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SANUWAVE Provides an Update on International Registrations Received, Attendance at Trade Shows and ISO Certification

/EIN News/ -- 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

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