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

Project Information

CADISS

Grant agreement ID: 882323

DOI

10.3030/882323

Project closed

EC signature date 4 November 2019

Start date 1 December 2019

End date 31 March 2020

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

AUXIN SURGERY
Belgium

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

Reporting period: 2019-12-01 to 2020-03-31

Summary of the context and overall objectives of the project

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.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

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.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

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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