For more than 4 years, we at Vivostat® together with Rivolution® have been working to develop and implement a new product that is focused on reducing anastomotic leakage in gastrointestinal surgery. This journey eventually led to the development of Obsidian® ASG, which combines a new intra-anastomotic application technique with the advantage of a product that both seals and provides growth factors to accelerate the healing process. After an initial observational trial, it is indicated that the use of Obsidian® ASG reduced leakage by more than 50% in gastrointestinal resections.

Gastrointestinal resections often result in anastomotic leakages:

• It occurs in up to 19% of gastrointestinal surgeries with a mortality rate of up to 35%, making it the most dreaded complication following GI surgery

• Cost per patient is 4x higher compared to an uncomplicated procedure

• About 450.000 anastomosis procedures in Europe every year to treat colorectal cancer

We are now proud to announce that Vivostat, after a competitive process, has been accepted to be part of the Horizon 2020 – EIC Accelerator Pilot program and receive funding to further research Obsidian® ASG as an effective method for reducing the anastomotic leakage rate in GI surgery. The EIC Accelerator funding will allow Vivostat to demonstrate a large-scale clinical Phase III trial, which will take place at min. 12 different clinics across the EU with more than 400 patients participating. The research will seek to indicate Obsidian® ASG as an effective method for reducing the anastomotic leakage rate in gastrointestinal surgery. The purpose of this study will be to gain large-scale data highlighting the sealing and healing benefits of Obsidian® ASG, which leads to its ability to significantly reduce anastomotic leakage in GI surgery.

This great achievement is the next step for Vivostat® to provide a leading innovative product to combat anastomotic leakage. Furthermore, this pivotal clinical trial will set the way for Vivostat to enter all EU markets with Obsidian® ASG before or by 2023 and subsequently the US, Asia, and Oceania in 2025. 

To read more information regarding Obsidian® ASG and the Vivostat® system  Click Here