SBIR-STTR Award

Clinical Evaluation and Development of a Diagnostic Multi-Modal Intravascular Imaging System
Award last edited on: 1/18/2018

Sponsored Program
SBIR
Awarding Agency
NIH : NHLBI
Total Award Amount
$2,846,885
Award Phase
2
Solicitation Topic Code
-----

Principal Investigator
T S Ramalingam

Company Information

OCT Medical Imaging Inc (AKA: OCTMI)

1002 Health Sciences Road
Irvine, CA 92617
   (310) 254-4962
   octmedical@gmail.com
   www.octmedicalimaging.com
Location: Single
Congr. District: 45
County: Orange

Phase I

Contract Number: 1R44HL129496-01
Start Date: 9/1/2015    Completed: 6/30/2016
Phase I year
2015
Phase I Amount
$350,430
Understanding that not a single imaging technique can alone address needs of all vascular diagnosis, OCT medical imaging Inc. (OCTMI) propose to develop a clinical multimodal intravascular imaging system encompassing ultra-high resolution optical coherence tomography(OCT) and IVUS. This Combined multimodal vascular imaging system will permit cross-sectional visualization of vascular artery with unprecedented resolution and depth not possible with any of these technologies alone. This multi-modal imaging strategy in a single system permits use of a single disposable guide wire, thereby reducing cost to hospital, patients and improving prognosis by early detection. We believe these technologies together will provide 1) critical 3D and cross-sectional details & functional information necessary for identifying vulnerable plaques 2) inside-out view of vessel necessary for stent sizing 3) extent of mal-apposition of stent struts in artery 4) extent of post-stent thrombosis. In a multi-institutional effort, we plan to create this multi-modal probe and necessary hardware in Phase I, followed by extensive clinical trials in phase II before seeking FDA approval and marketing in Phase III

Public Health Relevance Statement:


Public Health Relevance:
OCTMI is seeking funds that will directly contribute to the easy advanced detection and diagnosis of heart disease that affects human in every part of the globe. We are seeking funds to develop an advanced functional OCT system that will help reduce mortality, minimize number of invasive biopsies and dramatically improve the clinical outcome, while reducing cost and time required for diagnosis. Proposed module based system is a unique combination of the most advanced Ultrasound & Optical Coherence Tomography technologies, will likely change the diagnosis landscape of cardiovascular disease and outcome. OCTMI has licensed OCT, technology from University of California, Irvine. Researchers who participated in system development are either co-founders of OCTMI or collaborating in this project. We are collaborating with Univ. of Southern California; a leading center in Ultrasound will be our partners in this effort. This multi-institution effort, involving OCTMI, USC and researchers from UCI will ensure the success of this project. Technology which was developed in the laboratory is now being transferred to market place through OCTMI.

NIH Spending Category:
Bioengineering; Cardiovascular; Clinical Research; Clinical Trials and Supportive Activities; Diagnostic Radiology; Heart Disease

Project Terms:
abstracting; Address; Affect; Angiography; Area; Arterial Fatty Streak; Arteries; Back; base; biomaterial compatibility; Biopsy; Blood Vessels; Boston; Cadaver; Caliber; California; Cardiovascular Diseases; Catheters; Clinical; Clinical Research; Clinical Trials; Computer software; Contrast Media; Coronary; cost; cost effective; Coupling; Data; Decision Making; Detection; Development; Diagnosis; Diagnostic; Dimensions; Disease Outcome; Documentation; Early Diagnosis; Elements; Ensure; Exposure to; Family suidae; FDA approved; follow-up; Funding; Heart; Heart Diseases; Histopathology; Hospital Costs; Hospitals; Human; Hybrids; Image; Imagery; imaging system; Imaging Techniques; implantation; improved; Institution; Laboratories; Lead; Length; Letters; Licensing; Marketing; Measurement; Measures; Medical; Medical Device; Medical Imaging; medical schools; millimeter; miniaturize; Modality; Modeling; Mortality Vital Statistics; Multi-Institutional Clinical Trial; Multimodal Imaging; novel; Optical Coherence Tomography; Outcome; outcome forecast; Patients; Pennsylvania; performance tests; Phase; prevent; Procedures; prospective; public health relevance; research clinical testing; Research Personnel; Resolution; Rotation; Safety; safety testing; Saint Jude Children's Research Hospital; Sales; Sampling; Sensitivity and Specificity; sensor; Site; Specialist; Speed (motion); Stenosis; stent thrombosis; Stents; success; System; Systems Development; Technology; Testing; Thrombus; Time; time use; Tissues; Torque; Translations; ultra high resolution; Ultrasonography; Universities; volcano; Work

Phase II

Contract Number: 4R44HL129496-02
Start Date: 9/1/2015    Completed: 6/30/2018
Phase II year
2016
(last award dollars: 2018)
Phase II Amount
$2,496,455

Understanding that not a single imaging technique can alone address needs of all vascular diagnosis, OCT medical imaging Inc. (OCTMI) propose to develop a clinical multimodal intravascular imaging system encompassing ultra-high resolution optical coherence tomography(OCT) and IVUS. This Combined multimodal vascular imaging system will permit cross-sectional visualization of vascular artery with unprecedented resolution and depth not possible with any of these technologies alone. This multi-modal imaging strategy in a single system permits use of a single disposable guide wire, thereby reducing cost to hospital, patients and improving prognosis by early detection. We believe these technologies together will provide 1) critical 3D and cross-sectional details & functional information necessary for identifying vulnerable plaques 2) inside-out view of vessel necessary for stent sizing 3) extent of mal-apposition of stent struts in artery 4) extent of post-stent thrombosis. In a multi-institutional effort, we plan to create this multi-modal probe and necessary hardware in Phase I, followed by extensive clinical trials in phase II before seeking FDA approval and marketing in Phase III

Public Health Relevance Statement:


Public Health Relevance:
OCTMI is seeking funds that will directly contribute to the easy advanced detection and diagnosis of heart disease that affects human in every part of the globe. We are seeking funds to develop an advanced functional OCT system that will help reduce mortality, minimize number of invasive biopsies and dramatically improve the clinical outcome, while reducing cost and time required for diagnosis. Proposed module based system is a unique combination of the most advanced Ultrasound & Optical Coherence Tomography technologies, will likely change the diagnosis landscape of cardiovascular disease and outcome. OCTMI has licensed OCT, technology from University of California, Irvine. Researchers who participated in system development are either co-founders of OCTMI or collaborating in this project. We are collaborating with Univ. of Southern California; a leading center in Ultrasound will be our partners in this effort. This multi-institution effort, involving OCTMI, USC and researchers from UCI will ensure the success of this project. Technology which was developed in the laboratory is now being transferred to market place through OCTMI.

NIH Spending Category:
Bioengineering; Cardiovascular; Clinical Research; Diagnostic Radiology; Heart Disease

Project Terms:
abstracting; Address; Affect; Angiography; Area; Arterial Fatty Streak; Arteries; Back; base; biomaterial compatibility; Biopsy; Blood Vessels; Boston; Cadaver; Caliber; California; Cardiovascular Diseases; Catheters; Clinical; Clinical Research; Clinical Trials; Computer software; Contrast Media; Coronary; cost; cost effective; Coupling; Data; Decision Making; Detection; Development; Diagnosis; Diagnostic; Dimensions; Disease Outcome; Documentation; Early Diagnosis; Elements; Ensure; Exposure to; Family suidae; FDA approved; follow-up; Funding; Heart; Heart Diseases; Histopathology; Hospital Costs; Hospitals; Human; Hybrids; Image; Imagery; imaging system; Imaging Techniques; implantation; improved; Institution; Laboratories; Lead; Length; Letters; Licensing; Marketing; Measurement; Measures; Medical; Medical Device; Medical Imaging; medical schools; millimeter; miniaturize; Modality; Modeling; mortality; Multi-Institutional Clinical Trial; Multimodal Imaging; novel; Optical Coherence Tomography; Outcome; outcome forecast; Patients; Pennsylvania; performance tests; Phase; prevent; Procedures; prospective; public health relevance; research clinical testing; Research Personnel; Resolution; Rotation; Safety; safety testing; Saint Jude Children's Research Hospital; Sales; Sampling; Sensitivity and Specificity; sensor; Site; Specialist; Speed; Stenosis; stent thrombosis; Stents; success; System; Systems Development; Technology; Testing; Thrombus; Time; time use; Tissues; Torque; Translations; ultra high resolution; Ultrasonography; Universities; volcano; Work