivalents a December 31, 2015.

 

Recent Pronouncements

 

In May 2014, FASB and IASB issued a new joint revenue recognition standard that supersedes nearly all GAAP guidance on revenue recognition. The core principle of the standard is that revenue recognition should depict the transfer of goods and services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods and services. The new standard is effective for the Company to annual reporting periods beginning after December 15, 2017 (that is, a public organization is required to apply the new revenue standard beginning in the first interim period within the year of adoption). Additionally, the Board decided to permit public organizations to adopt the new revenue standard early, but not before the original public organization effective date (that is, annual periods beginning after December 15, 2016). A public organization should apply the new revenue standard to all interim reporting periods within the year of adoption.The Company has evaluated the impact of this ASU on the consolidated financial statements and has determined, at this time, the ASU's implementation would not have a material impact on revenue recognition. See below - Accounting Standards Update 2016-10 - Revenue from Contracts with Customers (Topic 606) Identifying Performance Obligations and Licensing
 

On January 05, 2016, the FASB completed its Classification and Measurement of Financial Instruments project by issuing ASU No. 2016-01, Financial Instruments—Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities. The new guidance improves certain aspects of recognition, measurement, presentation and disclosure of financial instruments. For public business entities, the new guidance is effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. The Company does not believe the impact of its pending adoption of this ASU on the Company’s consolidated financial statements will be material.

 

In November 2015, FASB issued ASU 2015-17 - Income Taxes (Topic 740) Balance Sheet Classification of Deferred Taxes which simplifies the presentation of deferred income taxes. For public business entities, the amendments in this Update are effective for financial statements issued for annual periods beginning after December 15, 2016, and interim periods within those annual periods. The Company does not believe the impact of its pending adoption of this ASU on the Company’s consolidated financial statements will be material.

 

 F-12 

 

 

Medifirst Solutions, Inc.

Notes to Consolidated Financial Statements

December 31, 2016

 

In March 2016, the FASB issued Accounting Standards Update 2016-09 Compensation—Stock Compensation (Topic 718) Improvements to Employee Share-Based Payment Accounting. The Board is issuing this Update as part of its Simplification Initiative. The objective of the Simplification Initiative is to identify, evaluate, and improve areas of generally accepted accounting principles (GAAP) for which cost and complexity can be reduced while maintaining or improving the usefulness of the information provided to users of financial statements. The areas for simplification in this Update were identified through outreach for the Simplification Initiative, pre-agenda research for the Private Company Council, and the August 2014 Post-Implementation Review Report on FASB Statement No. 123(R), Share-Based Payment. The Company is currently evaluating the impact of this ASU on the consolidated financial statements.

 

In April 2016, the FASB issued Accounting Standards Update 2016-10 - Revenue from Contracts with Customers (Topic 606) Identifying Performance Obligations and Licensing. The core principle of the guidance in Topic 606 is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in
exchange for those goods or services. To achieve that core principle, an entity should apply the following steps: 1. Identify the contract(s) with a customer. 2. Identify the performance obligations in the contract. 3. Determine the transaction price. 4. Allocate the transaction price to the performance obligations in the contract. 5. Recognize revenue when (or as) the entity satisfies a performance obligation. The amendments in this Update do not change the core principle of the guidance in Topic 606. Rather, the amendments in this Update clarify the following two aspects of Topic 606: identifying performance obligations and the licensing
implementation guidance, while retaining the related principles for those areas. The Company is currently evaluating the impact of this ASU on the consolidated financial statements.

 

Note 2. PROPERTY, PLANT AND EQUIPMENT (NET)

 

Equipment is recorded at cost and consisted of the following at December 31, 2016 and December 31, 2015:

 

   2016   2015 
Computer equipment  $8,956   $8,314 
Less: accumulated depreciation   (7,085)   (6,155)
           
   $1,871   $2,159 

 

Depreciation expense for the years ended December 31, 2016 and December 31, 2015 was $930 and $1,663, respectively.

 

 F-13 

 

 

Medifirst Solutions, Inc.

Notes to Consolidated Financial Statements

December 31, 2016

 

Note 3. DUE TO RELATED PARTY

 

The Company was indebted to a related party through common management in the amount of $8,921 at December 31, 2016 and December 31, 2015, respectively. The loan bears no interest and is payable on demand. See Note 10 for additional related party transactions.

 

Note 4. LOANS PAYABLE - STOCKHOLDERS

 

During the periods ended December 31, 2016 and 2015 a stockholder of the Company advanced the Company $-0- and $39,355 respectively. The loan has a balance of $8,955 at December 31, 2016 and a balance of $20,899 as of December 31, 2015. The loan bears no interest and is payable on demand.

 

In December 2012, the Company issued a promissory note to a stockholder in the amount of $5,000 with interest at 10% per annum. Principal and interest were due and payable on June 2, 2013. In April 2014, the note was amended to provide the note holder with the option to convert the note to the Company's common stock at $0.0001 per share. Subsequently, in 2014, in a private transactions, the note holder transferred $2,500 of note principal to third parties and the new holders converted their holdings into 2,500,000 shares of the Company's common stock. During 2015, the original note holder transferred an additional $2,400 of note principal to third parties who converted their holdings into 2,400,000 shares of the Company's common stock. At December 31, 2016 and December 31, 2015, the loan had balance was $100 and $100, respectively.

 

At December 31, 2016 and December 31, 2015, the Company was indebted to a stockholder in the amount of $1,500 and $1,500, respectively. The loan has an interest rate of 26.7%. Principal and accrued interest were due and payable on January 1, 2014.

 

In February 2016, the Company issued a promissory note to a stockholder in the amount of $7,000 with interest at the rate of 6% per annum. On September 6, 2016 the note holder converted the entire principal balance and accrued interest into common stock and therefore at December 31, 2016 there is no principal balance remaining on the note.

 

 F-14 

 

 

Medifirst Solutions, Inc.

Notes to Consolidated Financial Statements

December 31, 2016

 

Note 5. CONVERTIBLE NOTES PAYABLE

 

Note Payable-BS

 

In March 2011, the Company issued $800 aggregate principal amount of 6% convertible notes due in January 2012. Interest on the notes accrue at the rate of 6% per annum and are payable when the notes mature. The notes matured prior to conversion but have not been repaid. Interest continues to accrue at the rate of 6% per annum.

 

The holder of one of the notes converted $110 of note principal into 1,100,000 shares of common stock as follows:

 

Date of Conversion   Principal Amount Converted   Conversion Rate   Shares Received 
June 2013  $70   $0.0001    700,000 
August 2013  $40   $0.0001    400,000 

 

In August 2013, in a private transaction, the same note holder transferred $330 of the remaining note principal plus $55 in accrued interest to a third party.

 

In August 2013, in a private transaction, the new note holder transferred $5 of the remaining note principal to a third party who then converted the note into 50,000 shares of common stock.

 

In September 2013, the new note holder converted $100 of note principal into 1,000,000 shares of common stock.

 

In September 2013, in a private transaction, the new note holder transferred $35 of the remaining note principal to a third party who then converted the note into 350,000 shares of common stock.

 

In November and December 2013, the new note holder converted an additional $90 of note principal into 900,000 shares of common stock as follows:

 

Date of Conversion   Principal Amount Converted   Conversion Rate   Shares Received 
November 2013  $40   $0.0001    400,000 
December 2013  $50   $0.0001    500,000 

 

 F-15 

 

 

Medifirst Solutions, Inc.

Notes to Consolidated Financial Statements

December 31, 2016

 

In March and April 2014, the new note holder converted an additional $90 of note principal into 900,000 shares of common stock as follows:

 

Date of Conversion   Principal Amount Converted   Conversion Rate   Shares Received 
March 2014  $50   $0.0001    500,000 
April 2014  $40   $0.0001    400,000 

 

Subsequent to these conversions there remains $125 in note principal outstanding at December 31, 2016.

 

Note Payable-SF

 

In July 2013, the holder of the second note converted $240 of note principal into 400,000 shares of the Company's common stock at $0.0006 per share. At December 31, 2016 and December 31 2015, the note had a remaining principal balance of $60 and $60, respectively.

 

At any time on or after the maturity date, the holders of the notes, have the option of converting any of the unpaid principal and interest into the Company's common stock. The notes plus any accrued but unpaid interest are convertible at the rate of $0.0001 per share at the time of conversion up to a maximum of 9.99% of the then issued and outstanding common stock, or 22,562,213 shares at December 31, 2016 and 3,506,665 shares at December 31, 2015.

 

Note Payable-RK

 

In May 2012, the Company issued a $25,000 6% per annum note that matured in November 2012. In December 2012 the note was amended to be a convertible note. Interest on the note accrues interest at 6% per annum and is payable when the note matures.

 

The holder of the $25,000 note had the option of converting it at any time prior to maturity. The note plus any accrued but unpaid interest were convertible at the rate of $0.001 per share at the time of conversion up to a maximum of 9.99% of the then issued and outstanding common stock.

 

The holder of the note converted $1,010 of note principal into 1,010,000 shares of common stock as follows:

 

Date of Conversion   Principal Amount Converted   Conversion Rate   Shares Received 
December 2012  $150   $0.001   $150,000 
January 2013  $660   $0.001   $660,000 
March  2013  $200   $0.001   $200,000 

 

 F-16 

 

 

Medifirst Solutions, Inc.

Notes to Consolidated Financial Statements

December 31, 2016

 

In July 2013, the Company retired $14,000 of note principal in payment for consulting services provided to the note holder.

 

In July 2013, the note holder converted $300 of note principal into 300,000 shares of the Company's common stock.

 

In July 2013, in a private transaction, the note holder transferred the remaining note principal balance of $9,690 to a third party (See Note Payable-NW below).

 

Note Payable-NW

 

After receiving the transfer of the principal balance of $9,690 in July 2013 in the private transaction noted in Note Payable-RK above, in August 2013, in a private transaction, the new note holder of the aforementioned note transferred $4,475 of principal to a stockholder of the company.

 

In October 2013, the note holder converted $400 of note principal into 400,000 shares of the Company's common stock at $0.001 per share.

 

In October 2014, the note holder converted $1,100 of note principal into 1,100,000 of the Company's common stock.The note holder has the option of converting the balance at any time with the approval of the Board of Directors. The note plus any accrued but unpaid interest are convertible at the rate of $0.001 per share at the time of conversion up to a maximum of 9.99% of the then issued and outstanding common stock, or 22,562,213 shares at December 31, 2016 and 3,506,665 shares at December 31, 2015.

 

 F-17 

 

 

Medifirst Solutions, Inc.

Notes to Consolidated Financial Statements

December 31, 2016

 

In August 2016, the note holder converted $3,000 of note principal into 3,000,000 shares of the Company's common stock. At December 31, 2016 and December 31, 2015, the remaining principal balance on this portion of the note is $715 and $3,715 respectively.

 

Note Payable-MC #1

 

In August 2013, the note holder/stockholder who received the $4,475 in principal from the aforementioned noteholder, converted $700 of note principal into 700,000 shares of the Company's common stock at $0.0