Convatec secures US and European regulatory clearance for Aquacel™ ConvaFiber™ wound care innovation

London, UK, 24 July 2025 – Convatec, a leading medical products and technologies company focused on solutions for the management of chronic conditions, today announces that it has achieved clearance in the UK, EU, Australia and US for Aquacel™ ConvaFiber™, a next-generation Hydrofiber^® dressing designed to manage a broad range of wounds, including venous leg ulcers, diabetic foot ulcers, pressure injuries, surgical wounds, and partial thickness burns¹. It will be available from 2026.

The clearance, which is a significant milestone, will allow millions of patients to benefit from an innovation that will improve wound care and represents a step change in patient care.

Building on Convatec’s proprietary Hydrofiber^® technology, first launched in 1996, the innovative design of Aquacel™ ConvaFiber™ has been engineered to maintain the benefits of Aquacel™ Extra, increasing both absorbency and intimate contact with the wound, while preserving its structural integrity upon use and removal. 

Manufactured in the UK, Aquacel™ dressings have shown to be cost-effective² for various wound types, both acute and chronic, demonstrating superior healing rates³ and reduced pain during wearing and removal³. The dressings are highly rated by healthcare professionals³ and support millions of patients worldwide each year. 

David Shepherd, President & Chief Operating Officer, Advanced Wound Care, Convatec, said: “Aquacel™ ConvaFiber™ builds on the significant legacy of Convatec’s Hydrofiber^® technology which has seen almost 1.5 billion Aquacel^® dressings sold worldwide over almost 30 years. This exciting innovation will further improve the quality of life of patients and sets a new standard in wound care by bringing the benefits of innovation directly to patients, while supporting healthcare professionals with a next-generation solution in their vital day-to-day roles.” 

Aquacel™ ConvaFiber’s™ regulatory approval marks another important milestone in Convatec’s strongest-ever innovation pipeline, following regulatory approval for ConvaNiox™ - the first nitric oxide-generating multimodal dressing for the wound care market.

Contacts

Analysts & investors: ir@convatec.com

Media: mediarelations@convatec.com

About Convatec 

Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With more than 10,000 colleagues, we provide our products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec’s revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit http://www.convatecgroup.com 

About Aquacel™ ConvaFiber™
Aquacel™ ConvaFiber™ is a soft sterile, conformable and highly absorbent dressing indicated for a broad range of wounds, including venous leg ulcers, diabetic foot ulcers, pressure injuries, surgical wounds, and partial thickness burns¹. It is designed for use in both acute and community care settings by healthcare professionals.

Studies demonstrated that Aquacel ConvaFiber had the highest absorption potential and the largest capacity when compared in-vitro, with other modern dressings with gelling properties^4,5. The optimised dressing design conforms to wound beds and maintains structural integrity upon removal, for undisturbed wound healing of even the most complex wounds.

Convatec has initiated a global clinical evidence strategy to further validate performance in real-world settings. Early lab data and health economic models support its use as a cost-effective alternative to antimicrobial dressings when bioburden is under control. 

The product is positioned as a step-down solution from antimicrobial dressings, offering clinicians a high-performance option for managing chronic wounds while optimising resource use.

The product gained CE & UKCA mark approval and Class 1 510K exempt FDA listing in July 2025.
References

(1) Only in the United States
(2) Barnea Y, Weiss J, Gur E. A review of the applications of the hydrofiber dressing with silver (Aquacel Ag) in wound care. Ther Clin Risk Manag. 2010 Feb 2;6:21-7. PMID: 20169033; PMCID: PMC2817785.)
(3) Carrere C, Nghi J, Duchier A, et al. Community setting survey evaluating Aquacel dressings. J Wound Care 2021; 30(9): 763-74.
(4) When tested in-vitro compared to Aquacel EXTRA TM, Algosteril, Kerracel TM, Durafiber^®, Exufiber^®, BIatain^® Fiber, Cutimed^® Gelling Fiber, Maxorb^® Extra, Opticel^®, Suprasor^® Liquacel Pro, DracoFiber, UrgoClean^®, Urgostart Plus Pad, Biatain^® Alginate, and Cutimed^® Alginate
(5) WHRI10175 MS193, In-Vitro Performance Characteristics of Aquacel ConvaFiber versus key competitors, 2025, Convatec