NBIC’s Biofilm Awareness Week: Biofilms in Non-Healing Wounds

About DEBx Medical

My name is Bert Quint, I am the CEO and co-founder of DEBx Medical. In support of the first-ever biofilm awareness week, I would like to showcase how we contribute to battling biofilm related complications in wound care.

DEBx Medical B.V. was founded in 2019 by a strong team of four, consisting of a surgeon and expert in chronic wound management, a chemistry professor, a pharmaceutical industry experienced lawyer and myself with long-standing expertise in product development and executive functions.

We are a Dutch medical technology company dedicated to revolutionising the management of chronic wounds and improving the outcomes for millions of patients.

Our pipeline focuses on products targeting pathogens that corrupt wound healing. Our first product is a chemical composition that acts as a debridement agent for non-healing wounds, we therefore chose the name DEBRICHEM (DEBRIdement + CHEMical). DEBRICHEM® received a CE mark in early 2021 and is currently being launched in markets around the world.

Medical technology for non-healing or chronic wounds

In order for a chronic wound to heal, the balance between inflammation and tissue regeneration needs to be restored. However, 80% of chronic wounds have a biofilm. This is a thin layer of glycoproteic material formed by actively replicating bacteria, which adheres to the lesion and protects the infection.

Biofilm is often caused by planktonic bacteria that start embedding and multiplying to accumulate and become a polymicrobial structure. These same planktonic bacteria play an important role in the re-infection of the wound after treatment, by forming a new biofilm post debridement.

Replicating bacteria that form this biofilm contribute to aggravating the lesions and delaying the healing process to the point that the wound becomes chronic. A matured biofilm has become a polymicrobial structure that embeds its own micro-organisms and protects and nourishes them, at this point the wound becomes resistant to antimicrobials. Biofilm is invisible to the eye and it consists for 98% out of water (Malone M et all, J Wound Care, 2017).

Unsuccessful treatment of difficult to heal wounds may lead to enlargement of the wound, bone involvement or in the worst case, amputation. During the Covid-19 pandemic, amputations have tripled driven by wounds in diabetes patients as well as patients suffering from cardiovascular disease. Amputation survival rates are low, with only 20% of patients surviving after 5 years post-procedure.  

The economic burden of chronic (infected) wounds is enormous

Chronic wounds affect 1 to 2 % of developed countries’ populations at least once in their lifetime and represent a silent epidemic that affects a large fraction of the world population (Nussbaum SR et all, Value Health, 2018).

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 to 9 % with chronic wounds accounting for the largest share (Guest JF et all, BMJ 2020). These numbers exclude amputation costs which have tripled in the pandemic and have an 80% mortality rate over 5 years.

Chronicity and recurrence of infection are the main cost drivers in chronic wound care. In the USA, the direct cost of diabetic foot care is comparable to the total direct cost of cancer (Armstrong DG et all, J. Foot and Ankle res, 2020). The USA costs in 2018 for treating chronic wounds was estimated at ~$96.8bn for Medicare only, while strong drivers of the costs continue in an ageing population, with high obesity rates and the type 2 diabetes epidemic (Sen CK et all, wound Rep Reg, 2009).

Our Product

DEBRICHEM® is the world’s first wound debridement product developed to disrupt the biofilm with a unique mode of action. This new debridement treatment is based on desiccation of the biofilm to remove infection from non-healing wounds and periwound, allowing the healing process to restart.

What makes our product unique?

  • DEBRICHEM® allows for a simple and very fast procedure, which is only applied once.
  • DEBRICHEM® desiccates the biofilm, as well as the residing and planktonic micro-organisms within 60 seconds of application.
  • By instantly capturing water molecules from any type of exposed biological material, DEBRICHEM® has an immediate dehydrating effect, with minimal damage to the vital tissue below the wound bed.
  • After exposure to DEBRICHEM® the desiccated biofilm precipitates and coagulates together, this nonviable material separates from the underlying healthy surface over time by spontaneous detachment.

Within one minute of topical application this acidic red gel facilitates the removal of infection and biofilm in chronic wounds by desiccation, allowing healing to start in more than 90% of cases (Cogo, A et all, J Wound Care, 2020).

Current Competitive Situation

Debridement is the first step in cleaning a chronic wound, whereby physical removal of the dead and unhealthy tissue, with the biofilm and the pathogens inside it, is an essential part of all wound management regimes. There are several methods to debride wounds, the most common is surgical debridement since it is the most effective and fastest way to clean the wound, although costly. Unfortunately, the biofilm is not visible to the human eye and tends to be present also in deeper layers of the skin and tissue. This means that with one single debridement, you are unable to remove all bacteria and pathogens from the wound bed, which in turn start replicating and form a new biofilm that may cause reinfection. Therefore on average 3-6 surgical debridements are needed for the wound healing process to restart, resulting in discomfort for the patient and high costs.

The two main surgical debridement methods are used to clean millions of chronic wounds every year:

  • Sharp debridement removes non-viable tissue and biofilm from the wound bed with a scalpel.
  • Mechanical debridement by laser or a hydro surgical (liquid scalpel) method to remove the tissue.

DEBRICHEM® can be used outside a sterile room, unlike most debridement methods. It is a fast and easy procedure with a high success rate in even the most difficult of wounds (Cogo, A et all, Wounds 2021).

Current Unmet Needs Our Technology Addresses

DEBRICHEM® aims to disrupt the treatment of non-healing wounds, by curing the wound rather than treating wounds to maintain the status quo. The cost savings to the system are coming through as in most cases no operation room is required to apply DEBRICHEM® and it is a single application which is applied only once in the majority of cases for the wound to fully granulate within a median of 22 days (Cogo, A et all, Wounds 2021).

The cost savings come through at several levels:

  • Opening up time in the sterile room, as well as specialised staff, is hugely beneficial to clinics.
  • The efficacy, full granulation within 22 days median can reduced nurse time.
  • Wound pain and smell are coming down rapidly which is a relief to the patient and his/her environment, but most important the prevention of amputations could be the largest contributor to economic savings as well as the human cost.

In the Covid-19 pandemic, it has become clear that wound treatment needs to be moved away from the clinics into the home setting. DEBRICHEM® can play a crucial role in making cure rates in the home-setting more successful by addressing the biofilm early in this setting.

Our Wider Impact

DEBRICHEM® aims to disrupt the treatment of non-healing wounds, by curing non healing wounds rather than treating wounds to maintain status quo. Destroying the biofilm and its pathogenic constituents early will prevent escalation of chronic wounds keeping costs down while saving lives and limbs!

Our USP

The holy grail in chronic wound care is a product that is easy to use by healthcare professionals, that removes the infection completely and catalyses a quick wound healing process. DEBRICHEM® removes the biofilm and unhealthy tissue from infected zones of the skin within a few seconds after its application.

  • Fast and easy debridement procedure
  • Single-use medical device, one application is sufficient in most cases
  • No need for a surgical room
  • High wound closure rates in even the most difficult of wounds

There is a strong need to make the treatment of chronic cutaneous ulcers more effective and less inconvenient and, in particular, to overcome the significant limits by the known (surgical and non-surgical) debridement methods. DEBx Medical stands for improving healthcare and the quality of life of patients with innovative solutions to problems that cannot be solved with conventional medical treatments. We respond to developments and ever-growing concerns in healthcare; specifically, about the growing number of patients with chronic, infected wounds. Our core values are innovation and accessibility, while we have a strong focus on treatments at an affordable price, which is also easy to implement in daily clinical practice.

Has An Impact Already Been Made?

The impact of DEBRICHEM® on biofilm has been tested in an in-vitro biofilm model at the Ingham Institute of Applied Medical Research (AUS) and visualised by microscopic video at the Danish Institute of Technology (see DEBx Medical website). An article is under peer-review currently and will be published in a scientific journal. This study indicated that DEBRICHEM eliminated 100% of the biofilm with just one application.

Initial case studies show that DEBRICHEM® can make a real difference for patients with a bleak outlook since no other treatment seemed to improve their situation. These wound patients have regained perspective after treatment with DEBRICHEM® and often avoided amputation. We asked them how the treatment improved their situation and have listed some of the benefits, of which the reduction in wound pain is often the first indicator. The case reports of these patients and their wound healing journey are available, please feel free to contact us to receive a copy.

Call to Action

We are looking for academic collaborators to better understand the catalyst of wound healing post debridement with DEBRICHEM®. DEBx Medical is in the process of raising money to fund further research and the roll-out of DEBRICHEM® worldwide. If you would like to contact us, please use info@debx-medical.com.

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