With more than 10,000 treatments performed in over 30 Swiss hospitals, Piomic is already transforming the wound care field in Switzerland. Parallel to ongoing studies and pilot programs in Europe, the startup launched the MAVERICKS trial in the U.S. to assess the safety and efficacy of its COMS treatment for refractory diabetic foot ulcers.
Piomic Medical’s COMS therapy is a proprietary technology that delivers concurrent optical and magnetic stimulation to accelerate the healing of chronic ulcers. Treatment with COMS broadens the therapeutic apparatus exposed to wound care clinicians who have been challenged with ulcers that do not sufficiently respond to standard-of-care regimens.
During a pilot phase in Switzerland, Piomic introduced the COMS One therapy system to selected customers and Key Opinion Leaders (KOLs), receiving overwhelmingly positive feedback from customers and patients. With more than 10,000 treatments performed in over 30 Swiss hospitals, Piomic has already made a profound impact on the field of wound care in Switzerland. Moreover, the COMS One therapy system has garnered international attention and is currently undergoing further studies and pilot programs in Europe. These initiatives are carried out in collaboration with renowned KOLs in countries such as France, Germany, the Netherlands, and Austria.
Building on this success and following the investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) in November 2022, Piomic is taking the first step in introducing the therapy in the U.S. The startup has launched the MAVERICKS trial in the U.S. to investigate the potential beneficial effects of COMS® treatment in patients suffering from therapy-refractory diabetic foot ulcers. The prospective randomized, sham-controlled, double-blinded, pivotal clinical trial will be conducted on 224 patients at up to 20 centers throughout the United States. Recently, the Centers for Medicare & Medicaid Services (CMS) designated the MAVERICKS trial Category B designation, approving coverage for the COMS One therapy system along with associated and standard items and services.
“This study is poised to become the most comprehensive investigation in the wound care device industry for the entire decade. If it proves successful, it will be a groundbreaking achievement, marking the first sham-controlled trial in this research field to demonstrate significant results. The primary objective of this undertaking is to validate the effectiveness of the COMS One therapy system in treating diabetic foot ulcers that have been unresponsive to prior treatments. Furthermore, this research will serve as the foundation for presenting clinical evidence during future reimbursement negotiations,” said Christopher Herz, CEO and co-founder of Piomic.
(Press release/RAN)
Please login or sign up to comment.
Commenting guidelines