Source: Media Outreach
Debrichem(R) offers a very effective, alternative approach to chronic wound care, initiating healing in more than 90 % of cases after one application[1]
CE mark and ISO 13485:2016 certification are important prerequisites for upcoming launches in markets worldwide
Chronic wounds affect 1 – 2 % of developed countries’ populations,[2] unsuccessful treatment may lead to enlargement of the wound, bone involvement or in the worst case, amputation[3]
Debrichem soon to be launched in Europe, Hong Kong, South Africa, New Zealand and Australia
ROTTERDAM, THE NETHERLANDS – EQS Newswire – 25 February 2021 – DEBx Medical, the Dutch medical technology company revolutionizing the management of chronic wounds, is excited to highlight today the successful completion of the CE conformity assessment procedure for Debrichem(R). The innovative topical agent offers a superior alternative to surgical debridement, 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 and the strength of the DEBx Medical team to achieve this quickly even in such difficult times. 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.
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.[4] 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,1 an important step in the healing process.[5] Due to its fast action and applicability outside the surgery room, Debrichem can easily be integrated within standard wound care procedures.4
“Being granted the CE mark and ISO 13485 certification for Debrichem in less than two years after founding DEBx Medical is an exciting and important milestone. I am proud of our achievements and would like to thank the whole team involved in this huge effort,” said Dr. Bertus Quint, founding CEO of DEBx Medical. “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.”
“In my day-to-day work, I experience the patients’ despair associated with chronic wounds and the doctors’ frustration with their inability to provide patients long-term healing. With the current COVID-19 pandemic, the situation has been exacerbated: many of our patients are in high-risk groups – elderly, diabetic or chronic cardiovascular patients – who now cannot go to the hospital for their urgently needed treatment,” said David L. Helfet, MD, Professor of Orthopaedic Surgery, Weill Cornell Medical College and Hospital for Special Surgery, New York Presbyterian Hospital. “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.”
Chronic wounds are defined as wounds that have not healed, at least in part, after 4 to 12 weeks.[6] Physiologically, healing of chronic wounds is corrupted, among other factors, by excess inflammation and a recurrent or persistent, if not drug-resistant, microbial infection, often in the biofilm on a wound bed.4 The current gold standard treatment, maintenance surgical debridement, is a painful procedure performed in a sterile environment. Surgical debridement does not reliably initiate healing of the wound but can be part of an extensive wound management program requiring patients to repeatedly come into the hospital. Not surprisingly, general quality of life is impaired in patients with chronic wounds.6 Chronic wounds are estimated to have a prevalence of up to 2 % in the general population.[7] The wound etiology has an impact on outcome, arterial ulcers and venous leg ulcers are notoriously difficult to heal. Chronic wounds are also a common comorbidity of diabetes,[8] 13 % of patients with diabetes in North America to 17 % in Belgium are suffering from chronic wounds.[9] The burden of chronic wounds to healthcare systems and society around the world is substantial, exacerbated by the high rate of amputation in especially diabetic patients which is close to 34 % for diabetic foot ulcers.8 In the UK alone, chronic wounds generated costs of GBP 5.6 bn in 2018. The total wound care costs in the UK increased annually by 8 – 9 % with chronic wounds accounting for the largest share.[10]
References[1] Cogo A et al., J Wound Care 2020;29(Sup7b):63-64. https://doi.org/10.12968/jowc.2020.29.Sup7b.1[2] Nussbaum SR et al., Value Health 2018;21:27-32. https://doi.org/10.1016/j.jval.2017.07.007[3] Strohal R et al., J Wound Care 2013; 22 (Suppl. 1): S1-S52. https://doi.org/10.12968/jowc.2013.22.Sup1.S1[4] Cogo A et al., Wounds 2021;33:1-8. https://www.woundsresearch.com/article/restarting-healing-process-chronic-wounds-using-novel-desiccant-prospective-case-series[5]http://www.shieldhealthcare.com/community/popular/2015/12/18/how-wounds-heal-the-4-main-phases-of-wound-healing/[6] Olsson M et al., Wound Repair Regen 2019;27(1):114-125. https://doi.org/10.1111/wrr.12683[7] Martinengo L et al., Ann Epidemiol 2019;29:8-15. https://doi.org/10.1016/j.annepidem.2018.10.005[8] McCosker L et al., Int Wound J 2019;16:84-95. https://doi.org/10.1111/iwj.12996[9] Zhang P et al., Ann Med 2017;49:106-116. https://doi.org/10.1080/07853890.2016.1231932[10] Guest JF et al., BMJ Open 2020;10:e045253. https://doi.org/10.1136/bmjopen-2020-045253
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