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Personalised Bioelectronics for Epithelial Repair

Periodic Reporting for period 1 - ProBER (Personalised Bioelectronics for Epithelial Repair)

Reporting period: 2023-06-01 to 2024-11-30

Wound healing is a fundamental biological process that most of us take for granted. However, for individuals with chronic conditions such as diabetes or for the elderly, the ability of the skin to repair itself is severely compromised. This can lead to persistent wounds that fail to heal, resulting in pain, infection, and a significant burden on healthcare systems. Chronic wounds not only reduce the quality of life for millions of people but also generate substantial costs for medical care, especially in Europe, where aging populations are on the rise.

One of the key factors in wound healing is re-epithelialization—the process by which skin cells migrate to close a wound. Natural skin is more effective than any artificial dressing, making it essential to develop strategies that accelerate this process. Among various approaches, electrical stimulation therapy has shown promise in guiding epithelial cells through electrotaxis, a process where cells move in response to an electric field. Despite a strong body of research supporting this concept, electroactive wound healing therapy is not yet a widely available clinical tool. This gap exists because current technologies face practical and technical limitations that prevent the effective translation of in vitro findings into real-world applications.

Our project set out to bridge this gap by developing a novel technological platform that enables personalized electrotherapy for wound healing. Our innovation is based on delivering precise, controlled direct current stimulation (DCs) through advanced electrode materials, ensuring that the proper dosage reaches the wound at the right time. The ProBER idea originates from breakthrough technology developed in our ERC project SPEEDER, which allows us to translate well-established in vitro data into an effective, scalable, and patient-specific treatment strategy.

In ProBER we focused on three main objectives, which included
• Establishing a measurement, design, fabrication, and monitoring process for personalized bioelectronic therapy.
• Identifying regulatory pathways for clinical adoption under the MDR framework.
• Protecting the intellectual property of our innovation to ensure future development and commercialization.

By addressing a critical unmet need in wound care, our project has the potential to transform treatment strategies for chronic wounds, improve patient outcomes, and reduce healthcare burdens. This innovation marks a significant step toward a future where electrotherapy becomes a mainstream, accessible, and effective tool in the modern treatment for chronic wounds.
The technological development in ProBER was geared toward creating a Proof-of-Concept device, translating our previously established technology into a usable medical device while protecting our intellectual property. We addressed this by developing the required processes to fabricate a wound dressing device of adequate proportions for a particular wound based on laser-induced graphene electrodes coated with a conducting polymer hydrogel. The first step in this process was to develop an image processing algorithm capable of extracting a wound's actual geometry and dimensions from an image acquired with a conventional smartphone. The actual wound data is used in the fabrication of the wound dressing. We improved our technological concept, the required materials, and the processes for a cost-efficient and fast wound dressing fabrication that can be easily scaled up once a processing pipeline is established in a company setup. Furthermore, we have managed to develop and validate the implementation of a non-invasive monitoring approach that will complement our device's stimulation capabilities, providing users valuable and relevant information on the wound-healing process.

Besides the technological advancements achieved in ProBER, we focused on developing an adequate product-market fit and developing the entrepreneurial prospects of our vision. We performed a comprehensive market analysis and engaged with possible users and key opinion leaders in the chronic wound landscape. The insights provided by these key stakeholders were used to steer and guide technological development. Additionally, we established an intellectual property strategy, submitted a patent for our idea, and entered the technology transfer program of Chalmers Ventures, securing further incubation and maturing our concept into a future venture.
Through ProBER, we further matured our technological and business concept, increasing our innovation readiness level in key areas. The feedback from several stakeholders regarding the significant unmet need that our technology can address by bridging the gap between the conventional standard of care focused on wound management and the desired healing of wounds gives us confidence that we are on the right track. ProBER is a novel approach to the application of electrical stimulation in wound therapy and, to the best of our knowledge, is a first-of-its-kind combination of active healing therapy and constant remote monitoring.
Further research is needed to provide enough evidence that our technology can address the enormous burden chronic wounds place on people suffering from them. With this information and additional financing, we foresee a market entry of a ProBER device within the next 7 years, bringing us one step closer to changing the standard of wound care from management to healing.
ProBER uses electrical stimulation and constant monitoring to heal chronic wounds
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