SANUWAVE Health Announces Regulatory Clearance for dermaPACE in Mexico by the Federal Commission for Protection against Sanitary Risks (COFEPRIS)

Forms Joint Venture with MEDSTENT, S.A. to Market dermaPACE in Mexico to Treat a Variety of Chronic Wounds

SUWANEE, GA, Oct. 14, 2020 (GLOBE NEWSWIRE) -- via NewMediaWire -- SANUWAVE Health, Inc. (OTCQB: SNWV), focused on the development and commercialization of a robust and innovative advanced wound care product portfolio for the repair and regeneration of skin and vascular structures, announced today that the Company has received regulatory clearance from the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) to market its proprietary dermaPACE System to treat a variety of chronic wounds in Mexico, including diabetic foot ulcers (DFUs), venous and arterial ulcers, and post-traumatic and post-surgical wounds. 

In addition, SANUWAVE announces the formation of a joint venture with MEDSTENT, S.A. de C.V. for the exclusive rights to market and distribute the dermaPACE System as a treatment for chronic and acute wounds in Mexico in exchange for joint profit sharing.

"COFEPRIS clearance to market dermaPACE in Mexico is a key achievement in our global expansion strategy and represents our second distribution agreement in the Latin America region.  We look forward to working with MEDSTENT to bring our non-invasive shockwave technology to the millions of patients across Mexico who suffer with unhealing, chronic wounds. The MEDSTENT team has considerable experience and expertise in introducing and marketing innovative medical products in Mexico where more than 50% of the population has access to public healthcare. We believe that MEDSTENT’s knowledge of the Mexican market, its vascular sales teams and distribution centers will be very beneficial for successful market entry, especially to the governmental hospitals, which are the dominant healthcare provider in Mexico in general and specifically when it comes to the treatment of advanced wounds," stated Kevin A. Richardson, II, Chairman and Chief Executive Officer of SANUWAVE Health. 

“Incorporating SANUWAVE’s dermaPACE System into MEDSTENT medical products portfolio allows us to leverage our experience in the vascular surgery markets in Mexico.  We are creating a wound care specialty within our vascular expertise and this joint venture with SANUWAVE provides us with a broad offering for vascular surgeons, who also treat these recalcitrant, chronic wounds,” noted Daniel Capuano, Chief Executive Officer of MEDSTENT.  “We look forward to partnering with SANUWAVE and expect a successful launch of this end-to-end wound care offering in Mexico, where limited effective treatment options can often lead to lower limb amputations.”