Cuprina Holdings (Cayman) Limited (CUPR), a biomedical and biotechnology company, on Monday reported that its wholly-owned subsididiary Cuprina Pte. Ltd. received a 510(k) clearance from the U.S. Food and Drug Administration (FDA) for MEDIFLY Maggots in wound debridement.
Following the announcement, shares rose over 110% in Monday's trade.
Wound debridement involves the removal of all infected and necrotic tissue from the area surrounding an open wound, to prevent further infection or contamination. Chronic non-healing wounds, including diabetic foot ulcers and pressure injuries, affect an estimated 1%-2% of the population in developed countries suffer from chronic wounds.
The FDA previously approved the Medical Maggots product from the same company in 2004, for the treatment of open wounds. The product made use of the Lucilia sericata species, more commonly found in North America.
The MEDIFLY Maggot technique involves the use of Lucilia cuprina maggots to remove dead and infected tissue on non-healing necrotic skin and soft tissue wounds, including pressure ulcers, neuropathic foot ulcers, and non-healing traumatic or post-surgical wounds. L.cuprina is a species more common to warmer climates in Australia, Africa, Asia, and the Americas.
The product consists of medical-grade fly larvae, administered to the wound under medical supervision. It is seen as a viable alternative to antimicrobial techniques, as a biological, non-antibiotic approach to wound healing.
The clearance was granted by the FDA's Centre for Biologics Evaluation and Research (CBER), and will soon be commercially available for medical administration across the U.S. The company believes that the clearance will facilitate further regulatory approval in Saudi Arabia, Hong Kong and mainland China.
CUPR closed Monday at $8.41, up 111.84%. In the overnight trade, shares are trading at $7.96, down 5.35%.
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