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EX-99.1 - LETTER FROM THE U.S. FOOD AND DRUG ADMINISTRATION TO THE COMPANY - SANUWAVE Health, Inc. | snwv_ex991.htm |
8-K - CURRENT REPORT - SANUWAVE Health, Inc. | snwv_8k.htm |
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Exhibit 99.2
FOR IMMEDIATE RELEASE
SANUWAVE HEALTH TO HOLD CALL TO DISCUSS FDA APPROVAL
LETTER ON TUESDAY, JANUARY 2, 2018
SUWANEE, GA, December 29, 2017 – SANUWAVE Health, Inc.
(OTCQB: SNWV) announced today
that the Company has received notice from the United States Food
and Drug Administration permitting the marketing of the
dermaPACE® system for the treatment of Diabetic Foot
Ulcers.
The Company will issue a more comprehensive press
release and host a conference call on Tuesday, January 2, 2018,
beginning at 11:00AM Eastern Time to discuss the FDA letter and the
Company’s plans.
Shareholders and other interested parties can participate in the
conference call by dialing 877-407-8033 (U.S.) or 201-689-8033
(international) or via webcast at
http://www.investorcalendar.com/event/23276.
A replay of the conference call will be available beginning two
hours after its completion through January 16, 2018, by dialing
877-481-4010 (U.S.) or 919-882-2331 (international) and entering
Conference ID 23276.
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 CE Marked
throughout Europe and has device license approval for the treatment
of the skin and subcutaneous soft tissue in Canada, Australia and
New Zealand. In the U.S., the dermaPACE system has been approved
under FDA’s de novo
petition process for the treatment of diabetic foot ulcers.
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.
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:
Millennium
Park Capital LLC
Christopher
Wynne
312-724-7845
cwynne@mparkcm.com
SANUWAVE
Health, Inc.
Kevin
Richardson II
Chairman
of the Board
978-922-2447
investorrelations@sanuwave.com