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.