A novel, efficient and minimally invasive medical procedure to treat anastomotic leakage during colorectal cancer surgery.

Informations projet

CTI

N° de convention de subvention: 863492

DOI

10.3030/863492

Projet clôturé

Date de signature de la CE 27 Mai 2019

Date de début 1 Mai 2019

Date de fin 31 Août 2019

Financé au titre de

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Coût total

€ 71 429,00

Contribution de l’UE

€ 50 000,00

Coordonné par

TECNOLINE SPA
Italy

Periodic Reporting for period 1 - CTI (A novel, efficient and minimally invasive medical procedure to treat anastomotic leakage during colorectal cancer surgery.)

Période du rapport: 2019-05-01 au 2019-08-31

Résumé du contexte et des objectifs généraux du projet

When patients are diagnosed with rectal cancer, they undergo surgery to remove the tumor and, in doing so, a section of the rectum is also removed. In order to eliminate waste normally, an anastomosis is performed, i.e. the remaining healthy parts of the colon are reconnected. One of the major adverse events that can take place following this surgery is an anastomotic leakage, to prevent this a temporary ileostomies used to reduce the risk of anastomotic leakage. Once the rectum has healed from the tumor removal, the ileostomy may be reversed. We have developed CTI, to be used in tube ileostomy, as alternative of the current practices. After the rectal tumor is removed during surgery, CTI is implanted in order to perform a tube ileostomy. Since CTI can be used instead of a loop ileostomy, a stoma does not need to be created and the complications associated with it are avoided. Approximately 8–11 days after implanting CTI, it is can be removed and discharged. By using CTI can save the health care system 30% of direct cost and within the Eu this translate to about €330M. More importantly using CTI will provide patients better health outcomes because they have faster recovery and lower risk of infection.

Travail effectué depuis le début du projet jusqu’à la fin de la période considérée dans le rapport et principaux résultats atteints jusqu’à présent

We have assessed the technical viability of CTI and performed a detailed market analysis, verifying the commercial potential to support our go to market activities. The financial viability plan indicates a total investment for Phase 2 project of €1.9 million will be needed. Allowing us to go into the market in 2022. We have identified the barriers for entry and we are currently working to expand our medical advisory board to support our development.

Progrès au-delà de l’état des connaissances et impact potentiel prévu (y compris l’impact socio-économique et les conséquences sociétales plus larges du projet jusqu’à présent)

The impact of our devices on healthcare can be dramatic we can reduce 30% in direct health care cost will allowing patients to have shorter recovery time and lowering their risks of infection. CTI includes a medical-grade silicone tube, inside which a metal spiral is inserted to guarantee the non-occlusion of waste passage. This will be the only product on the market that is specifically designed for tube ileostomy and we are working with leading key opinion leaders to finalized the design to ensure adoption of new technique will be seamless.

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