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Healing Exosomes for sKIN

Periodic Reporting for period 1 - HEXKIN (Healing Exosomes for sKIN)

Reporting period: 2016-12-01 to 2017-03-31

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.
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
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.
Schematic illustation of Exo-101 secretion.