Health care systems around the world are overburdened with snowballing costs for medical care. For many conditions, these economic changes are related to increasing numbers of persons with chronic illnesses, increasing age and higher levels of obesity. In particular, the prevalence of diabetes is increasing among all ages globally and the World Health Organization (WHO) estimates 60 million people currently have diabetes in the European Region. Many persons with diabetes suffer from comorbid conditions including diabetic foot ulcers (DFU) with the incumbent risk of amputation. The increase in hard to heal DFU and increasing cost has created an urgent need for a novel and cost-effective treatment, especially in the European region.
Kerecis® Omega3 Wound is a sustainably manufactured medical device made from decellularized intact fish skin designed to treat chronic wounds, such as hard to heal DFU’s. Kerecis has followed a complex process to bring this medical device to market with no religious or ethical barriers while meeting all regulatory requirements. Clinical research has shown Kerecis Omega3 Wound to be a safe and effective medical device with a rapidly growing list of scientific and clinical use publications around the world. The clinical data derived from this early research serves as a backbone for reimbursement dossiers in the EU and worldwide to support the widespread adoption of this innovative and cost-effective technology into patient care settings following international guidelines.
This project was funded through the Fast Track to Innovation (FTI) funding from Horizon 2020 with the overall objective to conduct a real world, clinically meaningful, randomized controlled trial on the most severe DFUs and to disseminate the results at scientific conferences, and to meet regulatory and reimbursement purposes in Europe, USA and other global geographies. This funding is directly linked, in part, to the commercial success of the consortium partners leading to increased revenue and a 10-fold increase in employment at Kerecis which grew from 50 to over 500 employees during the term of this grant.
This program facilitated completion of a successful randomized controlled trial, scientific publications, and the ongoing adoption of fish skin technology for wound and burn care in Europe, the United States, and other geographies around the world. In addition, Kerecis was acquired by Coloplast in the final days of the project which directly opened distribution potential into 130 new additional countries.
