Cuprina Receives FDA Clearance for MEDIFLY Maggots

Singapore, Singapore - Cuprina Holdings (Cayman) Limited (Nasdaq: CUPR) has announced that its subsidiary, Cuprina Pte. Ltd., has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for MEDIFLY Maggots. This approval marks the first U.S. clearance for a medical-grade Lucilia cuprina maggot debridement product.

Key Highlights:

• FDA Approval: MEDIFLY Maggots is the first product of the Lucilia cuprina species to receive U.S. clearance for maggot debridement therapy (MDT).
• Medical Application: The product is indicated for the debridement of non-healing necrotic skin and soft tissue wounds, such as pressure ulcers, neuropathic foot ulcers, and traumatic wounds.
• Dual-Species Capability: With this clearance, Cuprina now holds U.S. commercial rights to both major maggot species used in MDT: Lucilia sericata and Lucilia cuprina.

The company, which acts as the licensed producer and distributor for the previously cleared Lucilia sericata (Medical Maggots), believes this dual-species portfolio provides a significant strategic advantage. By offering both species, Cuprina can cater to diverse clinical preferences in different global markets, as Lucilia cuprina is widely recognized in warmer climates across Australia, Africa, and Asia.

The FDA clearance was processed through the Center for Biologics Evaluation and Research (CBER). Cuprina management noted that this regulatory milestone establishes a strong foundation in the U.S. market and is expected to facilitate potential regulatory registration pathways in other international territories, including mainland China, Saudi Arabia, and Hong Kong.