The 130-patient study completed enrollment in November last year and each patient has completed a full-24-week follow-up, the Alpharetta, Ga.-based company said.
Sanuwave said it is completing an audit of the clinical documentation of each study site, which will be followed by a final review and locking of the study database. After the lock the data can be analyzed, and checked to see if the trial met primary endpoints, the company said.
“We are very pleased to have reached this major milestone in the supplemental clinical trial of Dermapace to treat diabetic foot ulcers. The positive feedback from the FDA at our meeting to discuss the Dermapace clinical study gives us the confidence to stop further enrollment in the study and move towards final data review and PMA submission to the FDA,” chairman Kevin Richardson II said in a press release.
Last month, Sanuwave said the oversight board for the clinical trial of its DermaPace wanted more data after determining that the trial was unlikely to meet its primary endpoint.
An interim analysis by the trial’s independent Data Monitoring Committee found that if the trend holds the endpoint “will likely not be met at the next predefined analysis point of 170 patients,” the company said.
After meeting with the FDA, Sanuwave said the federal watchdog was on-board with a new “plan to analyze additional secondary objectives,” and that “there is precedence of FDA approving devices via PMA based on the totality of the data,” according to a Sanuwave conference call.
“What this means is that, even failing to achieve a primary objective, if other data, including secondary endpoints, shows a clinically meaningful outcome, the FDA can still make an “approvable” decision,” veep of operations and regulatory affairs Pete Stegagno said in the conference call.
“With the recent positive feedback from the FDA, we have now begun discussions with various strategic parties about partnering on the commercialization of the product. The Dermapace, with its novel biologic regenerative effects, holds promise to heal diabetic foot ulcers and increase limb preservation, thus improving quality of life for these patients and their families and significantly easing the economic burden on an overwhelmed healthcare system that cares for these patients. We are moving quickly toward our ultimate goal of obtaining FDA approval for Dermapace and commercializing the technology in the U.S. where millions of people suffer from costly and debilitating diabetic foot ulcers,” Richardson said in prepared remarks.
Back in 2011 the FDA sent Sanuwave a “major deficiency” letter and asked the company to run another trial for DermaPace, an extra-corporeal shock wave technology. The company launched the 2nd trial more than 3 years ago.