European KOLs Initiate NAZARÉ Post-Market Clinical Study

Zurich, Switzerland – 20 January 2026 – Piomic Medical, a leader in innovative wound care solutions, announces the successful initiation of the NAZARÉ trial, a prospective post-market clinical study evaluating the COMS® One Therapy System in patients with chronic ulcers of vascular origin.
NAZARÉ (Concurrent Optical and Magnetic Stimulation for chronic vascular ulcers) is an investigator-initiated trial (IIT) launched by a consortium of leading European wound care opinion leaders. The study reflects routine clinical practice, including outpatient care and treatment in patients’ homes, addressing the growing importance of home-based wound care within modern healthcare systems.
“I am very excited that NAZARÉ has now officially kicked off,” said Prof. Dr. Sebastian Probst, Past-President of the European Wound Management Association (EWMA) and Sponsor and Principal Investigator of the study. “Generating high-quality real-world evidence is essential in chronic wound care, and this study has the potential to provide valuable insights into the role of COMS in patients with hard-to-heal vascular ulcers.”

The randomized, controlled, assessor-blinded, real-world clinical study designed to evaluate wound healing outcomes in patients with difficult-to-heal vascular leg ulcers (ABI 0.5–1.3) and is expected to enroll approximately 122 patients across multiple European countries. Recruitment began in 2025, with the study planned to conclude in 2027, generating a comprehensive real-world evidence dataset to inform clinical practice, reimbursement discussions, and long-term market access strategies. Participating Swiss centers include specialized wound clinics and university hospitals, providing a broad and representative real-world patient population.

“The University Hospital Zurich is pleased to participate in the NAZARÉ study,” said Prof. Dr. med. Jürg Hafner, Investigator at the University Hospital Zurich and Past-President of the International Society for Dermatologic Surgery (ISDS). “We see strong clinical relevance in evaluating innovative, non-invasive therapies such as COMS in a real-world setting, particularly for patients with limited treatment options.”

“NAZARÉ represents an important step in generating robust real-world evidence for COMS therapy,” said Rejelle Williams, Head of Clinical Development at Piomic Medical. “Chronic vascular ulcers remain a major unmet clinical need, and high-quality post-market data from routine care settings are essential not only to inform clinical practice, but also to support reimbursement discussions and long-term market access. By demonstrating effectiveness, usability, and integration into standard care pathways across multiple European healthcare systems, NAZARÉ is designed to create meaningful value for patients, providers, and stakeholders alike.”

Expanding Across Europe
Following successful study initiation in Switzerland, first ethics approvals have now been obtained in other countries such as Austria, Germany, France and the United Kingdom with site activations underway. First patients are expected to be randomized in these countries shortly, further expanding the geographic footprint and clinical diversity of the NAZARÉ study.

The multinational design enables evaluation of COMS across diverse healthcare systems, increasing the relevance of findings for clinicians, regulators, and payers. In parallel, COMS is being evaluated in the U.S. in the MAVERICKS study, a pivotal FDA-regulated IDE trial. Together, NAZARÉ and MAVERICKS provide a complementary real-world and pivotal evidence package to support global regulatory, reimbursement, and market access strategies.
Full study details are available on ClinicalTrials.gov:
👉https://clinicaltrials.gov/study/NCT06528873

About the NAZARÉ Study
NAZARÉ is an investigator-initiated, post-market clinical study designed to assess the safety and effectiveness of concurrent optical and magnetic stimulation (COMS) in chronic vascular leg ulcers under real-world conditions. The study evaluates healing outcomes, usability, and integration into standard wound care pathways.

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 technology, the COMS® One Therapy System, delivers concurrent optical and magnetic stimulation to support tissue repair across all phases of wound healing. Piomic combines strong scientific foundations, global IP protection, and deep clinical expertise to address one of healthcare’s most persistent challenges.