Sanuwave said Wednesday it has achieved 75 percent enrollment in a Phase III supplemental trial requested by the FDA after an earlier trial achieved its primary endpoint eight weeks after the intended 12. The Alpharetta, Ga., devicemaker expects to complete enrollment of the 90-patient study during the first quarter and file a PMA later this year, CEO Joseph Chiarelli said.
The new study is evaluating dermaPACE versus a sham device in patients with diabetic foot ulcers at 18 U.S. and Canadian sites, layering patients from the original and supplemental trials to achieve a new primary endpoint of complete wound closure at 12 weeks. Investigators will administer four noninvasive procedures in the first two weeks and four more between weeks four and 10.
DermaPACE generates high-energy acoustic shock waves that increase perfusion and blood vessel widening, production of growth factors, formation of new blood vessels and regeneration of skin tissue, musculoskeletal and vascular structures — all of which help to heal foot ulcers, the company said.
The device is currently in use in Europe, Canada, South Korea, Australia and New Zealand to treat skin and soft tissue conditions such as pressure sores, ulcers, scar reduction and wound healing.
According to Sanuwave, the U.S. market for dermaPACE is about $5 billion. The global market is roughly $22 billion, the company said. — Lena Freund
Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.