---------- OSD ----------

61 Phase I Selections from the 09.3 Solicitation

(In Topic Number Order)
Advanced Brain Monitoring
2237 Faraday Ave Suite 100
Carlsbad, CA 92008
Phone:
PI:
Topic#:
(760) 720-0099
Djordje Popovic
OSD 09-H06      Awarded: 4/1/2010
Title:Neuromonitoring of Traumatic Brain/blast Injury
Abstract:It is well known that the brain is the organ most sensitive to ischemia/hypoxia. Noninvasive continuous monitoring of cerebral blood flow autoregulation, cerebrovascular reactivity and related phenomena such as cerebral vasospams in combat casualties could guide clinicians/medics in adjusting the strategy of resuscitation and acute care, and therefore contribute to a substantially improved survival and functional outcome. We propose to develop a small, light-weight, battery powered and hand-portable 3-channel monitor that combines electro- and rheoencephalography (EEG and REG). While REG detects changes in cerebral vascular bed, EEG can be used to detect post-traumatic non- convulsive seizures or reversible breakdown of the synaptic transmission. The monitor consists of a smaller (2 x 2 x 0.5 in) wearable unit for data acquisition and a larger (7 x 5 x 0.8) unit for visualization and storage of data. The units communicate to each other wirelessly, via a Bluetooth link, or through a cable. The larger unit processes the incoming data in real time, and warns clinicians (via an audio alarm) of a deterioration of the patient''s condition. The bigger unit can connect to a LAN or the internet so that the REG/EEG data can be downloaded and analyzed offline by clinicians.

Empirical Technologies Corporation
P.O. Box 8175
Charlottesville, VA 22906
Phone:
PI:
Topic#:
(434) 296-7000
Martin C. Baruch
OSD 09-H06      Awarded: 4/1/2010
Title:Neuromonitoring of Traumatic Brain/blast Injury
Abstract:The objective of the proposed program is the development of a mobile and non-invasive cerebro-physiological monitor that will permit the tracking of cerebral functions and the identification of developing pathologic brain conditions in wounded soldiers during transport and under medical care in forward areas. Specifically, the purpose of the system will be to continuously track cerebral blood flow and perfusion by monitoring the state of autoregulation as well as by monitoring an EEG signal as a further detection mechanism for declining brain function. ETC proposes to enhance the capabilities of its existing mobile physiological monitoring platform, the CareTaker, to include the required brain monitoring functions. Beyond significant on-board computing power, data storage capability, and the ability to interface with other sensor systems, CareTaker provides the enabling physiological variable that is required to assess the state of CBF autoregulation, blood pressure, in a compact and highly mobile package.

Physical Optics Corporation
Information Technologies Division 20600 Gramercy Place, Bldg. 100
Torrance, CA 90501
Phone:
PI:
Topic#:
(310) 320-3088
Alireza Shapoury
OSD 09-H06      Awarded: 4/1/2010
Title:Screening of Cerebral Autoregulation and Neuroelectric Signals Through Hemodynamic Impedance Measurement and Electrocephalography
Abstract:To address the Office of the Secretary of Defense (OSD) need to perform noninvasive neuromonitoring of patients with traumatic brain injury (TBI), Physical Optics Corporation (POC) proposes to develop a new Screening of Cerebral Autoregulation and Neuroelectric signals through Hemodynamic Impedance Measurement and Electroencephalography (SCANHIME) system. It is based on recording brain neuronal activity using electroencephalography (EEG) and hemodynamic impedance variations using rheoencephalography (REG) to monitor and issue alerts on ischemic penumbra and neuropathological conditions. The innovation in hybrid integration of electrodes for both EEG and REG, optimization of electrode disposition, and a new artifact-removal algorithm, enables the SCANHIME to serve as a portable monitor on the battlefield. Therefore, SCANHIME offers inexpensive and reliable ambulatory monitoring of neurophysiological conditions in unattended TBI individuals for >30 days, with an 80 GB memory, which directly addresses the OSD requirements. In Phase I, POC will demonstrate, through modeling, analysis, and performance bound calculations based on a four-shell model of the head, the capability of SCANHIME to perform real-time monitoring with latencies of 2 seconds, and will develop component specifications. In Phase II, POC will develop a SCANHIME prototype, including a display for visualization of measurements, for human and animal studies.

Quantum Applied Science and Research Inc.
5764 Pacific Center Blvd Suite 107
San Diego, CA 92121
Phone:
PI:
Topic#:
(858) 228-1093
Konstantine Ermolaev
OSD 09-H06      Awarded: 4/1/2010
Title:Neuromonitoring of Traumatic Brain/blast Injury
Abstract:Brain related injuries are a major cause of disability, death and economic cost to modern society, and are a distinguishing feature of the US military’s recent conflicts. Rheoencephalography (REG) and Electroencephalography (EEG) are non-invasive, real- time measurements compatible with use in a miniaturized portable system to provide detailed information on the cerebrovascular and neurological status of a patient during evacuation from the battlefield and in the hospital during recovery. Quantum Applied Science and Research (QUASAR) has extensive experience in developing EEG and other bioelectric sensing systems for convenient, real-world use, including in battlefield settings. On Phase I of this program, QUASAR will apply its technology for no-prep dry electrode systems to develop an overall design and specifications for an REG/EEG system that will detect changes in the autoregulation of cerebral blood flow and alarm if the lower limit of autoregulation is reached. Similarly, the system will detect and alarm on failure of neuronal synaptic transmission indicating insufficient cerebral blood flow. In addition, the system will measure indications of vasospasm, and increase intracranial pressure. Phase II of the program will build the specified system, together with testing in human and animal studies.

JXT Applications, Inc.
1195 Meadow Bridge Drive, Suite C
Beavercreek, OH 45434
Phone:
PI:
Topic#:
(937) 321-6372
Dave Weldon
OSD 09-H07      Awarded: 4/1/2010
Title:Evidence-Based Evaluation Process for Traumatic Brain Injuries and Co-morbid Psychological Disorders in Service Members
Abstract:Mild traumatic brain injury (mTBI) is strongly associated with emotional and physical health problems, of which PTSD and depression are important mediators. There is a significant overlap between of military members who have experienced and/or witnessed a life threatening event and sustained a blast or other TBI. There is a need to develop a user- friendly, empirically-based, neuropsychological screening tool to be used by first responders to screen for mTBI. In Phase I, JXT will assess the co-occurrence of these neurocognitive and emotional events, determine the problems and associated conditions, examine the long term implications and evaluate diagnostic instruments in order to distinguish who is most at risk for becoming impaired. From this information, JXT will identify a pool of neuropsychological and emotional health test items to be used to construct a Statistical and Evidence-Grounded mTBI Evaluation and Neuro-assessment (SEGMEN) Tool; identify and document important control and mediator variables; specify the criterion/outcome variables; and prepare to evaluate the reliability and validity of the SEGMAN Tool in Phase II. This effort will be driven by the innovative JXT Test Construction and Validation Process Model. We will also create an automated conceptual demonstration of the SEGMEN Tool to assess usability and commercial potential.

Vista LifeSciences
PO Box 2396
Parker, CO 80134
Phone:
PI:
Topic#:
(303) 549-2435
S. Michael Lutz
OSD 09-H07      Awarded: 4/1/2010
Title:Evidence-Based Evaluation Process for Traumatic Brain Injuries and Co-morbid Psychological Disorders in Service Members
Abstract:This proposal will develop an empirically-based neuropsychological screening tool to be used by first responders. This tool will quickly and accurately identify service members who show probable impairments from combat-related experiences. The product will investigate de-identified patient data to assist in R&D. A thorough analysis of psychological assessments and their predictive power influencing functional status will be conducted. Plans and protocols will be prepared for Phase II. A prototype screening tool will be provided. Through their work in commercializing the neuropsychological assessment batteries in ANAM4TM, Vista LifeSciences brings a deep understanding of TBI in service-related exposures, the requirements of military neuropsychological testing, statistical analysis, human factors engineering, and the integration of sensitive health records into military systems. This experience will be broadened by a scientific team with a broad spectrum of independent research expertise across research and clinical neuropsychology, experienced in all relevant measures and tools, thus guaranteeing an objective evaluation of existing/emerging research and selection of the target tool set in this project. The result will be a tool with assessments most appropriate for the needs of emergency situations, appropriate for use by emergency responders, and technology platform(s) that can operate in emergency environments.

Activas Diagnostics
246 Sylvan RD, Suite C
Bangor, ME 04401
Phone:
PI:
Topic#:
(207) 973-4963
Marie Hayes
OSD 09-H08      Awarded: 4/9/2010
Title:Early Detection of Mild Traumatic Brain Injury
Abstract:Early detection of positive mild traumatic brain injury (mTBI) status is difficult in the post- trauma period and efficient, noninvasive screening methods are needed. Brain injury from trauma and other neurological conditions frequently escapes detection using current imaging technology such as magnetic resonance (MRI) and computer-assisted tomography (CAT). mTBI is associated with cognitive impairment in attention, learning and information processing is correlated with sleep disorder and accumulating sleep deprivation. This proposal aims to use the PI’s prior sleep and brain injury discoveries in humans to develop a prototype device that can detect sleep anomalies for the diagnosis of both mTBI presence and severity. An interdisciplinary approach will be used for prototype development using cutting edge engineering science innovation in sensor fabrication, wireless signal processing and software development. The prototype device will use proprietary sleep algorithms associated with brain injury and compare results to neurocognitive outcome measures. The Phase II plan is to test this simple, noninvasive device in a home-based setting. Recent mTBI military outpatients will be compared to a sample of military patients without brain injury in overnight tests using the device. Commercialization plans include device development for early diagnosis of mTBI and future applications to other brain injury etiologies.

CFD Research Corporation
215 Wynn Dr., 5th Floor
Huntsville, AL 35805
Phone:
PI:
Topic#:
(256) 726-4874
Madadevabharath Somayaji
OSD 09-H08      Awarded: 4/15/2010
Title:Model based analysis of sleep-wake cycle for early detection of mild TBI
Abstract:The goal of this project is to develop a computational algorithm/model to detect subtle changes in neurobiology of sleep-wake cycle due to mild TBI. We aim to quantify early enough the subtle changes in sleep-wake disorder by correlating objective sleep quality measurements as model inputs to the “Injury Leonardo” framework that

NeuroWave Systems Inc.
2490 Lee Blvd Suite 300
Cleveland Hts, OH 44118
Phone:
PI:
Topic#:
(216) 472-6333
Mo Modarres
OSD 09-H08      Awarded: 4/15/2010
Title:Wearable Device to Quantify Sleep & Sleepiness Abnormalities for Detection of mTBI
Abstract:The overall goal of this project is to develop a novel, miniaturized, wearable neurobehavioral device that will quantify the presence and severity of night sleep abnormalities and daytime sleepiness using state of the art EEG acquisition hardware as well as high-resolution signal acquisition and processing methods. The intended use of the device is for early detection of mild Traumatic Brain Injury (mTBI) based on quantification of sleep abnormalities and excessive daytime sleepiness. To achieve this goal, we will develop (and test with mTBI patients) a novel integrated device with the following two major technical capabilities (1) Hardware: Robust, convenient, and self- administering means of acquiring EEG and other biosignals during sleep study, and EEG and behavioral response during daytime test of sleepiness, and (2) Software/Algorithm: Sensitive and high-resolution signal processing methods and EEG-based algorithms for tracking the fluctuations in the wake and sleep stages for a more precise characterization of the sleep architecture and quality, as well as daytime sleepiness. The output of the algorithms, which are embedded within the EEG hardware, will be then utilized for a more sensitive quantification of wake-sleep disorder and abnormalities that would be correlated with the presence and severity of mTBI.

Dynamic Structures and Materials, LLC
205 Williamson Square
Franklin, TN 37064
Phone:
PI:
Topic#:
(615) 595-6665
Jeffrey S.N. Paine
OSD 09-H09      Awarded: 4/1/2010
Title:Parallel Kinematic Actuator with Reduced Size and Improved Performance
Abstract:Applications for ultrasound are expanding beyond medical imaging to include new functionality, with the potential to halt internal bleeding or provide an alternative to manual suturing. These types of functions are in some ways suited to a surgical robot, offering the potential for teleoperation or perhaps even autonomous functionality. However, the requirements for positioning an ultrasound device are different than those for a typical surgical robot. An end-effector is proposed that will use parallel kinematics and force feedback to make an actuator that is “actively compliant”. This end-effector will be fixed to the end of a conventional articulated robot, but will have high bandwidth in all six axes of motion, allowing it to correct for compliance and shifts in the position of the patient. Thus, controlled contact can be maintained between the ultrasound device and the patient, allowing for proper function of the device.

Energid Technologies
One Mifflin Place Suite 400
Cambridge, MA 02138
Phone:
PI:
Topic#:
(888) 547-4100
Pablo Valdivia y Alvarado
OSD 09-H09      Awarded: 4/15/2010
Title:Actively Compliant Parallel End-Effector Mechanism for Medical Interventions
Abstract:Many robot assisted medical procedures involve direct contact of medical tools with a patient’s body, posing a challenge in terms of accuracy and safety. In addition, the unpredictability of soft tissue movement and deformation during medical interventions makes execution of procedures through robotic systems especially challenging. Energid Technologies proposes a novel, actively compliant parallel end effector suitable for imaging and other medical interventions. The system consists of a unique, back drivable parallel system that, when coupled with Energid’s Actin robot control software and an innovative sensing system, will provide unprecedented accuracy and safety. With the proposed unique approach, the parallel mechanism will provide active compliance, active stiffness, real-time force feedback, and full spatial motion, making it unparalleled for compliance-based medical diagnosis and surgical tasks.

Infoscitex Corporation
303 Bear Hill Road
Waltham, MA 02451
Phone:
PI:
Topic#:
(781) 890-1338
James Goldie
OSD 09-H09      Awarded: 4/15/2010
Title:Actively Compliant Parallel End-Effector Mechanism for Medical Interventions
Abstract:With ultrasound capabilities increasing, such as for detecting internal bleeding and bone fractures, ultrasound usage is expanding on and off the battlefield. During a typical ultrasound image-guided procedure, accurate manual manipulation of an ultrasonic probe with one hand while manipulating a surgical tool with the other hand is cumbersome for a practitioner. Currently available serial-link robot arm manipulators are not capable of applying accurate, consistent force of the probe on the patient, particularly during probe manipulation. Infoscitex Corporation proposes to address these requirements with an actively compliant, parallel, 6-DOF end-effector, called ACE (Actively Compliant End- effector), capable of responding to patient body-surface movements with end-effector counter-movements in real-time. ACE’s responsiveness will be sufficient to maintain a consistent force between the probe and the patient’s body regardless of anatomical changes during an image-guided procedure. Infoscitex has assembled a distinguished team to address this work. In conjunction with our university research partner, Georgetown University, our medical/ultrasound consultant, Dr. Dan Swerdlow, and our commercialization partners, Barrett Technology and U-Systems, we are proposing an innovative approach to meet the requirements called for in this solicitation. At the conclusion of Phase II, a pre-production version of ACE will be ready for immediate deployment in selected applications.

Infoscitex Corporation
303 Bear Hill Road
Waltham, MA 02451
Phone:
PI:
Topic#:
(781) 890-1338
Vladimir Gilman
OSD 09-H10      Awarded: 3/25/2010
Title:Spatial and Temporal Control of Tissue Growth using DNA Aptamers
Abstract:The clinical need for improved craniofacial reconstruction materials drives the development of new tissue engineering scaffold materials to alleviate inherent problems with the current best practice, allo- and auto-grafting. Infoscitex, in collaboration with Tufts University and Serica Technologies, presents a novel silk fibroin derived scaffolding material, customizable to many form factors with tunable material properties, coated with cell-specific aptamers to promote selective affixation of mesenchymal stem cells, with the goal of reducing wound healing time and promoting vascularization through the depth of the scaffold. In Phase I, we will isolate aptamers that selectively bind to highly conserved identity regions of mesenchymal stem cells, affix these aptamers to the surface of Serica Technology''s SeriScaffold, and demonstrate in vitro that the treated scaffolds show an increased MSC affinity, viability, proliferation, and differentiation. In Phase II, we will transition to in vivo studies and demonstrate that with the addition of embedded chemokine signals, angiogenesis through the scaffold is enhanced and wound healing is more rapid and complete.

KeraNetics, LLC
1st Floor, Richard Dean Building 391 Technology Way
Winston-Salem, NC 27101
Phone:
PI:
Topic#:
(336) 202-1307
Luke Burnett
OSD 09-H10      Awarded: 3/25/2010
Title:Keratin Biomaterials for Cranio-facial Tissue Engineering
Abstract:The majority of personnel injured in OIF/OEF have suffered blast effects from IEDs. Blasts often cause cranio-facial trauma that is difficult to repair. There is a significant need to develop better platform technologies for these injuries and translate them into clinical and commercial use. A family of biomaterials derived from keratin proteins may provide a platform on which regenerative strategies can be built. Keratins have broad biocompatibility and can be formulated as films, foams, gels, fibers, or solid tissue constructs. One of the problems with many synthetic and naturally derived biomaterials is that they do not promote cell adhesion and migration into scaffolds that have weak cell- matrix interactions. Keratins have intrinsic cell-binding properties that can be exploited to offer potential new solutions to cranio-facial regeneration. This Phase I proposal seeks to perform initial testing of keratin materials using primary cell types relevant to cranio-facial tissues. Assessments will be made regarding cell attachment, proliferation, gene expression and other cell specific assays to validate that keratin materials provide a permissive extracellular matrix-like environment. Results will be used to tailor specific types of keratin proteins into biomaterial scaffolds for use in large animal cranio-facial defect studies to be conducted in Phase II.

Stratatech Corporation
505 S. Rosa Road, Suite 169
Madison, WI 53704
Phone:
PI:
Topic#:
(608) 441-8358
Mary A. Lokuta
OSD 09-H10      Awarded: 3/26/2010
Title:Natural Polymers for Cranio-facial Tissue Engineering
Abstract:Complex craniofacial tissue loss is a major medical problem affecting deployed military personnel. During the ongoing conflicts in Iraq and Afghanistan, approximately 88% of injured troops sustain severe blast-related injuries to their head and neck from improvised explosive devices. These severe and disfiguring injuries frequently involve volumetric loss of skin, muscle, cartilage, and bone, and result in increased morbidity, mortality, and recovery times. Reconstruction of damaged or missing craniofacial tissues typically requires repeated surgical procedures, frequently with poor functional and cosmetic outcomes. There is a substantial and urgent need for improved treatment options, capable of promoting regeneration of multiple craniofacial tissues and accelerating the healing process. The ultimate goal of this proposal is to develop a family of tissue-specific bioengineered connective tissue matrices to improve functional and cosmetic outcomes of craniofacial reconstruction. This will be achieved by culturing fibroblasts from different craniofacial tissues to produce cell-derived matrices (CDM) composed of naturally- synthesized extracellular matrix components. The CDM will be used as bioactive connective tissue scaffolds for the attachment of major craniofacial cell types to construct a variety of regenerative tissues. The connective tissue matrices will be assessed for strength, histological architecture, biochemical composition, and promotion of cellular attachment.

Creative Bioreactor Designs Inc.
3455 University Parkway
Winston-Salem, NC 27106
Phone:
PI:
Topic#:
(781) 771-1357
Kerr Spencer
OSD 09-H11      Awarded: 4/30/2010
Title:Development of a Novel Bioreactor System for Engineered Tissues
Abstract:The devastating traumatic injuries sustained by warfighters in OIF/OEF frequently involve the loss of large portions of bone, muscle and skin. Current management of tissue coverage and augmentation involves the use of existing host tissue to construct, for example, muscular flaps or grafts. In many instances this approach is not feasible due to lack of viable tissue and/or donor site morbidity. Such complications delay or prohibit rehabilitation and restoration of tissue function. Tissue engineering of bulk functional tissue may provide a solution for these injuries. Recent studies have documented the importance of bioreactor preconditioning in vitro to the enhanced function of engineered skeletal muscle following implantation in vivo. We will leverage these initial findings to address the critical need for clinical translation and commercial use of platform bioreactor technologies required to treat these injuries. An established protocol for engineered skeletal muscle will provide a model system to create novel bioreactors capable of both noninvasive real-time imaging of engineered tissue formation and promotion of vasculogenesis. The result will be a “next generation” bioreactor system capable of noninvasive high throughput evaluation of various cell sources and biomaterials, as well as production of tissues that can overcome existing size limitations for functional reconstruction.

Resodyn Corporation
130 North Main Street Suite 600
Butte, MT 59701
Phone:
PI:
Topic#:
(406) 497-5233
Todd McAdams
OSD 09-H11      Awarded: 5/3/2010
Title:Modular Perfusion Bioreactor for Tissue Engineering
Abstract:This project will develop and demonstrate a prototype Modular Perfusion Bioreactor (MPB) for tissue engineering applications. While many unique styles of bioreactors have been proposed for various types of stem cell and tissue cultures, there is not a single, easy-to- use device that accommodates the multiple diverse needs of multiple tissue culture types.. In order to take advantage of recent advances in stem cell culture, biomaterials, and tissue engineering techniques, Resodyn Corporation proposes to develop, design, fabricate, and test a multi-functional bioreactor platform system. As a starting point for this multi-functional system, Resodyn Corporation will use its highly scalable (50-1,500ml) and successful (>1x108 cells/ml) hypoxia perfusion bioreactor. The focus of the proposed work will be to design additional culture modules that can be plugged into an advanced platform system developed by Resodyn Corporation. Modules that allow the culture of cellular monolayers, encapsulated cells, microcarrier-attached cells, and cells attached to scaffolds of various types will be developed and tested for feasibility and applicability. The MPB system has significant long-term commercial potential both in the laboratory and the clinic as a tool to facilitate the translation of stem cell developments into practical replacement tissues for neural, hematopoietic, and mesenchymal lineages.

KnowMED
7000 Fannin, UCT650
Houston, TX 77030
Phone:
PI:
Topic#:
(860) 430-5371
Vipul Kashyap
OSD 09-H12      Awarded: 3/15/2010
Title:APPLICATION OF SEMANTIC WEB TECHNOLOGIES TO ALERT PROVIDERS REGARDING POLY-PHARMACY ISSUES IN TRAUMATIC BRAIN INJURY (TBI) AND/OR POST-TRAUMATIC STRES
Abstract:We propose to engage with all stakeholders (administrative, policy and decision makers, data providers, users of the system, technology developers) and survey the resources, opportunities, barriers and challenges and risks involved through a systematic process of “Solution Envisioning” in order to conceptualize an optimal systems architecture for pharmacovigilance and poly-pharmacy alerting and adverse reaction prevention for military patients with PTSD and/or TBI enabled by collaborative clinical information integration and sharing, in a network distributed across boundaries of institutions, organizational departments, health information systems, applications and databases. We will use the Semantic Web frameworks and technologies to develop the blue print for a pharmacovigilance and alerting network that can integrate structurally and semantically heterogeneous data across boundaries of multiple organizations, account for multi- organizational standards, vocabularies and terminologies, information models, contextualize multi-source data for disease classifications and hypothesis building and evaluation, and can enforce and enable policies, regulations and guidelines in accessing and uses of the information in a distributed and collaborative network. We hope that we will save lives, reduce morbidity and improve quality of life of military patients through reduction of clinical errors, reducing costs, improving standard of care, and implementing customizable preventive and alerting technologies.

SYSNET International, Inc.
2930 Oak Shadow Drive
Oak Hill, VA 20171
Phone:
PI:
Topic#:
(703) 855-2029
Odysseas Pentakalos
OSD 09-H12      Awarded: 3/15/2010
Title:An Ontology-based Adverse Drug Event Alert Generation System
Abstract:Medication errors cause the greatest number adverse drug events than any other single cause. Traumatic Brain Injury and Post-Traumatic Stress Disorder patients are especially likely to experience such adverse drug events as a result of the number medications and high dosage levels of the medications that they are prescribed to help them deal with their conditions. Detecting and preventing such adverse drug events is a complex data integration and reasoning problem due to the fact that the individual sources of data that are needed for inferring the potential occurrence of such an event are encoded using disparate medical terminologies and ontologies. SYSNET International, will leverage its extensive experience with clinical data systems integration and with the Military Health System in particular, to develop an ontology-based adverse drug event alert generation system. The system will utilize model-based schema transformation techniques to extract local ontologies from the individual sources of data and then ontology mapping algorithms to align them with a global ontology. A semantic inference engine will be then used to generate potential alerts of adverse drug events.

Zreyatech LLC
ITC Startup Suite 2112 Binghamton University
Binghamton, NY 13902
Phone:
PI:
Topic#:
(607) 221-4616
Sushil Gupta
OSD 09-H12      Awarded: 3/15/2010
Title:APPLICATION OF SEMANTIC WEB TECHNOLOGIES TO ALERT PROVIDERS REGARDING POLY-PHARMACY ISSUES IN TRAUMATIC BRAIN INJURY (TBI) AND/OR POST-TRAUMATIC STRES
Abstract:We propose a Semantic Web based Ontology Engine to map disparate medical terminologies to help patient management, and pharmacovigilance efforts with emphasis on TBI and PTSD patients. Currently, there are multiple terminologies being used both within and outside the MHS. The proposed system and study efforts will allow the MHS systems to interface with National Sentinel Network and the NCI JANUS CDR, enhancing the MHS pharmacovigilance efforts. Mapping terminologies will also allow bridging the drug information gap between clinical trials and post marketing pharmacovigilance.

Cornerstone Research Group, Inc.
2750 Indian Ripple Road
Dayton, OH 45440
Phone:
PI:
Topic#:
(937) 320-1877
Kristin Cable
OSD 09-H13      Awarded: 4/15/2010
Title:Next-Generation Aeromedical Spinal Stabilization System
Abstract:Cornerstone Research Group Inc. (CRG) proposes to redefine the immobilization and evacuation of SCI and TBI patients by developing a new patient stabilization system for aeromedical transport. This revolutionary system will be capable of properly immobilizing patients in a multitude of transport configurations while reducing the dynamic effects from flight. CRG’s design will improve the patient’s quality of care and decrease the co- morbidity associated with SCI and TBI injuries that stems from improper immobilization during transport. CRG’s concept is comprised of a three-layer platform that includes a rigid laminate substructure, formable immobilization support, and an interface pressure- reduction mattress system capable of addressing both patient stabilization and pressure ulcerations. By addressing the two main system challenges of the patient restraint system, including cervical spinal immobilization and flight load damping, CRG can improve the quality of care for the solider and efficiency of the caregivers. CRG’s design approach will capture the best features of current medical patient immobilization equipment and will merge this technology into an adaptable flight load stabilization system. CRG’s concept combines multiple, off-the-shelf immobilization design features coupled with the use of lightweight, inexpensive, advanced composite and polymer material systems.

Techshot, Inc.
7200 Highway 150
Greenville, IN 47124
Phone:
PI:
Topic#:
(812) 923-9591
Tony Shulthise
OSD 09-H13      Awarded: 4/15/2010
Title:Aeromedical Stabilization and Evacuation of Traumatic Brain and Spine Injuries: A Novel System for Patient Transport
Abstract:The Techshot Aeromedical Stabilization and Evacuation System (ASES) solution consists of three subsystems including a Patient Support Platform (PSP), a Comfort Mat System (CMS) and a detachable Aeromedical Equipment Module (AEM). The ASES system provides a stabilization and traction platform solution for aeromedical evacuation with a comfort mat subsystem using heated alternating pressure air bladders or gel technology to prevent pressure sores.

Design Interactive, Inc.
1221 E. Broadway, Suite 110
Oviedo, FL 32765
Phone:
PI:
Topic#:
(407) 706-0977
David Jones
OSD 09-H14      Awarded: 4/15/2010
Title:Virtual Evacuation Vehicles for Training Medics (VEV-TM)
Abstract:As the Army moves forward with the integration of the MRAP Heavy Armored Ground Ambulance (HAGA) as a ground platform for evacuation, there is a critical need to train medics on how to take advantage of the capabilities of the new platform (e.g. access to additional tools and storage space) and develop coping mechanisms for obstacles associated with performing tasks within the vehicle (e.g. space/movement restrictions). The Medic Vehicle Environment/Task Trainer (M-VETT) aims to meet these goals through the use of a portable mixed reality training environment. The proposed scenario-based training solution will provide trainees with the opportunity to gain a level of kinesthetic memory (muscle memory) required to quickly locate tools that are needed to complete a variety of medical procedures while recording performance on those tasks as and others that are required of them during the CASEVAC process (e.g. communicating to the next level of care). The critical training objectives, tasks, metrics and multimodal cues will be researched and translated into functional requirements under the proposed Phase I effort. In addition, training scenarios for the simulation environment and prototypes of key functionalities will be developed and evaluated for feasibility by Design Interactive and their Phase II development partners.

Systems Technology, Inc.
13766 S. Hawthorne Blvd.
Hawthorne, CA 90250
Phone:
PI:
Topic#:
(310) 679-2281
Ed Bachelder
OSD 09-H14      Awarded: 4/27/2010
Title:STI-TP-1120-Virtual Evacuation Vehicles for Training Medics (VEV-TM)
Abstract:Casualty evacuation (CASEVAC) in Iraq and Afghanistan has often been conducted remotely from the point of injury (POI) due to medical vehicle vulnerability to attacks. However, 90% of all soldiers who have historically died due to battle injuries did so before they were treated at a medical facility [Ref. 1], with hemorrhage being the overriding cause. To improve these statistics the Mine Resistant Ambush Protected (MRAP) vehicle/Heavy Armored Ground Ambulance (HAGA) has been developed, tested and recently deployed. By making the HAGA more survivable to IED and combat, its mission now includes POI treatment. But because of the very limited number of HAGA’s that have been produced there have been none available for stateside training. Consequently the first time combat medics see the HAGA is in theater, and a capability gap due to training exists for combat medics newly assigned to the HAGA. STI proposes the Combat Medic Simulator (CMS), employing Fused Reality and offering various hardware configurations so that training requirements can be optimally matched with available resources and constraints. CMS virtual training will include equipment familiarization, communications, operations in visually degraded environments, night vision goggle emulation, casualty assessment/treatment/movement, and casualty disposition.

Total Immersion Software, Inc.
1 Enterprise Pkwy Suite 330
Hampton, VA 23666
Phone:
PI:
Topic#:
(510) 521-1405
Michael Becker
OSD 09-H14      Awarded: 4/26/2010
Title:Virtual Evacuation Vehicles for Training Medics (VEV-TM)
Abstract:Total Immersion Software, Inc. proposes to leverage DARPA’s $40M+ investment in the development of the RealWorld® 3D virtual mission rehearsal and training platform and toolkit, and extend its capabilities to create a scenario-based virtual training tool for the HAGA. RealWorld is a government-owned, royalty-free, game technology based simulation platform and toolkit. The Phase I effort will focus on researching and defining the technology extensions required to provide a virtual world based medic trainer that will operate in teaching, learning and test modes. It will also elaborate upon the technology and content required to train operations such as physical placement and movement of diagnostic and treatment items; usage of treatment items and their special relationships; logistics and sequencing of care and operations; implement, train and test local “point of injury” and higher care communications; test effects of patient location and orientation with interior/exterior lighting on/off; emergency evacuation sequences; loading and unloading patients; moving patients to/from litters, seats, inside/outside; medic movements to diagnose & administer care to patients. Furthermore, this effort will analyze the currently available technologies and extensions required to achieve the sponsor’s goals in subsequent phases.

KAI SENSORS
3465 Waialae Avenue STE 370
HONOLULU, HI 96816
Phone:
PI:
Topic#:
(808) 687-2900
Amy Droitcour
OSD 09-H15      Awarded: 4/15/2010
Title:Non-Contact Monitor for Patients with Sleep Disorder
Abstract:We are proposing to develop a Doppler radar based portable sleep monitor for assessment and monitoring of sleep disorders associated with post traumatic stress disorder (PTSD) and traumatic brain injury (TBI). The proposed sleep monitor will include at least two respiratory variable, a cardiac variable, and activity level measurements. Based on these sensor outputs sleep quality will be assessed. Positive subject identification will also be provided in conjuction with warfighter RFID tags. This development effort would benefit Battle Casualty and Psychological Health Research addressing diagnosis, treatment, and mitigation of deployment related injuries and psychological health concerns.

PERL Research LLC
3414-A Governors Drive
Huntsville, AL 35805
Phone:
PI:
Topic#:
(256) 539-5364
Paul Cox
OSD 09-H15      Awarded: 4/1/2010
Title:SLeep Assessment Monitor (SLAM)
Abstract:According to a recent RAND report, of the 1.64 million deployed to date, the study estimates that approximately 300,000 veterans who have returned from Iraq and Afghanistan are currently suffering from Post Traumatic Stress Disorder (PTSD) or major depression, and about 320,000 may have experienced mild Traumatic Brain Injury (TBI) during deployment. The identification of affected or at-risk soldiers is critical to early intervention and successful treatment. For sufferers of PTSD, sleep disturbances are among the most treatment-resistant symptoms and can lead to drug and alcohol abuse, even suicide. To address this problem, PERL Research proposed a non-contact approach is based on using a thermographic camera coupled with machine vision processing algorithms – SLeep Assessment Monitor (SLAM). The machine vision algorithm will process the thermographic video to segment body, detect/track body and limb movements; detects features (eye movement, breathing, heart rate, skin temperature).

Summit Safety, Inc.
94 Jackson Road # 303
Devens, MA 01434
Phone:
PI:
Topic#:
(978) 772-9009
Wayne C. Haase
OSD 09-H15      Awarded: 4/1/2010
Title:Non-Contact Monitor for Patients with Sleep Disorder
Abstract:The proposed non-contact sleep monitor will incorporate a multi-beam ultrasonic sensor to measure displacement, velocity, and acceleration of specific locations on a patient. Data from the battery-powered sensor will be transmitted through a wireless communication link to a laptop computer for analysis and data storage. The monitor will represent a significant improvement over radar-based non-contact sleep monitors. The proposed portable, non-contact sleep monitor will not interfere with patients’ sleep and will provide a highly accurate diagnostic tool for use in the hospital or at home.

Cybernet Systems Corporation
727 Airport Boulevard
Ann Arbor, MI 48108
Phone:
PI:
Topic#:
(734) 668-2567
Ron Hay
OSD 09-H16      Awarded: 4/1/2010
Title:Medical Capability Simulator Interface Tool for OneSAF
Abstract:OneSAF is rapidly becoming a centerpiece for many training simulations in the Army, amongst other reasons, for its ability to interoperate with many different protocols and packages. It only makes sense, given this central position, to examine the possibility of connecting the myriad of medical training systems to OneSAF, to see what emerges. To realize this possibility, a standard means of connecting medical training systems into OneSAF is needed. Additionally, a suite of tools should be created that allows for the rapid development of the interconnections for specific medical training systems. The goal of this Phase I is to design an effective gateway to interface existing medical simulation training systems, both software and hardware, into tactical simulators such as OneSAF. We call this gateway “MedOne”.

Intelligent Automation, Inc.
15400 Calhoun Drive Suite 400
Rockville, MD 20855
Phone:
PI:
Topic#:
(301) 294-5241
Renato Levy
OSD 09-H16      Awarded: 4/1/2010
Title:Tactical Medical Technology Evaluator for OneSAF
Abstract:While there are numerous emerging combat casualty care technologies that offer the promise to impact battlefield mortality, development, approval, and fielding of these technologies is a time and resource intensive process. New simulation and modeling tools are needed to rapidly assess the impact of next generation combat casualty care technologies. Understanding the impact of the new technology, early in the design/development phase will benefit the Department of Defense by enabling the definition of more effective requirements, efficient resource allocation to those technologies with the greatest promise, and identifying key areas of future technological need. To address this critical need, Intelligent Automation, Inc. (IAI), along with our collaborators propose to develop an effective Medical Capability Simulation and Evaluation Architecture (MCSEA) for evaluating the impact of emerging medical capabilities. MCSEA offers the key advantage that high-fidelity combat medical simulations can be built in a flexible and scalable runtime environment. MCSEA will provide systematic architectural approaches and interfaces to allow OneSAF simulations to interact with medical simulation models in order to evaluate the impact of combat casualty care medical capabilities such as casualty evacuation, treatment and transportation.

PERL Research LLC
3414-A Governors Drive
Huntsville, AL 35805
Phone:
PI:
Topic#:
(256) 539-5364
Paul Cox
OSD 09-H16      Awarded: 4/1/2010
Title:Medical Capability Simulator Interface Tool for OneSAF
Abstract:Despite these advances, simulation models have lacked advancement for emerging medical technologies within the operational simulation system most prevalent at Army Battle Labs, i.e. OneSAF (Simulated Autonomous Forces). In addition, there are no combat casualty or patient models within OneSAF that can be used to assess or evaluate the effectiveness of a new medical technology or treatment technique when used by a combat life saver or combat medic during small unit maneuver exercises or simulations. Simulation technology is critical in evaluating new technology and how it will develop better tactics and train soldiers. The ultimate goal of these simulations is to have the best fielded medical technology and the best trained soldier to help reduce the number of casualties. In order to address this limitation, PERL Research and Lockheed Martin propose the development of a Medical Capability Simulator Interface Tool for OneSAF. The resulting tool will allow medical technologies to be assessed and evaluated at Army Battle Labs within tactical exercises and simulations. Our approach will allow output data for after action reports (AAR) along with analysis tools to allow assessment of the simulations which can support the development of tactics, techniques, and procedures (TTPs).

Vecna Technologies Inc.
6404 Ivy Lane Suite 500
Greenbelt, MD 20770
Phone:
PI:
Topic#:
(617) 864-0636
Andreas Hofmann
OSD 09-H16      Awarded: 4/1/2010
Title:Medical Capability Simulator Interface Tool for OneSAF
Abstract:Testing and validation of new medical devices and technologies for use in combat is at present a cumbersome process. Live exercises, though vital for certification, are costly. In contrast, simulations can be run at speeds faster than real-time for a fraction of the cost of live exercises. Thus, simulations could be used to speed the validation process. OneSAF, the Army''s mission simulator presently cannot model emerging medical technologies. Vecna proposes an open system specification and interface tool prototype that interfaces OneSAF with real or simulated combat medical technologies to evaluate their use. The interface tool includes several innovations. First, the OneSAF Instrumented Soldier is an extension of the OneSAF soldier model that incorporates functional models of behavior. Second, a general open system framework for physiological models is used to provide basic modeling of key physiological processes and also, easy incorporation of more detailed models. Third, a graphical interface specification tool is used for defining relevant inputs and outputs of a real or simulated medical device, and for how these interact with the physiological model framework. For Phase 1, Vecna will implement prototypes of these capabilities, and test them with a simulated medical device using a OneSAF mission scenario.

BioRegeneration Technologies, Inc
203 S. Martin Jischke Dr, Suite 105
West Lafayette, IN 47907
Phone:
PI:
Topic#:
(765) 201-0516
Darryl Dickerson
OSD 09-H17      Awarded: 4/15/2010
Title:Novel Biomaterials for Complex Tissue Repair and Reconstructive Surgery of Traumatic Injuries
Abstract:Wounded soldiers experience a variety of musculoskeletal defects resulting from ballistic and blast trauma. Improved body armor technology and advanced medical care has decreased mortality due to blasts. However, optimal therapies have not been developed to treat the polytissue trauma that remains. Warfighters often exhibit substantial soft tissue damage in addition to bone fractures, which often makes it difficult or impossible to regain strength in the extremities or move their joints normally. Musculoskeletal tissues of the extremities are often damaged to a point that may require limb amputation. New therapeutic modalities are required to provide robust reconstructive options that restore extremity structure and function without multiple rounds of surgery. The ability to regenerate musculotendinous tissue and reattach muscles to bone through a normal orthopaedic interface would allow clinicians to substantially improve the outcomes of musculoskeletal reconstruction. Soft tissue injury can leave soldiers unable to return to duty. Soldiers may experience significant decrease in quality of life due to the damaged limbs which may not resemble the pre-injured state in appearance or function. In order to reduce soldier loss and increase quality of life, this proposal focuses on determining the feasibility of an off-the-shelf biomaterial solution for complex musculoskeletal tissue regeneration.

Luna Innovations Incorporated
1 Riverside Circle Suite 400
Roanoke, VA 24016
Phone:
PI:
Topic#:
(434) 220-0159
Michael Danilich
OSD 09-H17      Awarded: 4/1/2010
Title:Stratified Craniofacial Tissue Engineering Construct
Abstract:While maxillofacial, head and neck structures compose approximately 12% of total body surface area, traditionally approximately 16% of battlefield injuries have involved the head and neck, with even higher percentages in the most recent conflicts. The head and neck have very complex anatomy. Battlefield injuries to this region tend to be “devastating and complex,” but are rarely life threatening. Susceptibility to infection is high, particularly when the mucosal lining of the oral cavity is disrupted and the deep structures of the face and neck become contaminated with bacteria-laden saliva. Because of many limitations of auto-, allo- and xenogenic tissues for definitive repair of traumatic battlefield injuries of the head and neck, Luna Innovations Incorporated proposes to demonstrate the feasibility of a stratified tissue engineering construct with well-defined molecular structure and microscale architecture, predictable properties and tailorable behavior. The construct will be biodegradable, antimicrobial, angiogenic, sterilizable, easily adapted to complex three- dimensional shapes and designed to regenerate adjacent, but different tissue types, such as bone and muscle. To minimize regulatory hurdles and manufacturing difficulties, the construct will not contain cells, proteins or vectors, but can easily be incubated with these or similar bioactive agents in the surgical suite immediately prior to implantation.

Advanced Anti-Terror Technologies Corp. (A2T2)
896 W Minneola Ave Suite 57
Clermont , FL 34711
Phone:
PI:
Topic#:
(407) 373-9281
Ezra Sidran
OSD 09-H18      Awarded: 3/24/2010
Title:Remote Monitoring and Diagnosis of Warfighters at Risk for PTSD
Abstract:The aims and opportunities of our Virtual-Reality-Assessment-Modules(VRAM) for Remote Monitoring and Diagnosis of Warfighters at Risk for PTSD are based upon A2-T2’s existing remote technologies already developed for OSD and commercial customers. Specifically, this project provides an ideal opportunity to extend our remote enabled TBI screening assessment and rehabilitation technologies along with entirely new classes of advanced video teleconferencing technologies we are developing under commercial contracts into the PTSD domain. Our extensions and evolutions into the PTSD domains will exploit our easy-to-understand, ease-to-use monitoring, screening, and diagnostic interfaces customized for medical staff uses for assessments of return-to-duty status, affective computing (artificial intelligence dynamic adjustment of task difficulty to the type and level of user), and our current audio/visual assessments built-in to our Internet-Based Rehab prototypes. PTSD-specific parameters are the focus of our scientific and technical efforts. Our multi-modal designs fulfills non-invasive tools requirements associated with providing important information regarding a warfighter’s mental health status through detection and monitoring of biological patterns and/or signals (e.g. based on normal phone conversations and video-teleconferences) includes advanced hearing and listening screening and diagnoses inclusive of automated audio and/or video cuing, facial emotional monitoring, along with composite diagnostic scoring based upon solid scientific principles.

Brain Computer Interface, LLC
1310 Prospect Farm Drive
Yardley, PA 19067
Phone:
PI:
Topic#:
(215) 872-1549
Adam J. Simon
OSD 09-H18      Awarded: 5/3/2010
Title:A Non-invasive Brain Computer Interface to Remotely Monitor and Diagnose Warfighters at Risk for PTSD
Abstract:Brain Computer Interface, LLC (BCI) proposes to investigate the feasibility of developing a non-invasive system (MindScope) to remotely monitor and diagnose warfighters at risk for PTSD. BCI will utilize wireless dry electrode electroencephalography (EEG) headsets communicating with laptop PC’s (later PDAs) running BCI software. Human Phase I study participants will perform BCI’s dynamic brain stimulation tests to generate data for analysis. In two independent studies, BCI will (i) record scans from healthy participants to confirm baseline reproducibility, and (ii) in collaboration with Sinai Hospital and the National Rehabilitation Hospital, assess feasibility to detect statistical differences in the power spectral density (PSD) metrics of PTSD patients, mTBI patients, and control participants. Established scientific literature has shown that EEG metrics can classify PTSD from healthy controls, but EEG technology has previously been too cumbersome to generate significant relevant data under dynamic brain stimulation conditions. BCI will leverage hardware advances and an extensive clinical data collection network to generate this data, and to innovate, analyze and apply it to create BCI’s MindScope mobile physiological testing system to assess brain health. Ultimately, the system will create personalized biometric brain signatures, allowing remote monitoring and diagnosis of brain status against baseline “normal” data.

Intelligent Automation, Inc.
15400 Calhoun Drive Suite 400
Rockville, MD 20855
Phone:
PI:
Topic#:
(301) 294-5242
Roger Xu
OSD 09-H18      Awarded: 5/3/2010
Title:Remote PTSD monitoring and diagnosis using an automated system
Abstract:In this proposal, Intelligent Automation, Inc., propose an automated system that remotely monitors and tracks the patient’s mental healthiness. The proposed system first extract acoustic features such as "F0-amplitude", "F0-6db-bandwidth", Speaking rate, Percent pause time and Vocalization/pause ratio from patient'' voice. Then the patients’ voice will also be separated into phonemes and log likelihood scores will be generated by matching these phonemes with their Gaussian models. These log likelihood scores will be incorporated as part of feature sets. An advanced feature selection method, Piecewise Linear Orthogonal Floating Search (PLOFS) will be used to identify, select and map the most relevant features to the patient’s mental healthiness. Finally, the selected features will then pass through a novel committee machine-based regression algorithm to estimate the patient’s mental health “score”. The proposed system monitors each individual’s mental healthiness in real time and even tracks his/her mental health by refining the general model into his/her own personal model.

Response Applications LLC
10 Goodfellow Road
Hanover, NH 03755
Phone:
PI:
Topic#:
(603) 643-5956
Harold Greeley
OSD 09-H18      Awarded: 3/23/2010
Title:Continuous Voice Analysis of Warfighters at Risk for PTSD
Abstract:The need for remote, daily or possibly near-real-time psychological assessment of injured warfighters, at risk for Post Traumatic Stress Disorder (PTSD), during their recovery period, is critical given the preverlance of this condition and the need for a rapid and effective medical response. The goal of this project is to characterize changes in human voice characteristics as the psychological state of the speaker changes and to use this information as the basis of an effective, psychological condition assessment (PCAs) system. Our proposed system of continuous voice monitoring during the day will be superior to ‘point-to-point’ recording sessions in its’ ability to differentiate voice changes due to stress or anger from those associated with fatigue or consumption of alcohol or medication. Leveraging our previous work in these areas, Phase I will employ publicly available speech corpra to validate the overall concept. During Phase II wearable Voice Change Analyzers (VCAs) will be used to collect and analyze voice data from patients exhibiting PTSD. These results will be compared to manual assessment of voice and data logs performed by clinical personnel.

PRESSURE BIOSCIENCES, INC.
14 Norfolk Ave
South Easton, MA 02375
Phone:
PI:
Topic#:
(508) 230-1828
Nathan Lawrence
OSD 09-H19      Awarded: 3/30/2010
Title:Development of a universal method for diagnostic sample inactivation, extraction and enrichment of pathogens in arthropod hosts of military importance
Abstract:We propose to develop an easy-to-use, safe, automated system, with related methods and consumables, to allow for the simultaneous inactivation and extraction of target molecules from pathogenic organisms, such as viruses, and rickettsia and non-rickettsial bacteria, that propagate and/or disseminate in arthropod hosts (herein referred to as Agents). The proposed System will use a combination of mechanical homogenization, alternating high hydrostatic pressure, elevated temperature, specialized processing containers, and optimized chemical reagents to inactivate said Agents and to extract the target molecules from host organisms. Following inactivation and extraction, the targets (pathogen-derived molecules such as proteins, DNA or RNA) will be fractionated and enriched for reproducible and accurate detection. We propose that the System would be equally effective in the field or in a laboratory environment. All sample processing steps will occur in individually sealed sample containers. These containers will facilitate sample homogenization, lysis, and rapid extraction of target molecules. Additionally, they will be suitable for sample collection, transportation, and storage (pre and post analysis). Such containers will help ensure strict chain-of-custody, prevent sample cross-contamination, and reduce the likelihood of exposing personnel to infectious Agents. The System will be made rugged and portable; will be capable of automating the steps of sample inactivation, fractionation, enrichment, and extraction; and will be deployable in the field environment.

InBios International
562 1st Ave S, Suite 600
Seattle, WA 98104
Phone:
PI:
Topic#:
(206) 344-5821
Raymond Houghton
OSD 09-H20      Awarded: 3/29/2010
Title:Development of a hand-held, field-deployable multiplex assay for the detection of Chikungunya Virus (CHIKV), West Nile Virus (WNV), and Dengue Virus i
Abstract:Chikungunya an alphavirus, and the West Nile and Dengue Flaviviruses are carried by mosquitoes. While all three initially lead to febrile illness the subsequent clinical outcomes are very different and in some cases dual infections can occur. All three viruses have the potential to lead to fatal outcomes. Knowledge of the particular viruses carried by mosquitoes in areas of troop deployment would lead to improved and potentially early intervention in military personnel presenting with febrile illness. The purpose of this proposal is to develop a Multiline Lateral flow Immunoassay that would be field deployable and capable of independently detecting the presence of Chikungunya, Dengue or West Nile Viruses directly in mosquitoes. The test would be based on the use of specific antibodies to viral antigens in capture immunoassays. It is anticipated the test will use a colloidal gold detection system. The test will be designed to be stable and field deployable. The availability of such a test would have both military applications in many troop deployment areas as well as utility by epidemiologists in countries where these viral diseases are prevalent.

Operational Technologies Corporation
4100 N. W. Loop 410 Suite 230
San Antonio, TX 78229
Phone:
PI:
Topic#:
(210) 731-0015
John G. Bruno
OSD 09-H20      Awarded: 3/16/2010
Title:Multiplex Aptamer-Based Sensor for Mosquito-borne Viruses
Abstract:Operational Technologies Corporation (OpTech) has patents pending for: 1) one-step plastic-adherent aptamer-magnetic bead (MB) plus aptamer-quantum dot (QD) sandwich assays (that have already been successfully applied to ultrasensitive detection of Crimean-Congo Hemorrhagic Fever under a recent SBIR project), and 2) a multiplex cartridge in which the assays self-assemble as they traverse fluidic channels and adhere to plastic windows. Various sized QDs are utilized with a monochrome light source to enable simultaneous multicolored emissions for each type of captured pathogen present in a sample. OpTech originally developed this concept for rapid (< 15 minute) food and water safety testing, but can apply it to mosquito-borne virus detection and other clinical diagnostics as well in panels of 20 or more analytes. In Phase I, OpTech will develop DNA aptamers that distinguish Chikungunya, Dengue, and West Nile viruses and team with the Southwest Research Institute (SwRI) to develop a cartridge and portable fluorometer design for Phase II development. OpTech will attempt to demonstrate multiplex assay potential in Phase I by use of a spectrofluorometer and commercially available handheld fluorometer. OpTech will also deliver 100 prototype assays to the DoD at the conclusion of Phase I for independent testing and evaluation by the military.

VecTOR Test Systems, Inc
2033 Yellowthroat Place
Thousand Oaks, CA 91320
Phone:
PI:
Topic#:
(805) 390-0647
Kirti Dave
OSD 09-H20      Awarded: 3/22/2010
Title:Development of a hand-held, field-deployable multiplex assay for the detection of Chikungunya Virus (CHIKV), West Nile Virus (WNV), and Dengue Virus i
Abstract:VecTOR Test Systems, Inc. will develop a rapid multiplexed detection hand-held assay capable of simultaneously determining whether mosquitoes are infected with CHIKV, WNV, and/or Dengue. Developed tests will quickly and accurately determine whether mosquitoes are infected with CHIKV, WNV, and/or Dengue, to minimize the impact of the disease. The technology is based on the simple and reliable immunochromatographic detection method by which sensitive test-strip based assays provide results in less than 30 minutes. The proposed assays will be easy to perform and results easy to interpret in far-forward situations. The assay will be made available in a kit with components required to perform the assay. The assay kit will be stable at ambient storage conditions.

Calbiotech, Inc
10461 AUSTIN DR STE D
SPRING VALLEY, CA 91978
Phone:
PI:
Topic#:
(619) 660-6162
Noori Barka
OSD 09-H21      Awarded: 5/10/2010
Title:Develop Field-usable Diagnostic Devices for the Specific Detection of Leishmania Major and L. Infantum in Sand Flies
Abstract:Leishmaniasis is a parasitic disease spread by the bite of the sandfly. Due to its distribution, US military and civilian personnel deployed overseas are at high risk of being infected. Traditional laboratory techniques such as parasite identification in blood smears are labor intensive, and require highly trained personnel. There is a demand for an assay or device that allows for simple, rapid identification of leishmaniasis. We believe that there is sufficient genetic and molecular data available on L. major and L. infantum to allow the development of novel loop-mediated isothermal amplification (LAMP) LAMP primers to detect Leishmania DNA in sandflies by this method. Unlike conventional PCR which requires a thermocycler, LAMP reactions are held at a constant temperature and the read out can be done with the naked eye. Currently, point of care devices are being developed which will make LAMP technology fully portable and effective in a variety of situations where conventional laboratories are not available.

Intelligent Optical Systems, Inc.
2520 W. 237th Street
Torrance, CA 90505
Phone:
PI:
Topic#:
(424) 263-6344
Srivatsa Venkatasubbarao
OSD 09-H21      Awarded: 5/10/2010
Title:Multiplexed Rapid Test Kit for Leishmania Detection in Sand Flies
Abstract:Sand flies are carriers of Leishmaniasis, a disease common to tropical and subtropical countries. Millions of people are infected every year, and thousands of fatalities are attributed to this disease. American and European military personnel stationed in Iraq and Afghanistan are being infected with Leishmaniasis. An effective strategy to prevent the spread of this disease would be to determine whether the local sand fly population carries the pathogens, and if so to use effective pest control methods to eradicate their population. This could be an important strategy for controlling outbreaks, and for using pesticides responsibly to avoid polluting the soil, air, and water. This would also mitigate the development of insecticide resistant pathogens. This proposal developed in collaboration with Prof. Diane McMahon-Pratt of Yale University School of Medicine describes the development of a field-usable test kit to identify L. major and L. infantum in sand flies. In Phase I, test strips will be fabricated for the detection of L. major and L. infantum, and their performance will be tested. Test kits to perform 100 assays will be delivered to the contractor during Phase I. In Phase II, the assay will be optimized to further improve performance and meet field needs.

Operational Technologies Corporation
4100 N. W. Loop 410 Suite 230
San Antonio, TX 78229
Phone:
PI:
Topic#:
(210) 731-0015
John G. Bruno
OSD 09-H21      Awarded: 4/1/2010
Title:Handheld Aptamer-Magnetic Bead-Quantum Dot Sensor for Leishmania
Abstract:Operational Technologies (OpTech) has developed a rapid (15 minute) ultrasensitive one- step plastic-adherent DNA aptamer-magnetic bead (MB) plus aptamer-quantum dot (QD) sandwich assay for Campylobacter detection (J. Fluorescence 19:427-435, 2009) that is quantified with a commercially available handheld and battery-operated fluorometer. This highly portable and facile system has a validated limit of detection of < 10 cfu/ml for C. jejuni and works with push-button ease under rugged field conditions. OpTech also has previous published (J. Clinical Ligand Assay 30:37-43, 2007) experience with aptamer development against several species of Leishmania. Therefore, OpTech proposes extension of its patent-pending one-step plastic cuvette-adherent aptamer-MB-aptamer- QD sandwich assays for sensitive detection of cutaneous L. major and visceral L. infantum in patients or promastigotes in homogenized pools of sand flies using its commercially available handheld, battery-operated fluorometer. At the end of Phase I, OpTech will deliver 100 lyophilized prototype L. major and L. infantum assays to the Army for testing and evaluation. In Phase II, OpTech will optimize assay performance with respect to specificity, sensitivity and shelf life. OpTech will optimize shelf life to > 2 years at 35oC by increasing the level of trehalose or other excipients and innovative vacuum or air-tight packaging of the lyophilized assays.

Phoenix Biosystem
6833 Corte Munras
Pleasanton, CA 94566
Phone:
PI:
Topic#:
(925) 998-5075
Kumar Subramanian
OSD 09-H21      Awarded: 4/1/2010
Title:Develop Field-usable Diagnostic Devices for the Specific Detection of Leishmania Major and L. Infantum in Sand Flies
Abstract:Leishmaniasis has been of concern to U.S. military personnel in the 20th century and has re-emerged in importance because of recent deployments to the Middle East. Although leishmaniasis is not considered a disease of strategic military signiÞcance, it may pose a significant threat to mission objectives. In this PHASE I project, we propose to develop of a simple, inexpensive, field usable, no cold-chain, assay using species-specific antibodies for the rapid screening and characterization of Leishmania in sandflies.

VecTOR Test Systems, Inc
2033 Yellowthroat Place
Thousand Oaks, CA 91320
Phone:
PI:
Topic#:
(805) 390-0647
Kirti Dave
OSD 09-H21      Awarded: 4/1/2010
Title:Develop Field-usable Diagnostic Devices for the Specific Detection of Leishmania Major and L. Infantum in Sand Flies
Abstract:VecTOR Test Systems, Inc. proposes to develop an assay to quickly determine, in a non- laboratory and minimal resource environment, whether sand flies collected in specific areas of a military deployment are infected with either L. major or L. infantum. The proposed assays will be performed in a rapid, one-step immuno-chromatographic process for detection of Leishmania sp such as L. major, and L infantum in infected sand- flies. These are the most ubiquitous species of Leishmania found in many parts of the mid-east. Leishmania is not prevented by vaccines or prophylactic drugs so prevention relies on personal protective measures and vector control measures that need to be targeted to be effective at reducing disease risk. The proposed dipstick assays will provide results within 30 minutes and will be stable at ambient storage conditions. Assays developed in similar format for other arthropod vectors e.g. the mosquito vector for detection of Malaria circumsporozoite proteins, WNV, SLE, EEE, and WEE and have found commercial application. The development of easy to use tests will be important for detection of pathogens of military importance and will be useful in the commercial sector for vector surveillance and control programs.

Advanced Mechanical Technology, Inc.
176 Waltham Street
Watertown, MA 02472
Phone:
PI:
Topic#:
(617) 926-6700
Francois Asseman
OSD 09-H22      Awarded: 5/10/2010
Title:A functional and multimodal biofeedback device to treat balance dysfunction in mTBI patients.
Abstract:According to existing data, there are more than 1.5 million of Americans sustaining a Traumatic Brain Injury (TBI) each Year. Balance disorders represent one of the main regular problems that patients have to deal with, and thus everyday. Rehabilitation programs do exist but they are dependable of the clinician or physiotherapist and they do not take in account the multimodal aspects of balance control. This proposal will be aimed to provide a novel and functional multimodal biofeedback device to train or retrain patients with mild TBI to control their balance. The biofeedbacks will be based on the Visual, proprioceptive and tactile/haptic information. This combination will allow the control of the level of information given to the patient as well as the customization to his deficit. We will primarly focus on the haptic mode, e.d. on the force feedback provided to the patient’s hand, in order to be able to conduct a neurosensorimotor retraining of the patient through a robotic device driven by the patient’s balance.

BalanceSense LLC
312 Acadia Lane
Celebration, FL 34747
Phone:
PI:
Topic#:
(407) 625-9680
Karen L. Atkins
OSD 09-H22      Awarded: 4/1/2010
Title:Treatment of mTBI Balance Dysfuntion via Multimodal Biofeedback.
Abstract:Rehabilitation intervention by the proposal PI successfully used a vibrotactile/visual force platform device to improve balance test scores, facilitate sit-to-stand, and reduce falls. The study found beneficial effects from dual modal testing and training in her physical therapy practice. The aim of this proposal is to refine the existing device, and to determine the feasibility of multi modal force platform device including vibrotactile, visual, and auditory biofeedback in a mTBI population, and other populations with sensory/neural deficits who complain of dizziness and imbalance. Device design and clinical application will be pursued concurrently. This proposal outlines device development and clinical trial study design. Team members have extensive knowledge of postural control, previous research and rehabilitation solutions for dysequilibrium, and successful to market records. The physical therapist and physician has access to potential study candidates: an active IRB is in place. The desire of this team is to bring to fruition a clinical and a smaller, home multi modal biofeedback device containing quantifiable objective testing and best practice protocols for the rehabilitation of patients with complaints of dizziness and imbalance.

Engineering Acoustics, Inc.
406 Live Oaks Blvd
Casselberry, FL 32707
Phone:
PI:
Topic#:
(407) 645-5444
Bruce Mortimer
OSD 09-H22      Awarded: 4/1/2010
Title:Treatment of mTBI Balance Dysfuntion via Multimodal Biofeedback.
Abstract:Traumatic brain injury (TBI) occurs when physical trauma causes temporary or permanent neurological damage. In some cases, symptoms can continue and contribute to disability. Dizziness and vertigo are associated with nearly all reported studies of mTBI and are a significant and functionally limiting component of the overall disability. This project has as its aim the development of a portable device and protocol for the treatment of balance deficit in mTBI and TBI, suitable for use in military and civilian therapeutic facilities. Our approach will focus on a modular set of low cost hardware and also a modular set of configurable protocols that allow a therapist to configure the system that is based on the patient, therapeutic needs and the particular sensory feedback requirements. The protocols will be based on functional activities appropriate for a soldier, and the system will be designed to provide multi-modal feedback and cuing using the tactile, visual and audio modalities. Work will leverage off EAI’s existing vibrotactile commercial (and research) products, and balance training software and hardware system.

Agave BioSystems, Inc.
P.O. Box 100
Ithaca, NY 14850
Phone:
PI:
Topic#:
(607) 272-0002
Kathie Berghorn
OSD 09-H24      Awarded: 5/1/2010
Title:Food Toxicity Detection Using C. elegans
Abstract:Current toxicity testing of foodstuffs involves mass spectrometry analysis which requires a >24 h turnaround time in deployed military operations. This length of time is dangerous for personnel. Rapid identification of toxic industrial chemicals (TICs) in food using a sensor that is biologically-based and easy to use eliminates that danger and would provide exactly what is needed for toxicity evaluation of food. In this Phase I, Agave BioSystems proposes to develop a rapid and accurate biosensor using mutant C. elegans to evaluate toxicity in food. This biosensor will use the nematode C. elegans as the model system and measure Green fluorescent protein (GFP) that has been linked to inducible promoters of genes responsive to specific stressors. Extended shelf life will be possible because the dauer stage within the lifecycle of C. elegans leaves the worm in stasis for extended periods of time until growth is resumed with improved conditions. By measuring the GFP response in a mixed population of mutant C. elegans, the outcome should be an accurate and sensitive assessment of chemical toxicity in food.

CFD Research Corporation
215 Wynn Dr., 5th Floor
Huntsville, AL 35805
Phone:
PI:
Topic#:
(256) 327-0666
Ketan Bhatt
OSD 09-H24      Awarded: 4/7/2010
Title:Microfluidic Yeast-based Impedance Sensor for Food Monitoring
Abstract:Current methods for detecting toxicity in food are labor intensive, time-consuming and require access to sophisticated laboratory equipment. To overcome these limitations we propose to develop a novel, microfluidics yeast-based sensor system for detection of Toxic Industrial Chemicals (TICs) in food. Robust yeast cell wires and membrane patches will be assembled on-demand and in-situ from suspensions of genetically modified yeast cells and functionalized colloidal micro- and nano-particles using dielectrophoretic forces. Presence of TICs will be detected by monitoring the impedance changes of the cell wires and patches. During Phase I, proof-of-concept will be demonstrated for detection of TICs in flour, ground beef and milk samples spiked with arsenic, methamidophos and cyanide. A conceptual design for the Phase II end-product will be developed. During Phase II, the sensor technology will be demonstrated for multiple TICs of interest. The device functionality will be demonstrated for reliable operation through the range of environmental conditions (temperature, relative humidity, etc.) We have assembled an interdisciplinary team of engineers and scientists from CFDRC, UAHuntsville and NC State University with experience in microfluidics, colloid and nanoscale engineering, fungal and plant molecular biology and functional genomics, and sensor fabrication to successfully develop the proposed device.

TRITON SYSTEMS, INC.
200 TURNPIKE ROAD
CHELMSFORD, MA 01824
Phone:
PI:
Topic#:
(978) 250-4200
John Lock
OSD 09-H24      Awarded: 5/10/2010
Title:Portable Trace Detector for Food Toxins(1001-450)
Abstract:A major threat to U.S. personnel stationed abroad are high levels of toxins that may be present in the local food supply as a result of unregulated pesticide use and the prevalence of toxic industrial chemicals and heavy metals in the environment. Rapid analytical methods are needed that are capable of identifying these threats in food at levels that exceed military exposure guidelines. Triton Systems is addressing the needs of the U.S. Army Center for Environmental Health Research with the development of a rapid food sample preparation and measurement process for the detection of cyano and phosphate-containing compounds, representative of pesticide and cyanide food toxins, as well as heavy metal contaminants. The proposed food sample preparation process uses only standard, relatively inexpensive equipment that is field-portable. This process takes about thirty minutes and the sensor response time upon exposure to the prepared sample is nearly instantaneous. The food sample preparation and sensor measurement system will be demonstrated on ground beef, milk, and bread loaded with known levels of threat compounds. All of the sensor components are environmentally robust, shelf- stable, and economically manufacturable.

Creare Inc.
P.O. Box 71
Hanover, NH 03755
Phone:
PI:
Topic#:
(603) 643-3800
Odile Clavier, Ph.D.
OSD 09-H26      Awarded: 5/4/2010
Title:Smart System for Auditory Assessment in Hearing Conservation Programs
Abstract: The nature and requirements of many military operations lead to high noise levels, thereby exposing military personnel to the possibility of noise-induced hearing loss (NIHL) and tinnitus. Hearing Conservation Programs (HCP) are designed to protect noise- exposed individuals from developing occupational hearing loss which negatively impacts their health, quality of life, and functional performance. However, audiometric data obtained with existing technology are often vulnerable to various quality control issues such as noisy test environments, examiner error, poor earphone placement, equipment malfunction and complications arising from individual ear status or cooperation. Creare’s Smart System for Auditory Assessment in Hearing Conservation Programs combines: (1) an expert system to generate decision support tools specifically designed for HCP, (2) quality control features for reliable auditory assessment, and (3) effective auditory tests with sensitivity to NIHL and malingering. Under ONR funding, Creare is currently developing a field-deployable earphone-based auditory assessment system that incorporates auditory tests and noise measurements. We will leverage this hardware system and our ongoing work in the field of auditory assessment systems to design and develop our smart software and quality control system.

Li Creative Technologies
25 B Handover Road, Suite 140
Florham Park, NJ 07932
Phone:
PI:
Topic#:
(973) 822-0377
Joshua Hajicek
OSD 09-H26      Awarded: 5/4/2010
Title:Novel Methods to Monitor Health Status and Clinical Laboratory Data
Abstract:A comprehensive test instrument, the Auditory Evaluation System (AES) is presented which utilizes advanced techniques in OAEs, middle-ear function evaluations, and audiometry. The AES utilizes advancements in OAE measurement techniques to effectively and more sensitively monitor hearing health. Middle ear evaluations utilized are a combination of novel techniques coupled with the existing techniques. The proposed OAE strategies support middle ear pathology identification. Additionally, the AES automatically calibrates itself in-situ, which significantly increases the repeatability and validity of all evaluations. The objective nature of the AES evaluations prevent malingering and make referrals easier. The AES also focuses on improving the performance of the hearing conservation programs (HCPs) by identifying weaknesses in the program and individuals who are more susceptible to NIHL.

Mimosa Acoustics, Inc.
60 Hazelwood Drive
Champaign, IL 61820
Phone:
PI:
Topic#:
(217) 367-9740
Patricia S. Jeng
OSD 09-H26      Awarded: 5/5/2010
Title:Novel Methods to Monitor Health Status and Clinical Laboratory Data
Abstract:Mimosa Acoustics will develop a portable binaural audiological device, based on our successful HearID system. HearID is a clinical system for otoacoustic emission and middle-ear power analysis testing; it is FDA(510k) approved and CE-marked. The new system will have the ability to conduct a variety of audiological tests especially for use in hearing-conservation programs, including: flexible otoacoustic emissions tests (transient- evoked, distortion-product, stimulus-frequency, and spontaneous), with the ability to easily customize test protocols; medial-olivocochlear reflex tests with contralateral elicitors; middle-ear power analysis, including middle-ear reflectance tests using tones and chirp stimuli; automated pure-tone audiometry tests; novel tests to detect functional hearing loss; and simultaneous otoacoustic emission-middle-ear reflectance tests. Enhanced calibration techniques will improve validity and reliability. A simple-to-use user interface will include a personnel database, access to all tests, ability to compare tests to find significant changes, and the ability to interface with military health databases.

Infoscitex Corporation
303 Bear Hill Road
Waltham, MA 02451
Phone:
PI:
Topic#:
(781) 890-1338
Robert Mulligan
OSD 09-H27      Awarded: 5/1/2010
Title:Computer Aided Optimization of a Vector Surveilence Tent Trap and Field Demonstration
Abstract:Arthropod-borne diseases common to present operational environments of the Middle East (Iraq) and Asia (Afghanistan) represent a major portion of the environmental threat to deployed military personnel, and Army entomologists utilize an aggressive vector surveillance program to monitor for the presence of disease carrying insects in deployed regions. Because of this, the Army has issued a request for an easily deployable, safe, and high performing human-baited tent trap that will allow field scientists to measure the health threats present to troops with a high degree of confidence. Infoscitex (IST) proposes to utilize state of the art computer aided engineering to determine the optimal tent trap designs for monitoring various insect species in different geographical locations. The Phase I program will culminate in an outdoor demonstration of a first generation working trap (non-human baited) in Colorado. Potential Phase II work may involve field evaluations of various designs in Mexico, Thailand, or Senegal.

Mainstream Engineering Corporation
200 Yellow Place Pines Industrial Center
Rockledge, FL 32955
Phone:
PI:
Topic#:
(321) 631-3550
Janelle M. Messmer
OSD 09-H27      Awarded: 5/27/2010
Title:Field Evaluated, Human-Baited Tent Traps with Novel Design Features to Increase Mosquito Collection
Abstract:Historically, more troops sent into battle are taken out of action by insect-borne diseases than are injured in combat, according to the Department of the Defense. In order to minimize the threat of insect-borne disease, military entomological units require an efficient collection device for sampling local mosquito vectors. Traditional collection methods present logistical challenges for widespread military deployment because they often require dry ice to produce carbon dioxide. To address this capability issue, Mainstream has developed two concepts for efficient tent trap designs which require no additional attractants other than the human occupant sleeping inside the tent. Mainstream has formed a partnership with Johnson Outdoors Inc., a commercial manufacturer of military tents, and will use their military tents to develop prototype designs during Phase I. Mainstream will also enlist the help of the experts at the Florida Medical Entomology Laboratory to provide field testing of each prototype design in order to determine which tent trap concept is more effective for capturing mosquitoes. Based on these results, the Phase II efforts will focus on producing a commercially available tent trap by optimizing the selected concept through additional design revisions and field testing.

SkySight Technologies
4916 Hollopeter Rd
Leo, IN 46765
Phone:
PI:
Topic#:
(260) 637-0588
Patrick McCammon
OSD 09-H27      Awarded: 5/6/2010
Title:Development and commercialization of a tent trap for the surveillance and control of disease-carrying flies
Abstract:Due to the possible transmission of blood-borne diseases, biting insects, mosquitoes, midges, and sand flies pose increasing danger to deployed military personnel and humans in locations around the globe. Because of these disease dangers, the collection of specimens during entomological surveys needs to pose as little risk to the human bait and/or collectors as possible. The SkySight Technologies approach to creating and demonstrating a tent trap to capture biting flies and mosquitoes that come to bite a human resting inside is to modify a standard tent with the components necessary to convert it into a specimen collection device using human bait in a manner that does not endanger the human. To preserve the specimen alive and intact, the specimen never passes through the fan blades and a unique air flow and ducting system traps the specimens into the capture system created as the base tent is assembled. The proposed tent trap system is based on a standard, readily available tent, uses a specimen safe pull air system to circulate the human odor, poses no risk to the human bait, preserves the live specimen, and is easy and intuitive to erect.

TDA Research, Inc.
12345 W. 52nd Ave.
Wheat Ridge, CO 80033
Phone:
PI:
Topic#:
(303) 261-1145
Brady Clapsaddle
OSD 09-H27      Awarded: 4/7/2010
Title:Tent Trap for Vector Surveillance of Disease-Carrying Flies
Abstract:Civilian and military organizations throughout the world perform vector surveillance to identify and control diseases transmitted by arthropods. Human disease vectors such as mosquitoes are attracted to human odors, and standard traps use CO2 as a surrogate for a human attractant. Human landing catch has been used for vector surveillance; although it should detect all threats to humans, it is unacceptable from health and ethical perspectives. The ideal solution would attract all human-biting arthropods while protecting any individuals involved. TDA Research, Inc. (TDA) proposes to fabricate and demonstrate the performance of a human-baited tent trap for vector surveillance. Previous animal-baited trap designs have suffered from low catch, and TDA has developed designs to improve the catch efficiency while completely protecting the operator from any exposure to the vectors.

Techshot, Inc.
7200 Highway 150
Greenville, IN 47124
Phone:
PI:
Topic#:
(812) 923-9591
Todd Fricke
OSD 09-H27      Awarded: 5/27/2010
Title:Development and commercialization of a tent trap for the surveillance and control of disease-carrying flies
Abstract:The Techshot Insect Vector Eradication, Control, Trapping, or Retrieval System (iVECTOR) trapping system employs a naturally seductive, ergonomically tailored system to attract and collect the maximum number of insect specimens for the given environment. The iVECTOR system is simple to erect, collect and teardown. It incorporates several upgrade/accessory modules to include photovoltaic power and battery backup if necessary. The Techshot iVECTOR is the next generation insect trapping system.