Obsidian | Obsidian Anastomotic SafeGuard – A powerful and efficient tissue sealant method for reducing the anastomotic leak rate in colorectal surgery

Summary
Obsidian ASG® is the first – and only - autologous fibrin tissue sealant applicable for gastrointestinal anastomosis, that will significantly decrease the anastomotic leak rate, following gastrointestinal resection when treating Inflammatory Bowel Diseases (IBDs) or Colorectal Cancer. The current number of anastomotic leak rates is a large societal issue, as studies show rates as high as 19%. Considering that approx. 1.8 million new cases of colorectal cancer will occur worldwide in 2018 (being the 3rd most common cancer type), the number of leaks is astonishing – and this is only for colorectal cancer. Adding the number of IBD patients needing a resection, Obsidian ASG® faces a market potential of 0.79M patients just in Europe, Asia and Oceania every year. Leveraging on this market opportunity, Obsidian ASG® contains all the components needed for on-site prepation and application of an autologous platelet rich fibrin selant – a preparation that can be completed in less than 30 minutes. As the only product in the market, Obsidian ASG® offers 1) a long-term cost-effective procedure for gluing and sealing intestinal stump-ends; 2) A fast and natural stimulation of wound healing that significantly reduces the anastomotic leak rates; and 3) Full biocompatibility, eliminated risk of blood disease transmission and no thrombin or bovine components added to the blood or Obsidian ASG® solution at any time during the process. Yet, to reach market commercialization, we need to conduct a clinical study of Obsidian ASG® with 300+ colorectal pre-surgery patients. The SME P1 grant will be crucial for completing the design of the clinical study as well as setting up key partnerships for the proposed clinical study (to be set up in a SME-2b Instrument Project). As such, the SME-Instrument represents a huge opportunity for Vivostat A/S, as we expect to grow a solid business case year 1-5 post-project, with a total revenue of €24.97M and profits of €14.42M.
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More information & hyperlinks
Web resources: https://cordis.europa.eu/project/id/887644
Start date: 01-12-2019
End date: 30-04-2020
Total budget - Public funding: 71 429,00 Euro - 50 000,00 Euro
Cordis data

Original description

Obsidian ASG® is the first – and only - autologous fibrin tissue sealant applicable for gastrointestinal anastomosis, that will significantly decrease the anastomotic leak rate, following gastrointestinal resection when treating Inflammatory Bowel Diseases (IBDs) or Colorectal Cancer. The current number of anastomotic leak rates is a large societal issue, as studies show rates as high as 19%. Considering that approx. 1.8 million new cases of colorectal cancer will occur worldwide in 2018 (being the 3rd most common cancer type), the number of leaks is astonishing – and this is only for colorectal cancer. Adding the number of IBD patients needing a resection, Obsidian ASG® faces a market potential of 0.79M patients just in Europe, Asia and Oceania every year. Leveraging on this market opportunity, Obsidian ASG® contains all the components needed for on-site prepation and application of an autologous platelet rich fibrin selant – a preparation that can be completed in less than 30 minutes. As the only product in the market, Obsidian ASG® offers 1) a long-term cost-effective procedure for gluing and sealing intestinal stump-ends; 2) A fast and natural stimulation of wound healing that significantly reduces the anastomotic leak rates; and 3) Full biocompatibility, eliminated risk of blood disease transmission and no thrombin or bovine components added to the blood or Obsidian ASG® solution at any time during the process. Yet, to reach market commercialization, we need to conduct a clinical study of Obsidian ASG® with 300+ colorectal pre-surgery patients. The SME P1 grant will be crucial for completing the design of the clinical study as well as setting up key partnerships for the proposed clinical study (to be set up in a SME-2b Instrument Project). As such, the SME-Instrument represents a huge opportunity for Vivostat A/S, as we expect to grow a solid business case year 1-5 post-project, with a total revenue of €24.97M and profits of €14.42M.

Status

CLOSED

Call topic

EIC-SMEInst-2018-2020

Update Date

27-10-2022
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Horizon 2020
H2020-EU.2. INDUSTRIAL LEADERSHIP
H2020-EU.2.1. INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies
H2020-EU.2.1.0. INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies - Cross-cutting calls
H2020-EIC-SMEInst-2018-2020
H2020-SMEInst-2018-2020-1
H2020-EU.2.3. INDUSTRIAL LEADERSHIP - Innovation In SMEs
H2020-EU.2.3.0. INDUSTRIAL LEADERSHIP - Innovation In SMEs - Cross-cutting calls
H2020-EIC-SMEInst-2018-2020
H2020-SMEInst-2018-2020-1
H2020-EU.3. SOCIETAL CHALLENGES
H2020-EU.3.0. Cross-cutting call topics
H2020-EIC-SMEInst-2018-2020
H2020-SMEInst-2018-2020-1