Maple Grove, MN, United States

Advanced Medical Electronics Corp.

www.ame-corp.com
Maple Grove, MN, 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: 693.21K | Year: 2016

DESCRIPTION provided by applicant This project aims to develop continuous pulse oximetry monitoring technology to facilitate the care of infants after they have transitioned from the neonatal intensive care unit NICU to home This technology targets the monitoring of neonates with chronic lung disease of infancy CLDI a group of respiratory diseases that usually evolves from an acute respiratory disorder experienced by a newborn infant Advances in perinatal care changes in health care economics and research suggesting a negative impact of prolonged hospitalization on development of the preterm newborn have influenced discharge practices for infants with CLDI The home environment has increasingly been recognized as the optimal setting for medically stable technology assisted infants to receive the complex and demanding care they require Infants in the NICU are commonly connected to multiple pieces of equipment and monitors While this lifesaving technology is a necessary part of providing care to these infants the many wires can also add to the complexity of caring for these infants particularly in a home environment with untrained personnel Very recent advances in electronic components allow miniature wireless medical instrumentation to be developed that is of a size and weight appropriate for a long term wearable neonate application This project includes a unique team of medical device experts with a history of FDA approved products research neonatologists pulse oximetry design experts and a human factors expert Testing will include FDA recommended K safety and performance evaluations a desaturation study and a gold standard comparison evaluation in neonates PUBLIC HEALTH RELEVANCE Chronic lung disease of infancy CLDI is a group of pulmonary disorders that start in the neonatal period Often the inciting factor is bronchopulmonary dysplasia BPD a chronic condition that usually evolves after premature birth and respiratory distress syndrome due to surfactant deficiency BPD is the most common pulmonary morbidity in preterm infants and affects approximately to infants in the United States each year


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 492.15K | Year: 2016

Project Summary Abstract The goal of this project is to develop a portable low cost tool to aid in the diagnosis and management of neonates born with neurologic complications The project will develop instrumentation technology and associated software to enable early detection of neurologic brain injury and seizure activity for newborns delivered in care facilities that lack a full suite of neurological diagnostic tools In neonates with birth asphyxia seizures are very common and most frequently subclinical Many studies have observed that even experienced clinicians have difficulty correctly identifying seizures in this population Subsequently clinical paroxysms that do not truly represent seizure are frequently over treated and subclinical seizures including status epilepticus go unrecognized and untreated As such the use of continuous video electroencephalograph EEG monitoring is the gold standard for recognizing and treating seizures in this population It is also very helpful at identifying which children have sustained brain injury including hypoxia This resource intense modality has become the standard of care at many tertiary medical centers but unfortunately remains unavailable to many clinicians at smaller birth facilities Quantitative EEG including the use of amplitude integrated EEG aEEG has gained widespread use at most neonatal ICUs and represents a more user friendly bedside tool for identifying brain injury and seizures The proposed phase II project aims to design build and evaluate a low cost telemedicine enabled aEEG monitor and associated multi instrument software package that supports widespread use of aEEG in community based birth care facilities Project Narrative The project will develop technology to aid in the diagnosis intervention and improvement of outcomes for neonates born with neurologic complications Treating electrographic seizures in babies with hypoxic ischemic encephalopathy has been associated with less neurological sequelae and improved long term outcomes


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: STTR | Phase: Phase II | Award Amount: 990.75K | Year: 2016

DESCRIPTION provided by applicant We propose to develop and evaluate the utility of a novel input camera system for retinal prosthetics that allows users to filter optical imagery based on distance from the observer We call this andquot depth filteringandquot which can be accomplished with a depth sensing stereoscopic camera system Retinal prostheses can restore partial vision to people blinded by outer retinal degenerative diseases such as Retinitis Pigmentosa RP or Macular Degeneration The Argus II Retinal Prosthesis System is intended to provide electrical stimulation of the retina to elicit visual perception in blind individuals with near total visionloss due to retinitis pigmentosa The implanted epiretinal array provides a x grid of electrodes Electrical pulses at these pixel sites stimulate the retinaandapos s remaining cells and result in the perception of patterns of light The current spatial resolution is only total pixels but the camera systems that provide image information to the prosthesis user transmit full resolution video information Information in the imagery consists of all visible items within the field of vie ranging for example from nearby obstacles to far away mountain scenery The lack of perceived spatial resolution makes it extremely difficult for prosthesis users to differentiate between important nearby elements within the scene and relatively unimportant distant elements of the scenery or vice versa An image capture and processing system is proposed that selectively removes elements in a viewed scene that are outside a user set depth range We hypothesize that system utility in important tasks such as people or object finding and mobility will be less burden some and performance improved by providing only relevant visual information to the wearer The proposed project seeks to develop and experiment with distance filtered optical imagery as an input modality to retinal implants Two prototype systems will be specified designed built and evaluated in Argus II patients In phase of the proposed project the image processing will be performed by a computer external to the Argus II system In phase a more powerful version of the next generation Argus II video processing unit capable of performing the image processing will be utilized This will be coupled with a new dual camera eyeglass assembly making the phase prototype fully integrated and ready for commercialization in the next generation Argus II system and possibly in other visual prosthesis systems and head mounted electronic low vision aids PUBLIC HEALTH RELEVANCE Retinal prostheses aim to help people who have lost their vision due to degenerative eye conditions such as retinitis pigmentosa to perceive shapes and movement to become more mobile or to perform other day to day activities The proposed project relates to the utilization of distance specific optical imaging as an input modality to a retinal prosthesis thus improving the prosthesis wearerandapos s understanding of the scene by removing unwanted irrelevant information


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 This project develops a novel social support aid SSA to allow persons with dementia PWDs to more fully engage in their social network and enhance their quality of life The SSA will assist people in an early stage of dementia e g Alzheimerandapos s disease or related dementia who desire social interaction but struggle to remember names and relationships It provides memory cuing by displaying and or announcing the names and relationships of the people with whom PWDs are engaged We anticipate that the SSA will offer robust support for care partners and PWDs in various communities The SSA is not intended to replace caregiver aids but rather augment them to further improve quality of life Millions of Americans have dementia the loss of mental functions e g thinking memory and reasoning which interferes with their daily functioning While some cases of dementia are caused by medical conditions that can be treated most cannot be reversed Hence the focus switches from treatment to palliative care i e developing a plan to make life easier and more comfortable for individuals with dementia and their caregivers Assistive technologies to enhance living with dementia let alone studies that evaluate their efficacy are underdeveloped The proposed project aims to begin filling this scientific and clinical gap by developing a social support aid and formally evaluating its utility via a sufficiently powered randomized controlled trial PUBLIC HEALTH RELEVANCE Millions of Americans have dementia the loss of mental functions e g thinking memory and reasoning which interferes with their daily functioning While some cases of dementia are caused by medical conditions that can be treated most cannot be reversed Hence the focus switches from treatment to palliative care i e developing a plan to make life easier and more comfortable for individuals with dementia and their caregivers The proposed project will develop an important tool to improve the quality of life for persons with dementia


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 224.99K | Year: 2015

DESCRIPTION provided by applicant The goal of this project is to develop a unique and engaging educational game that promotes behavioral modification regarding energy balance related behaviors EBRB The game targets high school aged students attending Alternative Learning AL programs through the platform of a serious game While serious games promoting positive behaviors regarding general nutrition have been developed and successfully implemented for younger students no examples have been found specifically targeting older teens in AL settings Few if any evidence based strategies or curricula exist to address EBRB for this population Because EBRB established in adolescence have a likelihood of continuing into adulthood and impacting weight and health adolescence provides an important window during which to positively address and modify these kinds of behaviors The unique formative youth voice approach to development of this game increases the likelihood of game play that makes learning highly engaging and relevant to the context social environmental cultural in which the participants live play learn and work Further participation in and incentives for the development and piloting of this game provides AL youth with an important leadership opportunity which may spark interest in careers related to research serious gaming or health promotion Finally this game has great potential for use by and integration with Supplemental Nutrition Assistance Program Education SNAP Ed programming in AL settings through which multilevel approaches system environmental policy can be implemented to support and reinforce positive behavioral goals During adolescence a high quality diet ensuring adequate intake of energy and nutrients is critical to optimize physical growth and development and prevent diet related chronic diseases that manifest in adulthood including heart disease cancer and osteoporosis Lifestyle changes and the drive for greater autonomy in food choice during adolescence can negatively impact eating behaviors and patterns High school students attending an AL programs are more likely to engage in poor eating and sedentary living practices than students attending a regular high school PUBLIC HEALTH RELEVANCE During adolescence a high quality diet ensuring adequate intake of energy and nutrients is critical to optimize physical growth and development and prevent diet related chronic diseases that manifest in adulthood including heart disease cancer and osteoporosis Lifestyle changes and the drive for greater autonomy in food choice during adolescence can negatively impact eating behaviors and patterns Since poor food choices in adolescence tend to continue into adulthood adolescence is an important time to intervene to promote healthy habits


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: STTR | Phase: Phase I | Award Amount: 225.00K | Year: 2015

DESCRIPTION provided by applicant This project will develop an FDA approved process D printing system and advanced D printable material suitable for point of care manufacturing of custom fit continuous positive airway pressure CPAP masks for neonates In extremely low birth weight infants nasal CPAP therapy is delivered via soft biocompatible neonatal sized nasal masks suitable for long term direct skin contact inserted into the nares and held firmly against face For the desired pressure to be transmitted to the distal airways and to minimize complications a tight seal is required between the mask nasal prongs and the soft tissues of the internal circumference of the nostrils Currently there are limited often just sizes of CPAP nasal prongs available to clinicians that must serve growing babies weighing less than grams up to babies weighing over kg Ill fitting nasal prongs contribute to adverse outcomes in this fragile population Recent advances in D printing support the possibility of custom fit neonatal nasal CPAP prongs manufactured effectively at the patient point of care Unfortunately a polymer and printer system has not yet been fully developed that can make the proposed type of FDA approved medical device Materials and applied research are necessary to prove both the science and the commercial markets in order to drive development from D printer and D printable materials manufacturers and adoption from clinicians The objective of this innovative project is to develop a material and printing system combination able to produce a pliable medical device in this application that can meet or exceed the expectations applied to comparable devices through FDA guidance and international consensus standards PUBLIC HEALTH RELEVANCE The proposed research aims to improve the efficacy of nasal continuous positive airway pressure nCPAP in the neonatal care environment Respiratory support in neonates ranging in weight from grams up to babies weighing over kg is extremely consequential to long term health and development Therapy effectiveness at this stage of human development is life altering


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: STTR | Phase: Phase I | Award Amount: 296.34K | Year: 2015

DESCRIPTION provided by applicant We propose to develop and evaluate the utility of a novel input camera system for retinal prosthetics that allows users to filter optical imagery based on distance from the observer We call this andquot depth filteringandquot which can be accomplished with a depth sensing stereoscopic camera system Retinal prostheses can restore partial vision to people blinded by outer retinal degenerative diseases such as Retinitis Pigmentosa RP or Macular Degeneration The Argus II Retinal Prosthesis System is intended to provide electrical stimulation of the retina to elicit visual perception in blind individuals with near total visionloss due to retinitis pigmentosa The implanted epiretinal array provides a x grid of electrodes Electrical pulses at these pixel sites stimulate the retinaandapos s remaining cells and result in the perception of patterns of light The current spatial resolution is only total pixels but the camera systems that provide image information to the prosthesis user transmit full resolution video information Information in the imagery consists of all visible items within the field of vie ranging for example from nearby obstacles to far away mountain scenery The lack of perceived spatial resolution makes it extremely difficult for prosthesis users to differentiate between important nearby elements within the scene and relatively unimportant distant elements of the scenery or vice versa An image capture and processing system is proposed that selectively removes elements in a viewed scene that are outside a user set depth range We hypothesize that system utility in important tasks such as people or object finding and mobility will be less burden some and performance improved by providing only relevant visual information to the wearer The proposed project seeks to develop and experiment with distance filtered optical imagery as an input modality to retinal implants Two prototype systems will be specified designed built and evaluated in Argus II patients In phase of the proposed project the image processing will be performed by a computer external to the Argus II system In phase a more powerful version of the next generation Argus II video processing unit capable of performing the image processing will be utilized This will be coupled with a new dual camera eyeglass assembly making the phase prototype fully integrated and ready for commercialization in the next generation Argus II system and possibly in other visual prosthesis systems and head mounted electronic low vision aids PUBLIC HEALTH RELEVANCE Retinal prostheses aim to help people who have lost their vision due to degenerative eye conditions such as retinitis pigmentosa to perceive shapes and movement to become more mobile or to perform other day to day activities The proposed project relates to the utilization of distance specific optical imaging as an input modality to a retinal prosthesis thus improving the prosthesis wearerandapos s understanding of the scene by removing unwanted irrelevant information


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: STTR | Phase: Phase I | Award Amount: 186.90K | Year: 2016

DESCRIPTION provided by applicant Insomnia of sufficient clinical severity to meet diagnostic criteria is present in approximately of older adults nearly million individuals n the US alone If left untreated it can lead to increased rates of depression cognitive impairment and cardiovascular disease Treatment relies on pharmacotherapy such as sedative hypnotic therapy which is associated with an increased risk of falls accidents and delirium cognitive behavioral therapy for insomnia CBT I which is effective but can take up to eight weeks or more and is limited by a paucity of trained providers and over the counter medications many of which contain diphenhydramine a medication that is on the Beers Criteria for Potential Inappropriate Medications in Older Adults There is clearly a pressing need to develop solutions that can treat insomnia in older adults Preliminary research conducted at the University of Pennsylvania suggests that a mobile device treatment based on core elements of CBT I and mindfulness especially thought redirection and disengagement can significantly improve insomnia symptoms in up to of patients compared to in the control arm Innovative aspects of this approach include the use of a physical task that of finger tapping timed to the breathing cycle to serve as an anchoring re orienting task and the ability to monitor in real time patient adherence by wirelessly transmitting to a central database a time stamped record of all taps The straightforward nature of this intervention allows for rapid training with treatment benefits seen in as little as weeks The overall goals of this fast track STTR are to develop and test this non pharmacological low risk treatment for insomnia in older adults Specific aims are Phase I Refining the application interface through structured interviews with patients and health care providers development of educational material for patients to access at home integration with accelerometer data and a pilot clinical study in study participants Phase II Further refining the educational material create interpretive risk classification algorithms to automatically flag non adherence and non responders for early intervention and a large randomized controlled trial of subjects to confirm efficacy The primary hypotheses are that a mobile device implementation of this monitored breathing awareness therapy with an anchoring task MBAT can be used by andgt of older adults and that it will lead to statistically and clinically significant improvements in insomnia within two weeks Advanced Medical Electronics has years of biomedical development experience and academic partners Gooneratne Benzo have expertise in sleep medicine geriatrics mindfulness therapy and clinical trials in older adults If successful this project will provide patients and health care providers with the first low risk low cost treatment option for insomnia that can be readily implemented in older adults It has the potential to fundamentally change how insomnia is treated thereby reducing the risks of untreated insomnia and avoiding the multifarious side effects of pharmacologic treatment such as with sedative hypnotics PUBLIC HEALTH RELEVANCE Insomnia can be a chronic problem for many older adults that leads to significant daytime fatigue stress and numerous negative health consequences including depression Advanced Medical Electronics in partnership with researchers are the University of Pennsylvania and the Mayo Clinic propose developing an innovative non drug low risk treatment that can be implemented on mobile devices for the treatment of insomnia in older adults


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 672.63K | Year: 2016

DESCRIPTION provided by applicant This project will develop a state of the art technology platform to support psychosocial interventions for persons with Alzheimerandapos s disease AD and other dementia PWD and their family members and friends FMs A tool will be developed that automatically solicits media allows communicating with caregivers and checks the quality of media feeding into the SimpleC Companion a behavior management technology for persons with Alzheimerandapos s disease and other dementia The main goals are to improve therapy personalization make it scalable thereby positively affecting the effectiveness of the SimpleC care intervention The number of people with dementia is large and growing Approximately million people in the U S and million worldwide have dementia These estimates are expected to nearly triple by Currently there is no cure and the cost to families the health care system and society is large Not only is dementia the sole top U S disease that cannot be prevented cured or slowed but it is also one of the costliest chronic diseases estimated national cost is $ billion half of which is carried by Medicare and expected to rise to $ trillion by if nothing changes In addition there are few tools to meet the needs of this population The general approach is medication which is costly and sedates people with dementia rather than engaging them Psychosocial interventions such as those offered by SimpleC are alternatives to pharmacology to address dementia related symptoms while improving both quality of care and quality of life Personalization is one key ingredient to the success of the interventions While SimpleCandapos s highly personalized interventions human customer service and advanced wireless computing network enable the creation and delivery of meaningful care interventions on a large cost effective scale these interventions still require significant manpower to gather personalized therapeutic content which is usually non digital e g Polaroid pictures reel to reel audio and video tape from caregivers and family members who are likely very busy stressed and may live far away The first goal of the proposed project mitigates this barrier by reducing manpower requirements providing guidance to caregivers and enabling even wider spread deployment Furthermore this project will both increase and sustain care recipientsandapos engagement which is crucial to psychosocial interventions The second goal addresses communication needs between care giving parties The proposed project addresses the challenge of offering a channel to communicate that is respectful of busy schedules and high workloads of all involved The project will assess technology acceptance and barriers in the field In phase I AME demonstrated feasibility of a caregiver tool that supports the collection of media required for psychosocial interventions and facilitates communication between staff caregivers and family members friends of older adults with dementia In phase II AME will partner with SimpleC to expand and integrate this functionality into their technology platform and products as well as conduct an in market test of the entire platform Testing will occur in the long term care facility high staff and high resident turnover and home market where the majority of persons with dementia PWD live PUBLIC HEALTH RELEVANCE Alzheimerandapos s Disease and related dementias is one of the costliest chronic diseases and they cannot be prevented cured or slowed SimpleC has developed a wireless media based behavior management technology that delivers psychosocial care interventions to improve the quality of life of persons with Alzheimerandapos s disease and related dementias PWD To better support caregivers AME is partnering with SimpleC to increase care interventionsandapos scalability to a large number of geographical diverse users while sustaining PWD engagement Additional support includes a new means for care giving parties to communicate


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 719.96K | Year: 2016

DESCRIPTION provided by applicant We propose to develop and evaluate the utility of a thermal imaging system as an input modality to a retinal prosthetic Retinal prostheses restore partial vision to people blinded by outer retinal degenerative diseases such as Retinitis Pigmentosa RP or Macular Degeneration The Argus II retinal prosthesis system is intended to provide electrical stimulation of the retina to elicit visual perception in blind individuals with severe to profound retinitis pigmentosa The implanted epiretinal array provides a grid of electrodes Electrical pulses at these sites stimulate the retinaandapos s remaining cells and result in te perception of patterns of light in the brain Ordinary light and color information is difficult for wearers to effectively process in many important tasks with the limited perceived spatial resolution Current compensation techniques in reduced resolution systems apply enhancement magnification and panning of visible light imagery and these techniques have utility to retinal implants However other information sources such as thermal imaging more naturally align to the limited resolution of retinal arrays and improve the utility of the system i important tasks such as people finding and mobility The proposed project seeks to provide thermal imagery as an input modality to retinal implants Following successful development of a prototype thermal imaging system and promising results during tests in Argus II retinal prosthesis wearers in phase I we are now proposing the development and validation of an integrated visible and thermal imaging system under phase II A fully integrated prototype system will be developed that includes visible and thermal cameras and associated digital signal processing software to provide user controllable combined thermal visible imagery options to prosthesis wearers This new system will be evaluated in a substantial trial PUBLIC HEALTH RELEVANCE The proposed project relates to the utilization of thermal imaging as an input modality to a retinal prosthetic Retinal prostheses aim to help people who have lost their vision due to degenerative eye conditions such as retinitis pigmentosa or macular degeneration to perceive shapes and movement to become more mobile or to perform other day to day activities

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