SANUWAVE Health 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
Image: SANUWAVE signs JV agreement for dermaPACE System. Photo: Courtesy of Free-Photos from Pixabay.
SANUWAVE Health 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.”
Source: Company Press Release