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Irvine, CA, United States

Grant
Agency: Department of Defense | Branch: Army | Program: SBIR | Phase: Phase II | Award Amount: 779.72K | Year: 2009

Inhalation airway injury is a major cause of morbidity and mortality for soldiers in modern combat. In inhalation burn victims, certain pathophysiological changes occur at a very small length scales in airway tissues immediately following exposure. Measuring these changes from within the lumen of airway during bronchoscopy is difficult because these changes occur in sub-mucosa at microscopic level. To solve above problems, OCT Medical Imaging Inc (OCTMI), proposes to develop and test an advanced light-based, fiber-optic imaging system using a platform imaging technology known as Optical Coherence Tomography (OCT). In Phase II, we will extend our successful Phase I results and develop an advanced compact real-time 3D-OCT system incorporating advanced light source. By consulting with clinicians, we pan to develop user-friendly software and test our 3D-OCT probes and OCT systems using an animal smoke inhalation model developed at our collaborators laboratory. Based on above studies, we will refine our 3D-OCT probe, systems and software and evaluate them in bronchoscopic airway detection sensitivity and specificity to gold standard histologic imaging in patients. After successful Phase II, we plan to apply for IDE and seek 510k FDA approval to enter the market.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 693.20K | Year: 2010

DESCRIPTION (provided by applicant): Laryngeal carcinoma is the most common primary head and neck malignancy. Flexible fiber-optic or rigid endoscopes are normally inserted through the nose or into the pharynx for conventional physical examinations, but endoscopy alone cannot be used to differentiate between benign, pre-malignant and early malignant lesions, which are characterized by identical symptoms such as throat pain, coughing, or hoarseness, and nearly identical physical appearance. Both conventional examination and endoscopy lack the ability to visualize the depth of penetration of disease into the deeper layers of the tissue, and provide information on vocal fold epithelial structure. Therefore, laryngeal cancer diagnosis has to rely on biopsies, which requires general anesthesia and surgical endoscopy. Multiple and repeated biopsies are common in order to increase diagnostic yield, and with this increasing morbidity form surgery. Regardless of the toll exacted on patients and their families, there are major costs associated with surgery, and significant patient time away from work. Hence, there is a huge need to develop a fast, mobile and noninvasive technology to aid in the early detection and monitoring of laryngeal malignant lesions, assist in selecting patients to undergo surgical biopsy. The use of OCT in managing early laryngeal epithelial cancer will be analogous to the use of macroscopic imaging modalities (i.e., MR, CT) in managing large solid tumors in the body. Using several licensed patents, OCT Medical Imaging Inc (OCTMI) proposes to address the treatment and diagnosis of early laryngeal cancer using light based fiber optic imaging technology known as optical Coherence tomography (OCT), which produces a cross- sectional images at near histopathological resolution(Fujimoto et.al 2000). The first in vivo endoscopic OCT images in animals and humans were reported in 1997 (Tearney et.al., 1997)). Many clinical applications require a large area or 3-D imaging, which is difficult to achieve with the Time Domain (TD) OCT. Hence, OCTMI proposes to use advanced Fourier domain (FD) OCT technology which provides 3D imaging at high speed and sensitivity (Leitgeb et.al, 2003). Second, the paradigm shift from OR based to office-based imaging is necessary to make OCT a useful technology for head and neck cancer screening, early detection, and monitoring of disease progression. Incorporating this technology, OCTMI proposes to develop an advanced compact, cost-effective office based real-time 3D-functional Fourier domain functional OCT system that will not only acquire images at near histopathological resolution, but also will provide clinically important structural information on suspect lesions, potential biopsy sites, and cancer margins of larynx in the office without the need for general anesthesia or sedation. OCTMI is well positioned to develop this technology since its founders and collaborators have developed several office-based real-time 3D-OCT systems and were first to conduct large scale clinical trials on laryngeal cancer to the best of our knowledge PUBLIC HEALTH RELEVANCE: Principal Investigator/Program Director (Last, first, middle): Ramalingam, Tirunelveli Narrative: OCTMI is seeking funds that will directly contribute to the easy advanced detection and diagnosis of laryngeal cancer. We are seeking funds from NCI 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 office based system is not only similar to the system already tested ex-vivo, but also tested in human clinical trials at the UCI labs. OCTMI has licensed OCT technology from University of California, Irvine. Researchers and clinician who participated in system development and clinical trials are either co-founders of OCTMI or collaborating in this project. Out technology which was developed in the laboratory is now being transferred to market place through OCTMI. Hence this proposal in ideal for PA-08-114 program. Public Health Relevance Statement Page 7


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 350.43K | Year: 2015

DESCRIPTION provided by applicant 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 critical D and cross sectional details andamp functional information necessary for identifying vulnerable plaques inside out view of vessel necessary for stent sizing extent of mal apposition of stent struts in artery 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 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 andamp 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


Lee S.-W.,Beckman Laser Institute | Lee S.-W.,Electronics and Telecommunications Research Institute | Heidari A.E.,Oct Medical Imaging, Inc. | Yoon D.,Beckman Laser Institute | And 10 more authors.
Biomedical Optics Express | Year: 2011

Smoke inhalation injury is frequently accompanied by cyanide poisoning that may result in substantial morbidity and mortality, and methods are needed to quantitatively determine extent of airway injury. We utilized a 3-D endoscopic frequency-domain optical coherence tomography (FD-OCT) constructed with a swept-source laser to investigate morphological airway changes following smoke and cyanide exposure in rabbits. The thickness of the mucosal area between the epithelium and cartilage in the airway was measured and quantified. 3-D endoscopic FD-OCT was able to detect significant increases in the thickness of the tracheal walls of the rabbit beginning almost immediately after smoke inhalation injuries which were similar to those with combined smoke and cyanide poisoning. © 2011 Optical Society of America. Source


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 631.55K | Year: 2012

DESCRIPTION (provided by applicant): Major common cause of subglotis is endotracheal intubation during the critical first days of life. In the premature infant and newborn patient, thi condition may pass undetected or present as a life-threatening and, atworst, a life-ending event. Further, the tissues of the subglottis are delicate in nature, easily damaged, and rapidly develop edematous changes. These circumstances, when taken together, significantly predispose the subglottis to inflammation, scar formation, and stenosis in the critically ill newborn requiring endotracheal intubation. In the premature infant and newborn patient, this condition may pass undetected or present as a life-threatening and, at worst, a life-ending event. Using several licensed patents, OCT Medical Imaging Inc (OCTMI) proposes to develop an advanced ultrafast compact, cost-effective, touch-screen real-time 3D-functional Fourier domain functional OCT (F- OCT) system. We also develop a Nitionl based fiber microprobes (lt 0.6mm) thatcan be slipped into an endoscope or through an endotracheal tube. With this imaging system and probes, we will not only acquire images at near histopathological resolution, but also provide clinically important structural and functional information on theonset and progression of subglottic airway disease in these critically ill patients. PUBLIC HEALTH RELEVANCE: Major common cause of subglotis is endotracheal intubation during the critical first days of life. In the premature infant and newbornpatient, this condition may pass undetected or present as a life-threatening and, at worst, a life-ending event. Further, the tissues of the subglottis are delicate in nature, easily damaged, and rapidly develop edematous changes. These circumstances, when taken together, significantly predispose the subglottis to inflammation, scar formation, and stenosis in the critically ill newborn requiring endotracheal intubation. In the premature infant and newborn patient, this condition may pass undetected or present as a life-threatening and, at worst, a life-ending event. Using several licensed patents, OCT Medical Imaging Inc (OCTMI) proposes to develop an advanced ultrafast compact, cost-effective, touch-screen real-time 3D-functional Fourier domain functionalOCT (F- OCT) system. We also develop a Nitionl based fiber microprobes (lt 0.6mm) that can be slipped into an endoscope or through an endotracheal tube. With this imaging system and probes, we will not only acquire images at near histopathological resolution, but also provide clinically important structural and functional information on the onset and progression of subglottic airway disease in these critically ill patients.

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