MAVERICKS IDE Trial Protocol Published in WOUNDS by Leading U.S. Experts

Zurich, Switzerland – August 15 2025 – Piomic Medical, today announced the publication of the clinical protocol for its pivotal MAVERICKS IDE (Investigational Device Exemption, NCT05758545) trial in the renowned peer-reviewed journal WOUNDS — The Trial Design of the Concurrent Optical and Magnetic Stimulation (COMS®) Therapy Study for Refractory Diabetic Foot Ulcers (MAVERICKS): A Multicenter, Randomized, Sham-Controlled, Double-Blind Investigational Device Exemption Clinical Study (WOUNDS. 2025;37(8):275-282. doi:10.25270/wnds/25037).The protocol was authored by nationally respected U.S. Key Opinion Leaders, reflecting the trial’s unparalleled scientific credibility and clinical relevance.

MAVERICKS — A Landmark Study Designed with Regulatory and Payer Alignment

The FDA approved MAVERICKS trial was designed with direct Medicare involvement, ensuring the results will be applicable to the Medicare beneficiary population. The trial received approval for Medicare Category B coverage, reimbursing not only standard of care (SOC) supplies and services but also the cost of COMS® therapy.

MAVERICKS will enroll 224 patients across up to 30 sites nationwide, spanning all major places of service, from outpatient wound clinics and physician offices to VA hospitals and including medical specialties such as vascular surgery, podiatry, endocrinology, plastic surgery, general surgery, internal medicine, and family medicine. Multiple participating study sites rank among the highest-performing wound care programs in the US.

Complexity and Bias Reduction at the Highest Level

The study is designed with rigorous methodology to address and reduce challenges frequently associated with wound care clinical trials, such as variability in wound assessment, inconsistent application of therapy, and bias from patient or clinician expectations. This is one of the most comprehensive and methodologically robust wound care device trials ever conducted:

• Sham-control arm to isolate true therapeutic benefit from potential placebo effect
• Double-blinding to eliminate patient and clinician expectation bias
• Centralized, blinded endpoint adjudication for objective wound healing measurement
• Extended 4-week run-in period to confirm non-healing (refractory) wound status and align with the latest CMS reimbursement guidelines for advanced therapies

The result is a trial designed to meet standards for market clearance and to produce payer-ready evidence for coverage and payment decisions, and to drive adoption with providers serving the Medicare population.

“With a long-standing research interest in wound care, I view the MAVERICKS trial as a groundbreaking and truly unique effort. Its rigorous methodology not only advances wound care research but also establishes a strong foundation for COMS reimbursement, paving the way for broader access to this innovative therapy,” said Aksone Nouvong, DPM, National Principal Investigator for MAVERICKS.

Reimbursement Environment Driving the Need for New Modalities

The U.S. wound care landscape is undergoing significant reimbursement reform. Proposed Local Coverage Determinations (LCDs) from Medicare Administrative Contractors (MACs) targeting cellular and/or tissue-based products (CTPs), including pricing caps, are set to reshape access to advanced wound therapies. This shift underscores the urgent need for novel treatment modalities that are clinically proven, cost-efficient, and deployable across a broader range of care settings.
COMS® therapy is uniquely positioned to meet this need. Unlike CTPs, platelet-rich plasma (PRP), or other advanced therapies that can be limited by cost, storage, or procedural complexity, COMS® is:

• Non-invasive and easy to administer in any setting
• Intuitive and mobile by design, enabling effective use across diverse care settings such as mobile wound care clinics and outpatient offices.
• Designed for consistent application without variability in tissue quality or operator technique.

In addition, the MAVERICKS trial specifically recruits refractory patients, which is a vulnerable, high-risk population due to the devastatingly high mortality rates observed when wounds fail to heal under standard of care and progress toward amputation. COMS® has the potential to significantly advance wound treatment, making it more accessible across diverse care settings and patient populations

Two Gold-Standard Trials to Drive Market Access

Piomic is conducting two gold-standard randomized controlled trials to support U.S. market clearance and global reimbursement for COMS® therapy:

• MAVERICKS — FDA IDE–approved and Medicare Category B–covered; a combined pivotal and reimbursement trial evaluating COMS® therapy in a high-mortality, refractory wound population.
• NAZARE — an investigator-initiated, real-world reimbursement trial in Europe evaluating COMS® therapy for vascular wounds in a home care setting.

Together, these studies form the evidence backbone for for U.S. market entry and continued global expansion.

“Publishing this protocol is a key step in delivering on our mission to make COMS® therapy accessible to patients who need it most,” said Christopher Hertz, CEO of Piomic Medical. “The trial’s design is not only clinically robust but also uniquely positioned to meet payer requirements and provider expectations from day one.”

About Piomic Medical
Piomic develops innovative medical devices for hard-to-heal wounds, based on its proprietary COMS® therapy (Concurrent Optical and Magnetic Stimulation) designed to enhance tissue regeneration in both chronic and acute wounds. Next-generation applications target infection management and soft tissue repair. COMS® therapy has been applied in over 2,000 patients in Europe, showing promising results across multiple wound types, including severe pressure injuries, for which it received the EPUAP Most Innovative Product Award in 2024.

Important Regulatory Disclaimers
The COMS® One therapy system is currently investigational in the U.S. and Canada and has not yet received regulatory approval in either region.