SBIR-STTR Award

System-independent quantitative cardiac CT perfusion
Award last edited on: 5/22/2023

Sponsored Program
STTR
Awarding Agency
NIH : NHLBI
Total Award Amount
$2,192,336
Award Phase
2
Solicitation Topic Code
837
Principal Investigator
David L Wilson

Company Information

Bioinvision Inc

781 Beta Drive Suite E
Cleveland, OH 44143
   (216) 310-0302
   inquiry@bioinvision.com
   www.bioinvision.com

Research Institution

Case Western Reserve University

Phase I

Contract Number: 1R41HL144271-01
Start Date: 8/1/2018    Completed: 7/31/2019
Phase I year
2018
Phase I Amount
$224,240
System-independent quantitative cardiac CT perfusion Summary BioInVision, Inc. and Case Western Reserve University researchers will develop software for quantitative anal- ysis of cardiac CT perfusion (CCTP), 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) with coronary anatomy from computed tomography angi- ography (CTA), it provides needed information on the physiologic significance of a stenosis. The CTA+CCTP combo 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, if flow is low and no stenosis is present, it will suggest microvascular disease, a very prevalent ailment of growing concern, especially among women and in diabetes. CT compares favorably to all other non-invasive cardiovascular imaging techniques (SPECT, PET, and MRI). It is available in many settings, including emergency departments. It provides both MBF and reliable coronary anatomy, not available in any other single modality. It has excellent resolution ena- bling 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 inclusion of MBF, CT would have an excellent opportunity to disrupt the diagnostic pathway leading to percutaneous intervention, a pathway now dominated by SPECT myocardial imaging, which includes zero information about coronary anatomy. To achieve reliable, accurate CT MBF measurements, we will invoke innovations to reduce beam hardening and to make reliable estimates of flow. Currently, CT perfusion is done on different CT machines with manufacturersÂ’ proprietary software, using algorithms that can give erroneous MBFs. Applicable to any commercial scanner; our solution would harmonize measurements across acquisition systems providing trust- worthy, standardized measurements to clinicians, thereby improving management of cardiovascular patients.

Public Health Relevance Statement:
Narrative We will develop software to enable reliable evaluation of blood flow in heart tissue using CT imaging. With suc- cess, our project could lead to an improved gateway examination that could reduce unnecessary invasive cor- onary angiography, thereby reducing costs, patient discomfort, patient risk, and possibly unnecessary interven- tional therapies.

Project Terms:
Accident and Emergency department; Affect; Algorithms; Anatomy; Angiography; Attention; Benchmarking; Blood flow; blood flow measurement; Blood Vessels; Calibration; Cardiac; Cardiovascular Diseases; cardiovascular imaging; Cardiovascular system; Cause of Death; Chest Pain; Clinical; Clinical Data; Computer software; Confidence Intervals; Coronary; Coronary Angiography; Coronary artery; cost; Cost Savings; Coupled; Data; design; Detection; detector; Development; Diabetes Mellitus; Diagnostic; digital; Disease; Dose; Electrocardiogram; Evaluation; Family suidae; Heart; Image; imaging system; Imaging Techniques; improved; Inferior; innovation; Intervention; Iodine; Lead; Machine Learning; Magnetic Resonance Imaging; Manufacturer Name; Measurement; Methods; Microvascular Dysfunction; Modality; Modeling; Morphologic artifacts; Myocardial; Myocardium; noninvasive diagnosis; Obesity; Pathway interactions; Patient risk; Patients; Perfusion; perfusion imaging; Persons; Phase; Physiological; Physiology; Positron-Emission Tomography; pre-clinical; Pre-Clinical Model; Prevalence; prototype; Quantitative Evaluations; Research; research and development; Research Personnel; Resolution; single photon emission computed tomography; software development; Source; Standardization; Stenosis; Stents; success; System; Test Result; Testing; Therapeutic Intervention; Tissues; tool; Trust; Universities; virtual; Woman; X-Ray Computed Tomography

Phase II

Contract Number: 9R44HL156811-02A1
Start Date: 8/1/2021    Completed: 7/31/2023
Phase II year
2021
(last award dollars: 2022)
Phase II Amount
$1,968,096

System-independent quantitative cardiac CT perfusionPhase II, SBIRBioInVision, Inc. and team - Case Western Reserve University (CWRU) biomedical engineers and UniversityHospitals Cleveland Medical Center (UH) imaging cardiologists - will develop software for quantitative analysisof cardiac CT perfusion (CCTP) data, creating an important tool for evaluation of cardiovascular disease. Withthis product, cardiologists will be able to identify functional flow deficits in coronary artery territories. When onecombines 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 forpercutaneous 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 cardiovascularimaging 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, withare unavailable in any other single modality, providing a unique ability to non-invasively discriminate cardiacmicrovascular disease. It has excellent resolution enabling detection of endocardial perfusion deficit, thought tobe an early disease indicator that is impossible to assess with SPECT. CT is cheaper and has higher patientthroughput than MRI or PET. With the inclusion of MBF, CT would have an excellent opportunity to disrupt thediagnostic 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, accurateCT 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, usingalgorithms that can give erroneous MBFs. Applicable to any commercial scanner; our solution would harmonizemeasurements across acquisition systems providing trustworthy, standardized measurements to clinicians,thereby improving management of cardiovascular patients.

Public Health Relevance Statement:
Narrative We will develop software to enable reliable evaluation of blood flow in heart tissue using CT imaging. With suc- cess, our project could lead to an improved gateway examination that could reduce unnecessary invasive coro- nary angiography, thereby reducing costs, patient discomfort, patient risk, and possibly unnecessary interven- tional therapies.

Project Terms:
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