Periodic Reporting for period 1 - Bio2Skin (Bio2Skin, the first clinically skin-preserving biomaterial replacing silicones/acrylate as medical skin adhesives)
Reporting period: 2024-11-01 to 2025-10-31
External medical devices (ostomy pouches, wound dressings, wearable electronics) rely on adhesives to remain on skin for hours or days, but conventional acrylic, hydrocolloid and silicone adhesives often cause Medical Adhesive Related Skin Injuries (MARSI), an underreported issue in about 25% of wound care cases that leads to pain, inflammation, higher infection risk and treatment interruptions, with major patient burden and healthcare costs. Bio2Skin (BH4U) was developed to break this cycle: a patented, glueless, bio based and cost effective adhesive that uses the skin’s natural properties to create a gentle water based bond, overcoming drawbacks of petrochemical systems while providing secure medical grade adhesion and atraumatic, skin friendly removal, supporting better outcomes and more sustainable material use. With market potential over 250 million EUR by 2030, it will be commercialised under licence to adhesive and device manufacturers, enabling integration into existing and next generation products and de risking adoption of bio based materials across the sector. Reducing MARSI also brings economic and environmental gains through fewer unplanned dressing and device changes, lower consumption of dressings and materials, and less staff time; given that each change takes about 15 minutes and generates roughly 150 g of waste, and over 18 million people replace skin attached devices three times weekly with MARSI prevalence 3.4% to 25%, Bio2Skin could avoid 14.2 to 105 tonnes of disposal waste, cutting material and waste management costs and the environmental footprint of care. At the same time, by preventing recurrent pain and skin damage, it improves comfort, well being and dignity, especially for ostomates (around 0.1% of the world population, about 8 million people) and for patients with chronic wounds (2.21 per 1,000) and chronic leg ulcers (1.51 per 1,000), encouraging active patient participation, strengthening patient provider relationships and adherence, and improving outcomes and satisfaction. These impacts are supported by a sustainability strategy using renewable biomaterials to reduce petroleum dependence and carbon footprint, with energy efficient, low waste, circular economy focused development and manufacturing across the product life cycle, so clinical, economic, societal and environmental benefits reinforce each other and support a more effective, responsible and resilient healthcare system.
Bio2Skin has now been validated as a medical-grade bio-adhesive ready to progress towards regulatory certification and clinical evaluation. The material can be produced reproducibly at engineering scale, and a robust sterilisation process has been established in line with international standards, without compromising its structure, performance or safety.
A broad set of physicochemical, mechanical and preclinical biocompatibility studies has confirmed that Bio2Skin maintains its integrity, provides controlled adhesion and handling, and does not impair the skin barrier. In some tests, it has even shown indications of improved skin hydration compared with conventional materials used in similar applications. An independent safety assessment concluded that the raw materials and processing inputs are non-cytotoxic, commonly used in medical devices and suitable for prolonged skin contact, reinforcing the strong biocompatibility profile of the technology.
In parallel, Bio2Skin has been successfully incorporated into a first commercial use case in ostomy care, demonstrating seamless integration into standard manufacturing processes for one-piece ostomy pouches. Overall, the work completed so far shows that Bio2Skin combines safety, performance and manufacturability, positioning it as a promising bio-based adhesive candidate to help prevent medical adhesive-related skin injuries (MARSI) in demanding medical device applications.
A broad set of physicochemical, mechanical and preclinical biocompatibility studies has confirmed that Bio2Skin maintains its integrity, provides controlled adhesion and handling, and does not impair the skin barrier. In some tests, it has even shown indications of improved skin hydration compared with conventional materials used in similar applications. An independent safety assessment concluded that the raw materials and processing inputs are non-cytotoxic, commonly used in medical devices and suitable for prolonged skin contact, reinforcing the strong biocompatibility profile of the technology.
In parallel, Bio2Skin has been successfully incorporated into a first commercial use case in ostomy care, demonstrating seamless integration into standard manufacturing processes for one-piece ostomy pouches. Overall, the work completed so far shows that Bio2Skin combines safety, performance and manufacturability, positioning it as a promising bio-based adhesive candidate to help prevent medical adhesive-related skin injuries (MARSI) in demanding medical device applications.
Bio2Skin goes beyond the current state of the art in medical adhesives by uniting clinical performance, patient-centred design, economic efficiency and sustainability in a single solution. Unlike conventional acrylic/silicone adhesives, it is specifically designed to reduce MARSI and its downstream burden. Fewer unplanned dressing and device changes mean lower use of consumables, less staff time and significantly less waste. Based on published data (≈15 minutes and 150 g waste per dressing change; >18 million people replacing skin-attached devices three times per week; MARSI prevalence 3.4–25%), Bio2Skin is estimated to avoid 14.2–105 tonnes of waste, delivering quantifiable economic and environmental gains. With a market potential >250 M€ by 2030 and a licensing model for integration into existing and next-generation devices, it also de-risks and accelerates industrial uptake of bio-based materials.
Socially, Bio2Skin targets vulnerable groups that current adhesives do not adequately serve, notably ≈8 million ostomates worldwide (~0.1% of the global population) and patients with chronic wounds (2.21/1,000; leg ulcers 1.51/1,000). By preventing recurrent pain and skin damage, it enhances comfort, dignity and patient empowerment, reinforcing the patient–provider relationship and supporting better adherence and outcomes. Environmentally, Bio2Skin replaces petroleum-based inputs with biomaterials and is manufactured with energy efficiency, waste reduction and circular-economy principles in mind. This integrated approach ensures that improvements in patient quality of life go hand in hand with reduced resource use and a lower environmental footprint, clearly surpassing the performance-only focus of current adhesive technologies.
Socially, Bio2Skin targets vulnerable groups that current adhesives do not adequately serve, notably ≈8 million ostomates worldwide (~0.1% of the global population) and patients with chronic wounds (2.21/1,000; leg ulcers 1.51/1,000). By preventing recurrent pain and skin damage, it enhances comfort, dignity and patient empowerment, reinforcing the patient–provider relationship and supporting better adherence and outcomes. Environmentally, Bio2Skin replaces petroleum-based inputs with biomaterials and is manufactured with energy efficiency, waste reduction and circular-economy principles in mind. This integrated approach ensures that improvements in patient quality of life go hand in hand with reduced resource use and a lower environmental footprint, clearly surpassing the performance-only focus of current adhesive technologies.