Breast cancer remains a leading cause of cancer related death among women in the United States. Mammography, the only cost effective method approved for population screening of breast cancer, fails to find cancer in many women and causes too many unnecessary call backs on the rest. Fischer Imaging has developed proprietary ?slot scanning? technology that significantly improves contrast and doubles the image resolution of today?s mammography with less than half the radiation dose (upto 60% lower). Our technology also removes the need for painful breast compression which is the reason why many women avoid mammograms. These essential enhancements will lead to improved clinical performance in breast cancer screening and diagnosis by finding missed cancers, reducing unnecessary treatment and increase screening compliance. This proposal describes the development and feasibility bench testing of MammoCAT? DM, our first product, which will provide superior two view mammography. This product is regulated as a Class II, 510k device and reimbursement is available from CMS and private payors allowing a facility with an average patient volume to pay off the device in about a year. A key feature of MammoCAT DM will be upgradeability to MammoCAT DBT, our second product, which will allow image capture over multiple angles to give it digital breast tomosynthesis capability. Finally, MammoCAT CT, or third product, will use the same gantry as our DBT device in a comfortable, prone configuration where the breast is held pendant without compression and will perform full field (360 degree) imaging at the same dose as standard digital mammography. MammoCAT CT will usher in a new era where tumors can be staged, localized and biopsied in the same device thus improving equipment and space utilization and improving hospital workflow.

Public Health Relevance

Fischer Imaging?s proposed products will improve breast cancer screening and diagnosis by finding missed cancers, reducing unnecessary treatment and improving screening compliance. Although X-ray mammography continues to be the best and only option for breast cancer screening there is an urgent need to improve it, particularly for women with dense breasts. Our proprietary technology enhances the image contrast and doubles the image resolution of today?s mammography using only half the radiation dose. This will make it easier for radiologists to identify features such as micro calcifications and fine tumor spicules indicative of cancer greatly improving their ability and confidence in reading mammography images. Our technology also removes the need for painful breast compression because of which many women avoid mammograms thereby improving compliance with mammography recommendations.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
3R43CA224851-01A1S1
Application #
9979025
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Narayanan, Deepa
Project Start
2018-06-29
Project End
2020-05-31
Budget Start
2018-08-01
Budget End
2020-05-31
Support Year
1
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Fischer Imaging, Inc.
Department
Type
DUNS #
080473449
City
Wheat Ridge
State
CO
Country
United States
Zip Code
80033