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Bringing Surgery to the 21st Century: Feasibility Verification of Real-time Tissue Analysis During Surgery

Periodic Reporting for period 1 - Olfactomics (Bringing Surgery to the 21st Century: Feasibility Verification of Real-time Tissue Analysis During Surgery)

Reporting period: 2018-07-01 to 2018-09-30

There is a global economy-justified need for real-time analysis in surgery. Currently, cancer tumor removal operation 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 the operation, a reoperation is needed, leading to additional costs, impaired cost-effectiveness and impaired quality of life of the patient. The rate of incomplete removal of a tumor ranges from 10-60 % with the median being approximately 20 %.
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 operation and facilitating the use of existing instrumentation — the solution is based on non-invasive, real-time analysis of surgical smoke. The add-on Olfactomics device is compatible with existing surgical instrumentation (smoke suction devices and diathermy knife) and uninterrupted surgical workflow. The reoperation rate is significantly reduced. This results in significant benefits for the patient, surgeon, hospital and society. Olfactomics medical device can be efficiently implemented to 850 000 breast surgeries every year and the demand is growing. The market potential is high. An easily reachable market for the key application area (breast cancer surgery) is 850 M€. When expanded to all applicable specialties (such as prostate cancer, skin cancer, and intestinal surgery) the market value is over 2 billion €.
Olfactomics Ltd is a Finnish university-based spinoff company developing a novel technology for intraoperative, real-time surgical tissue assessment fully aligned with current clinical workflow and instrumentation. The company was founded in 2015 to commercialize the results of over 10 years of clinical and technical research. The team of 13 consists of specialists in surgery, clinical medicine, medical technology, software, data analysis, financial sector and corporate law. The team has excellent connections in the international healthcare industry and sensor technology industry.
The aim of this feasibility study was to analyse the feasibility from different perspectives.
The feasibility studyy covered technical, market and financial feasibility. The results were gathered to a full business plan for the global commercialisation of the technology. The first commercial product will be Olfactomics research device launched in 2019. The scale-up to Olfactomics medical device on breast cancer surgery will follow after CE-marking process. Scale-up to several surgical areas will follow. The commercialisation and scale-up strategies have been detailed and the partner network has been developed to better support the work. The company needs access to larger funding to develop business further, to complete the technology finalisation and to complete the CE marking process for the medical device.
The project resulted in a full business plan describing the steps to market. The impacts of the overall commercialization project by 2027 include: 3,000+ Olfactomics medical devices sold; 15 % of the attainable market, 300,000+ Olfactomics breast cancer surgeries performed, 70,000+ women saved from reoperation, 900+ M€ costs savings reached in health care, and 100+ M€ revenue and 200+ direct workplaces generated.
The pilot versions of Olfactomics device in research use