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

Información del proyecto

CADISS

Identificador del acuerdo de subvención: 882323

DOI

10.3030/882323

Proyecto cerrado

Fecha de la firma de la CE 4 Noviembre 2019

Fecha de inicio 1 Diciembre 2019

Fecha de finalización 31 Marzo 2020

Financiado con arreglo a

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Coste total

€ 71 429,00

Aportación de la UE

€ 50 000,00

Coordinado por

AUXIN SURGERY
Belgium

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

Período documentado: 2019-12-01 hasta 2020-03-31

Resumen del contexto y de los objetivos generales del proyecto

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.

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

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.

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)

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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