Sbir phase II: non-planar spectral breast computed tomography (CT)

The National Science Foundation awarded Malcova Inc. $1,000,000 under the Technology, Innovation, and Partnerships federal grant program (CFDA 47.084) to develop a novel non-planar spectral breast computed tomography device. Malcova will use the one-year project grant term from May 1, 2023 to April 30, 2024 to further the device's design, build a working prototype, and conduct validation testing using anthropomorphic phantoms.

The non-invasive breast CT device employs a new scanning method and compact design intended to provide fast, high-quality 3D imaging of the entire breast while avoiding breast compression. Its spectral capability aims to distinguish cancerous from non-cancerous tissues in both dense and non-dense breast areas. Nearly 50% of U.S. women have dense breasts yet current mammography and tomosynthesis technologies underserve them. Malcova's device has potential to become a leading breast cancer screening modality, particularly for small clinics and hospitals, by addressing this unmet clinical need through improved detection capabilities.

Abstract

The broader impact/commercial potential of this small business innovation research (sbir) phase II project is to make available to the public a new imaging device that provides the anatomical and functional information necessary for effective and efficient diagnosis of breast cancer in women with dense breasts. The device employs a novel design and method of generating high-quality, three-dimensional images of the breast anatomy comfortably and at low levels of radiation dose. By design, the device will occupy a small space and support fast and efficient patient imaging. When commercialized, IT can be priced on PAR with existing x-RAY-based imaging technologies. Given these benefits and the large existing need nationwide need for a thorough dense-breast imaging solution, there is significant commercial potential. The prime objective of the project is to significantly increase the sensitivity and specificity in cancer radiological studies of women with dense breasts. Accordingly, this device has the potential to become the next generation breast cancer imaging modality of choice for small clinics as well as large hospitals, available to both patients and clinicians everywhere imaging is performed. This small business innovation research (sbir) phase II project supports development and validation of a comfortable, effective, dense-breast cancer imaging device built upon a new method and design for computed tomography (CT). This CT-based device does not require breast compression, and is smaller, faster, and higher in spatial resolution than alternative 3-dimensional imaging technologies. The instrument will provide spectral information used to distinguish deadly from non-deadly cancers from both dense and non-dense tissues across the entire breast, including regions near the chest and underarm. Nearly 50% of the U.S. Female population has dense breasts. The most widely used technologies for breast imaging today ?mammography and digital breast tomosynthesis ? Underserve these women. This technology cannot reliably image breast regions near the chest and underarm where cancers occur. Current methods also cannot reliably distinguish healthy, but dense, breast tissue from cancer. During this sbir project, testing and validation of the developed device will be carried out using human-like surrogates called anthropomorphic phantoms. The company will demonstrate that this new technology provides high quality dense-tissue imaging, consistent whole-breast imaging, and spectral information that is of clinical benefit in cancer detection and diagnosis. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the foundation's intellectual merit and broader impacts review criteria.