SANUWAVE Health, Inc. announced that it has submitted to the U.S. Food and Drug Administration (FDA) a de novo petition requesting Agency review and classification of the dermaPACE System for treating Diabetic Foot Ulcers (DFU) as a Class II device. Through the course of two trials, 336 patients were randomized in double-blind, parallel group, sham controlled, multicenter, 24-week pivotal clinical trials that were designed to quantify the safety and effectiveness of the noninvasive procedures with the dermaPACE System (dermaPACE®).

Working with Musculoskeletal Clinical Research Associates (MCRA), SANUWAVE submitted to FDA a de novo petition. Due to the extremely strong safety profile of the dermaPACE System and the efficacy of the data showing statistical significance for wound closure for dermaPACE subjects at 20 weeks and out to 24 weeks, SANUWAVE believes that dermaPACE should appropriately be considered for classification into Class II.  SANUWAVE chose the de novo pathway because we believe it is the most appropriate regulatory pathway for the dermaPACE for diabetic foot ulcers because of the continued, strong evidence of safety when using the device. 

Should FDA determine that guidance and evaluation criteria are met, FDA can grant the de novo, in which case the dermaPACE will be classified as Class II and may be marketed immediately.  SANUWAVE expects to hear feedback from the FDA within 120 days.

Commenting on today’s announcement, Kevin A. Richardson II, SANUWAVE’s Chairman of the Board, said, “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,” concluded Mr. Richardson.

Clinical Results

A total of 336 patients entered the dermaPACE study at 37 sites in the U.S, Canada, and Europe.  The patients in the study were followed for a total of 24 weeks by a team of investigators with specialties in vascular surgery, podiatry, plastic surgery etc.  The study’s primary endpoint, wound closure, was defined as “successful” if the skin was 100% re-epithelialized at 12 weeks without drainage or dressing requirements confirmed at two consecutive study visits.  A summary of the key study findings were as follows:

• Patients treated with dermaPACE showed a strong positive trend in the primary endpoint of 100% wound closure. Treatment with dermaPACE increased the proportion of diabetic foot ulcers that closed within 12 weeks. 

• We also conducted a series of secondary analyses of the primary endpoint of complete wound closure at 12 weeks and at each subsequent study visit out to 24 weeks.  At the 24 week endpoint, the rate of wound closure in the dermaPACE cohort was 37.8% compared to 26.2% for the control group, resulting in a p-value of 0.023

• Within 6 weeks following the initial dermaPACE treatment, and consistently throughout the 24-week period, dermaPACE significantly reduced the size of the target ulcer compared with subjects randomized to receive sham-control (p<0.05).

• The data indicates that in addition to the proportion of subjects reaching wound closure being higher in the dermaPACE group, subjects are also reaching wound closure at a faster rate when dermaPACE is applied.  

• Importantly, there were no meaningful statistical differences in the adverse event rates between the dermaPACE treated patients and the sham-control group. There were no issues regarding the tolerability of the treatment which suggests that a second course of treatment, if needed, is a clinically viable option.

Benefits of dermaPACE

While dermaPACE is intended to be a system used as part of the continuum of care in the patient population as the standard of care, the use of pulsed acoustic pressure shock waves for treatment is novel compared to other treatment options.

This non-invasive treatment provides lower patient adverse events compared with other procedures like amputation or skin grafting, and as a result, the dermaPACE system provides a safe and effective option for treating patients with diabetic foot ulcers. For more difficult to heal wounds, dermaPACE offers the ability to manage chronicity and to reduce wound size.

For additional information about the Company, visit www.sanuwave.com.