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8-K - CURRENT REPORT - SANUWAVE Health, Inc. | snwv_8k.htm |
Exhibit 99.1
FOR
IMMEDIATE RELEASE
SANUWAVE ANNOUNCES STRATEGIC PARTNERSHIP WITH PREMIER
SHOCKWAVE;
DERMAPACE ENTERS VA, INDIAN HEALTH SERVICES, AND MILITARY BASE
MARKET;
REVENUES EXPECTED TO OCCUR IMMEDIATELY
SUWANEE, GA, FEBRUARY 13, 2018 - SANUWAVE Health, Inc. (OTCQB:
SNWV) is pleased to announce a partnership agreement has
been reached with Premier Shockwave Wound Care, Inc. and Premier
Shockwave, Inc. (collectively “Premier”). The agreement
will cover the Veteran’s Administration (VA), Indian Health
Service (IHS) and Tribally operated healthcare services, and US
Military facilities/bases (MTFs). Per the agreement, Premier will
purchase an undisclosed number of dermaPACE units to service these
end markets and SANUWAVE will receive revenue from the sale of the
equipment and a per procedure fee from Premier. The contract
includes a minimum purchase of 100 units over 3 years and is
expected to provide a high margin, recurring revenue as Premier
rolls out its services. This agreement allows SANUWAVE to enter the
market immediately thereby accelerating revenue growth by
years.
The
targeted market for this strategic partnership is a large market.
The population of the VA and IHS markets combined is roughly 24
million people with 4 million having complications from diabetes.
These constituents are served through health care systems which are
made up of: 170 VA hospitals, 1,063 outpatient sites, 45 IHS/Tribal
hospitals, 343 health centers, 111 health stations, and 163 village
clinics in Alaska for a total of 2,295 locations. Premier plans to
roll the device placements out to the top locations in 2018, with
an accelerated ramp up through 2020.
“We
are extremely pleased to announce our partnership with Premier.
They bring to the table an understanding of both shock wave
technology and government contracting. This agreement allows us to
enter an underserved market immediately and begin rapidly
introducing dermaPACE System into the US market as a whole,”
said Kevin A. Richardson II, Chief Executive Officer of SANUWAVE.
“Our growth plan is to develop channel partners, like this
one, put in place proper financing to fund product placement, and
to work with Key Opinion Leaders to have the clinical support
needed to further penetrate all US wound markets while having a
strong reimbursement platform in place. This is one more step in
executing our plan for success at SANUWAVE. The goal is to increase market segment
by continuing to make healthcare professionals and clinicians aware
of this technology as an option in their treatment
arsenal.”
COL
(ret) Patrick Sesto, DPM, Medical Advisor to SANUWAVE said,
“dermaPACE will revolutionize the treatment of diabetic foot
ulcers. This is the first time a treatment modality has
dramatically reduced the time to wound closure and decreased costs to the payer. The
dermaPACE treatment application is straight-forward enough that the
physician can have their wound care nurse or technician provide the
treatment, freeing the physician to see other patients. The
promotion of circulation on a micro-vascular level coupled with the
releasing of essential growth factors lays down a foundation for
the wound to heal. In my 33-years of practice both civilian and
military, I have never seen such remarkable progress with these
types of ulcers. It will decrease dramatically the morbidity that
leads to amputation and thereby afford the patient a higher quality
of life.”
“We are proud to be able to serve the Indian Health Services
and the Veterans Administration and ensure that both Native
American Indians and Alaska Natives, as well as our country’s
Veterans receive the latest and most advanced technology available
to treat and cure diabetic foot ulcers,” said A. Michael
Stolarski, President and CEO of Premier Shockwave, Inc., the
Manager Partner. “The IHS and VA patient demographics are
quite similar in that about 16-17% of this population suffers from
diabetes mellitus (DM), and 3-4% of those with DM develop one or
more diabetic foot ulcers (DFUs) each year. In addition, the
amputation rate of these individuals is typically higher than the
national average.”
Jim Clare, COO of Premier Shockwave added, “Premier Shockwave
is looking forward to working with the IHS Special Diabetes Program
for Indians (SDPI) and the VA’s Prevention of Amputations in
Veterans Everywhere (PAVE) program.” Mr. Clare added,
“As the FDA study shows, the dermaPACE will materially reduce
the incidence of amputation and speed wound healing in the majority
of patients receiving treatment. The treatment can be conveniently
performed when the patient is receiving weekly wound dressing
changes. We believe the dermaPACE will prove to be significantly
more cost effective than other treatments for chronic diabetic foot
ulcers.”
David Anderson, Executive Vice President of Premier Shockwave Wound
Care, Inc. adds, “Treating chronic diabetic foot ulcers
usually requires a multi-pronged attack. The use of the dermaPACE
System will enable the IHS to treat more patients in-house,
decrease the number of amputations, and increase quality of life
for those DFU patients. The late John Ferris, MD, and Chief Medical
Officer for the Oklahoma City area Indian Health Service once told
me, ‘we (IHS) are paying between $17,000 to $22,000 per
patient to outsource DFUs.’ The dermaPACE is a game changer
and should save the IHS many millions of
dollars.”
Mr. Stolarski added, “We have filed paperwork with the VA to
get on the Government Services Administration (GSA) Schedule, which
should be completed within the next 4-6 months; however, in the
meantime, we are confident in our ability to place devices and
receive payment for dermaPACE services at IHS, VA and
MTFs.
About SANUWAVE Health, Inc.
SANUWAVE
Health, Inc. (OTCQB:SNWV) (www.sanuwave.com)
is a shock wave technology company initially focused on the
development and commercialization of patented noninvasive,
biological response activating devices for the repair and
regeneration of skin, musculoskeletal tissue and vascular
structures. SANUWAVE’s portfolio of regenerative medicine
products and product candidates activate biologic signaling and
angiogenic responses, producing new vascularization and
microcirculatory improvement, which helps restore the body’s
normal healing processes and regeneration. SANUWAVE applies its
patented PACE technology in wound healing, orthopedic/spine,
plastic/cosmetic and cardiac conditions. Its lead product candidate
for the global wound care market, dermaPACE®, is US FDA
cleared for the treatment of Diabetic Foot Ulcers. The device is
also CE Marked throughout Europe and has device license approval
for the treatment of the skin and subcutaneous soft tissue in
Canada, South Korea, Australia and New Zealand. SANUWAVE
researches, designs, manufactures, markets and services its
products worldwide, and believes it has demonstrated that its
technology is safe and effective in stimulating healing in chronic
conditions of the foot (plantar fasciitis) and the elbow (lateral
epicondylitis) through its U.S. Class III PMA approved
OssaTron® device, as well
as stimulating bone and chronic tendonitis regeneration in the
musculoskeletal environment through the utilization of its
OssaTron, Evotron® and
orthoPACE® devices in
Europe, Asia and Asia/Pacific. In addition, there are
license/partnership opportunities for SANUWAVE’s shock wave
technology for non-medical uses, including energy, water, food and
industrial markets.
About Premier Shockwave, Inc. and Premier Shockwave Wound Care,
Inc.
Premier Shockwave, Inc. is the leading shockwave company for
podiatric and orthopedic applications in the United States and
currently serves over 30 VA Hospitals and Military Treatment
Facilities in the continental United States and Alaska. Premier
Shockwave, Inc. will manage the dermaPACE business for Premier
Shockwave Wound Care, Inc.
Mr. Stolarski founded Premier Shockwave, Inc. in October 2008 and
has since served as its President and CEO. Mr. Stolarski is also
the President & CEO of Premier Shockwave Wound Care, Inc. He
has 25-years of healthcare experience with the last 20-years in the
shockwave industry in various C-Level positions. Mr. Stolarski also
serves on the Board of Directors of SANUWAVE Health,
Inc.
Jim Clare has been the COO of Premier Shockwave, Inc. since its
inception; he was previously the National Sales Director of
SANUWAVE’s OssaTron division beginning in 2005. Jim has added
great depth to our mission to serve the military, having been a
member of the armed forces from 1980 – 1986.
David Anderson founded and was the COO of Emerging Medical
Technologies, LLC, a shockwave company specializing in the
treatment of patients with plantar fasciitis in the Oklahoma Indian
Health Services market.
Messrs. Anderson and Stolarski are the founders and owners of
Premier Shockwave Wound Care, Inc.
Forward-Looking Statements
This press release may contain “forward-looking
statements” within the meaning of the Private Securities
Litigation Reform Act of 1995, such as statements relating to
financial results and plans for future business development
activities, and are thus prospective. Forward-looking statements
include all statements that are not statements of historical fact
regarding intent, belief or current expectations of the Company,
its directors or its officers. Investors are cautioned that any
such forward-looking statements are not guarantees of future
performance and involve risks and uncertainties, many of which are
beyond the Company’s ability to control. Actual results may
differ materially from those projected in the forward-looking
statements. Among the key risks, assumptions and factors that may
affect operating results, performance and financial condition are
risks associated with the regulatory approval and marketing of the
Company’s product candidates and products, unproven
pre-clinical and clinical development activities, regulatory
oversight, the Company’s ability to manage its capital
resource issues, competition, and the other factors discussed in
detail in the Company’s periodic filings with the Securities
and Exchange Commission. The Company undertakes no obligation to
update any forward-looking statement.
For additional information about the Company, visit
www.sanuwave.com.
Contact:
Christopher
Wynne
312-724-7845
cwynne@mparkcm.com
SANUWAVE
Health, Inc.
Kevin
Richardson II
Chairman
of the Board
978-922-2447
investorrelations@sanuwave.com