Sanuwave said it expects to hear a response from the FDA within 120 days, and is hopeful that evidence from over 336 patients across 2 trials are enough to “quantify the safety and effectiveness of the non-invasive procedures with the DermaPace system.”
“We are confident that the compelling clinical outcomes demonstrated in this rigorous double-blinded, sham controlled clinical trial provide credible, unbiased evidence that the DermaPace system combined with current standard of care significantly and positively impacts wound healing in these clinically challenging diabetic foot ulcers compared with standard of care alone. We are pleased to submit this strong package of clinical evidence to the FDA in support of our DermaPace System to treat diabetic foot ulcers. We look forward to a positive response from the agency so we can bring this novel, promising treatment to the millions of patients who suffer from these debilitating, recalcitrant wounds,” board chair Kevin Richardson II said in prepared remarks.
The company said it chose the de novo pathway as it was the “most appropriate regulatory pathway for the DermaPace for diabetic foot ulcers because of the continued, strong evidence of safety when using the device.”
In July, Sanuwave said it met with the FDA to discuss the progress of a pre-market approval trial of its Dermapace diabetic foot ulcer treatment.
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.
In June, 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.