CryoBiopsy: a bi-modal temperature sample preservation device for standardized breast cancer biopsy

Project Information

CryoBiopsy

Grant agreement ID: 761525

DOI

10.3030/761525

Project closed

EC signature date 26 January 2017

Start date 1 February 2017

End date 31 May 2017

Funded under

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

SOREK MEDICAL SYSTEMS LTD
Israel

Periodic Reporting for period 1 - CryoBiopsy (CryoBiopsy: a bi-modal temperature sample preservation device for standardized breast cancer biopsy)

Reporting period: 2017-02-01 to 2017-05-31

Summary of the context and overall objectives of the project

In most types of cancer biopsy is used as part of the diagnosis. Traditionally, the tissue obtained is preserved by fixation with formalin, embedded in paraffin, sectioned to thin tissue layers, and then analysed histologically under the microscope. This technique provides relevant information on tissue overall morphology.
Current advances in biomedicine make an increased use of sophisticate molecular technologies which, rather than looking only at tissue morphology, analyse changes in biomolecules involved in cellular pathways that are altered during cancer progression (biomarkers). The technologies behind the analysis of biomarkers require tissue that has not been compromised by traditional biopsy fixation methodology with formalin. Biomarkers are extremely sensitive to degradation, and tissue must be frozen as soon as possible. Unfortunately, current biopsy devices are not designed to meet this challenge.
We have developed two different devices to automatically split the tissue sample in two during biopsy acquisition. These devices enable formalin fixation, which is ideal for histology analysis, and freezing of the other part for biomarker analysis.

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

We have assessed the technical viability of CryoBiopsy devices and performed a detailed market analysis, verifying the commercial potential to support our go to market activities. The financial viability plan indicates a total investment for Phase 2 project of €3 million and a maximum cash flow need of €3.5 million in year 2020, being €3 million from project needs and €0.5 million, from commercialization financial needs of the first years.

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)

The impact of our devices on healthcare can be dramatic as they are critical for optimal determination of biomarkers in tumours, which are the cornerstone for individualized treatment of cancer. Optimal individualized treatment can reduce healthcare costs, improve patients survival and quality of life. CryoBiopsy devices will save money and chemicals to pathology labs as they will streamline the processing of biopsy tissue samples and will eliminate the use of expensive kits, currently needed to reverse the deleterious effects of formalin fixing on biomarkers.
For our company, CryoBiopsy will generate cumulative revenues of €39.5 million after five years of commercialization and the creation of 20 positions

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