SANUWAVE's Pivotal Phase III Clinical Trial Data will be the subject of upcoming presentation

By M.E.Garza

Friday, 23 September 2011 03:06

FDA calendar We still like the FDA approval odds for SANUWAVE Health's (OTCBB:SNWV) dermaPACE® technology as indicated for treatment diabetic foot ulcers. We first told you about this medical breakthrough in late August, and the more we hear about the company, the more we like their technology, especially given its current and future market potential.

Let's face it, if this were a pending approval decision for a new drug treatment aiming to address a ten billion dollar world-wide market, biotech investors woud already, easily be as excited as the three analysts who follow this company closely already are. But it's this is a medical device play and retail investors don't yet seem to understand what this regenerative technology can do or how it does it.

This is a game changer with proven clinical results which appears to be the best hope to date for the nearly 27 million people in the U.S. diagnosed with diabetes who suffer from diabetic foot ulcers. Most frequently, these open wounds cause hospitalization, and often lead to amputations. In the U.S. alone, more than 80,000 amputations are performed each year. And as you know the problem of diabetes is only getting worse.

The device is already CE marked for treatment of the skin and subcutaneous soft tissue and the company recently completed filing all the documents to the FDA from its highly positive pivotal Phase III, Investigational Device Exemption (IDE) clinical trial in the U.S. for the treatment of diabetic foot ulcers.

What is not to like here? Money in the bank, highly impressive Phase III trial results that not only measure up, but surpass any of the existing FDA approved technologies without bias, a management team that only got stronger on Wednesday, plus keen interest from competitors in the space like Kinetic Concepts (NYSE: KCI) and Shire plc (Nasdaq:SHPGY) whose multi-billion dollar market valuations have got to be threatened by this new device.

Based on Wednesday's addition of Ron Sparks, the 34-year veteran of the medical device industry whose credntials and experience in the same space run deep and impressive, it's clear that something big is brewing at SANUWAVE.

Sparks was integrally involved in the successful launch of Dermagraft®, a cell based therapy used to treat diabetic foot ulcers. Dermagraft quickly reached revenue of $140 million in 2010. And in case you missed it, Shire just acquired that firm and technology for $750 million in cash!

If you can actually stomach it, take a look at pages 18-32 of the company's corporate presentation (pdf) to see exactly what this device can do for patients whose foot ulcers would not heal- some even after months of other treatments. Many of these patients had already tried everything else without success.

SANUWAVE announced on Thursday that the Company’s dermaPACE^® device will be the subject of a presentation at Plastic Surgery 2011, the American Society of Plastic Surgeons’ National Meeting being held September 23-27 in Denver.

The presentation, titled “Changes in Wound Closure Rate Over Time in a Prospective, Randomized, Double-Blinded, Sham-Controlled, Multicenter Study of Shockwave Technology for the Treatment of Non-Healing Diabetic Foot Ulcers,” will take place as part of the Research & Technology Track I on Saturday, September 24 from 1:00 p.m. to 2:00 p.m. Mountain time. The presentation will be delivered by Lawrence Bass, M.D., Clinical Assistant Professor of Plastic Surgery, Department of Plastic Surgery, NYU School of Medicine, and the safety monitor for the recently completed pivotal Phase III, Investigational Device Exemption (IDE) clinical trial of dermaPACE for the treatment of diabetic foot ulcers.

“I am pleased that the dermaPACE clinical trial results have been accepted for presentation at the premier educational event for plastic surgeons and supporting industry in the U.S.,” stated Christopher M. Cashman, President and Chief Executive Officer of SANUWAVE. “This event marks the first time that an esteemed national and international audience of plastic surgeons will be exposed to the healing power of PACE^® technology to treat diabetic foot ulcers and to the commitment of SANUWAVE to support evidence-based medicine.”

Interestingy, Cashman was formerly with the U.S. wound space leader: Kinetic Concepts. He left a top leadership post in that company to join SANUWAVE when he saw the disruptive technology's potential. His leadership has helped guide SNWV to this point and things look like they are about to get far more interesting going forward.

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