SANUWAVE's dermaPACE Clinical Trial Results Highlighted in CME Presentation at Desert Foot Congress
Dr. Robert Frykberg Presents dermaPACE Phase III Clinical Trial Results to Federal Service Healthcare Providers
ALPHARETTA, Ga.--(BUSINESS WIRE)--Nov 17, 2011 - SANUWAVE Health, Inc. (OTCBB: SNWV), an emerging medical technology company focused on the development and commercialization of noninvasive, biological response activating devices in regenerative medicine, today announced that the highly positive data from its Phase III clinical trial of dermaPACE® to treat diabetic foot ulcers was the subject of a Continuing Medical Education (CME) accredited presentation at Desert Foot 2011: The 8th Annual High Risk Diabetic Foot Conference, honoring Federal Service Healthcare Providers, which took place at the Arizona Grand Resort in Phoenix.
Robert Frykberg, DPM, MPH, Chairman of Desert Foot 2011, a surgeon at the Carl T. Hayden Veterans Affairs (VA) Medical Center in Phoenix, and a principal investigator in the dermaPACE clinical trial, delivered the CME-accredited presentation, titled “A Shocking RCT: Getting Wounds to Heal,” on November 16 at 4:30 p.m. local time. Dr. Frykberg represents one of three VA facilities that enrolled patients in the dermaPACE clinical trial. The presentation highlighted the dermaPACE pivotal Phase III clinical trial results through 24 weeks, including:
- dermaPACE subjects reached statistical significance in 100% wound closure compared with Sham-control beginning at 20 weeks and continuing through 24 weeks (p<0.05).
- Within 6 weeks following the initial dermaPACE procedure, and consistently throughout the 24-week analysis period, dermaPACE significantly reduced the size of the target ulcer compared with subjects randomized to receive Sham-control (p<0.05).
- dermaPACE was associated with an extremely low, 4.5% rate of ulcer recurrence at 24 weeks.
- dermaPACE was shown to have an excellent safety profile, including a reduction in infection, and was well tolerated by subjects.
Dr. Frykberg said, “The results of this rigorously designed and executed pivotal Phase III clinical trial strongly suggest dermaPACE has an effect in the stabilization, size reduction and with time complete closure of diabetic foot ulcers. Pending FDA approval, the availability and utilization of dermaPACE has the potential to positively impact the way we treat diabetic foot ulcers, and may bring us closer to our goal of improving wound outcomes through primarily cost-effective, clinically efficient pathways.”
Christopher M. Cashman, President and CEO of SANUWAVE, said, “This CME-accredited presentation to a largely federal healthcare provider audience appropriately highlights the clinical relevance of the dermaPACE study results to this clinical community. Dr. Frykberg is a leading authority in the diabetic foot ulcer field, and as a principal investigator in the dermaPACE clinical trial, he was able to speak with first-hand experience about the study results and also share his personal insights into the overall value proposition that dermaPACE may offer.”
About Desert Foot 2011
The Desert Foot Conference is a multi-specialty high-risk diabetic foot conference designed to enable participants to improve clinical care for patients with diabetes, and to enhance communication among physicians and other foot care professionals. It serves as a resource to obtain up-to-date information on theory and management of diabetic foot disorders and as a venue to highlight research in the diabetic foot.
PACE, defined as Pulsed Acoustic Cellular Expression, delivers high-energy acoustic pressure waves in the shock wave spectrum to produce compressive and tensile stresses on cells and tissue structures to promote angiogenic and positive inflammatory responses, and quickly initiate the healing cascade. This results in revascularization and microcirculatory improvement, including an increase in arterial vessel diameter (arteriogenesis), the production of angiogenic growth factors, enhanced new blood vessel formation (angiogenesis), and the subsequent regeneration of tissue such as skin, musculoskeletal and vascular structures. PACE treatment triggers the initiation of an accelerated inflammatory response that speeds wounds into the proliferation phase of healing and subsequently returns a chronic condition to an acute condition, to help reinitiate the body's own healing response.
About SANUWAVE Health, Inc.
SANUWAVE Health, Inc. (www.sanuwave.com) is an emerging regenerative medicine company focused on the development and commercialization of noninvasive, biological response activating devices for the repair and regeneration of tissue, musculoskeletal and vascular structures. SANUWAVE's portfolio of products and product candidates activate biologic signaling and angiogenic responses, including new vascularization and microcirculatory improvement, helping to restore the body's normal healing processes and regeneration. SANUWAVE intends to apply its PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE, is CE marked for treatment of the skin and subcutaneous soft tissue and recently completed its highly positive pivotal Phase III, Investigational Device Exemption (IDE) clinical trial in the U.S. for the treatment of diabetic foot ulcers. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved Ossatron® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its Ossatron, Evotron™ and orthoPACE® devices in Europe.
This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company's ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the marketing of the Company's product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company's ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Company's periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.
Contact: SANUWAVE Health,
Barry Jenkins, CFO
Bernie Laurel, VP of Sales and Marketing
Anne Marie Fields, 212-838-3777
Mackenzie Mills, 212-838-3777
Posted: November 2011