Cuprina Holdings said its medicinal larvae product, MEDIFLY Maggots, has been approved by the FDA to treat non-healing injuries, such as diabetic foot ulcers.
- The prescription product is approved for 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 latest clearance comes more than two decades after the company’s first maggot species was first approved by the FDA in 2004.
- Cuprina is the only company currently holding commercial rights to both maggot species used in maggot debridement therapy.
Shares of Cuprina Holdings (CUPR) soared on Monday after the Food and Drug Administration approved the company's latest product for maggot debridement therapy (MDT), a process that uses larvae to treat certain injuries to prevent the risk of limb amputation.
At the time of writing, CUPR stock was up more than 150%.
The U.S. regulator has given 510(k) clearance to Cuprina’s MEDIFLY Maggots, its medical-grade larvae from the Lucilia cuprina species. The company claims it is also the first product from this particular species to be approved for MDT.
The medical-grade fly larvae product, which is only offered through prescription, is approved for treating non-healing necrotic skin and soft tissue wounds, including pressure ulcers, neuropathic foot ulcers, and non-healing traumatic or post-surgical wounds, Cuprina said.
Notably, Cuprina is the only company currently holding commercial rights to both maggot species used in MDT: Lucilia sericata and Lucilia cuprina. The latest clearance comes more than two decades after Lucilia sericata was first approved by the FDA in 2004.
“The two species fit different markets, the company said in a statement. “Holding both lets Cuprina lead with whichever species a given market knows best, an advantage as the company expands its wound-care presence across Asia and the Middle East.”
FDA oversight of the company’s medicinal larvae product commenced in December 2024 and was officially cleared by the regulator’s Center for Biologics Evaluation and Research.
On Stocktwits, retail sentiment on CUPR turned ‘extremely bullish’ from ‘bullish’ over the last 24 hours, amid ‘extremely high’ message volumes.
CUPR stock has nearly tripled in value so far this year, but is down 79% over the last 12 months.
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