SUWANEE, GA, April 10, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- SANUWAVE Health, Inc. (OTCBB: SNWV) is
pleased to provide an update regarding the Company’s regulatory status in the worldwide sales and distribution of the company’s
medical devices. In addition to our long-standing presence in Europe, Canada, and South Korea, SANUWAVE® has been extremely
active adding major and emerging medical device markets to our portfolio.
Regulatory Status World-Wide: As previously announced, SANUWAVE has received U.S. FDA clearance for the
sales, distribution, and marketing of the company’s flagship medical device, dermaPACE® System for the treatment of Diabetic Foot
Ulcers (DFUs). While the U.S. clearance is recent, SANUWAVE has maintained a strong and visible presence in several, major
international medical device markets. These include the company’s CE Marking for the European Union for both the dermaPACE®
System for wound care and orthoPACE® System for treating orthopedic conditions, with a primary concentration in Italy, Belgium, The
Netherlands, Luxembourg, Spain, Portugal, Romania, and Bulgaria. SANUWAVE has medical device licensing in Canada for
dermaPACE® System as well as medical device licensing in Australia and New Zealand, also for dermaPACE® System. South Korea
remains a strong market for the orthoPACE® System for various orthopedic conditions. Most recently, medical device licensing
was obtained for orthoPACE® System in Taiwan. Licensing for dermaPACE® System has also recently been obtained for
Malaysia. The ability to distribute in the Philippines has recently been made available.
In addition to countries in which SANUWAVE is making its presence known, we expect to expand this list with 3 – 4 more
registrations in 2019. We are actively engaged in the registration and licensing process in Asia with Indonesia, Singapore,
and Taiwan (for dermaPACE®). Closer to home, SANUWAVE is working on licensing in Mexico, Costa Rica, Panama, and
Brazil. These processes are time-consuming, and we are anticipating successful completion to most, but not all, of these
market applications.
Commenting on this activity, Peter Stegagno, Chief Operating Officer for SANUWAVE, said, “Having concentrated primarily in
obtaining U.S. FDA clearance for dermaPACE® over the past several years, we are excited to be able to re-focus our energies in
major and emerging markets outside of the U.S while still engaged in our placement process of dermaPACE® System domestically.
We are engaged with energetic and focused partners in several, global regions to help with the introduction of SANUWAVE’s
dermaPACE® System. This product is one of the first major advances in medical devices for the treatment of wounds to have hit
the market in many years, and we are hard at work in making sure this safe and effective product is introduced to these many
markets.”
An estimated 422 million adults were living with diabetes in 2014, according to WHO’s Global report on diabetes 2016. Between
1980 and 2014, the global prevalence of diabetes nearly doubled from 4.7% to 8.5%, with most of the new cases in low- and
middle-income countries. WHO’s South-East Asian Region has seen a recent dramatic increase in diabetes. An estimated 96
million people have diabetes in the region, 90% of whom have type 2, which is preventable. Shri Parikh, President of SANUWAVE
Health, says in reaction to these statistics, “Diabetes is a global epidemic that, unfortunately, is only rising. The growth rate
has nearly doubled to 9% in the past 40 years and among the 460 million adults living with diabetes globally, ~15% will develop a
foot ulcer due to diabetes. One of our key goals here at SANUWAVE is to improve this trend, helping to restore the
functionality and mobility for patients suffering from diabetes.”
Upcoming Attendance at Major Medical Shows and Conferences: In order to make SANUWAVE’s presence known in
these markets, the company has been, and will continue to be very active in attendance at many domestic and international medical
device trade shows and conferences. In March, SANUWAVE, in cooperation with our exclusive South Korean distributor, exhibited
orthoPACE® System at KIMES in Seoul, South Korea. Upcoming shows at which SANUWAVE will have a major presence include:
· Modern Wound Care Management, Greensboro, NC (April 26 -27, 2019)
· Symposium of Advanced Care (SAWC) Spring, San Antonio, TX (May 7 – 11, 2019)
· International Symposium on the Diabetic Foot (ISDF), The Hague, The Netherlands
(May 22 – 25, 2019)
· European Wound Management Association (EWMA), Gothenburg, Sweden (June 5 – 7,
2019)
· “The National” American Podiatric Medical Association (APMA), Salt Lake City, UT
(July 11 -14, 2019)
SANUWAVE will be announcing attendance at additional shows later in 2019. According to Shri Parikh, President of SANUWAVE
Health, “We are excited to be a part of EWMA again this year showcasing our dermaPACE® System and how the only FDA cleared
technology can effectively, and immediately, help patients suffering from DFUs.”
SANUWAVE Quality System: As part of our ongoing efforts to ensure that the products and services which
SANUWAVE provides to its customers are aligned with our Mission, Vision, Quality Policy, and Regulatory Requirements, we are
pleased to announce that SANUWAVE has successfully completed the transition of our Quality Management System (QMS) from ISO
13485:2003 to the current revision ISO 13485:2016. The British Standard Institution (BSI) performed the audit of SANUWAVE’s QMS on
February 26 – 27, 2019 and upon completion of the audit has recommended the company for certification. ISO 13485:2016 is the
Medical Devices – Quality Management Systems – Requirements for regulatory purposes. Organizations that design, manufacture,
install and service medical devices seek to obtain the voluntary ISO 13485 certification to demonstrate to regulatory agencies like
the U.S. FDA, Health Canada, the European Commission, and others that they are committed to operating under a defined Quality
Management System.
Adds Peter Stegagno, “For SANUWAVE, this is another step in ensuring our operations meet, and exceed, the quality and regulatory
requirements demanded by law within our industry. The next milestone will be to submit to the Medical Device Single Audit
Program in Q3 of 2019.” The MDSAP program is a comprehensive approach to quality system auditing and includes the development
of an international coalition of countries devoted to pooling resources, technology, and service the enhance the safety and
oversight of medical devices worldwide. The benefit of this program is that SANUWAVE’s Quality System can be audited once and
be certified for as many as five different medical device markets: U.S. (FDA), Brazil (ANVISA), Canada (Health Canada),
Australia (TGA), and Japan (MHLW). Mr. Stegagno continues, “Product development, clinical research, and market introduction are the
high visibility areas of our company, but without a solid backbone in business and quality systems, these high-visibility
activities would never come to be. Quality and reliability in our products and services will always be SANUWAVE’s most
important focus.”
Kevin Richardson, CEO and Chairman of the Board for SANUWAVE, concludes, “Our activities in 2019 are going to be the defining
milestones in the continuing success of SANUWAVE. We have been extolling the company’s recent commercialization efforts in
the placement of dermaPACE® System devices in key markets in the US for the treatment of DFUs. However, I am proud of all our
employees’ determination and hard work to not only make SANUWAVE® a success in the U.S. but to also introduce our novel
applications to areas of the world that are in desperate need of proven and cost-effective medical treatment for many
disease-induced conditions.”
About SANUWAVE Health, Inc.
SANUWAVE Health, Inc. (OTCQB: SNWV) (www.sanuwave.com) is a shockwave technology company initially focused on the
development and commercialization of patented noninvasive, biological response activating systems 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® System, is U.S. FDA cleared for the treatment of Diabetic Foot Ulcers. The System is also CE Marked
throughout Europe and has 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® System, as well as
stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron®,
Evotron®, and orthoPACE® Systems in Europe, Asia, and Asia/Pacific. In addition, there are license/partnership opportunities
for SANUWAVE’s shockwave 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 INFORMATION 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
