2019-05-008 - 3DBonT - 3D Biopsy on Tomosynthesis

3DBonT

2019-05-008

Innovative products and technologies in the field of tomosynthesis biopsy devices, improving the resolution of the medical imaging diagnostics, specifically for early breast diagnosis in prone position. This novel and smart device will provide a 3D volume of the breast and with detailed voxel (3D pixel) density structure of the breast tissue that is obtained from the X-ray spectral imaging to identify correctly the position of the anomaly and even classifying it as “good” or “bad” anomaly

Social and environmental advantages for public health system, reducing number of biopsies per patient and early detection of breast cancer.

Reduction of EU cancer mortality by early and precise breast tumor detection.

Current mammography systems suffer from false negatives reducing life expectancy, as well as false positives requiring unnecessary biopsies, both due to lack of scan image quality. Additionally the patient receives high radiation doses as a result of multiple x-rays exposures. The Biopsy system has a novel arrangement and method of operation for ensuring a more accurate and well targeted extraction of tissue samples. It reduces false positive cases, then reducing the number of biopsies to be performed by the hospitals. It also reduces false negatives, then increasing the survival factor of the patients and reducing the therapy costs.

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The technology can be licensed and installed in tomosynthesis biopsy machines and mammography CT scanners. The cost of the 2D model’s mammography systems ranges between $65,000 to $95,000 for GE Healthcare and Hologic, Inc products. Whereas 3D models of the same company range between $90,000 to $200,000. In addition to this, the premium 3D models of GE Healthcare and Hologic Inc. are priced between $1,40,000 to $2,75,000. The global mammography market size was valued at USD 2.35 billion in 2023 and is projected to grow at a CAGR of 8.87% from 2024 to 2030.

The rising prevalence of breast cancer is anticipated to contribute to the breast imaging devices market’s growth. A growing number of hormone replacement therapy (HRT), hormonal imbalances, menopause, and various reproductive disorders have significantly increased the risks of breast cancer. According to the World Health Organization (WHO), breast cancer is the most common cancer in women, impacting 2.1 million women annually. Breast cancer causes the highest number of cancer-related deaths among women. For instance, in 2020, according to the American Institute of cancer research, there were an estimated 18.1 million cancer cases around the world. It was estimated that 9.3 million cases were in men and 8.8 million in women. Among them, lung and breast cancers are the most common cancers in the world, and about 12.5% and 12.2% of the new cases are diagnosed in 2020. The main product types in breast imaging devices are tomosynthesis, breast ultrasound, breast MRI, mammography, nuclear imaging, and others. Tomosynthesis is an imaging method that is utilized to screen early signs of breast cancer in people with no symptoms. This kind of imaging can also be utilized as a diagnostic tool for a person who is having breast cancer symptoms, improving accuracy and detection rates of breast abnormalities. Data source: "Breast Imaging Devices Global Market Report 2023"; Research and Markets (2023).

The targeted market is the global hospital sector. This category is the largest market segment based on end-user, valued at US$ 2 billion.

Development of new readout electronics using MediPix 4 technology and x-ray detector for the current 3D biopsy machine prototype

7M€

EIC project proposal; Spin-off creation

High image resolution breast imaging diagnosis device for early cancer detection

R&D development is expensive; product certification needs; scale up is expensive due to use of advance production machinery.

In total, the time to market for a mammography detector typically ranges from 2 to 5 years, depending on the complexity of the technology and the length of the regulatory process. Advanced systems such as those used for 3D mammography or devices with AI integration may take even longer to reach the market.

1 patent abandoned but know-how on MediPix technology available

The patent was abandoned in 2021, but IFAE offers the associated know-how for licensing (TRL 5 ); The R&D project finished in 2021; The industrial partners are Idneo, BVentura Medical and more recently (2024) Hologic.

There is a related mammography system patent application (EP20382794A)* filed by IFAE in 2020 and granted in the US and the EU (unitary patent), not funded by the Ginjol fund

Regulatory Approvals and Certifications The medical device industry is highly regulated, especially for devices like mammography detectors used in critical diagnostic procedures. Startups need to obtain multiple certifications and approvals from regulatory bodies such as: FDA (U.S.): Premarket Approval (PMA) for Class III medical devices like mammography systems is a lengthy process, often taking years of clinical trials and reviews. CE Mark (Europe): Complies with the European Union’s Medical Device Regulation (MDR). Clinical Trials are typically required to demonstrate the device's safety and efficacy in detecting breast cancer. These trials add significant time before market entry and before a startup can scale its operations. Time Impact: It often takes 3-5 years just to achieve regulatory approvals in key markets, delaying the timeline to becoming a key player.

Patents: WO2006024679A1 ; PCT/ES2005/000426 - Date: Mar 9th, 2006 Status: Granted URL: https://patents.google.com/patent/WO2006024679A1/en

This device will help in reducing the breast biopsy interventions and brings great relieve to those patients that as been tagged with suspicious anomalies, based on the mammography screening results, when they are really healthy people. It reduces false negatives, increasing the image information in terms of quality specially by increasing signal to noise ratio, thank to the spectral X-ray photon counting approach, and this allows to optimize the treatment planning to be followed by the patient, resulting in a greater efficiency and sustainability of the therapy resources in hospitals and a higher recovery rate post-treatment of the patient, therefore a better quality of life of the population in general