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FDA De NovoFDA De Novo. Stage 4 of 4 (Authorized)

FDA Grants De Novo to Amferia's Peptide-Based Antibacterial Wound Dressing

The order creates a new class II device type for solid wound dressings with a permanently bound antimicrobial, and bars medically important antibiotics from it.

By News DeskFebruary 12, 20262 min read
A gloved hand lowers a thin, clear hydrogel sheet onto the inside of a person's forearm.
The Amferia Wound Dressing being placed on a forearm, in an image Amferia attached to its De Novo announcement. Photo: Amferia · Company press image attached to Amferia's February 12, 2026 release on Cision
FDA De Novonew device type · DEN250006FDA De Novo. Stage 4 of 4 (Authorized)

The FDA granted this device through the De Novo pathway, used for new low-to-moderate-risk device types with no existing equivalent.

Key points

  • The FDA granted Amferia's De Novo request DEN250006 on February 6, 2026, classifying the Amferia Wound Dressing in class II under a new regulation, 21 CFR 878.4013.
  • The cleared use is to cover and protect dry-to-low exuding wounds and maintain moisture balance; the new device type covers dressings whose bound antimicrobial serves a protectant purpose.
  • Amferia, a spinout of Chalmers University of Technology in Sweden, said it will seek partnerships with established wound care companies.

The US Food and Drug Administration has granted a De Novo classification request for the Amferia Wound Dressing, a hydrogel dressing with antibacterial peptides permanently bonded to it, Swedish company Amferia announced on February 12. The decision allows the company to market the prescription dressing in the US as a class II device.

The FDA's classification order, DEN250006, is dated February 6, 2026. The agency received the request on March 3, 2025.

What the FDA classified

According to the order, the dressing "is intended to cover and protect dry-to-low exuding wounds (e.g. abrasions, skin tears, lacerations, incisions and surgical wounds, superficial and partial-thickness burns, pressure ulcers, arterial ulcers), and to maintain an appropriate moisture balance within the wound."

Because no comparable product was already on the market, the FDA created a new generic device type, "solid wound dressing with permanently bound antimicrobial agent," under regulation 21 CFR 878.4013 with product code SHA. Later dressings of the same type can now be cleared through the 510(k) pathway by showing substantial equivalence to Amferia's.

The order defines the antimicrobial in such dressings as serving protectant purposes only: reducing microbial growth within the dressing while in use, or providing a barrier against microbes passing through it. The special controls bar the use of any antimicrobial the FDA considers medically important for human therapy, listing dozens of antibiotic and antifungal classes, and require antimicrobial leachability testing, an antimicrobial resistance risk assessment, biocompatibility and sterility testing, and shelf-life validation.

The company's account

Amferia said its peptides kill bacteria by drawing them close and physically puncturing their cell membranes. To satisfy regulators, the company said, it had to show that the dressing kills 99.99% of bacteria exposed to it without releasing active substances into the wound or the body, and that chemical analyses showed the peptides stay bound to the hydrogel.

The company said early talks with the FDA made clear the product was too novel for the 510(k) pathway, and that the agency asked at several points for additional testing, including expanded bacterial strain panels and further in-vivo safety studies.

"This approval validates years of scientific and regulatory work," said Anand Rajasekharan, Amferia's chief executive and co-founder, using the company's own term for the De Novo grant.

Amferia, based in Gothenburg, was built on PhD research at Chalmers University of Technology, according to a Chalmers news article. The company said it already sells a wound dressing for animals through European animal health partners, including Orkla Wound Care, and that it closed a 3.5 million euro investment round in December 2025. It said the FDA decision positions it as a partner for established wound care companies and that it plans to apply its peptide technology beyond wound care over time. It did not announce a US launch date or price.

Sources

  1. FDA Grants De Novo Classification Request to Market the World's First Antibacterial Peptide-Based Wound Dressing, Amferia AB (Cision), February 12, 2026
  2. De Novo classification order DEN250006, Amferia Wound Dressing, US Food and Drug Administration, February 6, 2026
  3. Chalmers-based Amferia receives FDA approval for a new type of wound care product (page as updated 2026-02-23; facts cited were in the 2026-02-12 version), Chalmers University of Technology, February 12, 2026