BIOINVISION INC — Department of Health and Human Services SBIR Phase II: NHLBI

BIOINVISION INC — SBIR Phase II award from Department of Health and Human Services.

Amount
$1,968,096
Agency
Department of Health and Human Services · National Institutes of Health
Program / Phase
SBIR · Phase II
Topic
NHLBI
Solicitation
PA19-272
NAICS
Place of performance
OH
Period
2021-08-01 → 2023-07-31

Description

System-independent quantitative cardiac CT perfusion Phase II, SBIR Summary BioInVision, Inc. and team - Case Western Reserve University (CWRU) biomedical engineers and University Hospitals Cleveland Medical Center (UH) imaging cardiologists - will develop software for quantitative analysis of cardiac CT perfusion (CCTP) data, creating an important tool for evaluation of cardiovascular disease. With this product, cardiologists will be able to identify functional flow deficits in coronary artery territories. When one combines functional myocardial blood flow (MBF) function with coronary anatomy from coronary computed to- mography angiography (CCTA), it provides needed information on the physiologic significance of a stenosis. The CCTP+CCTA combination could provide an ideal gateway exam for deciding whether to send a patient for percutaneous invasive coronary angiography and potential intervention (e.g., stenting). In addition, low flow with- out the presence of a stenosis suggests microvascular disease, a very prevalent ailment of growing concern, especially among women and diabetes patients. CT compares favorably to all other non-invasive cardiovascular imaging techniques (SPECT, PET, and MRI). It is available in many settings, including emergency departments, and is high throughput as compared to other methods. It provides both MBF and reliable coronary anatomy, with are unavailable in any other single modality, providing a unique ability to non-invasively discriminate cardiac microvascular disease. It has excellent resolution enabling detection of endocardial perfusion deficit, thought to be an early disease indicator that is impossible to assess with SPECT. CT is cheaper and has higher patient throughput than MRI or PET. With the inclusion of MBF, CT would have an excellent opportunity to disrupt the diagnostic pathway leading to percutaneous intervention, a pathway which has been dominated by SPECT my- ocardial imaging, a modality that gives zero information about coronary anatomy. To achieve reliable, accurate CT MBF measurements, we will invoke innovations to reduce beam hardening and to make reliable flow esti- mates. Currently, CT perfusion is done on different CT machines with manufacturers’ proprietary software, using algorithms that can give erroneous MBFs. Applicable to any commercial scanner; our solution would harmonize measurements across acquisition systems providing trustworthy, standardized measurements to clinicians, thereby improving management of cardiovascular patients.