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Reporting period: 2019-10-01 to 2020-09-30

• What is the problem/issue being addressed?
Precision medicine has become of great importance in current medical care. This approach enables to effectively tailor the disease treatments to individual patients based on genetic and environmental factors. Accurate identification of manageable targets requires multiple samples, high-quality tissue samples, and preservation of labile biomarkers. False positive or negative results from the evaluation of biomarkers 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 needed for accurate and reliable diagnosis and do not provide rapid preservation of tissue samples. Current multiple core biopsy acquisition requires repeated insertions of the needle to target tissue and laborious manual handling of the samples by the radiologist and in the pathology lab.

• 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 through single needle insertion will cut down the duration of the biopsy procedure and will save costs on physician fee, nurse and other clinical staff fees, and scanner use.
- Multimodal preservation compared with current formalin preservation will cut down costs on the use of kits that are needed to analyze 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 €80-100 for manual MCBD and €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.
MCBD will enable early detection of cancer thanks to better preservation of tissue samples for accurate molecular diagnosis, will reduce drug use and medical manpower and thus reduce healthcare costs. By streamlining tissue preservation and biomolecular analysis, most notably in oncology, 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 MCBD for acquisition and rapid preservation of multiple biopsy samples.
2 - Conduct animal tests to assess the advantages of MCBD in comparison with standard biopsy device.
3 - Conduct clinical study to demonstrate advantages of MCBD.
4 - Motorize the actuator module to automatically operate MCBD.
5 - Get CE marking and FDA clearance for the manual and motorized MCBD devices.
6 - Prepare HTA dossiers for targeted countries (Germany, UK and France).
7 - Establish strategic partnership alliances with corporations from various fields – medical devices, pharmaceutical and In-Vitro Diagnostic companies.
Objective 1: We have developed a manual MCBD and met our clinical collaborator (Dr. Wacker) and our medical consultant (Dr. Zurkiya) and let them experience with the device. They had two main comments: manual priming of the firing mechanism of the device, when the device is inside the body, may result with unintentional move of the device and injury to the tissues along the needle path; the manual MCBD requires operation with two hands, when the device is inside the body, which may limit its use to CT (with ultrasound imaging the operator typically holds the ultrasound device in one hand and the biopsy device with the second hand). They recommended to motorize the priming mechanism, which will eliminate the risk of moving the device during manual priming (we followed this recommendation and added an electrical actuator to prime the device); or to fully motorize the MCBD so it can be operated single handed (this is already achieved in Objective 4). We also developed a new method for samples unloading that minimizes the impact of sample unloading from the needle to the cassette.
Objective 2: The original workplan was to conduct the animal testing at the Charles River Laboratories (CRL) in Germany. Dr. Wacker, our clinical collaborator, recommended to conduct the animal study at the animal experimentation facility in his institution. Considering the time lost due to Covid-19 and the ongoing travel limitations we decided to accept his recommendation. Working together with our clinical collaborators we have finalized the protocol for the animal study and submitted it for review and approval by the Institutional Animal Care and Use Committee (IACUC) of the hospital.
Objective 3 – not started yet.
Objective 4 – we have developed a fully operational prototype of the motorized MCBD. It is currently being tested in the lab. We expect to be able to use it in the animal study.
Objective 5 – we started to update our regulatory system, which is needed to get the CE mark and FDA clearance for the motorized MCBD device once its development and animal testing are completed.
Objective 6 – we had the first consultation with Dr. Heiko Visarius, our business development coach, which will guide us in the process to get the HTA Dossier. We started to discuss the process of HTA dossiers with consulting firm from Germany.
Objective 7 – We had discussions with several device companies - Boston Scientific, GE Healthcare, Philips; and from several pharmaceutical companies – Roche, Boehringer Ingelheim, GSK, Abbvie – all expressed interest to review the technology after we get initial results from animal and clinical studies. We met leading biopsy manufacturers from Europe, USA and Japan during Medica 2019 and RSNA 2019 to understand their manufacturing and distribution capabilities.
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 tumor through a single needle insertion, while currently this requires multiple insertions of the needle to different locations in the tumor.
For this innovative objective we have developed prototypes of curved needle made of Nitinol, a highly flexible metal. The curved Nitinol needle can be straightened within the needle guide to enable the initial insertion of the needle to the target, then the curved needle can be deployed in different directions into the target, to acquire tissue samples from different areas of the tumour. We conducted laboratory tests to demonstrate the ability to acquire high quality tissue samples with the curved needle.