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Bio2Skin, a novel biomaterial for medical skin adhesives

Periodic Reporting for period 1 - Bio2Skin (Bio2Skin, a novel biomaterial for medical skin adhesives)

Reporting period: 2019-08-01 to 2020-01-31

What is the problem/issue being addressed?

Medical adhesives are used by all age groups and across several healthcare settings. They are components of a variety of medical products including tapes, dressings, electrodes, ostomy products, skin-patches, kinesiology bands, etc. and they provide numerous functions.

We, BestHealth4U, have the solution to preventing Medical Adhesive-Related Skin Injuries (MARSI). MARSI occurs when superficial layers of skin are removed by medical adhesives in which erythema and/or other manifestation of skin trauma or reaction including formation of vesicles, bulla, skin erosion, and epidermal tears, persist longer than 30 minutes after removal of the adhesive. MARSI not only causes pain and discomfort but also put patients at a higher risk of infection and chronic damage. The increase of the severity of the skin injuries caused by the adhesive can lead to a chronic and prevalent injury, inflicting an immense economic and social impact to both patients and healthcare providers.

Our revolutionary glue-less adhesive solution, Bio2Skin, provides a more natural solution to adhere medical devices, drug delivery patches and wound dressings to prevent MARSI. Our pre-clinical studies have shown that it reduces the skin injury in prolonged use or upon removal. Bio2Skin is a material made from the combination of highly biocompatible chemically modified polymers and displays excellent adhesion properties. As opposed to artificial and chemical- and petroleum-based glues, environmentally friendly Bio2Skin binds to the natural features of skin offering good adhesion properties without damaging the skin either during use or upon removal. The biocompatible adhesive reduces or even completely eliminates skin damage caused by continuous use of current glue-based adhesives.

Why is it important for society?

Adhesive removal is considered one of the most painful wound-care interventions, affecting the patients’ safety, satisfaction and quality-of-life. Patient satisfaction scores have risen in importance as value-based measurements for hospitals and healthcare services. Patient experience criteria like pain management and overall perception of care affect total performance scores, which can impact hospitals’ bottom line.

The most common factor impacting patient susceptibility to MARSI is extremes of age, namely elderly, infants and neonates. Elderly patients are more susceptible to skin injuries, since their skin lacks elasticity and gets thinner as part of the natural aging process. Incidence of MARSI is also higher in the delicate skin of neonates and premature infants, as their skin is thinner and undeveloped, being more prone to dehydration, allergic reaction and tear. In conjunction with the inadvisable use of adhesive removal products and barrier films in sensitive skins, the incidence and prevalence of MARSI is even higher.

According to the US National Database of Nursing Quality Indicators, 8-22% of elderly patients in long-term care facilities and 11% of the neonatal intensive care population develop skin injuries due to medical adhesives. MARSI is extremely costly to hospitals, healthcare systems and health insurance providers. Treating these injuries entails costs in service provision, supplies, nursing care time and hospital beds resources. Preventing these skin injuries is more effective with adhesives such as Bio2Skin that do not cause damage or pain upon removal.

What are the overall objectives?

The overall objectives of this project were to rationally analyse the novel adhesive technology’s business potential for success. During the project we conducted a wide range of analyses which are of key importance to developing a successful go to market strategy: a market assessment, an initial route to market strategy and an exploitation plan. Here, we analysed different commercialisation channels and routes to market within the healthcare industry. We carried out this research in several stages, reflecting our development priorities alongside this project. Our aim was to identify and assess the medical adhesives market, alongside commercialisation opportunities.

We assessed the possibility for Bio2Skin applications across several healthcare settings. We have conducted a large number of specialised interviews with vital feedback and concluded that the best route-to-market is the medical adhesives for ostomy pouches vertical. Moreover, we have used this grant to improve our understanding of the market, by investigating market drivers and barriers in different healthcare sectors.
This Phase 1 Feasibility Study aimed to objectively and rationally analyse the novel Bio2Skin technology. We assessed the business model from several angles: technical, economical, IP and operational. Furthermore, it provided parallel analysis which are of key importance to developing a success strategy: a market assessment, an initial route to market strategy and an exploitation plan, in which we analysed different commercialisation channels supported by valuable feedback from a wide range of key industry players which we met with. Several of the industry players are very open to work with us and incorporate our product into their technologies. This will be continued in Phase 2.

We are aiming to introduce the technology to multiple sectors within the MedTech industry, with an initial focus on ostomy care followed by wound care. Simultaneously to the Phase 1 market research, technical feasibility was continued by assessing biocompatibility and cytotoxicity.

In addition, we have also taken advantage of the coaching facilitated by the European Commission. We have worked closely with our chosen coach and his input has been invaluable.
BestHealth4U aims to make a difference in health care: improve the quality of health and life of patients (end-users), reduce the cost of medical expenses and reduce the environmental impact of medical waste.

BestHealth4U’s first focus is to develop an advanced solution for MARSI which can arise from the single or long-term use of medical adhesives. MARSI is a widely under reported issue that can occur in all health care settings in wound dressing, ostomy care and in any case where medical devices must be adhered to the skin. Current adhesives in the market do not provide a solution for MARSI, as they are the main cause of these skin injuries. Therefore, there is an urgent need for a medical adhesive that offers good adhesion and is gentle to the skin.

Bio2Skin is a revolutionary new generation of medical-grade adhesives with a wide range of uses in the areas of medical devices, drug delivery patches and wound dressings. This disruptive adhesive will provide a welcome alternative to the current glues used in application of devices and dressings to the skin which tend to provoke severe skin problems.

Discussion and interviews with numerous Key Opinion Leaders (KOLs) and industry stakeholders validated a clear market need for Bio2Skin which we are poised to dominate. Several companies expressed interest in licensing or acquiring the Bio2Skin technology to replace current adhesive materials used in their respective companies, with several expressing significant interest in the ostomy application of the technology. Several NDAs have been signed and partnership / collaboration discussions are ongoing which we are hoping to progress in the next phase of Horizon 2020, the EIC Accelerator.
The Bio2Skin biomaterial solution