Cuprina Receives U.S. FDA 510(k) Clearance for MEDIFLY Maggots - the First U.S. Clearance for a Lucilia cuprina Maggot Debridement Product

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Cuprina Receives U.S. FDA 510(k) Clearance for MEDIFLY Maggots — the First U.S. Clearance for a Lucilia cuprina Maggot Debridement Product SINGAPORE, June 15, 2026 (GLOBE NEWSWIRE) -- Cuprina Holdings (Cayman) Limited (Nasdaq: CUPR) (“CUPR” or “the Company”), a biomedical company developing and marketing products for the chronic wounds, infertility, medical waste recycling, and cosmeceuticals sectors, today announced that an indirectly wholly-owned subsidiary of the Company, Cuprina Pte. Ltd. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for MEDIFLY Maggots™, its medical-grade Lucilia cuprina larvae used in maggot debridement therapy (MDT). To the Company’s knowledge, MEDIFLY Maggots™ is the first maggot debridement product to receive U.S. FDA 510(k) clearance using the Lucilia cuprina species. MEDIFLY Maggots™ is cleared for the debridement of non-healing necrotic skin and soft tissue wounds, including pressure ulcers, neuropathic foot ulcers, and non-healing traumatic or post-surgical wounds. The prescription product consists of medical-grade fly larvae applied to a wound under the supervision of trained healthcare professionals to remove dead and infected tissue and support the body’s natural healing process. Chronic non-healing wounds, including diabetic foot ulcers and pressure injuries, affect millions of patients and place a significant and growing burden on health systems. It is estimated that 1-2% of the population in developed countries suffer from chronic wounds [Falanga et al., 2022]. With FDA clearance, MEDIFLY Maggots™ should soon become available to wound-care providers across the United States. As a biological, non-antibiotic approach to wound debridement, MDT is also drawing renewed interest amid global concern over antimicrobial resistance. BUILDING ON THE HERITAGE OF MODERN MAGGOT THERAPYMEDIFLY Maggots™ received clearance based on substantial equivalence to Medical Maggots™, the Lucilia sericata product that became the first medicinal maggot cleared by the FDA in 2004. That clearance is held by Dr. Ronald A. Sherman, a pioneer of modern MDT and Cuprina’s Medical and Scientific Director.  Cuprina is the licensed producer and distributor of Medical Maggots™ for the U.S. market. With the MEDIFLY cl...

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