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SANUWAVE Health Receives Approval from The National Health Surveillance Agency (ANVISA) to Market dermaPACE to Treat Chronic Wounds in Brazil
Plans for Immediate Commercial Launch via Established Joint Venture SUWANEE, GA, Aug. 24, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- SANUWAVE Health, Inc.
About this update from Sanuwave Health, Inc.
[{"type":"text","content":"\n Plans for Immediate Commercial Launch via Established Joint Venture SUWANEE, GA, Aug. 24, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- SANUWAVE Health, Inc. (OTCQB: SNWV), focused on the development and commercialization of patented PACE® technology platform for the repair and regeneration of skin, musculoskeletal tissue and vascular structures, announced today that the Company has received approval from the Brazilian Agência Nacional de Vigilância Sanitária (“National Health Surveillance Agency” or “ANVISA”) to market its proprietary dermaPACE® System to treat diabetic foot ulcers (DFUs) in Brazil. In November 2019, SANUWAVE Health entered into a joint venture agreement with the IDIC Group of Sao Paulo, Brazil for the exclusive rights to market dermaPACE as a treatment for chronic wounds in South America in exchange for joint profit sharing. The joint venture operates as Diversa, SA and will be responsible for marketing the dermaPACE in Brazil. SANUWAVE Health will receive the remaining US$100,000 of the partnership fee upon ANVISA approval of dermaPACE and the Company expects to record this as revenue in the third quarter of 2020. “Receipt of ANVISA approval to market dermaPACE in Brazil is a key milestone of our international strategy to bring our shockwave technology to benefit the millions of patients throughout South America suffering with chronic wounds,” said Kevin A. Richardson, II, Chairman and Chief Executive Officer of SANUWAVE Health, Inc. “As the largest country in South America, we are particularly pleased to launch our dermaPACE initiatives in wound care in Brazil with our partner, Diversa. Importantly, the team at Diversa shares our passion and commitment to bring our non-invasive, innovative technologies to patients in order to initiate the healing cascade, accelerate wound healing and provide a novel therapeutic modality for these difficult to treat chronic wounds.” Diversa expects to place ten dermaPACE systems in Brazil by the end of 2020, with a plan to initially deploy the systems in the private pay arena, which represents 45 million people. Diversa will conduct pharmacoeconomic studies to demonstrate both the clinical efficacy of the dermaPACE system to treat DFUs and to establish the economic value provided by reduced rehospitalizations and limb amputations, both of which carry a substantial economic ...