BRINGING SURGERY TO THE 21ST CENTURY: REAL-TIME TISSUE ANALYSIS DURING CANCER SURGERY. Improving Patient Safety, Quality and Cost-Effectiveness

Project Information

Olfactomics Surgery

Grant agreement ID: 848682

DOI

10.3030/848682

Project closed

EC signature date 5 March 2019

Start date 1 April 2019

End date 31 December 2022

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 2 649 375,00

EU contribution

€ 1 854 562,50

Coordinated by

OLFACTOMICS OY
Finland

Periodic Reporting for period 3 - Olfactomics Surgery (BRINGING SURGERY TO THE 21ST CENTURY: REAL-TIME TISSUE ANALYSIS DURING CANCER SURGERY. Improving Patient Safety, Quality and Cost-Effectiveness)

Reporting period: 2021-04-01 to 2022-12-31

Summary of the context and overall objectives of the project

Olfactomics Surgery is a project where Finnish Company Olfactomics develops a revolutionary device that enables cancer surgeons to do remove cancer tumors with better accuracy and less costs.

THE PROBLEM:
The surgical removal of the cancer tumor is based on preoperative imaging and postoperative pathological examination: Too much or too little tissue might be removed. There is a strong global trend towards more tissue-sparing and minimally invasive surgery. If all cancer is not removed in surgery, a reoperation is needed, leading to additional costs, impaired cost-effectiveness and impaired quality of life of the patient, increased cancer morbidity and mortality. The rate of incomplete removal of a tumor ranges from 10-60 % with the median being approximately 20 %

SOLUTION:
The breakthrough innovative Olfactomics medical device allows the surgeon to analyze the operated tissue in real-time during cancer surgery leading to optimal tissue removal without compromising the workflow of the surgery and facilitating the use of existing instrumentation — the solution is based on noninvasive, real-time analysis of surgical smoke. The reoperation rate is significantly reduced. This results in substantial benefits for the patient, surgeon, hospital and society.

IMPACT:
The novel medical device could save over 100 000 women from additional surgery for breast cancer and could save over 1 000 000 000€ in healhcare costs.

THE OBJECTIVE:
The objective of the project is to develop a commercially viable device for surgical margin assessment and build the evidence to support its adoption in Europe and beyond.

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

- A prototype of the device has been developed for technical iteration and usability studies.
- Olfactomics has has established a ISO 13485 -certified quality management system to enable efficient development of high-quality medical devices.
- A strategy for clinical testing has been established and extensive laboratory-based testing has been conducted.
- Olfactomics has worked extensively to build global awareness of its novel technology and was selected to a prestigious Medtech Innovator -accelerator as the first Finnish company and the only one in its batch to have received Horizon 2020 funding.
- FDA Breakthrough designation for the technology was obtained.
- The technology was demostrated in an operation room -environment

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)

Olfactomics has developed the fastest differential mobility spectrometer in the world for use in its demanding cancer surgery application and has a clear roadmap to bring the device to clinical practice. The technology has the potential to take the accuracy of cancer surgery to the next stage and the potential is not limited to breast cancer but has potential in applications such as brain, skin and oral malignancies as well. The more accurate surgery translates to significant clinical benefit for a large number of cancer patients, reduces healthcare costs and brings return on investment for Europe since the technology has global appeal.

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