Convatec update on InnovaMatrix® AC clinical data – second randomised controlled trial authorised
London, UK, 10 October 2024 – Convatec, a leading medical products and technologies company, continues to advance 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 United States (US) Food and Drug Administration (FDA) for wound management.
IDEAL RCT authorisation
Following Convatec’s statement on 20 September 2024 announcing our InnoVen RCT authorisation and recruitment in the venous leg ulcer (VLU) population, we are pleased to announce the authorisation of a second RCT evaluating efficacy of InnovaMatrix® AC in the treatment of diabetic foot ulcers (DFUs). The IDEAL trial (clinicaltrials.gov link) will evaluate for superior performance of InnovaMatrix® AC as an adjunct to standard of care versus standard of care alone. The trial has received Institutional Review Board (IRB) approval in the US and national recruitment will commence shortly.
IDEAL* 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.
ID: NCT06616844 (clinicaltrials.gov)
Update on InnoVen RCT
Patient recruitment for InnoVen, our VLU focused RCT, has commenced across multiple sites and is proceeding to plan.
We expect to publish further information on both the InnoVen and IDEAL RCTs in 2025 ahead of peer-review publication in 2026.
Our overall approach remains consistent with information published as part of our H1 financial results and subsequent trading updates.
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 Group revenues.
*IDEAL: Investigation of the Efficacy of Porcine Placental Extracellular Matrix AugmenteD Plus Standard of Care (SOC) Versus SOC AlonE for the Management of DiAbetic Foot Ulcers
Contact
Investor Relations: IR@convatec.com
Media: MediaRelations@convatec.com
Clinical notes
As of 2021, the International Diabetes Federation estimated that over half a billion people are affected by diabetes, representing over 10.5% of the world’s adult population1. In the United States (US) population, the Center for Disease Control and Prevention (CDC) estimated that there are 38 million Americans living with diabetes, including 8.7 million undiagnosed people2. The disease carries an enormous economic impact, with care for people diagnosed with diabetes accounting for 1 in 4 healthcare dollars spent in the US, representing a total estimated cost of $412.9 billion in 20222,3.
Diabetic foot ulcers (DFUs) are a major complication of uncontrolled diabetes and are associated with significant morbidities such as decline in functional status, infection, hospitalisation, lower-extremity amputation, and death. For patients with diabetes, the lifetime risk of developing a foot ulcer is 19% to 34% and is expected to continue to rise with increased longevity and consequent medical complexity. Among people with a DFU, the lifetime risk of lower-extremity amputation is approximately 20%, which carries an estimated 5-year mortality of 54-79% following minor amputation, and 53-91.7% following major amputation4.
A wound is considered hard-to-heal when it does not show progress towards closure, despite appropriate clinical invention and application of standard wound care practices5. In diabetic foot ulcers, a percent area reduction of 50% or more after 4-weeks of standard wound care has been demonstrated to be a robust predictor for wound healing outcomes at 12-weeks6,7. One approach to treating such hard-to-heal wounds involves the use of cellular, acellular, and matrix-like products (CAMPs). These materials have been used successfully for many years in wound care8. The device under investigation within this study is InnovaMatrix® AC, which is a decellularised preparation of porcine placental extracellular matrix (PPECM). The aim of this investigation is to determine whether PPECM augmented standard-of-care (PPECM+SOC) is more efficacious than standard-of-care (SOC) alone.
New evidence
At the recent Symposium on Advanced Wound Care (SAWC) summit in Las Vegas, Convatec, in association with Intellicure Analytics, presented real world evidence (RWE) on the efficacy of InnovaMatrix® in challenging wounds. In a retrospective analysis of the US Wound Registry, 60 wounds treated with InnovaMatrix® were identified and healing rates were assessed. Results showed 53% healing in this population of which 44% of wounds were classified as ’life or limb threatening’9.
References
1. Sun, H., et al., IDF Diabetes Atlas: Global, regional and country-level diabetes prevalence estimates for 2021 and projections for 2045. Diabetes Res Clin Pract, 2022. 183: p. 109119.
2. Prevention, C.f.D.C.a. National Diabetes Statistics Report Website. 06 September 2024]; Available from: https://www.cdc.gov/diabetes/php/data-research/index.html.
3. Parker, E.D., et al., Economic Costs of Diabetes in the U.S. in 2022. Diabetes Care, 2024. 47(1): p. 26-43.
4. McDermott, K., et al., Etiology, Epidemiology, and Disparities in the Burden of Diabetic Foot Ulcers. Diabetes Care, 2023. 46(1): p. 209-221.
5. van de Vyver, M., P.J. Idensohn, and C.U. Niesler, A regenerative approach to the pharmacological management of hard-to-heal wounds. Biochimie, 2022. 196: p. 131-142.
6. Sheehan, P., et al., Percent change in wound area of diabetic foot ulcers over a 4-week period is a robust predictor of complete healing in a 12-week prospective trial. Diabetes Care, 2003. 26(6): p. 1879-82.
7. Warriner RA, S.R., Cardinal MH., Differentiating diabetic foot ulcers that are unlikely to heal by 12 weeks following achieving 50% percent area reduction at 4 weeks. Int. Wound J, 2011. 8: p. 632-637.
8. Wu, S., et al., Best practice for wound repair and regeneration use of cellular, acellular and matrix-like products (CAMPs). Journal of wound care, 2023. 32(Sup4b): p. S1-S31.
9. Fife CE, Eckert KA, LeNoutillier B, Taylor CE, Marcinek B. Retrospective Analysis of Real-world Use of Porcine Placental Extracellular Matrix in Hard-to-Heal Wounds. Symposium on Advanced Wound Care Fall; 2-5 October 2024; Las Vegas, Nevada, US.
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
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