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ROTTERDAM, THE NETHERLANDS – EQS Newswire – 25 February
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Debrichem is a topical desiccant gel for chemical
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“Being granted the CE mark and ISO 13485
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“In my day-to-day work, I experience the
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Chronic wounds are defined as wounds that have
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\n2021 – DEBx<\/sup> Medical<\/a>, the Dutch medical technology company
\nrevolutionizing the management of chronic wounds, is excited to highlight today
\nthe successful completion of the CE conformity assessment procedure for
\nDebrichem(R). The innovative topical agent offers a superior alternative to
\nsurgical debridement, the current standard of care. Debrichem can now carry the
\nCE mark for a medical device class IIb and has also been awarded ISO 13485:2016
\ncertification. These certifications endorse the quality and safety of Debrichem
\nto treat a high unmet medical need and the strength of the DEBx<\/sup>
\nMedical team to achieve this quickly even in such difficult times. DEBx<\/sup>
\nMedical plans first to launch Debrichem in Europe, South Africa as well as Hong
\nKong, New Zealand and Australia through a network of distribution partners;
\nother markets will follow. DEBx<\/sup> Medical has started consultations
\nwith the FDA about the pathway to approval earlier this year.<\/p>\n
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\nwound debridement used for the treatment of chronic infected and\/or necrotic
\nwounds. This novel product desiccates (dehydrates) the biofilm and the
\npathogens in the wound bed, debriding the biofilm chemically instead of
\nsurgically. Surrounding healthy skin is not affected.[4]<\/a><\/sup>
\nThe data underlying the CE mark approval show that, after a one-time 60-second
\napplication, more than 90 % of wounds result in full granulation,1<\/sup>
\nan important step in the healing process.[5]<\/a><\/sup>
\nDue to its fast action and applicability outside the surgery room, Debrichem
\ncan easily be integrated within standard wound care procedures.4<\/sup><\/p>\n
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\ncertification for Debrichem in less than two years after founding DEBx<\/sup>
\nMedical is an exciting and important milestone. I am proud of our achievements
\nand would like to thank the whole team involved in this huge effort,” said
\nDr. Bertus Quint, founding CEO of DEBx<\/sup> Medical. “Chronic wounds
\nare painful and debilitating and patients have very limited options for
\nhealing. With Debrichem, we set out to significantly improve this situation which
\nis frustrating for healthcare professionals and patients alike. We believe that
\nDebrichem has the potential to meaningfully improve health outcomes and quality
\nof life for millions of patients worldwide.”<\/p>\n
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\npatients’ despair associated with chronic wounds and the doctors’ frustration
\nwith their inability to provide patients long-term healing. With the current
\nCOVID-19 pandemic, the situation has been exacerbated: many of our patients are
\nin high-risk groups – elderly, diabetic or chronic cardiovascular patients -
\nwho now cannot go to the hospital for their urgently needed treatment,”
\nsaid David L. Helfet, MD, Professor of Orthopaedic Surgery, Weill Cornell
\nMedical College and Hospital for Special Surgery, New York Presbyterian
\nHospital. “The major advantage of Debrichem is that with a relatively
\nsimple, quick, one time application it destroys the biofilm. Removing the
\nbiofilm is absolute key to get chronic wounds to heal. Debrichem is an
\nimportant step forward in the management of chronic wounds and will find its
\nplace in the standard of care in a very short time. It may even have the
\npotential to become the new gold standard for debridement in chronic wound
\ncare.”<\/p>\n
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\nnot healed, at least in part, after 4 to 12 weeks.[6]<\/a><\/sup>
\nPhysiologically, healing of chronic wounds is corrupted, among other factors,
\nby excess inflammation and a recurrent or persistent, if not drug-resistant,
\nmicrobial infection, often in the biofilm on a wound bed.4<\/sup> The
\ncurrent gold standard treatment, maintenance surgical debridement, is a painful
\nprocedure performed in a sterile environment. Surgical debridement does not
\nreliably initiate healing of the wound but can be part of an extensive wound
\nmanagement program requiring patients to repeatedly come into the hospital. Not
\nsurprisingly, general quality of life is impaired in patients with chronic
\nwounds.6<\/sup> Chronic wounds are estimated to have a prevalence of up to
\n2 % in the general population.[7]<\/a><\/sup> The wound
\netiology has an impact on outcome, arterial ulcers and venous leg ulcers are
\nnotoriously difficult to heal. Chronic wounds are also a common comorbidity of
\ndiabetes,[8]<\/a><\/sup> 13 % of patients with diabetes
\nin North America to 17 % in Belgium are suffering from chronic wounds.[9]<\/a><\/sup> The burden of chronic wounds to healthcare
\nsystems and society around the world is substantial, exacerbated by the high
\nrate of amputation in especially diabetic patients which is close to 34 % for
\ndiabetic foot ulcers.8<\/sup> In the UK alone, chronic wounds generated
\ncosts of GBP 5.6 bn in 2018. The total wound care costs in the UK increased
\nannually by 8 – 9 % with chronic wounds accounting for the largest share.[10]<\/a><\/sup><\/p>\n
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[1]<\/sup> Cogo A et al., J Wound Care
\n2020;29(Sup7b):63-64. https:\/\/doi.org\/10.12968\/jowc.2020.29.Sup7b.1<\/a>
[2]<\/sup> Nussbaum SR et al., Value Health
\n2018;21:27-32. https:\/\/doi.org\/10.1016\/j.jval.2017.07.007<\/a>
[3]<\/sup> Strohal R et al., J Wound Care 2013; 22
\n(Suppl. 1): S1-S52. https:\/\/doi.org\/10.12968\/jowc.2013.22.Sup1.S1<\/a>
[4]<\/sup> 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<\/a>
[5]<\/sup>http:\/\/www.shieldhealthcare.com\/community\/popular\/2015\/12\/18\/how-wounds-heal-the-4-main-phases-of-wound-healing\/<\/a>
[6]<\/sup> Olsson M et al., Wound Repair Regen 2019;27(1):114-125.
\nhttps:\/\/doi.org\/10.1111\/wrr.12683<\/a>
[7]<\/sup> Martinengo L et al., Ann Epidemiol
\n2019;29:8-15. https:\/\/doi.org\/10.1016\/j.annepidem.2018.10.005<\/a>
[8]<\/sup> McCosker L et al., Int Wound J
\n2019;16:84-95. https:\/\/doi.org\/10.1111\/iwj.12996<\/a>
[9]<\/sup> Zhang P et al., Ann Med 2017;49:106-116.
\nhttps:\/\/doi.org\/10.1080\/07853890.2016.1231932<\/a>
[10]<\/sup> Guest JF et al., BMJ Open
\n2020;10:e045253. https:\/\/doi.org\/10.1136\/bmjopen-2020-045253<\/a><\/p>\n
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