Cuprina Receives U.S. FDA 510(k) Clearance for MEDIFLY Maggots — the First U.S. Clearance for a Lucilia cuprina Maggot Debridement Product
Rhea-AI Summary
Cuprina (Nasdaq:CUPR) received U.S. FDA 510(k) clearance for MEDIFLY Maggots, a Lucilia cuprina maggot debridement therapy product. It is, to the company’s knowledge, the first U.S.-cleared MDT product using this species.
The product is cleared to debride non-healing necrotic skin and soft tissue wounds and gives Cuprina U.S. commercial rights to both Lucilia sericata and Lucilia cuprina MDT species, supporting global registration efforts.
Positive
- FDA 510(k) clearance for MEDIFLY Maggots Lucilia cuprina MDT product
- First U.S. 510(k)-cleared maggot debridement product using Lucilia cuprina
- Cleared for debridement of multiple non-healing necrotic wound types
- U.S. commercial rights to both Lucilia sericata and Lucilia cuprina MDT species
- 510(k) clearance may support registrations in Saudi Arabia, Hong Kong and mainland China
- CBER review establishes recognized U.S. regulatory foundation for MEDIFLY Maggots
Negative
- None.
News Market Reaction – CUPR
In the Jun 15 session, CUPR gained 111.84%, reflecting a significant positive market reaction. Argus tracked a peak move of +278.0% during that session. Argus tracked a trough of -5.5% from its starting point during tracking. Our momentum scanner triggered 67 alerts that day, indicating high trading interest and price volatility. Trading volume was very high at 4.5x the daily average, suggesting strong buying interest.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jun 12 | Listing compliance | Positive | +72.2% | Regained compliance with Nasdaq minimum bid price requirement. |
| May 29 | Reverse stock split | Negative | -27.3% | Completed reverse split and requested Nasdaq hearing after delisting notice. |
| May 22 | Share consolidation | Negative | -3.3% | Announced 1-for-8 share consolidation to address Nasdaq bid-price rule. |
| Mar 11 | Regulatory milestone | Positive | +8.1% | Saudi SFDA classification for MEDIFLY and advisory board strengthening. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
CUPR has shown strong positive reactions to regulatory and listing-compliance milestones, with no recent examples of negative divergence from seemingly positive news.
Over the past few months, Cuprina focused heavily on Nasdaq listing compliance and regulatory expansion. A 1-for-8 share consolidation and reverse split in late May aimed to restore the $1.00 bid price, followed by news on Jun 12 that the company regained Nasdaq compliance, which saw a 72.2% move. Earlier, on Mar 11, a regulatory milestone in Saudi Arabia for MEDIFLY and advisory board expansion coincided with an 8.11% gain. Today’s U.S. FDA 510(k) clearance extends this regulatory-driven trajectory.
Key Terms
510(k) clearance regulatory
maggot debridement therapy medical
antimicrobial resistance medical
Center for Biologics Evaluation and Research (CBER) regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
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
BUILDING ON THE HERITAGE OF MODERN MAGGOT THERAPY
MEDIFLY 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 clearance, Cuprina now holds U.S. FDA commercial rights to both maggot species used in maggot debridement therapy: Lucilia sericata, licensed from Dr. Sherman, and Lucilia cuprina, through its own MEDIFLY clearance. The Company believes this dual-species position is distinctive in the field and provides flexibility to serve clinicians and to pursue regulatory pathways in other markets.
The two species fit different markets. Lucilia sericata carries the longer track record in Western wound care, while Lucilia cuprina, found across Australia, Africa, Asia and parts of the Americas, is the species clinicians and regulators already recognise across many warmer-climate markets. 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.
“We now hold FDA clearance for both species used in MDT, a position no other company holds. This anchors our wound-care platform in one of the world’s most demanding regulatory markets and gives us a defensible edge as we continue to build our portfolio,” said David Quek, Chief Executive Officer of Cuprina.
“Maggot debridement therapy has earned its place in modern wound care, and adding a second FDA-cleared species strengthens the entire field,” said Dr. Sherman. “Lucilia cuprina has a meaningful international track record, and brings it under U.S. FDA clearance gives clinicians and their patients more flexibility in how this therapy is delivered.”
FDA 510(k) clearance is a globally recognized regulatory benchmark. The Company believes the clearance supports, and may help accelerate, registration pathways for MEDIFLY Maggots™ in other markets, including Saudi Arabia, Hong Kong and mainland China, where Cuprina is developing its wound-care presence. Any such registrations remain subject to the requirements and timelines of the relevant national regulatory authorities.
MEDIFLY Maggots™ was reviewed and cleared by the FDA’s Center for Biologics Evaluation and Research (CBER), which assumed regulatory oversight of medicinal maggots in December 2024. The clearance established a recognized U.S. regulatory foundation for the product and complements Cuprina's broader chronic-wound portfolio, creating commercial opportunities the Company continues to evaluate.
About Cuprina Holdings (Cayman) Limited
We are a Singapore-based biomedical and biotechnology company dedicated to the development and commercialization of innovative products for the management of chronic wounds, as well as operating in the infertility, medical waste recycling, and health and beauty sectors. Our expertise in biomedical research allows us to identify and utilize materials derived from natural sources to develop wound care products in the form of medical devices which meet international standards. For more information, please visit https://www.cuprina.com.
FORWARD-LOOKING STATEMENTS
Certain statements contained in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the Company’s belief that MEDIFLY Maggots™ is the first Lucilia cuprina maggot debridement product to receive U.S. FDA clearance; the commercial potential and market opportunity for MEDIFLY Maggots™; the Company’s plans to make the product available in the United States; and the potential for the FDA clearance to support or accelerate regulatory registrations in other markets, including Saudi Arabia, Hong Kong and mainland China. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties of obtaining regulatory clearances or registrations in jurisdictions outside the United States; the pace and extent of market adoption of maggot debridement therapy; risks related to commercialization, manufacturing and supply; and other factors discussed in the “Risk Factors” section of the Company’s filings with the U.S. Securities and Exchange Commission. For these reasons, among others, investors are cautioned not to place undue reliance upon any forward-looking statements in this press release. Any forward-looking statements contained in this press release speak only as of the date hereof, and Cuprina Holdings (Cayman) Limited specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.
Cuprina Holdings (Cayman) Limited Investor Contact
Investor Relations
c/o Blk 1090 Lower Delta Road #06-08
Singapore 169201
+65 8512 7275
Email: ir@cuprina.com.sg
Investor Relations Inquiries:
Skyline Corporate Communications Group, LLC
Scott Powell, President
1177 Avenue of the Americas, 5th Floor
New York, New York 10036
Office: (646) 893-5835
Email: ir@skylineccg.com
