A medical device for the selective dissection of pathological tissues and fibrosis

Informations projet

CADISS

N° de convention de subvention: 882323

DOI

10.3030/882323

Projet clôturé

Date de signature de la CE 4 Novembre 2019

Date de début 1 Decembre 2019

Date de fin 31 Mars 2020

Financé au titre de

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Coût total

€ 71 429,00

Contribution de l’UE

€ 50 000,00

Coordonné par

AUXIN SURGERY
Belgium

Periodic Reporting for period 1 - CADISS (A medical device for the selective dissection of pathological tissues and fibrosis)

Période du rapport: 2019-12-01 au 2020-03-31

Résumé du contexte et des objectifs généraux du projet

More than 10% of surgical procedures involve critical dissection steps whereby the pathological tissue is carefully separated from the healthy surrounding tissues. Despite the importance of selective dissection in surgical procedures, the current tools are sub-optimal because they are all still relying either on tearing force or on non-selective cutting, which frequently damage critical organs such as nerves, muscles and other organs.
The CADISS System is a novel method of dissection in general surgery based on the combination of mechanical surgery instruments with the topical deposition of a drug, which selectively facilitates separation of pathological tissues without using cutting instruments.
This feasibility study confirms the feasibility of the project in all technical, commercial and financial aspects. The main activities to be carried out include the development of new surgical tools, carrying out the required regulatory processes and scaling up production. We estimate an investment of €9.3M with €3.2M from the Grant support of the Accelerator Pilot SME Instrument and €6.1M from the equity finance under the EIC.

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

TECHNICAL FEASIBILITY. We have assessed the feasibility of our product development and regulatory strategy which includes pre-clinical and clinical studies.
COMMERCIAL FEASIBILITY. We have assessed our Freedom to Operate and the regulatory procedure in the EU and the USA. Our commercial analysis includes analysis of the market, end-users, drivers and barriers. We have also defined our commercial strategy.
FINANCIAL FEASIBILITY. We have performed the funding needs validation, delineated the cost structure and 5 years business projections. We will generate a big turnover and profit, reaching breakeven in 2023.
The Feasibility Study confirms the technical feasibility and commercial profitability of our project. Moreover, it shows the novelty of our innovation and the great benefits that would bring to patients and the health sector.

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)

Currently there is no effective solution for facilitating the dissection of pathological tissues that will successfully avoid unwanted damage during surgery. The CADISS system will have a big impact on 1) surgeons, providing an effective tool, 2) health systems and insurance companies, reducing the high associated costs, 3) patients and their relatives quality of life, and 4) our company´s growth.

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