In June, 2026, the U.S. Food and Drug Administration granted 510(k) marketing clearance to Singapore-based Cuprina Pte. Ltd., also known as Cuprina Wound Care Solutions, an indirect wholly-owned subsidiary of Cuprina Holdings, for its MEDIFLY Maggots™ product.  MEDIFLY Maggots™, is a biological medical device containing disinfected larvae of the blowfly Lucilia cuprina. The product is indicated for debriding non-healing necrotic skin and soft-tissue wounds, including pressure ulcers, neuropathic foot ulcers, and non-healing traumatic or post-surgical wounds (FDA, 2026).

I am devoting today’s post to this development because some reports about the marketing clearance have understandably generated confusion. Much of that confusion begins with the fly’s common name: the Australian sheep blowfly. That name deserves a closer look. That name deserves some context.

All references will be listed below, along with full disclosures. Background information about maggot therapy can be found here.

One species, two different subspecies

Lucilia cuprina is currently divided into two recognized subspecies: Lucilia cuprina cuprina and Lucilia cuprina dorsalis. They are remarkably similar morphologically and genetically, but their predominant ecologies are quite different.

L. c. cuprina occurs widely through the Americas, Asia and the Pacific region, as well as portions of northern Australia.  L. c. dorsalis occurs principally in most of Australia, as well as Africa, India and New Zealand (Kapoor et al., 2026).

Why does that matter?  Because the “Australian sheep blowfly” has an infamous reputation.

Flystrike, or sheep myiasis, causes considerable pain, morbidity and economic loss in the Australian sheep industry. The fly principally responsible for this is L. c. dorsalis, which initiates the great majority of Australian sheep flystrike cases. Recent studies describe this subspecies as predominantly parasitic and associated largely with rural livestock environments (Kapoor et al., 2026).

L. c. cuprina behaves quite differently. It is predominantly a necrophagous scavenger, feeding and developing in decomposing organic material. When L. c. cuprina does infest a living host, it feeds on dead tissue, not live tissue (Sherman, 2000). In North America, it is not considered an important cause of sheep myiasis. Comparative genomic studies now provide evidence that the strikingly different ecologies of the two subspecies – predominantly necrophagous in L. c. cuprina and predominantly parasitic in L. c. dorsalis – may be reflected in genetic differences between them (Kapoor et al., 2026).

Which L. cuprina is in MEDIFLY?

The subspecies used for MEDIFLY Maggots is Lucilia cuprina cuprina; not the predominantly parasitic L. c. dorsalis responsible for most Australian sheep flystrike. More specifically, the MEDIFLY lineage derives from the well-studied LA-07 strain of L. c. cuprina. Professor Aaron Tarone collected the founding flies during several collections in the Miracle Mile neighborhood of Los Angeles in 2007. Another laboratory colony was subsequently established in 2010 by Professor Maxwell Scott at North Carolina State University. These flies have been studied extensively by Professors Tarone, Scott, Kapoor, and other colleagues (Kapoor et al., 2026; de Paula et al., 2025).

L. c. cuprina LA-07 has been used in studies of genetics, genomics, insecticide resistance, sensory biology, sex determination and other aspects of L. cuprina biology. Most recently, investigators produced a chromosome-scale genome assembly of L. c. cuprina using material derived from this lineage, allowing direct genomic comparisons with the parasitic L. c. dorsalis (Kapoor et al., 2026).

Professor Scott provided the starter colony from which the L. c. cuprina material used in development of MEDIFLY was derived. Cuprina subsequently generated the testing required for its FDA submission. According to FDA’s 510(k) summary, laboratory testing demonstrated debridement performance comparable to the predicate Medical Maggots™ product, and FDA concluded that the differences between the products did not raise new questions of safety or effectiveness.

The BioTherapeutics Education & Research Foundation is also independently evaluating characteristics of this L. c. cuprina lineage, including its wound-debridement behavior, with the intention of publishing those findings. As a consequence, LA-07 may soon become one of the best characterized blowfly colonies; certainly one of the best characterized therapeutic blowfly colonies.

Why do we need another species?

There are already a maggot-debridement products on the U.S. market based upon the species Lucilia sericata. In fact, MEDIFLY’s predicate device was Medical Maggots™, the L. sericata product that received its original FDA clearance in 2004. Cuprina already licenses Medical Maggots™.  Thus, the clearance of MEDIFLY Maggots introduces a second Lucilia species into FDA-cleared maggot debridement therapy product category in the United States, and introduces a second species within Curpina’s U.S. product line.

That raises an obvious question: what might L. cuprina cuprina offer that L. sericata does not? Are there clinically meaningful differences in feeding behavior, development, environmental tolerance, debridement performance . . . or something else entirely? The question is obvious; the answer may not be. Several clues are already hiding in this post.

I will share some thoughts about this in a forthcoming post. In the meantime, I welcome your thoughts. Leave your ideas in the Comments section, below. I look forward to reading some ideas that I haven’t even yet thought of.

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References

FDA. 2026. BK251252—MEDIFLY Maggots. U.S. Food and Drug Administration. Decision date June 12, 2026. FDA MEDIFLY clearance page

FDA. 2026. 510(k) Summary: MEDIFLY Maggots, BK251252. U.S. Food and Drug Administration. FDA 510(k) summary

FDA. 2004/2026. Medical Maggots, K033391/BK251209. U.S. Food and Drug Administration.

Ingram, I. 2026. New Type of Maggots Cleared by FDA as Medical Treatment. Med Page Today. 06/15/2026.  

Kapoor S, Hickner PV, Dickey AN, et al. 2026. Comparative genomic analysis of necrophagous and parasitic subspecies of Lucilia cuprina (Diptera: Calliphoridae) provides important insight into their divergent biologies. International Journal for Parasitology. 56(1):104700. doi:10.1016/j.ijpara.2025.06.001.

Sherman RA. 2000. Wound myiasis in urban and suburban United States. Archives of Internal Medicine. 160(13):2004–2014. doi:10.1001/archinte.160.13.2004.


Disclosure

Ronald A. Sherman, MD, is one of the co-founders, and the current Director, of the BTER Foundation.  He is also an Advisor to Cuprina, serving as Medical and Scientific Director.  Dr. Sherman holds the original FDA 510(k) clearance for Medical Maggots™, cited as the predicate device in Cuprina’s MEDIFLY 510(k) submission. Cuprina licenses the U.S. marketing rights from Dr. Sherman.