Capture.PNG

 

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