- Piomic becomes the first medtech investment of Swisscanto (CH) Private Equity Switzerland Growth II L-QIF KmGK (“Swisscanto”), Zürcher Kantonalbank’s private equity second growth fund, backing COMS® One, an innovation with FDA Breakthrough Device Designation for hard-to-heal wounds
- Growth financing facility of USD 25 million, led by a CHF 10 million commitment from Swisscanto, with strong participation from existing shareholders, bringing Piomic’s total funding since inception to more than USD 50 million
- The financing follows major U.S. regulatory and reimbursement milestones, including FDA Breakthrough Device Designation and retained eligibility for Medicare transitional payment under the Alternative Pathway
- Proceeds fund the timely completion of the company’s current clinical development program, including the MAVERICKS IDE pivotal trial and the NAZARÉ trial, U.S. market approval filing and market entry for the COMS® One Therapy System, and expansion of the COMS® platform into future applications
Zurich, Switzerland – 18 September 2026 – Piomic Medical, an emerging regenerative medtech company focused on complex tissue healing, today announced the closing of a growth financing of USD 25 million. The financing is led by a CHF 10 million commitment from Swisscanto (CH) Private Equity Switzerland Growth II L-QIF KmGK (“Swisscanto”), the growth fund of Zürcher Kantonalbank’s asset management division. Piomic is the fund’s first medtech investment. The financing includes strong participation from existing shareholders, including Diabetes Venture Fund, Zürcher Kantonalbank, Verve Ventures, Sky Stiftung, N&V Capital and the Swiss Single Family Office, as well as further private and institutional investors. Piomic has secured more than USD 50 million in equity, convertible capital and non-dilutive funding and grants since inception.
It funds the company through its next value inflection points, including the MAVERICKS interim readout and the FDA market approval process. Clinical and industry interest in the COMS® platform continues to grow, with the investigator-initiated NAZARÉ trial led by a consortium of European key opinion leaders now underway across Europe.
Positioned for a U.S. Wound Care Market in Transition
The U.S. advanced wound care market is in transition, creating a significant opportunity for new treatment modalities that combine rigorous clinical evidence with an established reimbursement framework. With Medicare implementing capped site-neutral payment for skin substitutes and increasingly emphasizing evidence-based coverage, technologies entering the market with high-quality controlled evidence and established reimbursement infrastructure are positioned to capture significant market share. Market analyst SmartTRAK, in its 2026 review of U.S. advanced wound care devices, identified COMS® One as a frontrunner among emerging technologies entering the market with defined regulatory and reimbursement pathways.1
COMS® One holds FDA Breakthrough Device Designation, granted in September 2025. Under the recently finalized CMS FY 2027 IPPS rule, COMS® One retained eligibility, through CMS’s grandfathering provision, for the Alternative Pathway to Medicare New Technology Add-on Payment and OPPS transitional device pass-through payment, a position now closing to new entrants and rare among wound care technologies. Together with recently granted CPT® III codes for COMS® therapy in effect since January 2025 and Medicare coverage of the MAVERICKS IDE Category B study, this gives COMS® One an unusually advanced reimbursement foundation ahead of U.S. market authorization.
The FDA’s Breakthrough Device Designation for COMS® reflects the significant unmet need faced by patients with refractory diabetic foot ulcers, where associated five-year mortality is comparable to many cancers.2 This financing supports the timely completion of our clinical development program and enables us to accelerate preparations for U.S. market approval and global launch of COMS® One, while expanding the COMS® platform into additional indications to address the clinical needs of a broader patient population.
Christopher HertzChief Executive Officer, Piomic MedicalFew technologies in advanced wound care and tissue repair reach the pre-commercial stage with this level of regulatory, clinical and reimbursement readiness. Swisscanto’s commitment, together with the continued support of our existing investors, strengthens Piomic’s ability to execute against its next major clinical, regulatory and commercial milestones.
Bertrand HughesChairman of the Board, Piomic MedicalPiomic combines a technologically compelling, clinically validated therapy with a highly attractive regulatory and reimbursement position in a large, structurally growing market. With our investment, we are supporting a treatment modality that has the potential to assume a globally leading role in wound care. Piomic is an excellent first addition to our new growth fund’s life sciences portfolio, and we look forward to working with the Piomic team and board to scale the business and realize its long‑term potential.
In connection with the financing, Andy Weymann, MD, joins Piomic’s Board of Directors as a Board Observer. An orthopedic surgeon by training, Dr. Weymann served for nearly 14 years as Chief Medical Officer of Smith+Nephew, where he led clinical, scientific and medical affairs across the group, including Advanced Wound Care. He has since held chairman and executive roles at medtech start-ups and scale-ups in wound care and regenerative medicine, and brings more than 25 years of board and M&A experience in the sector.
Clinical Development Progress
COMS® One is being evaluated in MAVERICKS (NCT05758545), one of the most comprehensive IDE pivotal trials conducted to date in wound care: a prospective, randomized, sham-controlled, double-blinded Category B IDE study across 30 U.S. sites in 224 patients with refractory diabetic foot ulcers. CMS approved Medicare coverage of the study in June 2023; the trial’s endpoints and age-stratified enrollment were designed to generate evidence relevant to both FDA and Medicare decision-making, with results generalizable to the Medicare population. The MAVERICKS protocol was published in the peer-reviewed journal WOUNDS in 2025.3
In Europe, where COMS® One is CE marked under the EU Medical Device Regulation, a consortium of leading European wound care clinicians has launched NAZARÉ, an investigator-initiated clinical trial evaluating COMS® in chronic vascular leg ulcers under real-world conditions across European wound centers in Switzerland, Austria, Germany, France and the UK.4
About Piomic Medical AG
Tissue regeneration is among the most energy-intensive cellular processes in the body, and many disease states are linked to mitochondrial dysfunction and reduced energetic capacity. Piomic Medical is a Swiss ETH Zurich start-up and an emerging regenerative medtech company focused on deep tissue regeneration through physical stimulation therapies. The company is headquartered in Zurich with U.S. operations in Chicago. Its proprietary COMS® platform (Concurrent Optical and Magnetic Stimulation) delivers synergistic stimulation designed to modulate key regenerative pathways, including ion channel signaling, nitric oxide production and mitochondrial activity, to support cellular metabolism and facilitate tissue repair.
Its lead product, the COMS® One Therapy System, is a portable, non-invasive device for the treatment of non-healing wounds, designed for use across hospital, outpatient and home-care settings. It holds FDA Breakthrough Device Designation and is CE marked under the EU Medical Device Regulation. Beyond wound healing, the COMS® platform has potential applications in further disease areas, including infection management (COMS® Blue, supported by an EU Eurostars grant ID: 6870), sports medicine, ophthalmology and aesthetics. Piomic’s mission is to advance regenerative therapies and improve outcomes for patients with difficult-to-treat conditions worldwide.
About Swisscanto
The asset management division of Zürcher Kantonalbank, now the second-largest asset manager in Switzerland, manages all funds under the Swisscanto product brand. Swisscanto (CH) Private Equity Switzerland Growth II L-QIF KmGK invests predominantly in unlisted Swiss growth companies with innovative technologies and scalable business models in health industry and information and data services, typically taking a board or observer seat and remaining invested until the portfolio companies’ exit.
Forward-Looking Statements
This release contains forward-looking statements regarding Piomic’s clinical, regulatory, reimbursement and commercial plans. Such statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially.
Important Regulatory Disclaimers
The COMS® One Therapy System is CE marked under the EU Medical Device Regulation. It is currently investigational in the United States and has not received regulatory approval in the United States or Canada. Any statement in this press release regarding the safety and effectiveness of the system does not apply to either country.
References
- Merkel J. The future of US advanced wound care devices in 2026 and beyond. SmartTRAK Life Sciences News and Analysis Blog. 2026 Feb 3. Available from: blog.smarttrak.com. Accessed 2026 Sep 7
- Armstrong DG, Swerdlow MA, Armstrong AA, Conte MS, Padula WV, Bus SA. Five year mortality and direct costs of care for people with diabetic foot complications are comparable to cancer. J Foot Ankle Res. 2020;13:16.
- Galiano RD, Li RA, Lantis JC, Oropallo A, Ulloa J, Iafrati M, Lavery LA, O’Connell J, Nouvong A. 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.
- Probst S, Saini C, Stefanelli A, Frei A, Stuermer EK, Dissemond J, Kamolz LP, Weber B, Lembelembe JP, Traber J, Mayer D, Zehnder T, Baer D, Ruzza C, Hafner J. Adjunctive optical and magnetic stimulation for venous and mixed etiology leg ulcers: protocol for the NAZARÉ multicenter randomized controlled trial. Trials. 2026;27:574.