DEBx Medical Receives CE Mark Clearance and ISO 13485 Certification for Debrichem(R), a Novel Desiccant Gel for Chemical Debridement to Initiate Healing in Infected, Chronic Wounds

• 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 – DEB^x 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 DEB^x
Medical team to achieve this quickly even in such difficult times. DEB^x
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. DEB^x 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 DEB^x
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 DEB^x 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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