SANUWAVE, Inc.'s Foot Ulcer Treatment Technology Appears Poised for FDA Approval
“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.” 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.”
The Company will showcase dermaPACE and discuss the clinical trial data at Exhibit Booth #614.
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.
Forward-Looking Statements
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Contacts
SANUWAVE Health, Inc.
Barry Jenkins, CFO
Bernie Laurel, VP of Sales and Marketing
678-578-0103
investorrelations@sanuwave.com
or
Lippert/Heilshorn & Associates
Anne Marie Fields (Investors)
212-838-3777
afields@lhai.com
or
Mackenzie Mills (Media)
212-838-3777
mmills@lhai.com