Anastomotic leakage is a frequent and severe complication following curative surgery for gastrointestinal (GI) diseases, occurring in up to 29% of all GI surgeries with a mortality rate of up to 35%. The increasing global number of incidences of colorectal cancer (1.8 million new cases annually), esophageal cancer (572,000 new cases annually) and inflammatory bowel disease (IBD, 7 million total cases) will result in more than 4.8 million anastomoses – making anastomotic leakages a huge problem and a EUR 1.14 billion market opportunity for Vivostat. In the EU, an anastomotic leakage from a colorectal surgery causes an increase in cost per patient by 4-fold due to the increased length of hospital stay, reoperation and rehospitalization. Globally, the incurred cost for anastomotic leakages is more than EUR 33 billion. Vivostat has developed the CE marked Obsidian ASG® - a best-in-class autologous bioactive fibrin matrix with improved tissue generation capabilities, reducing the anastomotic leakage rate by at least 50% compared to current methods. Clinical Phase II trial data shows that Obsidian ASG® had an anastomotic leakage rate of only 1.98% (2 leaks in 101 patients). In the OBSIDIAN project, we aim to reach a fully matured solution for anastomoses in colorectal surgery ready for commercialization, by securing funding for our large-scale multicenter clinical Phase III trial in the EU. Vivostat has a strong value chain including external strategic partners, distributors and clinical partnerships in DK, GE, AT, IT, ES, CH etc., who will be key to establish the large-scale clinical evidence needed to overcome market skepticism. In addition, it will ensure regulatory compliance with the upcoming Medical Device Regulation in the EU. As a result, Obsidian ASG® will save thousands of lives by reducing anastomotic leakages, decrease the immense global healthcare care spending, and generate an accumulated revenue of EUR 50.61 million 5-year post-project for Vivostat.
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