Convatec update on InnovaMatrix® AC clinical data

London, UK, 20 September 2024 – Convatec, a leading medical products and technologies company, continues to make good progress in generating and disseminating clinical evidence for InnovaMatrix^® AC.

InnovaMatrix^® AC is a pioneering technology in the treatment of wounds and is the first-ever porcine placental-derived extracellular matrix (ECM) medical device cleared by the US Food and Drug Administration (FDA) for wound management.

As announced at Convatec’s H1 financial results, we are on track to publish strong results from the first phase of our real-world evidence (RWE) including venous leg ulcers (VLU), diabetic foot ulcers (DFU) and other indications in 2024*. We also intend to publish further RWE in H1 2025. Also as previously announced, Convatec initiated randomised controlled trials (RCTs) for both VLU and DFU earlier this year.

InnoVen RCT authorisation
Convatec is pleased to now announce that InnoVen, our RCT to evaluate InnovaMatrix^® AC for the treatment of VLU, has been authorised by the Institutional Review Board (IRB) in the United States (available on clinicaltrials.gov). Following a comprehensive planning process, national recruitment is underway for a multi-centre, blinded, RCT which seeks to assess superior clinical performance of InnovaMatrix^® AC over the standard of care.

InnoVen, is an adaptive design RCT with an interim analysis that enables Convatec to accelerate the execution process, ensuring that these advancements can benefit patients more quickly and efficiently. We expect to publish further information on InnoVen in 2025.

We will release a further update regarding our DFU RCT in the near future.

***

Clinical notes

In the US, it is estimated that over 1 million Medicare beneficiaries – a US-government health insurance programme – experience a venous leg ulcer in any given year^1,2. Venous leg ulcers (VLUs) account for approximately 70% of all chronic leg ulcers². Chronic wounds are typically defined as wounds that do not heal properly within a standard healing duration. 

Despite an established standard of care for chronic wounds, real world evidence suggests that in complicated hard-to-heal wounds, achieving healing rates greater than 40% is unlikely³. Chronic wounds have a multi-modal negative impact on quality of life with adverse effects on mental health, social interactions, and professional life. The estimated annual cost of treating VLUs in the United States in 2022 was over $4.9 billion, which includes expenses for practitioners, wound care products, hospital stays, medications, and compression therapy⁵.

Convatec’s InnoVen RCT is planning to enroll 120 subjects from up to 15 locations across the US. The primary endpoint of the study is wound closure at 12 weeks. Secondary endpoints include measurement of wound percent area reduction, time to wound closure, quality of life, pain, and durability of closure.

ID: NCT06606210 (clinicaltrials.gov)

Reference list

1. Rice JB, Desai U, Cummings AK, Birnbaum HG, Skornicki M, Parsons N. Burden of venous leg ulcers in the United States. J Med Econ. 2014 May;17(5):347-56.
2.https://data.cms.gov/summary-statistics-on-beneficiary-enrollment/medicare-and-medicaid-reports/medicare-monthly-enrollment (last accessed 13September2024)
3. Fife CE, Eckert KA, Carter MJ. Publicly Reported Wound Healing Rates: The Fantasy and the Reality. Adv Wound Care (New Rochelle). 2018 Mar 1;7(3):77-94.
4. Falanga, Vincent et al. “Chronic wounds.” Nature reviews. Disease primers vol. 8,1 50. 21 Jul. 2022.
5. Kolluri, Raghu et al. “An estimate of the economic burden of venous leg ulcers associated with deep venous disease.” Vascular medicine (London, England) vol. 27,1 (2022): 63-72. 

Editor notes

Following 510(k) FDA clearance, InnovaMatrix^® launched in the US in early 2022 as the first porcine placental-derived extra cellular matrix device. Our material is derived from a closed herd with a controlled diet and environment, ensuring high quality and low variability. Tricleanse process is pivotal in preserving the structural integrity of the matrix while reducing cellular debris, making our offering unique for wound care solutions.

The InnovaMatrix^® products are cleared for use by the FDA for the management of wounds including pressure ulcers, diabetic foot ulcers, venous leg ulcers, chronic vascular ulcers, surgical wounds (including post-Mohs surgery), partial/full-thickness wounds and trauma wounds. In 2023 revenue from InnovaMatrix^® products was $74 million, equating to just over 3% of Convatec’s Group revenue.

*During H1 2024, Intellicure Analytics, renowned for its unique wound care app and powerful real world data insights, completed a RWE study on InnovaMatrix by drawing on data from 502 US wound centres and practices. The data, which is to be presented at US national wound conferences later this year, shows total healing in 53% of wounds amongst a diverse at-risk population, where 44% of the wounds treated were life or limb-threatening. These are strong results for healing of wounds which are more challenging than those typically treated in RCTs.

Contact
Investor Relations: 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 around 10,000 colleagues, we provide our products and services in almost 100 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 2023 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