Peer-reviewed NAZARÉ Trial Protocol Published in Trials

Zurich, Switzerland – 01 July 2026 – Piomic Medical, a Swiss medical device company pioneering non-invasive optical and magnetic stimulation therapy for tissue regeneration, today noted the publication of the NAZARÉ study protocol in the peer-reviewed journal Trials (published online 29 Jun 2026; DOI 10.1186/s13063-026-09859-1). NAZARÉ is an investigator-initiated randomized controlled trial evaluating the COMS® One Therapy System as an adjunct to standard of care in patients with vascular ulcers.

A rigorous, real-world evidence design

NAZARÉ is a phase IV, multicenter, parallel-group, superiority RCT with blinded outcome assessment, conducted at over ten specialist wound-care centers across Switzerland, France, Germany, United Kingdom and Austria (ClinicalTrials.gov NCT06528873). The trial plans to enroll 122 adults with venous leg ulcers (VLU) or VLU complicated by peripheral arterial disease. Following a two-week run-in on optimized standard of care, designed to enrich the population for genuinely chronic wounds, participants are randomized 1:1 to standard of care plus COMS® or standard of care alone.

The primary endpoint is percentage wound area reduction at week 12, measured by centrally blinded digital planimetry. Secondary endpoints include complete wound closure, time-to-healing, pain, health-related quality of life, recurrence, and healthcare resource use over 24 weeks. The study is sponsored by Prof. Sebastian Probst (HES-SO Geneva School of Health Sciences / Geneva University Hospitals) and funded by an unrestricted research grant from Piomic Medical AG, which had no involvement in the study design, conduct, analysis, or reporting. Recruitment commenced in Switzerland in October 2025, with anticipated completion in December 2027.

“NAZARÉ addresses a patient population with a high clinical need for which robust randomized evidence remains scarce,” said Prof. Sebastian Probst, study sponsor and Full Professor of Tissue Viability and Wound Care at HES-SO Geneva. “By using a pragmatic, multicenter design across five countries, the study will generate evidence that is directly applicable to everyday wound-care practice”

Part of a broadening clinical portfolio

NAZARÉ complements MAVERICKS, Piomic’s pivotal FDA IDE trial in the United States evaluating COMS® therapy in therapy-refractory diabetic foot ulcers under a sham-controlled design. In September 2025, the COMS® One Therapy System received FDA Breakthrough Device Designation. Refractory diabetic foot ulcers rank among the most lethal conditions in medicine. Once a wound stops responding to standard care, five-year mortality reaches 50 to 70 percent, comparable to or worse than many common cancers, and fewer than a quarter of ulcers heal within twelve weeks of standard therapy. Outcomes of this severity are why patients who have exhausted conventional options need genuinely new therapeutic approaches rather than incremental variations on existing care. Vascular ulcers carry a parallel, if less visible, burden: they account for the majority of lower-extremity ulcers, recur in up to three quarters of patients within a year of closure, and consume a disproportionate share of chronic-wound spending across European health systems.

“Vascular ulcers are among the most burdensome chronic wounds clinicians face, and patients whose arterial disease limits full compression have few good options. NAZARÉ is designed to show, rigorously, whether COMS® can help close that gap,” said Rejelle Williams, Head of Clinical Development at Piomic Medical.

NAZARÉ is designed to close the evidence gap that stands between a CE-mark and broad clinical adoption. Its assessor blinded, comparative, multi-country design and its health-economic and quality-of-life endpoints are aligned with the comparative-effectiveness and real-world evidence expectations of the major health-technology-assessment and reimbursement bodies governing access in markets, including G-BA (Germany), HAS (France), NICE (United Kingdom), AIHTA (Austria) and BAG (Switzerland), alongside the real-world evidence pathways increasingly emphasized by payers in the United States. Together with MAVERICKS, NAZARÉ is intended to build the coordinated clinical and health-economic dataset required to support reimbursement for COMS therapy globally.

About Piomic Medical AG

Piomic Medical AG is a Swiss ETH Zurich startup pioneering deep tissue regeneration through physical stimulation therapies. Its flagship platform, the COMS® One Therapy System, delivers concurrent optical and magnetic stimulation to support tissue repair across healing phases and is designed for use across hospital, outpatient, and home-care settings. Beyond wound healing, the COMS® platform has potential applications in various other disease areas, such as sports medicine, aesthetics, and infection management. Piomic is headquartered in Zurich with U.S. operations in Chicago.

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.