Amferia’s technology is a hydrogel permanently bonded with peptides, which kill pathogenic bacteria by drawing them close and physically puncturing their cell membranes. Even antibiotic-resistant bacteria cannot effectively resist this interaction, the company states.

Amferia was obliged to demonstrate that their novel mode of action kills 99.99% of bacteria exposed to it – an FDA threshold – without releasing active substances into the wound or the body.

To confirm the dressing’s efficacy and safety for FDA regulators, Amferia was obliged to demonstrate that their novel mode of action kills 99.99% of bacteria exposed to it – an FDA threshold – without releasing active substances into the wound or the body.

The FDA’s approval of Amferia’s innovation establishes a new regulatory category for antimicrobial wound dressings and enables a unique and powerful tool in the worldwide battle against wound infection, the company states.

“This approval validates years of scientific and regulatory work,” said Anand Rajasekharan, Amferia CEO & Co-Founder. “More importantly, it opens the door to safer, more sustainable ways to fight infection – at a time when the need for new antimicrobial strategies has never been greater. Bacterial infections are likely to surpass cancer and heart disease as a number one cause of human deaths in the future, and this is largely due to resistance to commonly used antibiotics. Our hydrogel technology enables the safe and stable use of antibacterial peptides, allowing them to effectively target bacteria without harming surrounding tissue.”