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

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

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.
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.
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