DEBx Medical, the Dutch medical technology company revolutionizing the management of chronic wounds, has successfully completed the CE conformity assessment procedure for Debrichem – a disruptive and innovative topical agent for surgical debridement and an altnerative to the current standard of care.
Debrichem can now carry the CE mark for a medical device class IIb and has also been awarded ISO 13485:2016 certification. These certifications endorse the quality and safety of Debrichem to treat a high unmet medical need.
Debrichem is a topical desiccant gel for chemical wound debridement used for the treatment of chronic infected and/or necrotic wounds. This novel product desiccates (dehydrates) the biofilm and the pathogens in the wound bed, debriding the biofilm chemically instead of surgically. Surrounding healthy skin is not affected. The data underlying the CE mark approval show that, after a one-time 60-second application, more than 90% of wounds result in full granulation, an important step in the healing process. Due to its fast action and applicability outside the surgery room, Debrichem can easily be integrated within standard wound care procedures.
DEBx Medical plans first to launch Debrichem in Europe, South Africa as well as Hong Kong, New Zealand and Australia through a network of distribution partners; other markets will follow. DEBx Medical has started consultations with the FDA about the pathway to approval earlier this year.
Dr Bertus Quint, founding CEO of DEBx Medical, commented: “Chronic wounds are painful and debilitating and patients have very limited options for healing. With Debrichem, we set out to significantly improve this situation which is frustrating for healthcare professionals and patients alike. We believe that Debrichem has the potential to meaningfully improve health outcomes and quality of life for millions of patients worldwide.”
David L. Helfet, MD, Professor of Orthopaedic Surgery, Weill Cornell Medical College and Hospital for Special Surgery, New York Presbyterian Hospital, said: “The major advantage of Debrichem is that with a relatively simple, quick, one time application it destroys the biofilm. Removing the biofilm is absolute key to get chronic wounds to heal. Debrichem is an important step forward in the management of chronic wounds and will find its place in the standard of care in a very short time. It may even have the potential to become the new gold standard for debridement in chronic wound care.”
For more information, visit: www.debx-medical.com