Piomic Medical Announces First Patients Enrolled in MAVERICKS Study Sites

Zurich, Switzerland – 03 September 2023 – Piomic Medical, a medical device company at the forefront of innovation in the treatment of hard-to-heal wounds, announces the enrollment of their first patients in the company’s MAVERICKS U.S. pivotal clinical study sites (NCT05758545).

MAVERICKS will investigate potential beneficial effects of COMS® treatment in patients suffering from therapy-refractory diabetic foot ulcers. COMS® is the company’s proprietary technology that delivers concurrent optical and magnetic stimulation to accelerate healing of chronic ulcers. The prospective randomized, sham-controlled, double-blinded, pivotal clinical trial will be conducted in 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.

Piomic Medical received an investigational device exemption (IDE) approval for the study from the U.S. Food and Drug Administration (FDA) in November 2022. This robustly designed clinical study will support a De Novo regulatory submission for novel medical devices, and if successful in achieving FDA marketing authorization, will provide a solid foundation for reimbursement and commercialization efforts.

Dr. Heliodoro Ruiz, Principal Investigator at Clever Medical Research in Miami, FL, enrolled first patients in August. “I am honored to participate in the MAVERICKS clinical trial to evaluate the use of COMS® treatment for non-healing diabetic foot ulcers. We were excited to see previous positive results from European studies for this pioneering technology and hope to improve upon those outcomes in this U.S. trial,” said Dr. Ruiz. “It is vital for patients suffering from chronic ulcers that their wound clinicians have effective treatment options when standard of care fails. Absent such options, physicians are often limited to surgical procedures that are known to ultimately increase rates of morbidity and mortality for these compromised patients.”

Christopher Hertz, CEO of Piomic Medical, commented, “This is an important milestone for the company, and I would like to personally thank Dr. Ruiz and his entire research team for their diligent recruitment and enrollment efforts.” Mr. Hertz added, “Our partnership with all our principal investigators is highly valued and instrumental in our efforts to bring COMS® to the U.S. market. We look forward to working with the participating study sites as we gain traction and enrollments for ongoing clinical validation.”

About Piomic Medical
Piomic develops innovative medical devices for the treatment of hard-to-heal wounds based on the proprietary COMS® therapy, which incorporates the technology for concurrent optical and magnetic stimulation. Treatment with COMS® is intuitive and conforms to the established workflow of healthcare professionals. As an advanced treatment for therapy-refractory ulcers, COMS® adds to the therapeutic armamentarium of wound care clinicians challenged with ulcers that do not sufficiently respond to standard of care regimens. With diabetes reaching epidemic levels globally, innovative therapies are essential to preventing amputations, improving patient quality of life, and minimizing the deleterious clinical and economic impacts of non-healing ulcers. COMS® was developed with input from virtually all clinical environments, allowing for its application across the full continuum of care, from in-patient facility to home care.

Important Regulatory Disclaimers
The COMS® One therapy system has not yet received regulatory approval in the U.S. and Canada. As such, use is limited to investigational use only in the U.S. Any statement in this press release about the safety and effectiveness of the system does not apply to the U.S. and Canada because the device is currently undergoing clinical investigation in these geographies.