ALPHARETTA, Ga.–(BUSINESS WIRE)–SANUWAVE Health, Inc., (OTC BB: SNWV) (www.sanuwave.com), an emerging medical technology company focused on the development and commercialization of non-invasive, biological response activating devices in the regenerative medicine area, reports its achievements and financial results for the three and nine months ended September 30, 2009.
Christopher M. Cashman, President and CEO of SANUWAVE said, “We are pleased to update our shareholders on a regular basis, and are reporting on our achievements for the third quarter. Included in this quarterly review are our business achievements and financial results. It is important to note that our efforts are on the continued research and development of dermaPACE™, our lead product in our technology platform.”
“Our initial focus is on the $10 billion global wound care opportunity for dermaPACE™, including the diabetic foot ulcer market, for which we are in the midst of an Investigational Device Exemption (“IDE”) wound care study. SANUWAVE is also pursuing with the FDA alternative regulatory pathways to Class III PMA routes which could provide for the clearance of a PACE™ device to be marketed for applicable orthopedic and plastic/cosmetic conditions that would benefit from improved circulation into the localized site. We expect to finalize next steps for a submission package by the end of 2009.”
He continued, “We have a broad product development pipeline that includes degenerative disease and non-healing injuries in the orthopedics, spine/neuro, plastic/aesthetics and cardiac markets. Our preclinical studies in each of these areas demonstrate the potential use of our technology for multiple platforms.”