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2241912

Project Grant

Overview

Grant Description
SBIR Phase II: Non-Planar Spectral Breast Computed Tomography (CT) - 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.
Awardee
Awarding / Funding Agency
Place of Performance
Newark, California 94560 United States
Geographic Scope
Single Zip Code
Related Opportunity
None
Malcova was awarded Project Grant 2241912 worth $1,000,000 from National Science Foundation in May 2023 with work to be completed primarily in Newark California United States. The grant has a duration of 1 year and was awarded through assistance program 47.084 NSF Technology, Innovation, and Partnerships.

SBIR Details

Research Type
SBIR Phase II
Title
SBIR Phase II:Non-planar Spectral Breast Computed Tomography (CT)
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._x000D_ _x000D_ 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._x000D_ _x000D_ 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.
Topic Code
BM
Solicitation Number
NSF 22-552

Status
(Complete)

Last Modified 5/4/23

Period of Performance
5/1/23
Start Date
4/30/24
End Date
100% Complete

Funding Split
$1.0M
Federal Obligation
$0.0
Non-Federal Obligation
$1.0M
Total Obligated
100.0% Federal Funding
0.0% Non-Federal Funding

Activity Timeline

Interactive chart of timeline of amendments to 2241912

Additional Detail

Award ID FAIN
2241912
SAI Number
None
Award ID URI
SAI EXEMPT
Awardee Classifications
Small Business
Awarding Office
491503 TRANSLATIONAL IMPACTS
Funding Office
491503 TRANSLATIONAL IMPACTS
Awardee UEI
GSB6L7B1FB13
Awardee CAGE
9BXA8
Performance District
17
Senators
Dianne Feinstein
Alejandro Padilla
Representative
Ro Khanna

Budget Funding

Federal Account Budget Subfunction Object Class Total Percentage
Research and Related Activities, National Science Foundation (049-0100) General science and basic research Grants, subsidies, and contributions (41.0) $1,000,000 100%
Modified: 5/4/23