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

Informazioni relative al progetto

Olfactomics Surgery

ID dell’accordo di sovvenzione: 848682

DOI

10.3030/848682

Progetto chiuso

Data della firma CE 5 Marzo 2019

Data di avvio 1 Aprile 2019

Data di completamento 31 Dicembre 2022

Finanziato da

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Costo totale

€ 2 649 375,00

Contributo UE

€ 1 854 562,50

Coordinato da

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)

Periodo di rendicontazione: 2021-04-01 al 2022-12-31

Sintesi del contesto e degli obiettivi generali del progetto

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.

Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti

- 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

Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora)

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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