Convatec receives regulatory approval for ConvaNiox™

New solution set to improve outcomes for hard to heal wounds  

·         First nitric oxide-generating multimodal dressing technology with a potent antimicrobial^{1 2} and antibiofilm³* agent, nitric oxide. Full launch in 2026, following initial markets later this year

·         Highly complementary of Convatec’s strong advanced wound care portfolio and provides best-in-class⁴ transformative solutions for patients

·         60% more diabetic foot ulcers healed within 12 weeks of treatment versus the standard of care⁴

London, UK, 25 April 2025 – Convatec, a leading medical products and technologies company focused on solutions for the management of chronic conditions, confirms plans for an initial market launch of ConvaNiox^TM later this year, ahead of full launch in 2026. This new technology is powered by a potent antimicrobial^{1 2} and antibiofilm³* agent - nitric oxide - and is supported by strong clinical evidence. As ConvaNiox^TM scales up, it will initially be available for the management of diabetic foot ulcers (DFUs), for which it has demonstrated outstanding clinical results⁴, reducing wound area three times faster and increasing DFU healing by 60%, compared to the standard of care, in a randomised controlled trial.

Convatec’s pioneering research and development teams have developed ConvaNiox^TM following the acquisition of 30 Technology’s anti-infective nitric oxide technology in 2023⁵. When it comes to market later this year, ConvaNiox^TM will be the first nitric oxide-generating multimodal dressing in the wound care market. It has significant potential for life changing impact for those suffering from DFUs and Convatec continues to advance plans to leverage the new technology for other clinical indications.

DFUs affect 40–60 million globally⁶, resulting in disability^{7 8}, emotional distress^{7 8}, and higher healthcare costs – at $9-13 billion p.a. in the United States⁹ alone. DFUs account for 85% of diabetes-related amputations and a 2.5x higher 5-year mortality risk than people with diabetes without foot complications^{10 11}.

Following regulatory approval, ConvaNiox^TM will be available for DFU patients in France, Germany, Italy, Poland, Spain and the UK later this year as part of an initial market launch. Other markets will follow. The initial market launch will focus on secondary care and specialist clinics, supporting patients and healthcare professionals (HCPs) manage DFUs.

Less than 35% of DFUs successfully heal in a year¹². In a disease with many variables to control, small misses can be devastating. ConvaNiox™ has been designed to optimise the healing environment of DFUs and combat the challenge of biofilm by combining an advanced multimodal dressing technology with a potent antimicrobial^{1 2} and antibiofilm³* agent, nitric oxide.

David Shepherd, President & Chief Operating Officer, Advanced Wound Care at Convatec said: “ConvaNiox™ has significant potential for patients and healthcare professionals. Regulatory approval marks the beginning of what this new technology can bring to the treatment of chronic conditions. The reality for many patients is that sadly, big losses can start from small misses. ConvaNiox™ will offer patients and healthcare professionals renewed confidence by unlocking the potential of nitric oxide to treat a range of hard to heal wounds.

Dr Divakar Ramakrishnan, Chief Technology Officer and Head of Research & Development at Convatec said: “ConvaNiox™ is a novel multi-modal wound dressing, uniquely powered by nitric oxide technology and designed to provide a natural antimicrobial and antibiofilm mode of action with compelling clinical outcomes. Convatec will unlock the potential of this platform technology through our technical and translational science expertise. Antimicrobial resistance is one of the key challenges of our time and we believe the nitric oxide technology has significant potential for application across a multitude of MedTech devices, starting with advanced wound care. Convatec’s exciting innovation pipeline is the strongest in our history.”

Convatec is committed to helping patients and HCPs by raising awareness and sharing educational resources. Click here to learn more about nitric oxide and how big losses can start from small misses.

*Not all claims are supported in every market

Notes to editors
This announcement is consistent with the update shared at our FY24 results and there is no change to our FY25 guidance.

About Nitric Oxide (NO) 
NO is an essential molecule of the human immune response, produced in the body by nitrogen synthases (NOS) from L-arginine through a series of oxidation reactions¹³. The immune system uses NO to kill microorganism encapsulated within phagosomes through protein and DNA disruption¹⁴. The ability of NO to disrupt proteins, DNA, and act as a signal molecule, means NO can also be effective as an antibiofilm agent. Generation of NO in a wound dressing would be an effective method of disrupting biofilm within hard-to-heal wounds, such as diabetic foot ulcers (DFUs). Click here for more

Contact
Media: MediaRelations@convatec.com 
Investor relations: ir@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 over 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 about Convatec, please visit http://www.convatecgroup.com 

References
1. An evaluation of the antimicrobial efficacy of nitric oxide (NOx) generating dressings. Scientific Background Report. RPT-058749, 2023, Data on file, Convatec
2. Antimicrobial efficacy of real-time aged EDX110-5 dressing samples using a direct inoculation simulated wound fluid model against P. aeruginosa, MRSA and C. Krusei. RPT-064148, 2023, Data on file, Convatec
3. Assessing antibiofilm efficacy of CNAP dressings using the CDC biofilm reactor®. RPT-077512, 2024, Data on file, Convatec
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