Sanuwave Health Inc, Alpharetta, Ga, an emerging medical technology company focused on the development and commercialization of noninvasive, biological response-activating devices in regenerative medicine, says results from its pivotal study show dermaPACE® may efficiently and effectively treat diabetic foot ulcers.
The device has been submitted for FDA approval.
“The scientific mechanism activated by dermaPACE technology has a direct and lasting impact on wounds by immediately increasing blood perfusion and stimulating the body’s own angiogenic and positive inflammatory wound healing responses,” said Robert Galiano, MD, a principal investigator in the study." The dermaPACE clinical trial results provide the necessary clinical evidence to validate the benefits of such a mechanism when combined with proper wound care.”
Pulsed Acoustic Cellular Expression (PACE) delivers high-energy acoustic pressure waves in the shock wave spectrum to produce compressive and tensile stresses on cells and tissue structures. PACE treatment triggers the initiation of an accelerated inflammatory response that speeds wounds into proliferation phases of healing and subsequently returns a chronic condition to an acute condition to help reinitiate the body’s own healing response, the company says.
[Source: Sanuwave Health]