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

Información del proyecto

Obsidian

Identificador del acuerdo de subvención: 887644

DOI

10.3030/887644

Proyecto cerrado

Fecha de la firma de la CE 5 Noviembre 2019

Fecha de inicio 1 Diciembre 2019

Fecha de finalización 30 Abril 2020

Financiado con arreglo a

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Coste total

€ 71 429,00

Aportación de la UE

€ 50 000,00

Coordinado por

Vivostat A/S
Denmark

Periodic Reporting for period 1 - Obsidian (Obsidian Anastomotic SafeGuard – A powerful and efficient tissue sealant method for reducing the anastomotic leak rate in colorectal surgery)

Período documentado: 2019-12-01 hasta 2020-04-30

Resumen del contexto y de los objetivos generales del proyecto

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 A/S 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.

Trabajo realizado desde el comienzo del proyecto hasta el final del período abarcado por el informe y los principales resultados hasta la fecha

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.

Avances que van más allá del estado de la técnica e impacto potencial esperado (incluida la repercusión socioeconómica y las implicaciones sociales más amplias del proyecto hasta la fecha)

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. By commercializing its innovative solution, Vivostat expects the following socio-economic impact (Year: Net profits € /New Employees):
2021: €0.3M/3; 2022: €0.9M/5; 2023: €1.6M/6; 2024: €2.8M/8; 2025: €4.3M/9.

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