Zurich - Piomic Medical has been given the green light by the U.S. Food and Drug Administration (FDA) to carry out a pivotal trial. If the outcome is positive, the medtech company will be authorized to sell its COMS therapy system for chronic leg wounds in Europe as well as in the USA.

The U.S. Food and Drug Administration (FDA) has approved a pivotal clinical trial for the COMS One therapy system developed by Piomic Medical. A total of 224 patients with diabetic foot ulcers, which are notoriously difficult to treat and heal, will be tested at up to 20 health centers across the USA from the start of next year, further details of which can be found in a press release. The medical device developed by the Zurich-based company was awarded CE Mark Approval in May 2020 for a broader application spectrum in the European Union (EU).

As Piomic also explains in a video, this adjunctive wound treatment combines cellular respiration through optical and magnetic stimulation. Increased microvascular perfusion stimulates the immune response to destroy the bacteria. The increased blood supply delivers extra oxygen and nutrients to the inflamed area. Both processes contribute to accelerating the tissue regeneration process.

According to Piomic, comparative clinical studies in Switzerland have demonstrated the significant clinical benefit of COMS treatment in therapy-resistant wounds of different origins. The time to wound closure could be “significantly” reduced compared with a standard treatment approach.

“This is another significant milestone for Piomic and a result of a multi-year R&D program”, comments Martin Walti, COO of Piomic, in the press release. He adds: “We are very pleased with the high level of market acceptance we are experiencing in Europe”. The company will now turn its attention towards successfully concluding the clinical trial, before tapping into the US market.

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