Dermapace System receives FDA Approval

This order by FDA is the culmination of intensive clinical studies by SANUWAVE and diligent work by both SANUWAVE employees and our regulatory partners, Musculoskeletal Clinical Regulatory Advisers (MCRA) in successfully submitting documentation and interacting with FDA during the clearance process.

The dermaPACE system was evaluated using two studies under an FDA approved IDE. The studies were designed as prospective, randomised, double-blind, parallel-group, sham-controlled, multi-center 24-week studies at 39 centers.

A total of 336 subjects were enrolled and treated with either active dermaPACE plus conventional therapy or sham dermaPACE plus conventional therapy (a.k.a. standard of care). Conventional therapy included, but was not limited to, debridement, saline-moistened gauze, and pressure reducing footwear.

The objective of the studies was to compare the safety and efficacy of the dermaPACE System to sham-control application. The prospectively defined primary efficacy endpoint for the dermaPACE System studies was the incidence of complete wound closure at 12 weeks post-initial application of the dermaPACE system (active or sham).

Complete wound closure was defined as complete skin re-epithelialisation without drainage or dressing requirements, confirmed over two consecutive visits within 12-weeks.

If the wound was considered closed for the first time at the 12-week visit, then the next visit was used to confirm closure. Investigators continued to follow subjects and evaluate wound closure through 24 weeks.

The patients who were treated with the dermaPACE System showed an increase in wound healing at 24 weeks with a 44 percent wound closure rate. Those patients treated with the sham shock wave therapy showed a 30 percent wound closure rate during the same time period.

Unlike other advanced DFU treatment modalities, the dermaPACE protocol did not allow any form of closure by secondary intent (e.g. sutures). The wound closures in the dermaPACE arm were robust with less than 10% rates of recurrence.

In addition, the rate of wound area reduction in the dermaPACE cohort was significant compared to that of the Sham arm beginning at six weeks and continuing on through the remainder of the 24 treatment and follow-up phases.

The dermaPACE System offers a novel treatment modality for DFUs, delivering shock wave energy in a non-invasive manner. Treatment consists of 4 - 8 short, non-invasive applications over a 2 to 10 week period. Monitoring and standard of care is required thereafter.

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.

There are many different modalities, ranging from simple dressings, to biologics, matrices, pharmaceuticals, and devices. Existing therapies require either:

continuous application of a pharmacologic agent;

• repeated application of a skin equivalent (up to 8 times over a 12 week period); 
• repeated implantation of a dermal substitute (weekly, up to 8 applications and after a 6 week run-in); or
• the attachment of a vacuum assisted device to the wound area for prolonged periods of time.

SANUWAVE’s Chairman of the Board and CEO, Kevin A. Richardson II said, “This regulatory clearance marks the biggest milestone yet for SANUWAVE, and the Company is poised to commence the commercial rollout in the United States shortly.”

The dermaPACE System is currently available in the European Union, South Korea, Canada, Australia, and New Zealand and is under regulatory review in Taiwan and Indonesia. SANUWAVE has just entered into a major distribution agreement in Brazil, where device approval is anticipated later in 2018.

According to American Diabetes Association statistics from 2015, 30.3 million Americans, or 9.4% of the population, had diabetes. And the annual cost of diabetes, was $245 billion in 2012. This figure comprises $176 billion in excess healthcare expenditures and $69 billion in reduced workforce productivity.

Approximately 15% of diabetic patients will develop lower extremity ulcers and 14 – 24% of DFUs will eventually undergo amputation. “The market opportunity for the dermaPACE System in the U.S. is significant.

As U.S. diabetes rates continue to rise and growing numbers of diabetics develop DFUs, we are confident dermaPACE will positively redefine the treatment of diabetic foot ulcers in the U.S.,” said Mr. Richardson.

In addition to causing suffering and morbidity, foot lesions in diabetic patients have substantial economic consequences. Diabetic foot complications result in huge costs for both society and the individual patients. The economic burden of DFUs and the complications arising from them are enormous.

The cost to treat a DFU over a 2-year period was $27,987 in 1995 and, based on the medical component of the US Consumer Price Index, rose to $46,841 in 2009.

These high costs have been linked to frequent outpatient appointments, in-patient days, laboratory tests, drugs/medications, hospital stays, and secondary complications of osteomyelitis and amputation. Direct costs for a lower-extremity amputation range from $22,700 to $51,300.

Mr. Richardson continues, “Due to its non-invasive nature, the dermaPACE System does not prevent the use of other treatment options (i.e., dermal grafts, wound matrices, biologic gels, and surgery) in conjunction with the dermaPACE System or in later stages of wound care.

In fact, wound care professionals using the device in Europe, Canada, and Australia use the dermaPACE System in the progression of their treatment regimen for wound management with healing as the final intent.

Not all wounds, nor all patients are the same; therefore, each wound is treated on an individual basis based on the treating physician’s knowledge and the treatment options available. The dermaPACE system offers the ability to manage the DFUs chronicity and is a powerful tool in the clinician’s arsenal to achieve wound closure.”