Positive Data Demonstrating SANUWAVE, Inc.'s dermaPACE Safely Heals Diabetic Foot Ulcers to Be Highlighted in CME Presentation at the American Podiatric Medical Association Meeting
The presentation, titled “Pulsed Acoustic Cellular Expression Technology in the Treatment of Diabetic Foot Ulcers: A Sham-controlled, Double-blinded, Randomized Clinical Trial,” will take place on Thursday, July 28 from 2:30 – 3 p.m. Eastern time. The presentation highlights and expands on the dermaPACE pivotal Phase III clinical trial results, including:
- dermaPACE subjects reached statistical significance in 100% wound closure compared to Sham-control beginning at 20 weeks (p=0.018) and continuing through 24 weeks (p=0.022).
- 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 rate of ulcer recurrence at 24 weeks (4.5%).
- dermaPACE was shown to have an excellent safety profile, including a reduction in infection.
The presentation will be delivered by Vickie R. Driver, DPM, MS, FACFAS; Associate Professor of Surgery; Director, Clinical Research Limb Preservation and Wound Healing; and Director, Research Fellowship and International Scholars Program, Boston University Medical Campus and Boston University School of Medicine, and one of the principal investigators in the recently completed pivotal Phase III, Investigational Device Exemption (IDE) clinical trial of dermaPACE for the treatment of diabetic foot ulcers.
SANUWAVE Health will be showcasing dermaPACE and the strongly compelling clinical data from its Phase III clinical trial about diabetic foot ulcers at Exhibit Booth #620 throughout the meeting.
Christopher M. Cashman, President and Chief Executive Officer of SANUWAVE, said, “The results for dermaPACE are compelling. Diabetic foot ulcers treated with dermaPACE, in general, immediately stabilized and did not worsen. These ulcers quickly reduced in size and continued to full closure in a significantly greater proportion than ulcers in the comparative Sham-control group. Ulcers closed with dermaPACE didn’t tend to recur, and dermaPACE procedures were shown to be safe and were associated with a lower overall incidence of infection.”
“We already know that dermaPACE procedures can be delivered at a much lower cost to the healthcare system than existing advanced wound treatment modalities – and with improved ease of use and convenience for both clinicians and patients. These highly positive dermaPACE study results complete the picture and position dermaPACE well for early adoption and widespread utilization. We are pleased to have these results presented in the first nationally accredited CME presentation at an annual scientific meeting,” concluded Mr. Cashman.
About PACE
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 proliferation phases 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 this 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.
Forward-Looking Statements
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, Inc.Barry Jenkins, 678-578-0103CFOorBernie Laurel, 678-578-0103VP of Sales and Marketinginvestorrelations@sanuwave.comorLippert/Heilshorn & AssociatesAnne Marie Fields (Investors), 212-838-3777afields@lhai.comorMackenzie Mills (Media), 212-838-3777mmills@lhai.com