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ALBUQUERQUE, NM, United States

Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 211.07K | Year: 2015

DESCRIPTION provided by applicant Diabetes affects an estimated million people worldwide including more than million Americans Diabetic patients are at risk for a wide array of complications including heart disease kidney disease nephropathy ocular diseases diabetic retinopathy and diabetic foot peripheral neuropathy Fifteen percent of diabetics wil develop a foot ulcer as a result of peripheral neuropathy during their lifetime Foot ulcers are th main cause of lower extremity amputation in patients with diabetes VisionQuest Biomedical LLC and the University of New Mexico UNM have formed a team to study a population of diabetics with and without diagnosed peripheral neuropathy in order to gain a better understanding of how a personandapos s auto thermo regulation after a cold provocation reflects neuronal changes in peripheral neuropathy The study will use standard clinical examinations such as monofilament sensory tests as well as less standard exam techniques such as sympathetic skin response to compare with dynamic infrared functional imaging The functional infrared imaging techniques have been developed and applied by our group as part of a pilot study A prototype functional thermal imaging device has been tested on a number of subjects that shows strong indications of its capacity to measure thermal regulation in the plantar foot and demonstrates potential as a biomarker for accurate quantification of DPN changes progression in type T D or type diabetes T D Our preliminary experimental data results produced highly compelling evidence that thermal functional technology can detect differences between normal controls and diabetics with or at risk for peripheral neuropathy There are three specific aims to be accomplished in this grant application The first aim is to establish a normative range for the functional response to thermal stimulus as measured by an infrared imaging device by studying control subjects In the second aim we will study the variation in the thermally derived functional signal in diabetics with diagnosed peripheral neuropathy The third aim is to apply the protocol developed in Aim to conduct a clinical study with diagnosed subjects with diabetes without peripheral neuropathy Features such as recovery time recovery pattern both temporal and spatial will be correlated with clinical diagnostic measurements such as nerve conduction velocity tests and ankle brachial index tests Clinical examinations will be performed by our collaborating podiatrist PUBLIC HEALTH RELEVANCE Peripheral neuropathy is a complication of diabetes that causes lower extremity amputations a year Fifteen percent of diabetics will undergo amputation some time in their lives In this project we will study the nature of thermal autoregulatory response in diabetics with and without peripheral neuropathy A thermal optical imaging system will be used to study the thermo regulation in the plantar foot after cold provocation This methodology has great promise as an inexpensive non invasive and most of all very sensitivity clinical exam for early detection of diabetic peripheral neuropathy

Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 187.27K | Year: 2016

DESCRIPTION provided by applicant Alcohol misuse is a significant public health problem not only in the US but around the world Just in the US alcohol misuse is estimated to be the second cause of preventable death at a cost of more than $ billion in a single year Further it is also estimated that it reduces the lives of those who died by years Screening and brief interventions have proved effective in promoting behavior changes that lead to increased awareness and decreased consumption when properly conducted at the primary care setting However there remain four main barriers that have curtailed broad adoption of screening and brief interventions by primary care lack of access to validated tools lack of training reluctanc to raise the subject to the patient and lack of face time Overcoming these barriers creates a vastly significant clinical public health and commercial opportunity VisionQuest Biomedical and the University of New Mexico have formed a team to develop and test the feasibility of PA MSTM a mobile platform for the delivery of screening and brief interventions for alcohol misuse PA MSTM technical innovation is that it shifts the delivery paradigm from paper and in person delivery to software as a service PA MSTM is not an electronic form only but a complete set of tools that allow electronic communication between patients providers and support groups from screening to brief interventions to follow up care By enabling on demand up to date patient centered screening and brief interventions PA MSTM clinical innovation is that it extends the reach of primary care and facilitates care coordination and decision making In Phase I a prototype PA MSTM will be developed and tested in a primary care setting on patients who will be followed for two months Standard metrics of usability acceptability and user satisfaction will be assessed in order to prove the feasibility of the prototype and plan for an improved version that will be tested in a multi center clinical study in Phase II PUBLIC HEALTH RELEVANCE Alcohol misuse is a major public health problem that represents significant costs in money and lives Conducting screening and brief interventions can help decrease alcohol consumption but there are barriers to adopt these techniques especially in primary care Our project will develop and test PA MSTM a new way to conduct screening and brief interventions that overcomes these barriers using mobile applications and electronic communications

Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 821.71K | Year: 2016

DESCRIPTION provided by applicant Cerebral malaria CM is a life threatening neurological complication associated with malarial infection Malaria affects about million people worldwide and claims lives annually of whom are African children under years of age CM is mistakenly over diagnosed about of the time in which the cases of concurrent non CM diseases with similar symptoms produce false positive test results and result in incorrect treatment An accurate means to confirm the presence of CM or to investigate for a non malarial illness is critically needed to improve outcomes The retinal lesions associated with malarial retinopathy MR are highly specific to CM and a retinal screening for MR represents an effective means to assist in and improve the specificity of CM diagnosis VisionQuest Biomedical and its collaborators have assembled a team of inter disciplinary scientists with considerable experience in automated retinal image analysis clinical ophthalmology with specialized research in malarial retinopathy MR and cerebral malaria diagnosis CM This team will develop and test ASPIRE a system for detection of MR consisting of automated MR detection software integrated with a low cost and portable retinal camera especially designed for use in clinical settings in Africa The system components will be selected to demonstrate an economically viable product affordable to the targeted population in Africa The proposed ASPIRE system will augment not replace the current CM diagnostic standard increasing the accuracy of CM diagnoses leading to a smaller number of false positive outcomes In Phase I the research team at VisionQuest Biomedical demonstrated the feasibility of a fully automated MR detection system that includes software to provide automated detection of MR lesions interfaced with a portable retinal imaging camera In Phase II the ASPIRE system will be refined optimized and validated on retrospective as well as prospective datasets We will accomplish this through three specific aims In the first aim the software system for MR detection will be optimized to perform in real time and validated on a retrospective image dataset In the second aim we will refine the retinal imaging hardware and integrate the software system with the camera which automatically detects MR The third aim will focus on evaluating the on site performance of ASPIRE system in a clinical research study to be conducted in in Malawi Africa PUBLIC HEALTH RELEVANCE Cerebral malaria is a life threatening neurological complication associated with malarial infection which affects about million people and claims the lives of people worldwide mostly African children The presence of malarial retinopathy can provide additional insight and improve the diagnostic accuracy of CM This project proposes the development of a malaria retinopathy detection system consisting of an automatic malaria retinopathy detection software integrated with low cost retinal camera designed for use in clinical settings in Africa

Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 689.28K | Year: 2015

DESCRIPTION provided by applicant In the US there are annual incidences of heart attack out of which are first time heart attacks Risk factors for cardiovascular disease CVD are thought to be well defined but they do not identify all at risk individuals Therefore there is a need to detect other factors that provide more near term risk assessment for CVD The early manifestations of risk factors found in the retina can detect a threat of an impending cardiovascular event and monitoring these precursors provides an early insight into risk of CVD For this reason we have developed the andquot Comprehensive Assessment of Retinal Vasculatureandquot CARV a fully automated screening device for the detection of retinal abnormalities and assessment of associated CVD risk In Phase I the research team at Vision Quest Biomedical demonstrated the feasibility of the CARV second reader system to provide objective measurements and detect potential vascular abnormalities to assist a retinal reader resulting in increased disease detection at a reduced reading time In Phase II the second reader system will evolve into a fully automatic first reader system that quantifies the risk of CVD based on retinal abnormalities We will accomplish this through two specific aims In the first aim we will add additional methods for detecting retinal abnormalities and lesions We will then develop a classifier to automatically assign a CVD risk of low moderate or severe to each case CARV processes In the second aim we will combine these software tools to produce a near real time system to automatically detect signs of hypertensive retinopathy and assign a CVD risk grade based on the results At the end of Phase II we will demonstrate a validated CARV first reader and second reader system CARV second reader will likely be given a Class I device by the FDA and we expect clearance within a year The intended use will be that of an aid to readers in a telemedicine environment With CARV second reader serving as a predicate device the CARV first reader system can be submitted as a k device to the FDA following the successful completion of a clinical trial PUBLIC HEALTH RELEVANCE Signs of cardiovascular disease CVD manifest in the retina including changes to the vasculature and lesions These abnormalities can provide additional insight into CVD risk especially for those patients who may not have more traditional risk factors Manual grading these abnormalities as they appear in retinal images can result in inaccurate and variable results In Phase I of andquot Comprehensive Assessment of Retinal Vasculatureandquot CARV we demonstrated that our system was capable of assisting retinal graders improving disease detection and reducing time needed to do so In Phase II we will develop an automatic system that can detect retinal abnormalities associated with hypertensive retinopathy and provide a CVD risk grade based on those findings It is our intention that successful implementation of this product will identify patients who were previously unaware of their risk for a cardiovascular event

Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 189.13K | Year: 2013

DESCRIPTION (provided by applicant): According to the National Institutes of Health, there are more than 80 million people in the US who suffer from a potentially sight-threatening disease. Doctors see seven to eight million new cases of eye disease annually. More than two million Americans age 50 and older have advanced AMD, the stage that can lead to severe vision impairment and 10 million have early or intermediate AMD. Glaucoma affects more than 2.3 million Americans age 40 and older. Another two million individuals with glaucoma are undiagnosed. Diabetes cases in the US and throughout the world have been on the rise. Poor eating habits and lack of exercise, factors which contribute to type 2 diabetes, have led to an increasingly overweight population. According to the International Diabetes Federation, there are 285 million cases of diabetes in the world as of 2010. For the type 2 diabetics, 50% will develop diabetic retinopathy within 15 years of disease diagnosis. Regular eye disease screening is necessary to prevent the progression of eye diseases to advanced, sight-threatening stages. The objective of this project is to develop and test a low-cost, hand-held, non-mydriatic retinal camera for widespread applications, including teleretinal screening foreye diseases such as diabetic retinopathy, glaucoma, and age-related ocular diseases. The proposed camera fills an important unmet need: low-cost (under 1,500 cost of goods); small footprint (principally a hand-held device); and easy to use (ergonomically designed for operation by a minimally trained medical technician or nurse). Introducing this technology to a clinic environment will allow underserved individuals to receive regular eye screenings without traveling to an eye care professional. To meet this goal, our proposal has two aims. First, we will produce a prototype of the low-cost, hand-held, non-mydriatic camera, which will be based on an early prototype of a mydriatic camera that was developed, and for which early testing has shown significantfunctionality. The design is based on low-cost, off-the-shelf components that can be assembled easily for a high- volume market. Second, we will test this camera in a screening or clinic environment. Making the camera ergonomically suitable for use by a minimally trained individual will be the goal of this aim. Quantitative analysis will be performed as to field of view, resolution, and safety. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: Retinal screening for diseases such as diabetic retinopathy is performed currently with specialized cameras that cost approximately 20,000. For small medical practices and clinics, especially those in underserved areas who are most in need of screening technology, this cost is prohibitive. In this project, we will develop a non-mydriatic, low-cost, hand-held camera that could be sold for 5,000 as a component of a telemedicine-based eye disease screening system.

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