December 2019 - April 2020

Colorectal cancer is the 2nd most common form of cancer in Europe with 500.000 new cases every year. The surgical procedure involves removing the diseased part of the colon and reconnecting the healthy ends (creating an anastomosis) by using a sewing or stapling technique. The most dreaded complication is a leak from the anastomosis. A leak will cause stool material to enter the bowel cavity leading to an infection. A leak may occur in up to 20% of the cases and in around 10% of these cases the patient will die. An anastomotic leak is not easily detectable and may lead to a multitude of problems manifested in extended hospital stay/readmission, reoperations or death. Costs to the society of a leak is a factor 4 compared to the costs of a standard case without a leak (+ € 50.000).

Vivostat has successfully developed Obsidian ASG® to prevent a leakage. This is achieved through a combination of a new application technique and the advantage of a product that both seals and provides growth factors to accelerate the healing process. 

Pre-clinical studies indicate that the use of Obsidian ASG® reduces the leakage rate by more than 50%. To document this properly a randomized clinical trial (RCT) has to be conducted and the Phase 1 grant was used to design a clinical study and prepare and agree a protocol in preparation for ethics approval. Based on a hypothesis of being able to reduce the leakage rate by a minimum of 33% the required sample was calculated to be 1.300 patients.

Part of the grant was also used to prepare key elements of the business plan including the assessment of the addressable market size and a go-to market plan including sales and marketing activities towards customers and influencers. Besides convincing clinical data a commercial success requires that the product is being reimbursed by the payers. The required process and necessary documentation to apply for reimbursement in relevant major markets was also investigated.

If we are able to document in a planned RCT that the leakage rate can be reduced by more than 33% (and possibly more than 50%) this will be the first really significant improvement in anastomosis related surgery in more than 30 years and a giant leap that will be embraced by colorectal surgeons and the society.