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Reporting period: 2022-04-01 to 2023-01-31

• What is the problem/issue being addressed?
Tumour heterogeneity emerges as a major cause of therapy failure and resistance to various oncology treatments. Accurate identification of the biomolecular profile of manageable targets requires multiple samples that are collected throughout the target, high-quality tissue samples, and preservation of labile biomarkers. False positive or negative results from the evaluation of biomarkers, or incomplete biomolecular profile of the disease, can directly affect patient diagnosis, treatment and outcomes. For most types of cancer, where correct diagnosis is critical, biopsy is the main source for biomarkers. Most of current devices do not collect multiple samples from multiple sites as needed for accurate and reliable diagnosis and do not provide rapid preservation of tissue samples.
• Why is it important for society?
We develop the Multi-Core Biopsy Device (MCBD) to eliminate current limitations in biopsy collection and processing. The MCBD provides substantial cost saving through the following innovations and improvements:
- Multi-core biopsy acquisition from different sites in a volume of interest (VOI) through single needle insertion will cut down the duration of the biopsy procedure, will save costs on physician fee, nurse and other clinical staff fees, and scanner use, and will provide more comprehensive assessment of the target to better account for tumour heterogeneity.
- Multimodal preservation compared with current formalin preservation will cut down costs on the use of kits that are needed to analyse the formalin-fixed tissue samples.
- About 50-60% of breast biopsies are done with costly vacuum-assisted biopsy (VAB) devices with price tags of €300-400, compared with price tag of €50-60 per use with the motorized MCBD.
- The sectionable cartridge will eliminate manual handling of multiple biopsy samples and will reduce substantially the costs of downstream processing in the pathology lab.
The new MCBD device will contribute to the emerging concept of precision/ personalized medicine, that by targeting the best treatment to each patient will improve outcome for patients with treatable targets and will eliminate unnecessary, disabling therapies to non-suitable patients. This will have an enormous impact on society by improving quality of life and survival of patients, benefiting not only the patients but also to their families and caregivers.
• What are the overall objectives?
1 - Optimize the design of motorized MCBD for acquisition and rapid preservation of multiple biopsy samples from a volume of interest (VOI).
2 - Conduct animal tests to assess the advantages of motorized MCBD in comparison with standard biopsy device.
3 - Conduct clinical study to demonstrate advantages of motorized MCBD.
4 - Get FDA clearance and then CE mark for the motorized MCBD device.
5 - Achieve additional funding to enable commercialization of the developed technology and establish strategic partnership alliances with corporations from various fields – medical devices, pharmaceutical and In-Vitro Diagnostic companies.
1. Objective 1 - Development of motorized MCBD: Failure of the motorized MCBD in the animal study led us to focus on the second generation MCBD that eliminates the technical problems we had in the first generation MCBD and add unique feature of the use of curved needle that enables collections of tissue samples from a volume of interest. The second generation MCBD is an advanced device that was designed and built for future use as clinical device. We now complete the laboratory testing of the device and plan to conduct an animal study in the next few months.
2. Objective 2 - Animal study: Animal study at Dr Wacker’s laboratory was conducted with the motorized MCBD. The device did not perform as expected and failed frequently in the transfer of the tissue samples from the needle tip to the cassette. Together with our clinical collaborators we decided to conduct an additional animal study, this time with the second generation MCBD, where we expect to get better results.
3. Objective 3 – Clinical study: Not started yet – the clinical study cannot be conducted before we complete the animal study and demonstrate the safety and efficacy of the motorized MCBD.
4. Objective 4 – motorized MCBD: We decided to focus on the development of the second generation MCBD. Currently we test the MCBD and improve its performance; and we work on the integration of the disposable module to the motorized handpiece.
5. Objective 5 – regulatory clearance: We updated our regulatory system to account for the revisions in the ISO 14385:2016 edition which is needed to get the CE mark for the motorized MCBD device. We had a pre-submission meeting with the FDA where we reviewed the development of the motorized MCBD and got the FDA examiner’s recommendations on the required regulatory requirements to achieve 510k clearance for marketing in the USA.
6. Objective 7 – We continue to look for investments and presented the MCBD technology to several VC funds and angel groups. The Mid-Atlantic Bio-Angels group expressed interest in the technology and we plan to start the application process for investment.
Overview of the results and their exploitation and dissemination
Laboratory and animal studies demonstrated that multiple samples can be acquired and stored in a multi-sample cassette. The second generation MCBD is an advanced clinical prototype that will enable rapid and automatic acquisition of multiple samples from a volume of interest around the needle. We plan to present the MCBD to interventional radiologists in scientific meetings, for example the Society of Interventional Radiology (SIR) or the European Society of Radiology (ESR); and to manufacturers of biopsy devices who participate in technical exhibitions in such meetings.
We have achieved progress beyond the state of the art in our field. By inventing and developing the curved biopsy needle we expect to change the current practice of image-guided biopsy from unidimensional (samples can be acquired along the needle penetration line) to three-dimensional (samples can be acquired from a volume of interest around the needle penetration line). This will enable rapid acquisition of tissue samples from different areas of the tumour through a single needle insertion, while currently this requires multiple insertions of the needle to different locations in the tumour.
Currently, at the end of the project, we still need to conduct the final animal study with the second generation MCBD, then to continue with the clinical study. Our initial results on the feasibility of multi-sample acquisition and the ability to acquire tissue samples from different sites within the VOI indicate the importance of the device we develop. It will provide the ability to better characterize the biomolecular properties of the tumour and this will enable the selection of better therapy for each patient, will reduce the waste of resources due to the use of expensive therapies on patient that are unlikely to benefit from these therapies, and will improve the outcome of patients that will get better tailored therapy to their specific disease.