Cuprina gains FDA 510(k) nod for MEDIFLY Maggots

Cuprina Holdings (Cayman) Limited reported that its indirectly wholly owned subsidiary, Cuprina Pte.

(Neutral)

Form Type

6-K

Rhea-AI Filing Summary

Cuprina Holdings (Cayman) Limited reported that its indirectly wholly owned subsidiary, Cuprina Pte. Ltd., has received U.S. FDA 510(k) clearance for MEDIFLY Maggots, a medical-grade Lucilia cuprina larvae product used in maggot debridement therapy for chronic, non-healing wounds.

The product is cleared to debride non-healing necrotic skin and soft tissue wounds such as pressure ulcers, neuropathic foot ulcers, and non-healing traumatic or post-surgical wounds. The company believes MEDIFLY Maggots is the first maggot debridement product using the Lucilia cuprina species to receive U.S. FDA 510(k) clearance.

Cuprina now holds FDA commercial rights to both species used in maggot debridement therapy, Lucilia sericata and Lucilia cuprina, which it views as a distinctive position as it builds its wound-care presence in the United States and other markets.

Positive

U.S. FDA 510(k) clearance for MEDIFLY Maggots establishes regulatory validation in a major market and could open commercial opportunities for Cuprina’s chronic-wound portfolio.
Dual-species maggot debridement portfolio (Lucilia sericata and Lucilia cuprina under U.S. FDA clearance or rights) may give Cuprina a differentiated position when expanding into diverse international wound-care markets.

Negative

None.

Insights

FDA 510(k) clearance strengthens Cuprina’s wound-care platform and global expansion plans.

Cuprina has obtained U.S. FDA 510(k) clearance for MEDIFLY Maggots, a Lucilia cuprina-based maggot debridement therapy. This gives regulatory validation in a key market and expands options for treating chronic non-healing wounds like pressure ulcers and neuropathic foot ulcers.

The company already produces the FDA-cleared Lucilia sericata product Medical Maggots, licensed from Dr. Ronald Sherman. Holding commercial rights to both maggot species used in maggot debridement therapy may help Cuprina tailor products to different geographies where each species is better known.

The press release notes that FDA 510(k) clearance is a globally recognized benchmark and may support regulatory registrations in markets such as Saudi Arabia, Hong Kong and mainland China, though timing and outcomes depend on each national regulator. Execution will hinge on physician adoption, manufacturing, and supply capabilities.

Key Figures

Chronic wounds prevalence: 1–2% of the population First medicinal maggot FDA clearance year: 2004 CBER oversight change: December 2024 +1 more

4 metrics

Chronic wounds prevalence 1–2% of the population Estimated share of people in developed countries with chronic wounds

First medicinal maggot FDA clearance year 2004 Year Medical Maggots (Lucilia sericata) was first cleared by the FDA

CBER oversight change December 2024 Month and year FDA’s CBER assumed oversight of medicinal maggots

FDA pathway 510(k) clearance Regulatory pathway used to clear MEDIFLY Maggots in the United States

Key Terms

510(k) clearance, maggot debridement therapy, Lucilia cuprina, Center for Biologics Evaluation and Research, +1 more

5 terms

510(k) clearance regulatory

"has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for MEDIFLY Maggots"

A 510(k) clearance is a U.S. regulatory approval that lets a medical device be sold because it is shown to be substantially similar to an already-legal device; think of it as a passport saying the new product is close enough to a known item to enter the market without a full, lengthy review. For investors, 510(k) clearance signals faster, lower-cost market access and reduced regulatory risk compared with new, untested device pathways, which can materially affect timelines, costs and revenue prospects.

maggot debridement therapy medical

"used in maggot debridement therapy (MDT)"

Maggot debridement therapy is a medical wound-treatment that uses sterilized fly larvae to remove dead tissue, reduce bacteria, and promote healing; think of the larvae as tiny, living vacuum cleaners that clear away damaged material without cutting. It matters to investors because clinical evidence, regulatory approvals, manufacturing scale and insurance coverage determine whether products or services based on this therapy can be commercially adopted and generate predictable revenue.

Lucilia cuprina medical

"medical-grade Lucilia cuprina larvae used in maggot debridement therapy"

Center for Biologics Evaluation and Research regulatory

"was reviewed and cleared by the FDA’s Center for Biologics Evaluation and Research (CBER)"

The Center for Biologics Evaluation and Research (CBER) is the U.S. regulatory unit that reviews and approves biological medicines and vaccines, similar to a safety and quality inspector for complex medical products made from living cells. Investors watch CBER because its decisions on approvals, safety alerts, or production standards can quickly affect a company’s ability to sell products, generate revenue, or face costly delays and recalls.

forward-looking statements regulatory

"may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995"

Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Cuprina Holdings (CUPR) announce regarding MEDIFLY Maggots?

Cuprina announced that its subsidiary received U.S. FDA 510(k) clearance for MEDIFLY Maggots, a Lucilia cuprina maggot debridement therapy product. This clearance allows use for debriding non-healing necrotic skin and soft tissue wounds under trained healthcare supervision in the United States.

Why is the MEDIFLY Maggots FDA clearance significant for Cuprina (CUPR)?

The clearance gives MEDIFLY Maggots official U.S. regulatory recognition, which the company describes as a key benchmark. It complements Cuprina’s existing Medical Maggots product, creating a dual-species maggot debridement portfolio and potentially strengthening its wound-care platform and competitive positioning.

What types of wounds is MEDIFLY Maggots cleared to treat in the U.S.?

MEDIFLY Maggots is cleared for debridement of non-healing necrotic skin and soft tissue wounds. Indications include pressure ulcers, neuropathic foot ulcers, and non-healing traumatic or post-surgical wounds, where removing dead and infected tissue helps support the body’s natural healing process.

How does MEDIFLY Maggots relate to Cuprina’s Medical Maggots product?

MEDIFLY Maggots, based on Lucilia cuprina, received 510(k) clearance using substantial equivalence to Medical Maggots, a Lucilia sericata product cleared in 2004. Cuprina is the licensed producer and distributor of Medical Maggots in the U.S. and now holds commercial rights to both MDT species.

Could the MEDIFLY Maggots clearance help Cuprina (CUPR) expand internationally?

Cuprina believes the FDA 510(k) clearance, a globally recognized benchmark, may support regulatory pathways in markets like Saudi Arabia, Hong Kong and mainland China. Any expansions remain subject to local regulatory requirements and timelines as the company builds its chronic wound-care presence.

What medical need does MEDIFLY Maggots address in chronic wound care?

MEDIFLY Maggots targets chronic non-healing wounds, such as diabetic foot ulcers and pressure injuries, which affect millions of patients. An estimated 1–2% of people in developed countries suffer chronic wounds, creating a significant burden on healthcare systems that debridement therapies aim to reduce.

AI-generated analysis. How Rhea-AI works. Not financial advice.

Form 6-K: How Foreign Companies Report to the SEC →

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Accepted by SEC EDGAR 06/15/2026 - 09:00 AM

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of June 2026

Commission File Number: 001-42288

Cuprina Holdings (Cayman) Limited

(Registrant’s Name)

c/o Blk 1090 Lower Delta Road #06-08

Singapore 169201

(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F ☒ Form 40-F ☐

INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K

On June 15, 2026, Cuprina Holdings (Cayman) Limited (the “Company”) issued a press release announcing receipt of clearance from the U.S. Food and Drug Administration (FDA) for MEDIFLY Maggots. This press release is furnished herewith as Exhibit 99.1.

Exhibit Index

Exhibit No.		Description
99.1		Press Release dated June 15, 2026

SIGNATURES

Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

	Cuprina Holdings (Cayman) Limited

	By:	/s/ David Quek Yong Qi
	Name:	David Quek Yong Qi
	Title:	Chief Executive Officer and Director

Date: June 15, 2026

Exhibit 99.1

Cuprina Receives U.S. FDA 510(k) Clearance for MEDIFLY Maggots —

the First U.S. Clearance for a Lucilia cuprina Maggot Debridement Product

SINGAPORE, June 15, 2026 – 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 1-2% of the population in developed countries suffer from chronic wounds [Falanga et al., 2022]. With FDA clearance, MEDIFLY Maggots™ should soon become available to wound-care providers across the United States. As a biological, non-antibiotic approach to wound debridement, MDT is also drawing renewed interest amid global concern over antimicrobial resistance.

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

Source: View Original Filing on SEC EDGAR

Filing Exhibits & Attachments

2 documents

Cuprina gains FDA 510(k) nod for MEDIFLY Maggots