AMA granted unique U.S. CPT III reimbursement codes for concurrent optical and magnetic stimulation (COMS)

Zurich, Switzerland – 01 March 2024 – Piomic Medical, a pioneer in the treatment of hard-to-heal wounds and management of surgical site infections, today announces that the American Medical Association (AMA) has approved the creation of two new Category III Current Procedural Terminology (CPT) codes for the COMS® One therapy system. This milestone marks an important step in facilitating reimbursement for the Company’s innovative medical device currently undergoing U.S. clinical investigations for the treatment of refractory diabetic foot ulcers.

CPT codes are used in the U.S. by physicians and public and private health insurance programs to identify specific medical services and procedures for reimbursement. Category III CPT codes, specifically designated for emerging technologies, procedures, and services, provide a temporary coding system for novel advancements. The two codes will become effective January 1st, 2025 for procedures related to the COMS® One therapy system, including application, wound assessment, dressing care and instructions for ongoing care.

This development closely follows the Centers for Medicare & Medicaid Services (CMS) Category B designation for Piomic’s pivotal IDE study called MAVERICKS. This robustly designed clinical study, poised to become the most comprehensive investigation in the wound care device industry over the past decade, will not only support the Company’s FDA De Novo submission but also establish a solid foundation for reimbursement and commercialization endeavors.

Martin Walti, Chief Operations Officer at Piomic Medical, commented: “We are delighted with the issuance of two new Category III CPT codes by the American Medical Association for our COMS® One therapy system, which is a further important step in our U.S. commercialization strategy. The introduction of CPT III coding is a pivotal development, enabling future utilization of COMS® therapy to be accurately reported. Upon FDA approval, healthcare professionals will be able to submit claims for the COMS® One therapy system, paving the way for broader adoption and supporting our commercial roll-out in the U.S.”

Bernard Laurel, President at Piomic Medical U.S., added: “Today’s announcement marks another important milestone in our U.S. commercial strategy for the COMS® One system. We are intensifying preparations for the U.S. commercial launch of this groundbreaking therapy targeting refractory diabetic foot ulcers — a patient population in dire need of innovative, advanced treatment options due to increased prevalence, elevated amputation rates and substantial morbidity. We are confidently taking steps to ensure that the introduction of COMS® therapy will be widely accepted by U.S. clinicians, while also enhancing patient quality of life and delivering meaningful benefits to payors and healthcare systems alike.”

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® 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.