USFDAJun 15, 2026, 09:02 AM
Cuprina Holdings Receives U.S. FDA Clearance for MEDIFLY Maggots
AI Summary
Cuprina Holdings announced that its subsidiary, Cuprina Pte. Ltd., received U.S. FDA 510(k) clearance for MEDIFLY Maggots, a medical-grade Lucilia cuprina larvae product for maggot debridement therapy. This marks the first U.S. clearance for a Lucilia cuprina maggot debridement product, expanding Cuprina's portfolio to include both major maggot species used in MDT. The product is cleared for debridement of non-healing necrotic skin and soft tissue wounds, and the company believes this clearance will accelerate regulatory pathways in other international markets.
Key Highlights
- Cuprina Holdings received U.S. FDA 510(k) clearance for MEDIFLY Maggots.
- MEDIFLY Maggots is the first U.S. FDA-cleared maggot debridement product using Lucilia cuprina species.
- The product is cleared for debridement of non-healing necrotic skin and soft tissue wounds.
- Cuprina now holds U.S. FDA commercial rights for both Lucilia sericata and Lucilia cuprina species.
- The clearance is expected to support and accelerate registration pathways in other markets like Saudi Arabia, Hong Kong, and China.
- FDA's Center for Biologics Evaluation and Research (CBER) reviewed and cleared the product.
Price Impact
More from CUPR