A powerful and efficient tissue regeneration method for reducing the anastomotic leakage rate in gastrointestinal surgery

For more than 4-years, Vivostat® together with Rivolution® have been working to develop Obsidian ASG® with the aim to reduce anastomotic leakage in gastrointestinal (GI) surgery.

Obsidian ASG® is a best-in-class autologous bioactive fibrin matrix with sustained release of active cells and growth factors providing improved sealing and healing.

A preliminary retrospective, single-arm study with 261 patients from two participating colorectal units in Austria, indicate that application of Obsidian ASG® at anastomotic site following colorectal resection is safe and associated with a low rate of anastomotic leakage of 2.3% (1). Obsidian ASG® may therefore reduce leakage by more than 50% in gastrointestinal resections.

Gastrointestinal resections often results in anastomotic leakages: • In Europe more than 450.000 new cases of colorectal cancer every year - most of these will undergo anastomosis surgery • In up to 19% of gastrointestinal surgeries the resection results in anastomotic leakage making it one of the most dreaded complication following GI surgery • The cost per patient experiencing anastomotic leakage is up to 4 times higher compared to an uncomplicated procedureThe EIC Accelerator funding allows Vivostat® to conduct a large-scale multicenter clinical trial across the EU (up to15 hospitals in 7 countries) with inclusion of approximately 440 patients.

The main objective of the study is to investigate whether the application of Obsidian ASG® during colorectal resection reduce the rate of postoperative anastomotic insufficiency compared to standard anastomotic technique.

Market access and reimbursement strategy with focus on Germany, marketing strategy with product launch plans as wells market expansion plans are also key elements in the project.

These activities will strengthen and accelerate the commercialization of Obsidian ASG® to the benefit of patients, surgeons, hospitals as well as job creation.(1) Shamiyeh et al. Obsidian ASG ® Autologous Platelet Rich Fibrin Matrix and Colorectal Anastomotic healing: A Preliminary Study.

Surgical Technologies International, Volume 39, 2021.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 53,49 million 5-year post-project for Vivostat.