Cuprina’s MEDIFLY Maggots Win FDA Clearance, Shares Soar Over 150%
CUPR•Cuprina Holdings won FDA 510(k) clearance for its MEDIFLY cuprina maggots, extending rights to both maggot species for debridement of necrotic wounds such as pressure and neuropathic foot ulcers. The approval sent shares up more than 150% while the company regained Nasdaq compliance by restoring a $1 bid price.
1. FDA 510(k) Clearance for MEDIFLY cuprina
Cuprina Holdings received 510(k) clearance from the FDA for its MEDIFLY Lucilia cuprina maggots, marking the first approval of this species for maggot debridement therapy. The prescription-only product treats non-healing necrotic skin and soft tissue wounds, including pressure ulcers, neuropathic foot ulcers and post-surgical wounds.
2. Market Exclusivity Across Two Maggot Species
The new clearance extends Cuprina’s exclusive commercial rights to both Lucilia cuprina and Lucilia sericata species, enhancing its ability to tailor therapy to regional preferences. The company leverages Lucilia sericata’s established presence since 2004 while expanding MEDIFLY cuprina into Asia and the Middle East.
3. Regulatory Compliance and Stock Reaction
Following the FDA approval, shares surged more than 150% as investors reacted to the expanded product portfolio. On the same day, Cuprina regained Nasdaq Capital Market compliance by restoring its share price above the $1 minimum bid requirement, eliminating delisting risk.
