Sanuwave Health, a medical technology company focused on regenerative medicine, has submitted the first module of Premarket Approval (PMA) application to the US Food and Drug Administration (FDA) for the company's dermaPACE device for the treatment of diabetic foot ulcers (DFU).
Sanuwave received FDA permission through the acceptance of its shell application in August 2010 to file the PMA for dermaPACE in a series of three sections or ‘modules’.
The first module included preclinical data and results of prior clinical testing. The company plans to submit the second module containing a quality manufacturing system review prior to year end.
Sanuwave expects to file the third module containing data from the recently completed pivotal Phase III clinical trial of dermaPACE to treat diabetic foot ulcers, proposed product labeling and a summary of safety and effectiveness in the first quarter of 2011.
Sanuwave president and CEO Christopher Cashman said the filing of the first PMA module brings us one step closer to the goal of offering a safe, effective and economical option for the millions of people with diabetes who suffer with chronic foot ulcers.
"A Class III PMA approval is the most stringent approval level granted in the US for a medical device, and our efforts to obtain this approval for dermaPACE are the result of our commitment to a highly credible, disciplined clinical process and to a world-class quality system throughout the company," Cashman said.
"We look forward to announcing the top-line results from our Phase III clinical trial and to filing the remaining two modules in support of an FDA approval for dermaPACE to treat diabetic foot ulcers."