FDA Breakthrough Device Designation for COMS® One Therapy System

ZURICH, Switzerland, September 19, 2025 – Piomic Medical, a medical device company pioneering non-invasive optical and magnetic stimulation therapy for chronic and acute wound management, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its COMS® One Therapy System.

Concurrent Optical and Magnetic Stimulation, or COMS, is a category-defining medical device that delivers physical deep-tissue stimulation to reactivate and accelerate the body’s natural wound healing cascade. COMS improves mitochondrial function, nitric oxide and ATP production, and cellular energetics, mechanisms critical to restoring healing progression in chronic, non-resolving wounds.

“This designation represents a major milestone in Piomic’s mission to bring advanced, accessible wound care to patients at greatest risk,” said Christopher Hertz, CEO of Piomic Medical. “With diabetes reaching epidemic levels globally, innovative therapies are essential to preventing amputations, improving 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 inpatient settings to home health. We believe COMS can help save lives and limbs, support caregivers on the front lines, and offer hope to patients and families navigating the burden of chronic wounds.”

Positioned for Broad Impact and Long-Term Value

Published European studies have shown encouraging results for COMS across diabetic foot, venous leg, arterial, and mixed-etiology ulcers, supporting CE (MDR) certification and ongoing commercialization in select countries. A large Randomized Controlled Trial (RCT) in venous leg ulcers is also underway, highlighting the therapy’s growing role in real-world care. This investigator-initiated trial (IIT), called NAZARÉ, is led by Prof. Sebastian Probst (HEdS Genève / University Hospital Geneva).

In the U.S., COMS has received two CPT III codes from the American Medical Association, enabling future billing and reimbursement following market approval under the De Novo pathway. Its portable design and ease of use support broad adoption by wound care teams.

Led by Aksone Nouvong, DPM (David Geffen School of Medicine at University of California Los Angeles, UCLA) as National Principal Investigator, COMS is also being evaluated in MAVERICKS, a pivotal FDA IDE trial enrolling patients at 30 U.S. sites. With its rigorous sham-controlled design, including a 4-week screening phase to identify truly refractory diabetic foot ulcers (DFU), the protocol was recently published in WOUNDS in recognition of the new benchmark it sets in chronic wound research. As a result of MAVERICKS’ Category B IDE status, Medicare has approved payment for the device and routine supplies and services during the trial.

“Patients with chronic ulcers deserve effective options when standard care fails,” said Martin Walti, COO of Piomic Medical. “COMS was designed to work independently or alongside advanced therapies such as NPWT and skin substitutes, with the potential to become a foundational treatment in modern wound healing.”

FDA Breakthrough Devices Program Overview

The FDA Breakthrough Devices Program is an initiative designed to accelerate the development, review, and market access of medical technologies that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions. The program offers medical device manufacturers prioritized and interactive engagement with FDA experts throughout the premarket review process.

By incorporating early and frequent communication, the program aims to help patients receive timely access to breakthrough technologies that may offer significant advantages over existing standard-of-care options. Eligibility requires that the device addresses an unmet medical need and demonstrates the potential to improve clinical outcomes.

About Piomic Medical AG

Piomic Medical AG is a Swiss medical device company developing innovative, non-invasive therapies for hard-to-heal wounds. Its flagship platform, the COMS One Therapy System, delivers concurrent optical and magnetic stimulation to promote tissue repair across all healing phases. COMS is backed by strong global IP, a fully industrialized supply chain, and a team with over 180 years of wound care experience, including support from leading clinical and reimbursement experts.

Important Regulatory Disclaimers

COMS One Therapy is currently being studied in an FDA IDE clinical trial and is not yet available for clinical use in the United States.