HEXKIN

Objective

Currently, there are about 50 million reported cases globally of patients suffering from hard-to-close wounds, which constitute a severe cost burden to the global healthcare systems. Considering that for these patients up to 70% of the wounds may not heal with standard care, there is a high demand for new solutions with better efficacy for the treatment of wounds. Cell therapies have emerged as promising therapeutic strategies to solve the problem of chronic wounds, but the limited engraftment and survival of the cells have restricted their efficacy in late stages of human trials.

Exogenus is a spin-out company dedicated to develop a new therapeutic tool for the treatment of chronic wounds – Exo-Wound – which the company now seeks to clinically validate for diabetic ulcers. Exo-Wound is based on factors secreted by Umbilical Cord Blood (UCB) cells which accelerate the healing of skin wounds through models reveal important improvements in the healing capacity, treatment duration and biocompatibility when compared to competition. Nevertheless, in order to secure swift product development and successful commercialisation Exogenus is in need of partnerships and capital to overcome the classic ”Valley of death” gap. We believe the SME instrument is the ideal funding vehicle for us to establish Exo-Wound clinical validation and undertake the necessary activities to demonstrate safety and efficacy of the product in humans, and eventually achieve successful, global commercialization.

The project will contribute to place Exogenus in a competitive position within the advanced wound care market and assist Europe in maintaining its competitive position in the fast growing segment of active therapies. The accomplishment of the project objectives will lead to a significant business opportunity for Exogenus, and generate revenues of around €30 million, five years after market entrance.  

Summary of the context and overall objectives of the project

Exo-Wound is an innovative biological product derived from Umbilical Cord Blood for the treatment of chronic wounds, developed by Exogenus Therapeutics. Exo-Wound end-users are patients with hard-to-heal wounds for more than 6 weeks who are not responding to conventional treatment. These patients suffer from constant pain and impaired mobility, increased risk of infection, frequently leading to lower limb amputation, and increased risk of death. These patients struggle, with a dramatic decrease in quality of life, while facing social embarrassment from wound odor and exudate abundance, forcing them to withdraw from social and family activities. Chronic wounds also constitute a heavy burden for the health care systems, with each treatment costing an average €10k. The main goals of this project were to: validate Exo-Wound competitive advantages and market size, its novelty, define the clinical and regulatory strategy, and select the stakeholders necessary for the Phase 2 innovation project.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

During the project we: i) analysed market potential and identified competitors for Exo-Wound; ii) identified the stakeholders for the Phase 2 project, namely to access UCB and implement the clinical trial; iii) evaluated the risk of other competing technologies compromising our freedom to operate; iv) validated our clinical and regulatory strategy by interacting with INFARMED; v) enquired key stakeholders of the value chain to validate the relevance of our product from the others perspective, enriching our value proposition. We now have a clear view of the value chain, and the added value of Exo-Wound, which has been validated by different stakeholders now integrated into a strong network that we have built during the project.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The key novelty of Exo-wound relies on the use of exosomes as active ingredient, and their capacity to regulate gene expression of the cells within the wound bed, which impact different pathways important for wound healing. Exo-wound will address several limitations associated with other solutions for chronic wound management such as: lack of regenerative effect, low effectiveness, strong secondary effects and complex manipulation. The advanced wound management products segment is a growing market, and it is expected to reach $12 billion in 2021. Predictive analysis of the potential savings suggests that the use of Exo-wound for the treatment of the three types of chronic wounds within EU, may lead to a total of € 1 800 millions savings per year.