DEBx Medical publishes first clinical data on novel desiccant gel for chemical debridement of infected, chronic wounds in peer-reviewed journal, Wounds

DEB^x Medical publishes first clinical data on novel desiccant gel for chemical debridement of infected, chronic wounds in peer-reviewed journal, Wounds

- Chemical debridement with newly developed desiccant agent (Debrichem^(R)) removes biofilm and pathogens, enabling the natural healing process to start^[1]

- Case series (n = 10) demonstrated full granulation of wound bed in all patients within 12 weeks after one-time application of desiccant agent^[1]

- Fast and easy application does not require sterile surroundings of surgery room^[1]

- Chronic wounds affect approximately 1-2 % of the general population in developed countries^[2] with different healing outcomes based on the woundsize and etiology of the wound^[3]

Rotterdam, The Netherlands, February 16, 2021 - DEB^x Medical, the Dutch medical technology company revolutionizing the management of chronic wounds, announced today that clinical data on the efficacy and safety of its novel desiccant debridement gel (Debrichem^(R)[*]) was published by three of its founders, Dr. Alberto Cogo, Dr. Bert J. Quint, and Dr. Carlo Alberto Bignozzi in the renowned medical journal, Wounds. In the peer-reviewed article, "Restarting the Healing Process of Chronic Wounds Using a Novel Desiccant: A Prospective Case Series", the authors describe how this newly developed debridement gel with strong desiccating properties facilitates the removal of the biofilm and infection from the chronic wound bed, resulting in full granulation of all wounds treated within 12 weeks.

The initial open-label prospective case trial shows the agent's desiccating effect on the wound bed, its effect on progression to granulation, and its side-effect profile. The case series involved ten patients (median age: 72.5 years) with chronic wounds in the lower extremity persisting for 6 to 52 weeks (median: 10 weeks) and covering a wound bed area of 8 to 140 cm² (median: 64 cm²). Included were the typical etiologies of chronic wounds (2 diabetic foot ulcers, 5 venous insufficiency leg ulcers, 1 revascularized ischemic leg ulcer, 1 vasculitic leg ulcer, 1 posttraumatic ulcer). Patients were treated with the debridement gel once and then followed up weekly for at least six months. All follow-ups included wound rinsing and re-dressing. The visit at which the wounds showed 100 % granulation was defined as the primary endpoint. All wounds proceeded to full granulation after a median time of 20.5 (7-78) days without the need for further intervention, such as surgical debridement or use of further medication. The only side effect of the chemical debridement treatment was transient pain (median time: 5 min; 1-180 min). Healthy skin surrounding the wound bed was degreased by the chemical debridement procedure but did not show redness, nodules or vesicles. In addition to the clinical data, the study presents in vitro data demonstrating the inhibition of bacterial growth induced through the debridement gel.

"Independent of the underlying morbidities, most chronic wounds do not heal due to persisting infections and their biofilm. In the case series presented, we demonstrate full granulation in all patients within 12 weeks after a one-time treatment with our novel desiccant gel. Given the low probabilities of chronic wound healing, this demonstrates the high efficacy of our debridement approach. When you reach granulation early in the treatment process you will save time and tissue by avoiding the wound to increase in size, bone involvement and the risk of amputation," said Dr. Bert Quint, co-author and founding CEO of DEB^x Medical. "We feel very encouraged by our findings that greatly improve the outcomes for patients and doctors. A follow-up randomized clinical trial to investigate the clinical benefit of this innovative desiccant agent is currently ongoing."

Chronic wounds are defined as wounds that have not healed, at least in part, after 4 to 12 weeks.^[4] These difficult to treat wounds have different healing outcomes based on the underlying conditions of the patients, the size of the wound and the wound etiology. In a recently analyzed dataset of more than 620.000 chronic wounds, a total of 58.9 % had healed after 12 weeks, thereof 34.8 % diabetic ulcers, 26.5 % venous ulcers, 14.9 % pressure ulcers, and 2.4% arterial ulcers.^[3]

About DEB^x Medical
DEB^x Medical B.V. is a Dutch medical technology company dedicated to revolutionizing the management of chronic wounds by enabling their healing, thereby improving the outcomes for millions of patients. DEB^x Medical aims to support doctors and their patients from diagnosis through treatment, follow-up care and maintenance of a healthy wound bed. The Company focuses its pipeline on targeting pathogens that corrupt wound healing, aiming to deliver affordable and effective treatment approaches that can easily be applied and implemented in daily clinical practice. After certification, DEB^x Medical intends to commercialize Debrichem^(R) through a worldwide network of distributors, with the first market launches expected in Q1 2021.

References

^[*] The formulation of the agent is described in patent application PTC NR: IB2019/051146. DEBx Medical intends to market the gel under the brand name Debrichem^(R) (DEBRix^(R) in South Africa).
^[1] Cogo A et al., Wounds 2021;33:1-8. https://pubmed.ncbi.nlm.nih.gov/33476282/
^[2] Nussbaum SR et al., Value Health 2018;21:27-32. https://doi.org/10.1016/j.jval.2017.07.007
^[3] Sang Kyu Cho et al., Advances in Woundcare 2020; 9:516-24. https://doi.org/10.1089/wound.2019.1091
^[4] Coleman S et al., J Tissue Viability 2017;26:226-240. https://doi.org/10.1016/j.jtv.2017.09.007