ALBUQUERQUE, NM, United States
ALBUQUERQUE, NM, United States

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Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 1.48M | Year: 2015

DESCRIPTION provided by applicant The long term objective of this project is to engineer test validate and commercialize the i RxCamandquot a low priced portable and easy to use retinal camera Because of our Phase I technical accomplishments and demonstrated effectiveness we can achieve the overarching goal of this Phase II final verification and validation of the low priced non mydriatic retinal camera and repackaging of i RxCamandquot for manufacture and commercialization Our innovative approach for the i RxCamandquot is based primarily on a significant departure from current generations of desktop and handheld commercial retinal imaging devices and those cameras under development Our design strategy is based on an extensive survey analysis and consideration of the user requirements to ensure maximum ergonomic utility Existing portable retinal imagers as well as those known to be under development do not meet the requirements of a low price camera with sufficient technical capabilities field of view image quality portability battery power and ease of use to be distributed widely to the offices of medical practices where trained retinal photographers may not be available We will achieve the Phase II objectives through two specific aims to build and assemble two new cameras based on a finalized Phase I prototype camera design but with minor changes to improve usability and reduce costs and to re engineer an advanced prototype that increase the field of view from degrees to degrees Both cameras will undergo testing in a clinical environment The metrics for testing will be feedback from imagers on the usability Percentage of acceptable images for reading will be a second metric Quantitative metrics such as resolution contrast and dynamic range will be used as metrics in the bench testing of the devices In Phase II we will make design changes to improve on the following aspects larger field of view smaller pupil access auto focus ergonomics and portability We will perform extensive clinical testing in a cohort of N subjects imaged by at least two photographers of differing levels of experience in retinal imaging The testing and feedback from users will be used to prepare the i RxCamandquot for high volume manufacturing while constraining the cost of goods and manufacture to under $ and maintaining the small footprint and portability requirements We will conduct the necessary quality and safety studies needed for producing a commercial ready device that can be submitted for FDA market clearance The i RxCamandquot is a low priced alternative to expensive retinal cameras and its development is aligned with the NIH objective to reduce disparities in medical care in rural and underserved populations PUBLIC HEALTH RELEVANCE The objective of this project is to engineer test validate and commercialize the i RxCamandquot a low priced portable and easy to use retinal camera This project is relevant to public health because it addresses the lack of access to low cost retinal disease screening and diagnosis equipment in rural and underserved clinics Widespread access to retinal examinations can significantly reduce the incidence of sight threatening retinal diseases resulting in economic and societal benefits to the government and the affected populations


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 1.09M | Year: 2015

DESCRIPTION provided by applicant This Phase II project is motivated by current issues associated with screening for retinopathy of prematurity ROP ROP is the leading cause of blindness in infants In recent years the number of infants at risk for ROP has been increasing In the United States the rate of prematurity has risen from of all births in to in for a total of over preterm births Preterm neonate disease management depends largely on timely screening and intervention Unfortunately low reimbursement levels for ROP screening insufficient equipment for ROP screening in remote locations and long term exposure to medical malpractice actions make it difficult to provide appropriate care to neonates at risk To mitigate these problems VisionQuest Biomedical LLC and its collaborators Oakland University MI and the Retina Institute of South Texas RIST will demonstrate and test NeoScan a family of software products aimed at improving the management and detection of ROP NeoScan consists of two products NeoScan Assist and NeoScan Detect NeoScan Assist is aimed at increasing the productivity and reducing the variability in interpretation by th neonatal healthcare providers through accurate quantification of vasculature tortuosity and caliber factors that have been demonstrated to correlate with the presence of advanced stages of ROP The objectives of NeoScan Assist are to reduce variability in the diagnosis of advanced stages of ROP and to provide a tool for accurate screening and staging of ROP in neonates NeoScan Detect is aimed at automatically identifying infants that need further examination by an ophthalmologist The objectives of this project will be accomplished through three specific aims In Aim we will finalize the product development of NeoScan Assist by productizing the methods developed during Phase I of this project In Aim a prospective clinical study will be performed to evaluate the effectiveness of NeoScan Assist and to provide data for validation of NeoScan Detect In Aim we will demonstrate the image processing techniques that will be part of NeoScan Detect At the end of this Phase II project we will be ready to submit an FDA k market clearance for NeoScan Assist and in parallel with that submission we will perform a clinical trial to demonstrate the safety and effectiveness of NeoScan Detect in preparation for an FDA market clearance submission of that product PUBLIC HEALTH RELEVANCE Retinopathy of prematurity ROP is a disease that affects low birth weight infants and is the leading cause of blindness in children worldwide In this project we will demonstrate NeoScan a family of software products aimed at improving the management and detection of ROP This project is relevant to public health because it addresses the need of providing better and more widespread eye care to preterm infants thus improving their health outcomes and potentially preventing blindness


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 158.12K | Year: 2014

DESCRIPTION (provided by applicant): A mild traumatic brain injury (mTBI) is a complex pathophysiologic process affecting the brain, induced by traumatic biochemical forces to direct or indirect forces to the head. In sports, it has been estimated that 1.6to 3.8 million mTBIs occu annually, yet many remain unidentified because symptoms are unreported by athletes or symptoms are not detected at the point of injury. VisionQuest Biomedical and the University of New Mexico (UNM) Sport Administration Departmentpropose to develop an mTBI screening tool, ConQuest, with innovative testing and screening methods to address these shortfalls. Objective neurocognitive and neurosensory tests will be combined on a tablet to provide on-site, real-time screening. ConQuest's innovation lies in its ability to combine neurocognitive and neurosensory tests onto a tablet to be an integrated portable mTBI assessment tool. Existing computerized tests, such as ImPACT, DETECT, HeadMinder CSI, and ANAM, test only short-term memo


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 172.34K | Year: 2014

DESCRIPTION (provided by applicant): This Phase I project is motivated by current issues associated with screening for retinopathy of prematurity (ROP). ROP is the leading cause of blindness in infants. In recent years the number of infants at risk for ROPhas been increasing. In the United States, the rate of prematurity has risen from 9.4% of all births in 1981 to 12% in 2010, for a total of over 500,000 preterm births. Neonate disease management depends largely on timely screening and intervention. Unfortunately, low reimbursement levels for ROP screening, insufficient equipment for ROP screening in remote locations, and long-term exposure to medical malpractice actions make it difficult to provide appropriate care to neonates at risk. To mitigate these problems, Vision Quest Biomedical LLC and its collaborators, Oakland University (MI) and the Retina Institute of South Texas (RIST) will demonstrate and test NeoScan, a software system for automatic ROP screening that provides improved retinal image qu


Grant
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


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 1.26M | 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


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 794.69K | Year: 2016

Summary The objective of this project is to validate the i RxTherm VisionQuest s patented functional thermal imaging system that produces biomarkers for early detection of diabetic peripheral neuropathy DPN This device is based on the principle that changes in microvascular function are correlated to quantifiable changes in nerve function as expressed in measureable microvascular changes 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 will develop a foot ulcer as a result of peripheral neuropathy during their lifetime Foot ulcers are the main cause of lower extremity amputation in patients with diabetes In Phase I of this project VisionQuest developed and tested the i RxTherm Phase I results demonstrated that the i RxTherm produced biomarkers to detects early signs of DPN Our results showed that the i RxTherm can differentiate between normal controls and patients with DPN with high sensitivity and specificity Furthermore we demonstrated that the i RxTherm identified diabetics who were undiagnosed with DPN but who were later confirmed to show early to moderate signs of DPN In Phase II of this project our objective is to validate these results in a larger cohort of subjects and to develop a low cost clinical prototype that can be used in the primary care setting There are three specific aims to be accomplished in this grant application The first aim is to identify and quantify specific biomarkers of levels of severity or stages of DPN To achieve this aim we will collect data from subjects that will include normal controls and patients diagnosed with DPN The second aim is to collect data from diabetics with previously undiagnosed DPN and to demonstrate that our classification methodologies identify patients with diabetes who present with early to moderate signs of DPN and who have not been previously diagnosed for the disease In the final aim we will develop and test a low cost version of the i RxTherm that can be used in the primary care setting At the end of this project we will have a fully validated device that will provide a more effective means of screening and early detection of DPN Narrative Peripheral neuropathy is a complication of diabetes that causes amputations in of diabetics with of them having lower extremity amputations a year In this project we will complete the development of the i RxTherm a thermal optical imaging system that can detect early signs of diabetic peripheral neuropathy thus solving the public health need for screening and early detection of this complication of diabetes


Grant
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


Grant
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


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 499.79K | Year: 2016

Summary VisionQuest Biomedical LLC VisionQuest has developed a diabetic retinopathy DR screening system EyeStar enabled by automated screening software DR RACS that was developed under the EY Phase II SBIR project Our product provides immediate feedback to the physician on the state of diabetic eye disease without burdening an eye care specialist to review those cases without retinal disease Diabetes affects over million Americans and DR is one of its main complications If not detected early DR leads to vision loss and blindness With the number of diabetics projected to grow to over million by worldwide DR has become a serious healthcare concern DR RACS will improve DR screening rates by providing a solution that is low cost and integrated at the point of care and that will result in increased revenues for insurance companies and healthcare providers The main objective of this grant application is to complete the final steps needed to commercialize VisionQuest s EyeStar DR screening system For commercialization VisionQuest requires FDA clearance of the enabling component the DR RACS software This objective will be achieved through two specific aims In Aim we will make VisionQuest and the DR RACS product compliant with the quality system regulations QSR in preparation for regulatory submissions In Aim we will prepare DR RACS for FDA k submission To achieve this goal we will prepare a k pre submission carry out a multi center clinical study and submit a De Novo k application to the FDA At the completion of this project we will have the first FDA cleared automated DR screening software We will then be positioned to commercialize our automatic retinal screening system EyeStar to serve the needs of the healthcare industry in the US and worldwide Narrative Diabetic retinopathy DR is a complication of diabetes a disease that affects over million Americans and is the leading cause of blindness in working age population The main objective of this project is to complete the final steps needed to commercialize VisionQuestandapos s EyeStar DR screening system This project is relevant to public health because it addresses the need of providing better and more widespread eye care to diabetics thus improving their health outcomes and preventing blindness

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