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Reporting period: 2020-10-01 to 2022-03-31

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. 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. 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.
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 provider 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 €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 enable better targeting of treatment for each patient, will reduce drug use and medical manpower and thus reduce healthcare costs. 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.
1. Objective 1: During the first reported period we worked with our clinical collaborators (Dr. Wacker and Dr. Zurkiya) who expressed the importance of singe hand operation of the device. A semi-motorized MCBD, as described in the previous report, was still difficult to operate by single hand. Following additional discussions with our clinical collaborators we decided to focus on the development of a fully motorize the MCBD that can be operated single handed. As a replacement to the abandoned manual MCBD we have developed an accessory device that enables rapid removal of the tissue samples from a regular biopsy device (i.e. with single sample) into a cassette similar to the cassette of the MCBD. This device uses the same unloading apparatus and multi-sample cassette as the motorized MCBD.
2. Objective 2: Animal study at Dr Wacker’s laboratory has not been conducted yet due to technical difficulties in the development of the motorized MCBD and due to delays due to the Covid pandemic. We evaluated the new unloading device in an animal study and demonstrated the ability to rapidly unload multiple samples to the cassette. We also conducted animal testing of the curved needle concept in collaboration with Dr. Zurkiya, our clinical collaborator in the USA (these studies are beyond the scope of the SME project and will be briefly described to provide a full review of the overall project progress).
3. Objective 3 – 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 – we have completed significant revisions of the mechanical and electrical design of the motorized MCBD to account for technical difficulties in the acquisition of high quality tissue samples. We have completed comprehensive technical testing of the device in our lab and presented it to our clinical collaborators. We expect to conduct the animal study with the motorized device in the next few months.
5. Objective 5 – we updated our regulatory system to account for the revisions in the ISO 14385:2016 which is needed to get the CE mark and FDA clearance for the motorized MCBD device. We have submitted application for pre-submission meeting with the FDA to review the development of the motorized MCBD and to get their recommendations on the required regulatory requirements to achieve 510k clearance for marketing in the USA. Work on materials for the CE Mark has not been completed yet due to substantial increase in the requirements following the transition of the EU from the Medical Device Directive (MDD) to the Medical Devices Regulation (MDR).
6. Objective 6 – during the first reported period we had series of consultations to prepare us for the development of the required materials to achieve HTA dossiers for our main initial markets in the EU (Germany and UK).
7. Objective 7 – We have secured additional funding to further development of the technology through our parent company in the USA, and had discussions with several device companies
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.
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.
Until the end of the project we expect to complete the animal study and to start preparations for 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 to the important 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.