SANUWAVE Signs Agreement for dermaPACE® System Joint Venture in Brazil

Company Receives Cash Payments for Territorial Rights

SUWANEE, GA, Nov. 07, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to announce that it has signed a term sheet for a Brazilian joint venture for the dermaPACE® System with IDIC Group of São Paulo, Brazil. 

The companies will share profits equally in the wound care arena with the dermaPACE® System as the center piece of the Brazilian joint venture’s product portfolio.  SANUWAVE will receive $600,000 from IDIC Group for the exclusive territorial rights for the dermaPACE® System in Brazil.  The transaction is scheduled to close in December of 2019.

SANUWAVE has already received the initial installment of cash payments related to the partnership fee and expects to recognize $500,000 in revenue in the fourth quarter of this year from the transaction.  The joint venture anticipates receiving regulatory approval for the dermaPACE® System from ANVISA (Agência Nacional de Vigilância Sanitaría), the National Health Surveillance Agency of Brazil, in the third quarter of 2020.  SANUWAVE’s recent announcement regarding the successful completion of the Medical Device Single Audit Program (MDSAP) will facilitate a faster ANVISA approval.  Shipment of the first dermaPACE® Systems and training will occur in the fourth quarter of 2019, to be followed by local KOL case work in early 2020. 

IDIC Group is a group of primarily senior pharmaceutical and medical device industry executives and investors from Brazil, the United Kingdom and the Czech Republic that was formed to create and finance the local partner operation for the SANUWAVE Brazil joint venture.  The group includes Morningside Holdings Pharmaceuticals Ltd., the investment division of the Morningside group of companies in the U.K., and Pharmexon Consulting, a specialty regulatory affairs company based in the European Union.

IDIC will be led by two veteran global and Brazilian medical and wound care product executives, Daniel Feliciano Ferreira, who will serve as the CEO of the joint venture company in Brazil, and his colleague, Maurício Grimoni, who will be the Commercial Director.

Mr. Ferreira possesses 20 years of experience in the pharmaceutical industry and most recently served as the Portfolio and Alliances Director Latin America for Abbott, where he was responsible for product introductions and alliance management in Latin America. He is also a Managing Director of Synova Health, a leading CRO in Latin America.  Mr. Ferreira also previously served as Business Development Director Latin America at Merck Serono and as Business Development and International Division Director at the EMS Group of Brazil.

Mr. Grimoni has over 27 years of experience in leading the Latin America or Brazil operations for pharmaceutical and medical device companies such as, Bristol Myers Squibb (Convatec), Merck Serono, Novartis, Janssen and Becton Dickinson.   Mr. Grimoni pioneered the wound care market in the region and was Convatec's General Manager for Brazil at the beginning of the implementation of the concept of wet healing.  For the past eight years, he has led projects in Latin America for major pharmaceutical and medical device companies in his own specialized consulting firm, Latina Health Solutions.

According to International Diabetes Federation data, Brazil has 12.5 million adults diagnosed with diabetes.  This represents the fourth largest in country population in the world and approximately 9% of the adult population.  Reliable local studies indicate that 7% of diabetic adults develop diabetic foot ulcers, so the current DFU patient population in Brazil stands at approximately 900,000.  Currently there are no effective curative treatments for DFUs being utilized in the country, which has led to high rates of lower limb amputations. 

Kevin A. Richardson II, Chairman of the Board and CEO of SANUWAVE, stated, “SANUWAVE is extremely pleased to form a joint venture with a tremendous partner in IDIC Group. IDIC consists of a group of senior level Brazilian medical and wound care professionals that are experienced in building medical product markets in Brazil.  This partnership is another significant step toward achieving our goal of having a dermaPACE® System anywhere and everywhere a diabetic foot ulcer (DFU) is treated, while importantly enabling SANUWAVE to rapidly enter a top five global wound care market, while at the same time maintaining our focus on driving value creation in the U.S. advanced wound care market.  The wound care market in Brazil is a very large opportunity, as evidenced by the significant prevalence of diabetes and the extremely high rate of lower limb amputations, so we are very excited to partner with IDIC Group to prevent amputations in Brazil with the dermaPACE® System.”

About SANUWAVE Health, Inc.

SANUWAVE Health, Inc. (OTCQB:SNWV) () is a shockwave 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 shockwave technology for non-medical uses, including energy, water, food and industrial markets.

About IDIC Group

IDIC Group is a group of primarily senior pharmaceutical and medical device industry executives and investors from Brazil, the United Kingdom and the Czech Republic that was formed by Morningside Holdings Pharmaceuticals Ltd., the investment division of the Morningside group of companies in the U.K., to create and finance the local partner operation for the SANUWAVE Brazil joint venture.

In addition to Morningside Holdings, Daniel Feliciano Ferreira, and Maurício Grimoni, the group also consists of Parvinder Punia and Laura Nae senior executives with pharmaceutical background in regulatory affairs and business development, who are shareholders of Pharmexon Consulting, a specialty regulatory affairs boutique; Dr. Fernando Delmonte, an orthopedist specialist with a practice in Salvador, Bahia, Brazil; and Paulo Cesena, who is currently the CEO of TV Globo Bahia in Brazil.  Mr. Cesena possesses 20 plus years of experience in managing high growth large companies and has led international transactions, previously serving as Chairman of the Board of joint ventures involving local and international partners. 

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.

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