---------- DHP ----------

33 Phase I Selections from the 10.3 Solicitation

(In Topic Number Order)
Infoscitex Corporation
303 Bear Hill Road
Waltham, MA 02451
Phone:
PI:
Topic#:
(781) 890-1338
Kristen LeRoy
OSD10-H01      Awarded: 3/8/2011
Title:Tailorable Accurate Blood Simulant (TABS)
Abstract:Many blood simulants that are currently available for medical training to teach and practice hemorrhage-handling skills lack the ability approximate real blood in many aspects. In order to provide the best training, the blood simulant needs to mimic the viscosity of blood through the vasculature of the model, the ability to clot, and the ability to represent blood in cases ranging from fresh hemorrhage on a normovolemic patient to oozing presentations. Infoscitex’s Tailorable Accurate Blood Simulant (TABS) is meant to fill the gap in available technologies by providing a blood stimulant and training system that can be implemented in different presentations. TABS is purchased as a thick liquid and is mixed with water by the user ahead of the simulation according to simple measurements directly on the package. TABS can then be pumped through any of a number of physical simulators, providing medical trauma trainees a more realistic experience. TABS flows like real blood, and clots in the presence of realistic bandage materials preformulated with clotting agents.

Luna Innovations Incorporated
1 Riverside Circle Suite 400
Roanoke, VA 24016
Phone:
PI:
Topic#:
(434) 220-0159
Michael J. Danilich
OSD10-H01      Awarded: 3/3/2011
Title:Advanced Blood Simulant for Simulation Based Medical Trauma Training
Abstract:The aim of this proposal is to develop an advanced blood simulant to replace current simulants used in combat medical training. A successful blood simulant will exhibit a caking/clotting response in the presence of simulated hemostatic agents while accurately approximating the viscosity and color of human blood.. Luna’s proposed simulant will approximate the look, feel and biological characteristics of real human blood and will be, easily cleansed with soap and water, low cost and will not contain any biohazardous components . Additionally we will develop simulated hemostatic agent prototypes that will initiate a clotting-like response when in contact with our blood simulant. Our advanced blood simulant can be used in conjunction with mannequin-type simulators or in live action role playing trauma training.

Spectra Group Limited, Inc.
27800 Lemoyne Road Suite J
Millbury, OH 43447
Phone:
PI:
Topic#:
(419) 837-9783
Alex Mejiritski
OSD10-H01      Awarded: 3/8/2011
Title:Advanced Blood Simulant for Simulation Based Medical Trauma Training
Abstract:Several approaches to make a fully functional commercial blood simulant are proposed. The simulant will have similar flow characteristics, tactile properties, color, and coagulation capabilities to blood. In this effort, Spectra Group will formulate a product that will be waterbased, have blood reological properties, shade, and opacity. Simulating each critical physical property will ensure the equivalent behavior in the actual demonstrations and training exercises. A waterbased product can be safely handled and pose no biological hazard.

Control-X LLC
17 East Galvez Court
Pensacola Beach, FL 32561
Phone:
PI:
Topic#:
(850) 572-9705
Tom Allen
OSD10-H02      Awarded: 3/8/2011
Title:Non-Invasive Detection, Differentiation, Diagnosis and Treatment of Balance Pathologies
Abstract:Control-X proposes the development of a highly specific device that integrates several classical approaches to study of vestibular, visual, and balance disorders for the detection and treatment of secondary pathologies resulting from concussion or mild traumatic brain injury.

Neuro Kinetics, Inc.
128 Gamma Drive
Pittsburgh, PA 15238
Phone:
PI:
Topic#:
(412) 963-6649
Alexander Kiderman
OSD10-H02      Awarded: 4/18/2011
Title:Non-Invasive Detection, Differentiation, Diagnosis and Treatment of Balance Pathologies
Abstract:Military personnel frequently suffer blast and/or blunt head injuries. A number of recent studies have indicated the presence of vestibular deficits in the acute period following mTBI accounting for up to 90% of all injuries. Dizziness is the most common symptom and objective evidence of a balance disorder documents the injury. In civilian application it was reported that from 2001 through 2004, 35.4% of U.S. adults aged 40 years and older (69 million Americans) had vestibular dysfunction. These balance disorder signs and symptoms can persist or worsen, over time, from injury, if left untreated. For diagnostics and assessment of balance pathology are used battery of tests as an oculomotor, optokinetics, yaw rotation tests (sinusoidal harmonic acceleration, step test), visual vestibular interaction tests, otolith tests off vertical axis rotation test (OVAR), position and positioning and caloric. Recently new group of tests are emerges that can also help and improve diagnostics: antisaccade, memory guided saccade, reaction time, head thrust, dynamic visual acuity. Balance patient treatment involves controlled multiaxis body positioning for Benign Postural Positioning Vertigo and desensitization of the sensory. New device for research and clinical diagnosis and treatment balance patients will be capable to do evaluation and treatment in one single session.

Infoscitex Corporation
303 Bear Hill Road
Waltham, MA 02451
Phone:
PI:
Topic#:
(781) 890-1338
Vladimir Gilman
OSD10-H03      Awarded: 2/25/2011
Title:Nano-Structured Spatiotemporally Controlled Delivery System that Promotes Functional Tissue Regeneration
Abstract:There is a substantial clinical need for regenerative therapies that effectively restore function to damaged tissues. For many tissues, autograft remains the clinical standard despite the limited volume available, associated patient morbidity and the resulting non-functional tissue. An alternative therapeutic strategy is to deliver progenitor cells or key biomolecular signals that augment or stimulate endogenous repair mechanisms. It is believed that this capability will allow for the regeneration of functional tissue. This theory has been demonstrated in bone using high doses of osteoinductive proteins loaded onto simple collagen sponge matrices. However, concerns and complications associated with the rapid release of high doses of proteins have motivated recent investigation into sustained delivery strategies that may provide efficacy at lower doses. To address this issue, Infoscitex Corporation and the University of Nebraska Medical Center (UNMC) propose to develop a concept for an advanced topical delivery systems that will provide spatiotemporal release or presentation of biological factors for musculoskeletal tissue repair using nanoencapsulated promoters of tissue regeneration. In this Phase I effort, the technical objectives are to determine the general structure of the nano-complex for controlled delivery of the signaling molecules, generate and characterize the complexes and demonstrate efficacy in vitro.

KeraNetics, LLC
391 Technology Way Dean Research Building, Suite 168
Winston-Salem, NC 27101
Phone:
PI:
Topic#:
(336) 725-0621
Luke Burnett
OSD10-H03      Awarded: 2/18/2011
Title:Spatiotemporally Controlled Keratin Biomaterial Delivery System for Functional Tissue Regeneration
Abstract:A principal approach in regenerative medicine is to stimulate or augment endogenous repair mechanisms that promote functional restoration of damaged or diseased tissues. When loss of significant volumes of multiple functionally integrated tissues occurs, the need for effective regenerative therapies is clear. Advanced delivery systems must provide controlled spatiotemporal release that maximizes the potency of signaling molecules and/or cells. Keratin hydrogels may provide a solution to the challenges presented by composite injuries by offering a versatile platform for functional tissue regeneration. The goal of this phase I research will be to develop keratin hydrogel formulations that can provide spatiotemporal control over growth factors and cells that facilitate the regeneration of bone and muscle. To that end, we propose to evaluate the binding affinity, loading efficiency, preservation of bioactivity, and release kinetics of injectable keratin hydrogels loaded with muscle progenitor cells, BMP-2, VEGF, IGF-1, FGF and combinations thereof. Ex situ tissue formation assays in mice will be used to test the feasibility of using an injectable keratin hydrogel system to regenerate muscle and bone. The innovation of this proposal lies in a combination of properties related to keratin proteins.

Luna Innovations Incorporated
1 Riverside Circle Suite 400
Roanoke, VA 24016
Phone:
PI:
Topic#:
(434) 220-0159
Michael J. Danilich
OSD10-H03      Awarded: 2/24/2011
Title:Spatiotemporally Controlled Delivery System that Promotes Functional Tissue Regeneration
Abstract:As advances in battlefield care have led to increased survival, improved strategies for treating devastating, multi-tissue injuries are needed. Historical regenerative medicine strategies to restore function to damaged tissues have failed to fulfill the tremendous potential. Limited success of these initial approaches has lead to new strategies attempting spatial and temporal delivery of growth factors and cytokines to promote wound healing and tissue repair. Unfortunately, the success of sequestering and binding selected agents into a tissue construct for strategic release can only be successful if one knows the precise environment needed for the desired regenerative outcome. To address this significant challenge, Luna Innovations and the University of Virginia propose to utilize an innovative approach to strategically pre-condition and select a pericyte sub-population from human derived adipose stromal cells (hASCs) that can be seeded into a hydrogel tissue construct to provide the desired spatiotemporal cellular signaling to allow host cell invasion and revascularization. This selection methodology will be incorporated into a high-throughput cellular sorting device to achieve a clinically relevant number of cells. This approach will exploit the cells’ innate abilities to sense the environment to initiate healing by stimulating the growth and stabilization of a functional microvasculature.

Luna Innovations Incorporated
1 Riverside Circle Suite 400
Roanoke, VA 24016
Phone:
PI:
Topic#:
(434) 972-9952
Patrick Cottler
OSD10-H04      Awarded: 2/10/2011
Title:The Development of an Injectable Cartilage Regeneration Construct
Abstract:Craniofacial injuries to warfighters are on the rise as improvements to body armor have caused the unprotected face of the soldier to become a target for attack. These injuries are often associated with severe trauma to the underlying cartilage structure. Cartilage is critical to the shape and flexibility of the face’s key features as it comprises the structural support of both the nose and ears, and its structure is important to maintaining a normal breathing cycle and sensory function. The nose in particular, as the most prominent cartilaginous tissue of the face, requires extensive repair as there are cosmetic and psychological costs associated with nasal trauma in the recovering soldier. Cartilage is relatively avascular with a low cell density and does not tend to regenerate following serious trauma, often requiring external assistance to induce regeneration. To address this unmet clinical need, Luna Innovations proposes an injectable, cell-seeded chondrogenic gel for regeneration of nasal cartilage. By devising an injectable delivery system, Luna will minimize surgical scar formation. The cells within the construct will improve attachment of the construct to the surrounding tissue and enhance new cartilage growth in the wound site.

Physical Optics Corporation
Photonic Systems Division 20600 Gramercy Place, Bldg. 100
Torrance, CA 90501
Phone:
PI:
Topic#:
(310) 320-3088
Anya Asanbaeva
OSD10-H04      Awarded: 3/3/2011
Title:Cell-based Cartilage Tissue Matrix for Repair of Focal Defects in the CMF Cartilages
Abstract:Head and neck surgeons are often challenged by the paucity of autografts to reconstruct large CMF defects; a grafting technology for replacing and regenerating lost tissue is needed. To address this OSD need, Physical Optics Corporation (POC) proposes to develop a new cell-based CARtilage TIssue MATrix (CARTIMAT). The matrix is a cartilage substitute, prepared using the combination of a scaffold, mesenchymal stem cells (MSCs), and growth factors. The scaffold mechanical properties and the biodegradation rate can be tailored to match properties of native tissue at the implantation site, such as cartilage of the ear, nose, and trachea, and cartilage in the temporomandibular joint. Growth factors are packaged into microspheres to provide sustained release over time. The innovation in integration of a scaffold with embedded growth factors and MSCs for enhanced ECM production, tissue integrity, and healing of the graft is key to the success of CARTIMAT. In Phase I, POC will develop the technology for the formation of the CARTIMAT construct and outline the path for its implementation as a graft for implantation. In Phase II, further characterization of CARTIMAT will be performed with detailed in vitro studies, followed by implantation and evaluation in an animal model.

SpherIngenics, Inc.
313 Ferst Drive Suite 3113
Atlanta, GA 30332
Phone:
PI:
Topic#:
(404) 520-6226
Anthony Nicolini
OSD10-H04      Awarded: 3/23/2011
Title:Technologies for Treating Cartilage Tissue Loss Following Traumatic Injury
Abstract:Regeneration of cartilage and cartilage repair are challenging due to limited cellularity of the tissue and the failure of allografts and tissue engineered cartilage constructs to integrate with host tissue. To overcome this limitation, many surgeons are trying cell therapy approaches, using autologous chondrocytes. However, these cells must be harvested from other cartilage sites and expanded in culture to obtain sufficient numbers of cells to produce a positive clinical result. This may not be possible following traumatic injuries, which cause loss of existing cartilage tissue. In addition, chondrocytes tend to lose their differentiated phenotype during culture expansion, and like fat cells used for soft tissue augmentation, they tend to migrate from the implant site. Most of what we know about cartilage repair has been learned from treating articular cartilage, but reconstruction of the hyaline cartilages of the nose and the elastic cartilage of the ear require strategies for chondral defect repair, which may differ considerably from the methods used to treat osteochondral defects in the articulating cartilages of the knee and other joints. We have developed a method for encapsulating autologous adipose derived stem cells (ASCs) with chondrogenic potential and human chondrocytes using low viscosity alginate to encapsulate the cells in microspheres of less than 200 micrometers in diameter (US and international patents are pending). These microbeads flow easily through small-bore needles making them suitable for percutaneous placement with no shear damage to the cells and only minimal damage to the skin and supporting soft tissues, thereby reducing scar formation. Cells harvested from the patient can be encapsulated and used directly, expanded in vitro, and/or stored for later use. As a result, injections of microencapsulated high viability cells can be used for reconstructive and cosmetic procedures with greater persistence in soft tissue augmentation and the potential for in-vivo cell replication and engraftment. This Phase I SBIR application is based on the hypothesis that adipose-derived stem cells can be used to enhance chondrogenesis when delivered in alginate microbeads percutaneously to hyaline cartilage defects. To test this hypothesis, we propose the following aims: I. To characterize the rate and extent of growth factor production by ASCs encapsulated in alginate microbeads less than 200 micrometer in diameter; II. To determine the effect of pre-treatment of ASCs in chondrogenic media on growth factor production by microencapsulated ASCs; and III. To develop a protocol for establishing clinical effectiveness of microbeads containing ASCs will promote chondrogenesis when injected into a hyaline cartilage defect in vivo.

StemRD, Inc.
332 Beach Road
Burlingame, CA 94010
Phone:
PI:
Topic#:
(650) 343-1888
Songzhu An
OSD10-H04      Awarded: 3/1/2011
Title:Technologies for Treating Cartilage Tissue Loss Following Traumatic Injury
Abstract:Regenerative cell therapy using adult mesenchymal stem cells (MSCs) offers great potential to therapeutic cartilage repair. However, the current MSC chondrogenesis method of using TGF-beta is inefficient and assumes fibrocartilage-like features and hypertrophy. Clearly, more efficient MSC chondrogenesis methods and factors promoting the formation of authentic chondrocytes are needed. Strong evidence in animal and human osteochondral development has accentuated one signaling pathway, the Hedgehog (Hh) pathway, as a central player in the development of cartilages in the head and extremities. Disappointedly, however, despite the great advances in developmental biology, application of Hh modulators in chondrogenesis for regenerative cartilage repair has been slow, partly due to the lack of high-quality research reagents. StemRD has developed several high-quality Hh reagents and a chemically-defined MSC expansion medium to definitively test the hypothesize that Hh signaling is important for chondrogenesis from adult MSCs. Using these new tools, we will determine the effects of Hh modulators on MSC chondrogenesis and the subsequent hypertrophy. The results will help design a new chondrogenesis method superior to the current TGF-beta protocol. Owing to the importance of Hh signaling in the craniofacial region, trachea and extremities, such an improved method may allow repair of cartilages in these regions preferentially.

Infoscitex Corporation
303 Bear Hill Road
Waltham, MA 02451
Phone:
PI:
Topic#:
(781) 890-1338
James H. Goldie
OSD10-H05      Awarded: 3/4/2011
Title:Deployable Automated Analgesia and Anesthesia System
Abstract:An automated, closed loop system for administration of analgesic and anesthetic medication to patients is proposed. Even with vigilant, trained personnel, infusion rates of propofol and other analgesic/anesthetic drugs can depart from their optimum rates, due to rapid changes in patient status. As a result, both underdosing and overdosing can and do occur. Closed loop control of analgesic and anesthetic infusion offers a solution to this problem, as well as a means to improve pain management and sedation of injured warfighters. The automated, closed loop system optimally sets the infusion rate, based on continual physiologically- and neurologically-meaningful sensor feedback. Furthermore, automation means that a greater number of patients can be treated effectively by limited numbers of trained medical personnel at a forward medical facility, thereby significantly improving care, safety and outcomes. Phase I consists of (1) evaluation with rats of a novel means for assessing cortical excitability of the brain, (2) a design study to identify system user requirements and packaging for deployability/ruggedness, (3) application of system theory and a population PK approach to the overall system design, (4) identification of additional candidate sensors to provide neurologically-meaningful feedback, and (5) planning for Phase II prototype development and animal studies.

Medical Conservation Devices, LLC
One Mill ST Suite 105
Batavia, NY 14020
Phone:
PI:
Topic#:
(716) 961-8978
Douglas DuFaux
OSD10-H05      Awarded: 3/16/2011
Title:Self-Regulating Anesthesia/Analgesia Device Using Automated Fresh Gas Flow to Deliver Inhaled Agents
Abstract:The control of pain, anxiety, discomfort, and the sequellae of injury and illness is an over- arching healthcare issue in both military and civilian settings. Current strategies for pain relief, sedation and anesthesia involve infusion of intravenous agents with continual monitoring and updating. Efforts to facilitate intravenous dosing by closed loop technology have met with limited success because analytic methods are cumbersome and slow, they reach equilibrium dosing slowly, elimination of agents from the body competes with internal storage of active agent, because blood and exhaled concentrations correlate poorly with anesthetic and analgesic effect and because regulatory issues. The reversal of these agents is erratic and contextual half-life and tachyphylaxis further complicates the issue. This proposal focuses on a system to use volatile agents as a means to provide inhaled analgesia, sedation and anesthesia. Such an approach is gaining acceptance because it does not suffer from the above problems. Further, volatile agents are readily and rapidly analyzed in expired air and automatically reach equilibrium levels in brain that are determined, simply by the concentration of agent in inspired air. Their use is ubiquitous in the OR and is gaining acceptance for other settings, including primarily the ICU.

NeuroWave Systems Inc.
2490 Lee Blvd Suite 300
Cleveland Hts, OH 44118
Phone:
PI:
Topic#:
(216) 472-6337
Stephane Bibian
OSD10-H05      Awarded: 4/14/2011
Title:Deployable Closed-Loop Anesthesia System
Abstract:This proposal will address the needs described in sub-topic OSD10-H05 (“Deployable Automated Analgesia and Anesthesia System”), by developing the AutoTIVATM, a portable closed-loop anesthesia system based on non-invasive cortical monitoring. This system will be capable of administrating Total Intra-Venous Anesthesia (TIVA) automatically, from induction to emergence, such as to provide both analgesia and sedation. Combined with a portable ventilator and life sign monitor, the proposed AutoTIVA will provide anesthesiologists with a readily deployable state-of-the-art anesthesia station. The proposed AutoTIVA will be based on the concept of closed-loop anesthesia, where anesthesia drug delivery is adjusted continuously and automatically by a controller, based on measurements of the patient's state. The controller will continuously adjust infusion rates in order to maintain the patient in an adequate and stable state, as defined by the attending anesthesia professional. The controller will be capable to automatically compensate for abrupt changes in patient's state due, e.g., to surgical stimulation, blood loss, liver/kidney failure, etc., and to drive the patient in a different anesthetic plane following a change in target.

Sterling Point Research, LLC
53 Oxford Street
Winchester, MA 01890
Phone:
PI:
Topic#:
(781) 721-4462
Jesse Lock
OSD10-H05      Awarded: 4/18/2011
Title:Deployable Remotely Enabled Analgesia Management System
Abstract:Sterling Point Research has assembled an interdisciplinary team composed of researchers from Children’s Hospital Boston and Boston University, an anesthesiologist, and a former U.S. Army medic to develop a Deployable Remotely Enabled Analgesia Management System (DREAMS). DREAMS will enable quicker, safer pain control to wounded soldiers on the battlefield. Equipped with a robust battery of medications, DREAMS will dramatically decrease the physical pain and psychological trauma of the injured warfighter. Remote medication control and medication feedback control capabilities will greatly enhance medic effectiveness on the battlefield. On-board sensors collect high fidelity patient physiological data, which is then used to systematically optimize medication delivery. Through expedited pain management and systematically optimized medical protocols, DREAMS can significantly improve battlefield care as a whole.

Charles River Analytics Inc.
625 Mount Auburn Street
Cambridge, MA 02138
Phone:
PI:
Topic#:
(617) 491-3474
Peter Weyhrauch
OSD10-H06      Awarded: 3/16/2011
Title:Haptics for Medical Simulation (HAMS)
Abstract:Minimally invasive surgery (MIS), including laparoscopic surgery (LS), is beneficial in terms of the improved recovery of the patient, including shorter convalescence times, less postoperative pain, and less scarring. Training surgeons in these new techniques is clearly of critical importance, and virtual reality (VR) training simulations have the potential advantages of reusability, low cost per use, anatomical accuracy, wide availability, and the potential to standardize training and certification. However, a key challenge to VR training simulations is that they lack of realistic haptic feedback. Therefore, we propose to design and demonstrate the feasibility of Haptics for Medical Simulation (HAMS), a novel method to produce realistic haptics in MIS/LS training simulations. HAMS provides improved haptics models of tissue and fluid properties and algorithms that conduct rich structural simulations but are efficient enough to support the high frame rates that are necessary for effective haptic simulations. HAMS accomplishes this by (1) focusing on modeling those elements of VR haptics that significantly alter the effectiveness of the training, (2) building on point assisted finite fields (PAFF), a novel and efficient meshless deformable body physics simulation technique, and (3) improving models of haptics tissue and fluid properties within this technique.

Infoscitex Corporation
303 Bear Hill Road
Waltham, MA 02451
Phone:
PI:
Topic#:
(781) 890-1338
Gordon Hirschman
OSD10-H06      Awarded: 3/4/2011
Title:THEO: Tactile and Haptics Enabled Open Surgery Simulator
Abstract:The field of surgical simulation is fairly crowded with many products and research groups developing physical and virtual simulators. Much of this previous work is in simulating minimally invasive surgeries. The considerable body of work generated in developing the tissue properties and image generation engines for these simulators, along with more recent work in haptic and tactile feedback, can be built upon now to create a realistic simulator for open surgery. Tactile feedback sufficiently detailed for textural information enables the Tactile and Haptics Enabled Open (THEO) Surgery Simulator to simulate the feel of open surgery as well as the use of tools, therefore creating a truly multi-purpose simulator for a wide range of applications. Infoscitex is partnered with clinical collaborators at the Lahey Clinic and research collaborators at the Rensselaer Polytechnic Institute to develop the THEO surgery simulator.

Intelligent Automation, Inc.
15400 Calhoun Drive Suite 400
Rockville, MD 20855
Phone:
PI:
Topic#:
(301) 294-4768
Timothy Judkins
OSD10-H06      Awarded: 2/18/2011
Title:Hands-Free Kinetic System for Medical Simulation
Abstract:In recent years, many human-computer interaction and virtual environment systems have incorporated haptic devices. However, the range of environment properties and types of interactions enabled by existing haptic interfaces are very limited. Haptic feedback is typically restricted to that provided by artificial materials (e.g., mannequins) or resolved forces (e.g., use of PHANTOM-type force feedback haptic interfaces in virtual reality simulators). The user normally grasps a stylus or places a fingertip in a thimble, which is represented as a tool in the virtual environment. There is a need for medical simulators that integrate the cutaneous sensations of direct interaction with typical kinesthetic feedback in order to provide a complete haptic experience. To address this need, Intelligent Automation, Inc. (IAI), in collaboration with Dr. Allison Okamura at Johns Hopkins University (JHU) and Kinea Design, proposes to develop hands-free kinetic system for medical simulation, KineSys MedSim, that accurately simulates kinesthetic and cutaneous properties (e.g. stiffness, friction, texture, temperature, etc.) of skin, bone, muscle, and internal organs (which may have hard inclusions such as tumors). The proposed innovation in this SBIR effort will provide a solution for next-generation surgical simulators.

AEgis Technologies Group, Inc.
410 Jan Davis Drive
Huntsville, AL 35806
Phone:
PI:
Topic#:
(256) 922-0802
Richard Severinghaus
OSD10-H07      Awarded: 3/8/2011
Title:Deployed First Responder Course of Action (COA) Evaluation and After Action Review (AAR) Tools
Abstract:Many geospatial technologies and modeling techniques exist, especially for 3-D visualization of correlated layers of data. A gap remains in integrating the unstructured world of voice, chat, and free-form text communications to the more structured world of existing validated geospatial data. A gap in research is the interlinking – by mapping/translation of data – from the unstructured world to the structured one. For COA development, and execution via a COP visible across multiple C3 nodes, new interlinkage tools are needed. Research will focus on four tasks: 1) humanitarian operations analysis – characterization of problems, issues, challenges, and communications difficulties common to disasters, 2) research and development of a tool serving COA, COP, and AAR needs of on-scene and higher level node commanders, 3) design of an interface to interlink ScenePlotR and APAN to existing iCAV and ACAMS systems, and 4) creation of a proof of concept demonstration. A key to the approach is to discover a set of unstructured communications recurringly seen in disaster events, and to design and produce a library of communications-to-model/icon transforms to enable transformation of unstructured communications data to the geospatial world of COA and COP visualization. This will yield a prototype technology set for proof-of- concept demonstration.

Cognitive Performance Group of Florida
3662 Avalon Park Blvd E Suite 205
Orlando, FL 32828
Phone:
PI:
Topic#:
(407) 282-4433
Karol Ross
OSD10-H07      Awarded: 3/4/2011
Title:Deployed First Responder Course of Action (COA) Evaluation and After Action Review (AAR) Tools
Abstract:Humanitarian organizations hold the same objectives: to save lives, alleviate suffering, and maintain human dignity. Humanitarian organizations large and small respond in numbers to large-scale disasters such as Hurricane Katrina or the devastation in Haiti. The impact of these organizations could be substantially improved through better coordination, communication, and collaboration. The Cognitive Performance Group (CPG) Team will use Decision-Centered Design (DCD) to develop a Proof of Concept and an accurate and comprehensive set of high-level requirements. Decision-Centered Design is one of several frameworks for conducting Cognitive Engineering (Militello et al, 2009). It has been applied in domains characterized by highly distributed decision making across teams including emergency response organizations (Klinger & Klein, 1999). Elicitation techniques, such as Cognitive Task Analysis, describe what people are thinking about, paying attention to, and the strategies used to detect problems and make decisions (Crandall, Klein, and Hoffman, 2006). The CPG Team will apply these methods and cutting edge research to integral issues such as cross-agency collaboration, information sharing, knowledge building, and situational awareness to support COA Planning, After-Action Review support, and visualization tools.

Perceptronics Solutions, Inc.
3527 Beverly Glen Blvd.
Sherman Oaks, CA 91423
Phone:
PI:
Topic#:
(818) 788-1025
Gershon Weltman
OSD10-H07      Awarded: 3/7/2011
Title:Collaborative Information Infrastructure for Planning, Operations and Evaluation (CIIPOE)
Abstract:This proposal is to develop an integrated Collaborative Information Infrastructure for Planning, Operations and Evaluation (CIIPOE). The CIIPOE will include capabilities for critical information integration, COA development and evaluation, operations planning, after action review, and continuation training. The proposed work builds on the previous successes of the team partners and will use an integrated hybrid of advanced multi-source information technology and decision support tools to provide knowledge management, COA development and evaluation, and after action review (AAR) and training. Our approach will enhance performance in three key areas: (1) Fusion of information from a variety of agencies; (2) Development and evaluation of COAs; and (3) Provision of AAR and training capabilities by natural extension of the information and decision support functions. We will focus on support to command groups in a combined military-civil humanitarian operation, initially adapting a simulation recently developed by the Army Research Institute. This will bound the problem sufficiently to ensure that our product is demonstrable and relevant in Phase I and empirically testable in Phase II. However, we will ensure that the architecture and components of our software are scalable to a large number of agencies and will support full- spectrum humanitarian and other operations.

Bennett Aerospace, Inc.
2054 Kildaire Farm Road #181
Cary, NC 27518
Phone:
PI:
Topic#:
(919) 859-5454
Douglas Bennett
OSD10-H08      Awarded: 5/6/2011
Title:Medical Game
Abstract:Bennett Aerospace of the Research Triangle, North Carolina, and Team Members Virtual Heroes, and Duke University Medical Center and Health System, propose to develop a web- based, multiplayer, 3D serious medical game as a cognitive trainer, called HumanSim™: Care Continuum Management (HumanSim™: Continuum), for the OSD Defense Health Program / U.S. Air Force (USAF). The game will be a cognitive skills individual and team-trainer that covers the continuum of care. In Phase 1 we will leverage advances in game technology-based medical training and education. The web-based game will run on the USAF standard desktop configuration (SDC) using browser agnostic capabilities. It will be designed for the widest possible dissemination as SCORM-compliant modular content that will integrate with an overarching virtual medical training world but not require it to operate. Our application will be compatible with the Air Force Medical Modeling & Simulation Training (AFMMST) website currently being developed.

Critical Mass Interactive, Inc.
12805 Steeple Chase Drive
Austin, TX 78729
Phone:
PI:
Topic#:
(210) 365-6161
Michael Eyman
OSD10-H08      Awarded: 5/6/2011
Title:MedWorld Medical Gaming Suite
Abstract:MedWorld™ will apply virtual world gaming techniques to enable military medical personnel to experience the impact of real world conditions in performance of their duties, whether they are on the battlefield or in a stateside hospital. MedWorld™ is structured to provide extensive flexibility to trainers through a series of self-populating dropdown menus that allow selection of venues, environmental conditions, provided equipment, available transport, patient characteristics and surrounding events. MedWorld™ is built on a gaming engine that eases integration, using development tools that expedite the design and implementation processes.

Ontar Corporation
9 Village Way
North Andover, MA 01845
Phone:
PI:
Topic#:
(978) 689-9622
John Schroeder
OSD10-H08      Awarded: 5/6/2011
Title:Medical Gaming
Abstract:Web based training has matured into fully immersive, interactive scenarios that enhance the student’s retention of critical study information through experience based simulation. Creation and use of web based Serious Games can be quite complicated, depending on the training needs. A robust support infrastructure is required to deploy the game, load/unload user specific information, maintain persistent storage of results, enable metric analysis to evaluate training effectiveness, etc. Ontar Corporation has extensive experience in this arena through the development of the web-based training facility. TENOR. Ontar will make use of several Open Source architectures and tool kits for game development. These favor code and content reuse, and allow easy modification to game play and scenario selection through scripting. The script files allow for administration modifications without the requirement of compiler tools. Future versions will allow web based setup through hierarchical data selection (audio, texture, 2D/3D geometry), variable/parameter editing and scene layout/ordering. During the proposed work Ontar will design and implement: a system and tools for game creation, a system for game distribution/playing, and a game to illustrate the approach. We will utilize technology we have developed for other SBIR programs to meet the program goals including our SCORM compliant TENOR LCMS.

Physical Optics Corporation
Applied Technologies Division 20600 Gramercy Place, Bldg. 100
Torrance, CA 90501
Phone:
PI:
Topic#:
(310) 320-3088
Shean McMahon
OSD10-H08      Awarded: 5/6/2011
Title:Serious Medical Online/Offline Game Technology
Abstract:To address the OSD need for web-based, Sharable Content Object Reference Model (SCORM)-compliant, photorealistic, virtual medical training tools in a serious medical game, Physical Optics Corporation (POC) proposes to develop a new Serious Medical Online/Offline Game (SMOG) software application. POC’s proposed SMOG software is based on a loosely coupled client-server architecture, COTS available gaming middleware, and a natural language processing SCORM rendering routine. Innovations in SCORM object rendering significantly reduce the manpower-intensive process of translation of SCORM objects; the loosely coupled client-server architecture supports unlimited scaling of technology to address additional users and capabilities, enabling SMOG to provide for nearly any training scenario of interest to the OSD, including medical, maintenance, and battlefield scenarios. POC’s SMOG, which directly addresses OSD requirements, will be able to integrate with virtual medical training for the AFMS Medical Modeling & Simulation program, meeting all DIACAP and IM/IT security requirements. In Phase I, POC will demonstrate the feasibility of SMOG by developing both the SCORM rendering routine and a small demo game, such as setting a limb. In Phase II, POC plans to develop additional game scenarios, expand and optimize the various software components, and identify a suitable teaming partner for Phase III productization.

Sonalysts, Inc.
215 Parkway North P.O. Box 280
Waterford, CT 06385
Phone:
PI:
Topic#:
(757) 490-3927
David Fliesen
OSD10-H08      Awarded: 5/6/2011
Title:Medical Gaming
Abstract:Throughout history, the ability of a fighting force to respond to battlefield casualties, perform triage, and evacuate their wounded to a treatment facility has been crucial to the long-term success of the force. Until now, the ability of medical personnel to gain experience and refine their procedures and techniques has often been accomplished through real-life experience in a complex battlefield environment – a costly and inefficient means. Sonalysts is pleased to offer this proposal to provide a web-based, serious medical game to prepare medical personnel in the full continuum of medical care. Our realistic 3D environment for the MEDATAR serious game will challenge students’ knowledge of procedures at all echelons of patient treatment. This medical serious game will analyze student performance to reveal areas for further training to ensure mastery of the learning objectives are achieved. Once feasibility for the MEDATAR serious game is established with scripted scenarios in Phase I, Sonalysts further proposes to assess options for including features for intelligent tutoring, scenario creation/editing, artificial intelligence, human-in-the-loop monitoring/feedback, and an avatar delivery system in later SBIR phases. This adaptable serious game will empower medical training commands with maximum flexibility and control over the instructional curriculum for optimum results.

Vcom3D, Inc.(formerly Seamless Solutions, Inc.)
11474 Corporate Blvd. Suite 140
Orlando, FL 32817
Phone:
PI:
Topic#:
(407) 737-7309
Edward M. Sims
OSD10-H08      Awarded: 5/6/2011
Title:Serious Game for Continuity of Care Training
Abstract:For this Phase I SBIR, Vcom3D will design a Web-based medical game for the development of the cognitive skills required to provide highest quality of care from far-forward locations through evacuation to level 1 trauma facilities. The training will emphasize the continuity of care through the course of hand-offs ranging from far-forward care under fire, through EMEDS and field hospital facilities, to air evacuation to definitive stateside care. Based on a cognitive task analysis, a design concept and storyboard for the game will be developed. Specific attention will be given to the required perceptual cues, and to measures of performance based on trainee actions and patients’ response. The game will feature highly detailed user avatars and virtual patients that exhibit appropriate physiological and communicative behaviors. These avatars will be based on Vcom3D’s Plug-and-Play Communicating Avatars (PPCA) project, which provides a library of accurate and detailed virtual human models and behaviors, as well as a development pipeline for creating cross-platform content that is compatible with Windows and Macintosh computers, as well as Apple iPod/iPhone/iPad and Android mobile devices. At the end of Phase I, a proof-of-concept will be demonstrated and tested on the full range of target platforms

Infoscitex Corporation
303 Bear Hill Road
Waltham, MA 02451
Phone:
PI:
Topic#:
(781) 890-1338
Kristen LeRoy
OSD10-H09      Awarded: 5/6/2011
Title:Solid and Hollow Organs for Trauma Simulation (SHOTS)
Abstract:Although many surgical simulators exist on the market today, they are limited in their ability to replicate live tissue and how it responds to injury and treatment, decreasing the simulator’s utility in training medical personnel. Infoscitex has developed a concept for fabricating Solid and Hollow Organs for Trauma Simulation (SHOTS) that supports tissue-tool surgery using the same surgical equipment as live tissue (scalpel, sutures, retractors, bovie). These can be incorporated into a number of existing surgical phantoms or can be used as a stand alone device comprised entirely of SHOTS components. In Phase I we will focus on the key differentiating factor of our tissue simulator, namely the composition and concomitant behavior of the organs of SHOTS. To do so, we will fabricate and test both types of organs integrated with SynDaver Lab’s torso and vasculature to demonstrate the feasibility of SHOTS as a medical surgical simulator tool.

Physical Optics Corporation
Applied Technologies Division 20600 Gramercy Place, Bldg. 100
Torrance, CA 90501
Phone:
PI:
Topic#:
(310) 320-3088
Ninad Patnekar
OSD10-H09      Awarded: 5/6/2011
Title:Synthetic Human Medical Trainer
Abstract:To address the Office of Secretary of Defense’s need for a synthetic tissue trainer, Physical Optics Corporation proposes to develop a Synthetic Human Medical (SY-MAN) Trainer to limit live animal use. The SY-MAN trainer is based on a combination of multiple actuators embedded within a synthetic material that mimics human anatomical structures. Innovations in SY-MAN technology enable the device not only to simulate anatomical and physiological functions but also to offer training in various invasive and surgical procedures. POC’s SY- MAN trainer simulates battlefield injury complications, such as penetrating chest, abdominal, and head wounds with severe hemorrhage, burns, soft tissue wounds, and bone fractures. It allows a trainee to perform various surgical interventions not currently available, such as suturing, venous cut down, soft-tissue debridement, chest decompression, decompression craniectomy, and cricothroidotomy. Standard manufacturing practices and COTS components allow development of the SY-MAN trainer at reasonable cost; its modular design allows replacement of used parts. In Phase I, POC will identify various invasive procedures, build a technology-readiness-level (TRL)-3/4 prototype, and investigate the cost of manufacturing the SY-MAN trainer. In Phase II, we plan to build and validate a complete fieldworthy SY-MAN trainer (TRL-6), demonstrate its operation, and evaluate its production and quality control.

POLYMERight, Inc.
4404-C Enterprise Place,
Fremont, CA 94538
Phone:
PI:
Topic#:
(510) 252-9090
Alex Vainer
OSD10-H09      Awarded: 5/6/2011
Title:Synthetic Tissue Trainer
Abstract:We propose to develop a family of stand-alone synthetic tissue/organ training systems to replace live animal tissue and cadaver training for the Air Force Medical Modeling & Simulation Program, as well as for other surgery training facilities. The developed trainers will replicate segments of human anatomy and will be comprised of multiple modular components simulating human organs. These models of human organs will be produced from polymers that will imitate the tactile response as well as the tensile, lubricious and other properties of life tissues, such as skin, fascia, fat, muscle, cartilage, tendon, bone, blood vessels, nerve, intestine, organ (lung, liver, bladder, etc.) tissue. Trainers will be organized to imitate the human anatomy and will be able to simulate blood circulation and massive hemorrhage, including imitating such physiological parameters as blood pressure, pulse and, possibly, respiration. All the synthetic tissue trainer components will be mass producible and completely or partially reusable and replaceable, allowing for multiple individual training sessions. The targeted trainers will support tissue-tool surgery with the same surgical equipment as live tissue procedures (scalpel, sutures, retractors, bovie), and it will allow training in both laparoscopic and open surgery procedures.

Sim*Vivo
7 Brownell Way
South Burlington, VT 05403
Phone:
PI:
Topic#:
(802) 497-1234
John B. Fortune
OSD10-H09      Awarded: 5/6/2011
Title:Synthetic Tissue Trainer - Development of Realistic Tissue Elements for Surgical Task Training for Mangement of Combat Injuries
Abstract:The main outcome of this proposal will be the development of a new generation of task training manikins that will provide a realistic training platform for the instruction of invasive trauma resuscitation procedures (ITRP) such as peripheral IV insertion, chest decompression, percardiocentesis, criccothyryotomy, central venous line insertion, hemorrhage control and simple suturing. Current trauma training models are characterised by a design structure that emphasizes "durability" making them unrealistic, bulky, teathered, heavy, and expensive. We propose to sacrifice long term durability in the development of a fabric-based, fully integrated simulator that will emphasize realism (avoiding rubbery latex components), portability, and versatility. There will be few replaceable components allowing for turn-key initial and repeated use. Fabrication will utilize inexpensive materials with simple construction techniques allowing for an very competitive cost compared to current simulation platforms with an emphasis on visual and tactile realism. The ultimate goal is to develop simulation trainers that will allow repititive deliberate and distributive practice for each learner that will be followed by use for realistic assessment exercise in simulated combat environments. Successful completion of phase I objectives will result in a working prototype of a Combat Injury Torso capable of demonstrating the treatment of multiple chest injuries (including cutaneous bleeding wounds), cricothyrotomy, and the insertion of central venous catheters. Additional objectives include the advanced development of a currently prototyped self-contained IV practice arm to pre-manufacture status, and the development of a technical prototype for a Combat Injury Limb simulator as a model of massive hemorrhage.

Syndaver Labs
10770 N 46th Street, Suite C500
Tampa, FL 33617
Phone:
PI:
Topic#:
(813) 600-5530
Christopher Sakezles
OSD10-H09      Awarded: 5/6/2011
Title:Synthetic Tissue Trainer
Abstract:A synthetic human body has been developed which mimics normal human anatomy and the properties of living tissue. This SynDaver™ Synthetic Human (SSH) employs a functioning circulatory system capable of massive hemorrhage, a respiratory system capable of ventilation and pneumothorax, and a complete gastrointestinal system. The goal of this project is to evaluate the SSH as a medical training platform and improve performance with instruments such as scalpels, suture, and retractors, devices employing RF, electrical, thermal, or laser energy, and ultrasound, x-ray, fluoroscopy, CT, and MRI imaging equipment. To accomplish this we propose a two-tiered effort. First, SSH prototypes (n=10) will be sent to Columbia University, Duke University, University of Massachusetts, University of South Florida, Ethicon, Covidien, Cook, Medtronic, Procter and Gamble, and the Andersen Simulation Center (U.S. Army). Each institution will evaluate the SSH as a platform for training, surgical simulation, or the development of consumer and medical products. Second, feedback from these sites may be used to modify the structural design of the SSH or the formulation of muscle, fascia, skin, or other organ tissues. This system will be shown to be capable of replacing human cadavers, live animals, and other simulators for medical training and surgical simulation.