Press Release: DEBx Medical Receives CE Mark Clearance and ISO 13485 Certification for Debrichem®

Rotterdam, The Netherlands, February 25, 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®. 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. 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.

“Being granted the CE mark […]”

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In Depth: Debridement

The presence of a biofilm in a wound is known to be detrimental to wound healing as is the case with the presence of necrosis

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