Cuprina Holdings Receives FDA Clearance for MEDIFLY Maggots
Cuprina Holdings (Cayman) Limited announced that its subsidiary, Cuprina Pte. Ltd., has received 510(k) clearance from the U.S. FDA for MEDIFLY Maggots™, a medical-grade Lucilia cuprina larvae product for maggot debridement therapy (MDT). This marks the first U.S. FDA clearance for a Lucilia cuprina maggot debridement product. MEDIFLY Maggots™ is indicated for debriding non-healing necrotic skin and soft tissue wounds. The company highlights that MDT offers a biological, non-antibiotic approach, which is particularly relevant given concerns about antimicrobial resistance. Cuprina now holds U.S. FDA commercial rights to both Lucilia cuprina and Lucilia sericata species, positioning it uniquely in the market. The FDA clearance is expected to support regulatory pathways in other international markets, including Saudi Arabia, Hong Kong, and China.