Amferia’s road to a cutting-edge antibacterial wound dressing

They act like little knives,” says Anand Rajasekharan, calling from a conference in Las Vegas, USA. “They basically stab the bacteria through their skin and kill them instantly.”

He is talking about antimicrobial peptides: short chains of amino acids that form part of the body’s first line of defence against bacteria, viruses and fungi. Rajasekharan is CEO and co-founder of Amferia, a Gothenburg company spun out of research at Chalmers University of Technology, which has built a wound dressing around them.

A fragile molecule, protected

Antimicrobial peptides have been known since before penicillin, yet Rajasekharan says no medical device based on them had reached the market in nearly a century until Amferia’s US approval this year. The obstacle is stability: outside the body, enzymes break peptides down.

The solution came from two PhD projects that began separately: Rajasekharan’s gel-like nanomaterials for implants and Saba Atefyekta’s peptide research, both supervised by Professor Martin Andersson. A side project combined them into a hydrogel, a water-rich network of entangled polymer chains. “The gel itself kind of hugs the peptide and locks it in place,” he says. The peptides stay on the surface rather than being released into the wound, which keeps their action predictable, and are drawn to bacteria rather than human cells, since they are positively charged and bacterial membranes negatively.

A category of its own

Amferia, founded in 2018, won de novo approval from the US Food and Drug Administration (FDA) earlier this year, a route for novel devices with no comparable product on the market. Few are granted each year, and here the FDA created a new category, with new rules, for antimicrobial wound dressings. Approval took five years, and competitors must now meet the standards Amferia demonstrated. Rajasekharan calls it a rare feat for a company of 12 people.

The product is not yet approved in Europe. A pilot in a few US hospitals starts this fall, to show at scale that the dressing kills 99.99% of bacteria, including resistant strains, and saves time and money. “It can be a very good product, but if it’s not usable, then it will always face that friction,” Rajasekharan says.

In veterinary care, access has been faster: distributors now sell the product in 15 European markets. Rajasekharan reports faster healing in cats, dogs and horses, and possibly fewer return visits. The data is under review for publication.

Gothenburg’s part

A key component of Amferia’s growth has been BioVentureHub, a community AstraZeneca created for small life science companies, offering infrastructure and peer support while operating independently. Another success factor has been Gothenburg’s rich competence in medical devices and wound care, whose experience can advise on product development and manufacturing.

Early money came from among others Almi Invest, Chalmers Ventures, and private investors. “The region is strong up to a first product and approval, but the next stage needs investors across Sweden, the EU and the US,” Rajasekharan says. For example, Stockholm’s investment scene is more active.

He also finds EU medical device rules can be challenging for a small company to access due to longer and expensive process, although he notes this is changing with encouraging signals. He finally adds: “With a rich history in medical devices and now an important breakthrough with Amferia’s de novo, I think we could accelerate things from Gothenburg without having to go out and establish anywhere else.”