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

60 Phase I Selections from the 12.2 Solicitation

(In Topic Number Order)
Charles River Analytics Inc.
625 Mount Auburn Street
Cambridge, MA 02138
Phone:
PI:
Topic#:
(617) 491-3474
Peter Weyhrauch
DHP12-001      Awarded: 1/15/2013
Title:Tourniquet Master Training System for Junctional and Inguinal Hemorrhage Control Devices
Abstract:Junctional and inguinal bleeding is a significant and challenging problem on the battlefield. Inventors have developed new types of tourniquets, including the Abdominal Aortic Tourniquet™ (AAT) and the Combat Ready Clamp™ (CRoC) to address these abdominal and pelvic injuries. While these hemorrhage control technologies have been developed, validated, and approved for use, training systems that teach and refresh skills related to these technologies have not been developed. Training systems for these types of injuries are vital because the injuries are rare on the battlefield and difficult to train. To address these needs, we propose to design and demonstrate the feasibility of Tourniquet Master Training (TMT), a scenario-based training system featuring a reconfigurable, sensor-enabled mannequin linked to a software-based virtual mentor that teaches, assesses, and provides refresher training.

Infoscitex Corporation
303 Bear Hill Road
Waltham, MA 02451
Phone:
PI:
Topic#:
(781) 890-1338
Kristen LeRoy
DHP12-001      Awarded: 2/25/2013
Title:HITS – Hemorrhage Instrumented Training System
Abstract:Junctional and non-compressible bleeding is a life-threatening injury that requires immediate intervention. Therefore it is best to train even non-medics in the application of the life-saving methods to stop these hemorrhages. The ideal system would enable training on multiple injury types, react realistically to properly applied intervention, utilize the adjuncts as would be used in the field, and provide immediate, quantified feedback as to the trainee’s performance. In consideration of these requirements, Infoscitex is developing a physical mannequin that can provide the most realistic representation of junctional and non-compressible hemorrhage. The Hemorrhage Instrumented Training System (HITS) presented here is designed specifically for this purpose and includes the following features: - Realistic full-body mannequin enables training of body repositioning as necessary with medical intervention - Multiple pre-molded injuries allow rapid test setup for the instructor and allows multiple scenarios for the trainees - Realistically clotting blood analogue provides accurate and realistic response to appropriately applied interventions - Water cleanup makes test reset easy and quick - Instrumented mannequin skin and vasculature provide data that conforms with standardized scoring systems such as SCORM.

Operative Experience, Inc.
75 Greenhaven Drive
Elkton, MD 21921
Phone:
PI:
Topic#:
(484) 557-8876
Robert Buckman
DHP12-001      Awarded: 3/11/2013
Title:Simulation-based Training System for Junctional and Noncompressible Hemorrhage
Abstract:Deployed military medics and non-medic soldiers on the battlefield may be required to manage junctional and noncompressible hemorrhage. Devices such as the Combat Ready Clamp (CRoC) and abdominal aortic tourniquet have recently been developed and deployed to meet this requirement. There are currently no realistic training systems for these devices which can limit their effectiveness in the field. For example, current training on the CRoC is limited to learning how deploy the device on unwounded, non-bleeding human volunteers. Operative Experience, Inc. proposes to meet this requirement through the development of a training program based on an anatomically accurate, vascularized, human body simulator with standardized size and weight, standardized artificial blood vessels and tissues, standardized blood pressure and flow and multiple, junctional wound patterns. These models will be based on our operative surgical model technology. The phase I effort will focus on a high-fidelity physical simulator of the shoulder with pressurized blood flow in an artificial axillary artery that is compressible by a properly-placed Combat Ready Clamp and that can exposed and clamped by surgical means.

POLYMERight, Inc.
4404-C Enterprise Place,
Fremont, CA 94538
Phone:
PI:
Topic#:
(510) 252-9090
Aleksander Yam
DHP12-001      Awarded: 2/1/2013
Title:Junctional and Non-Compressible Hemorrhage Control Training System
Abstract:This proposal is to develop an adaptable and expandable simulation-based training system for teaching and training the soon-to-be-deployedÂť medics in junctional and non- compressible hemorrhage control and other point of injury care trauma control scenarios using Combat Ready Clamp, Abdominal Aortic Tourniquet or similar devices. Training system will include: 1. A model of a torso mimicking anatomy of upper thighs, pelvic, abdominal, and thoracic/axillary segments of human body with major bones, muscles, aortic and venous vasculature, and simulated organs; 2. A programmable pulsatile/constant flow circulator that simulates arterial and venous bloodflow. 3. Monitored pressure/flow sensors embedded within vasculature to evaluate the efficiency of the applied hemorrhage control devices; and 4. A SCROM-compliant training course program that tests, evaluates, improves cognitive/psychomotor skills of trainees, and assesses the training effectiveness of the system. The training system will a) support acquisition of cognitive/psycho-motor skills required by field medics: b) minimize time and resource expenditures of training staff, improve quality and efficiency of cognitive/psychomotor training, c) reduce the cost of cognitive and psychomotor training, e) address virtual mentoring capability, reduce the time required by instructors and students, f) not generate any hazardous wastes from disposable elements, or require hazardous materials for storage/operation.

SimQuest, LLC
1010 Wayne Avenue, Suite 230
Silver Spring, MD 20910
Phone:
PI:
Topic#:
(301) 587-9440
Dwight Meglan
DHP12-001      Awarded: 2/27/2013
Title:Junctional and Non-Compressible Hemorrhage Control Training System
Abstract:The proposed simulation-based system will provide training in applying a wide variety of hemorrhage control technologies and techniques, especially those that have been developed to manage junctional and non-compressible hemorrhage. The initial focus will be to provide learning scenarios for use of direct pressure, packing, and use of the Combat-Ready Clamp (CRoC) and Abdominal Aortic Tourniquet (AAT). Using as a foundation the work we have done to simulate hemostatic agent application (which in turn leverages our prior work in surgical simulation), we propose to use a combination of sensors, physics-based interactive computation, and display techniques with standard, low-cost, readily available manikins to create a robust, flexible configuration approach to providing hemorrhage control training that focuses on non-tourniquetable injuries. The system is envisioned as consisting of a thin battery-powered sensor that reliably measures pressure applied to it and wirelessly sends that information to a simulation computer.

Advanced Diagnostic Technologies LLC
536 E. Arrellaga Street
Santa Barbara, CA 93103
Phone:
PI:
Topic#:
(800) 273-5517
Cristopher Geiler
DHP12-002      Awarded: 1/29/2013
Title:3D Printed heterogeneously integrated sensors embedded in Anatomical training models
Abstract:Despite the large number of procedural simulation models currently available, there is a definite need for low cost anatomical training models with integrated sensors capable of recording the location and pressure measurements of a user’s performance in training of cuts, and sutures. A paradigm shift in medical training is possible if sensors can either be fabricated independently and embedded into the model, or ideally incorporated in the fabrication process directly such that the user’s manipulation of the mode are tracked and recorded. Unfortunately, current synthetic models require validation and most still need an expert to review the novice’s actions subjectively. In an ideal system, extensive data on the performance of the user could be fed into realistic overall systemic models. In this work we propose a method of incorporating force sensors heterogeneously with synthetic tissue by using a multi-material 3D printing platform. This approach is expected to enable low cost sensing that can be integrated with additional sensors in a simulator to accurately track the performance of a student without requiring an instructor to watch.

Infoscitex Corporation
303 Bear Hill Road
Waltham, MA 02451
Phone:
PI:
Topic#:
(781) 890-1338
Kristen LeRoy
DHP12-002      Awarded: 3/5/2013
Title:Physical Anatomical Trainer Instrumented for Education and Non-subjective Testing (PATIENT)
Abstract:Mannequins are often used to develop skills and train medical personnel. Existing models fall short of ideal functionality, however. Mannequins that can provide simulated systemic responses are generally not equipped for simulating surgical intervention. Mannequins that can simulate surgical intervention are not able to record exact student actions for quantifying their performance. In careful consideration of the needs of the system, and the best way to economically and realistically meet the needs, Infoscitex Corporation is developing the Physical Anatomical Trainer Instrumented for Education and Non-subjective Testing (PATIENT). PATIENT uses complementary technologies to present the most realistic model for modern training requirements for organs, vasculature, instrumentation, and controls. With the right components, the physical configuration of a proper tissue trainer is relatively straightforward. Under previous funding, we have developed inexpensive polymeric organ models that bleed realistically under traumatic or surgical events. We have also developed a blood analogue that clots in the presence of bandage and pressure. In this Phase 1 effort, we will address the instrumentation for the organs, the method for relaying force data and controlling the response of each organ, and develop the control algorithms that govern PATIENT.

Operative Experience, Inc.
75 Greenhaven Drive
Elkton, MD 21921
Phone:
PI:
Topic#:
(215) 557-8876
Robert Buckman
DHP12-002      Awarded: 2/13/2013
Title:Integrating Sensor Technology into Synthetic Anatomical Training Models For Objective User's Performance Measurement
Abstract:There is a need to accelerate the integration of advanced sensor technology into synthetic mannequins in order to facilitate objective measurement of user metrics during training and education activities. Although synthetic mannequins have become a common tool for medical training and education, until recently there have not been any artificial mannequins of sufficient anatomic or surgical fidelity for the performance of major operations. Operative Experience, Inc. has developed models and training modules to support the rapid training of combat medics and surgeons in approximately 20 critical trauma skills. These models will be enhanced through the incorporation of sensors to monitor, measure, and grade the performance medical trainees including trauma surgeons and combat medics as they undergo training. The phase I effort will consist of proof of concept demonstration by incorporating sensors in models for training in the diagnosis and treatment of tension pneumothorax and four compartment fasciotomy of the leg for compartment syndrome.

Advanced Diagnostic Technologies LLC
536 E. Arrellaga Street
Santa Barbara, CA 93103
Phone:
PI:
Topic#:
(800) 273-5517
Cristopher Geiler
DHP12-003      Awarded: 1/29/2013
Title:3D Printed Digital nanocomposite synthetic tissue
Abstract:The DOD and commercial markets have a distinct need for low cost anatomically accurate, complex synthetic human tissue in order to improve training and improve surgical precision. In this project a novel multiple material print-head is developed using a 3D printer capable of depositing a wide range of materials such that bone, skin, blood vessels, adipose tissue, and muscle material properties are tightly matched with live human tissue.

Infoscitex Corporation
303 Bear Hill Road
Waltham, MA 02451
Phone:
PI:
Topic#:
(781) 890-1338
Anna Galea
DHP12-003      Awarded: 3/5/2013
Title:Synthetic Heterogeneous Anatomy by Rapid Prototyping (SHARP)
Abstract:Modern advances in 3D printing and related additive manufacturing technologies offer an approach to provide high-fidelity anatomical models that can be used for medical simulation and training. Current 3D printing systems do not provide a method for various materials to be simultaneously deposited to represent the various properties of tissue, bone, muscle, etc, nor do they provide directionality of supporting structures on a micro-scale. For simulated tissues we need to be able to print materials that include the following properties: • Wide range of stiffness from solid bone to gelatinous fatty tissues • Modulus of elasticity that is different along one direction than in the orthogonal directions • Controlled adhesion between layers of dissimilar materials • Ability to create cavities for hollow organs and vessels • Provide representative mechanical properties in addition to tactile feel and realistic colors Because of these unusual requirements, a rapid prototyping system for simulated organs and anatomical structures will require a custom design that advances the state of the art in rapid manufacturing. Infoscitex Corporation and its collaborators at Rensselaer Polytechnic Institute are currently developing the Synthetic Heterogeneous Anatomy by Rapid Prototyping (SHARP) system to address these needs.

SERAPH ROBOTICS, INC
100 FAIRVIEW SQ 5H
Ithaca, NY 14850
Phone:
PI:
Topic#:
(203) 415-9267
Jeffrey Lipton
DHP12-003      Awarded: 2/14/2013
Title:Anatomic 3D Synthetic Tissue Printer for Medical Training
Abstract:Military medical personnel are not prepared to provide trauma care to severely injured soldiers in wartime due to inadequate and unrealistic battlefield training opportunities during peacetime. Training has historically been done on human cadavers and live animals, but cadavers are in limited supply, and animal rights groups and physicians are increasing pressure to end the practice of using live animals. Anatomically-accurate, high-fidelity mannequins have thus become more and more widely adopted as legitimate medical education tools. Seraph Robotics proposes to develop a solid freeform fabrication (SFF) method of creating medical simulation devices for training combat medical personnel in battlefield surgical techniques. Such devices would be superior to current patient simulator mannequins because they would be made of materials that are more similar to human bodies, and they could be designed to bleed like human bodies. This Phase I project would develop methods for the heterogeneous printing of objects with desired anisotropic material properties; develop methods for the SFF of structures that are pre-stressed in a controlled manner; develop methods for producing objects that are infusible with liquids for the simulation of capillaries and larger blood vessels; and develop a composite anatomical simulant for bone, muscle, adipose tissue, fascia and skin.

Charles River Analytics Inc.
625 Mount Auburn Street
Cambridge, MA 02138
Phone:
PI:
Topic#:
(617) 491-3474
Erik Thomsen
DHP12-004      Awarded: 2/7/2013
Title:Healthcare Exchange Language Management, Expansion, and Translation Services (HELMETS)
Abstract:The 2010 President’s Council of Advisors on Science and Technology report on health information technology states that today, “there is relatively little standardization in the health data captured and stored by different providers of healthcare services” for the millions of active duty service members supported by the Military Health System. This lack of standardization leads to interoperability problems and the development of healthcare exchange models, which rely on capturing complex concepts in a fixed set of codes. However, these codes, used to share healthcare data across systems, become rapidly out of date as new techniques, research, and practices are adopted by caregivers and administrators. To enable truly universal exchange of healthcare information, we propose to design and demonstrate Healthcare Exchange Language Management, Expansion, and Translation Services (HELMETS). Our service consists of three primary elements: (1) an analysis layer that learns how languages are being used (i.e., convention) based on information extraction and document classification techniques; (2) a knowledge representation layer that captures the semantic structure in disparate exchange languages; and (3) a probabilistic modeling framework that translates between languages based on convention and semantics. This approach ensures that changes in practices, rather than changes in administration and policy, are always reflected.

InferLink Corporation
326 Loma Vista St.
El Segundo, CA 90245
Phone:
PI:
Topic#:
(310) 944-4813
Greg Barish
DHP12-004      Awarded: 2/27/2013
Title:A Universal Translator for Health Languages
Abstract:The potential to transform healthcare management through information technology continues to grow, as more systems, devices, and people than ever before provide and collect health data. Unfortunately, progress is slow because the multitude of systems to integrate do not speak a common language. We propose to create a universal translator between health languages, which will allow multiple systems to co-exist, yet share key information. We intend to do this based on a proven, sound statistical inference methodology that is, in turn, powered by a machine learning approach. Combining both methods yields a systems that is both accurate and flexible, with the potential to significantly the reduce the cost of current methods. We have begun to demonstrate this to be the case in working with a prominent health informatics company on a similar challenge. Through this SBIR, we intend to extend that prototypical system to further improve the translation technology, while integrating the resulting system with important emerging sources like 3M's Healthcare Data Dictionary, all the while navigating towards the open sourcing of the end result.

Kitware
28 Corporate Drive
Clifton Park, NY 12065
Phone:
PI:
Topic#:
(518) 371-3971
Wes Turner
DHP12-004      Awarded: 2/1/2013
Title:Learning the Language of Healthcare: Enabling Semantic Web Technology in CHCS
Abstract:The goal of this project is to implement a Universal Exchange Language suitable for nationwide adoption across healthcare providers, and accessible to patients and medical researchers under appropriate protections for security and privacy, as envisioned in the 2010 PCAST report on Health Information Technology. The team combines unique expertise on (a) the design and implementation of data management for healthcare applications, in particular in VistA and CHCS, (b) how to use data analytics to map this information into Linked-Data representations, and (c) open source software development and the promotion of open source communities. In Phase I of this project, a prototype implementation of this universal exchange language will be developed by following open source practices, and the resulting language and its associated infrastructure will be made publicly available as an open source resource in order to facilitate its wide adoption. The language will be constructed using agile methodologies and will be based on the data architecture of VistA and CHCS. The experience of the team indicates that the major elements required for implementing this language do exist already, and therefore the effort will be focused on the proper execution of the language implementation and its further promotion.

Stottler Henke Associates, Inc.
951 Mariners Island Blvd., STE 360
San Mateo, CA 94404
Phone:
PI:
Topic#:
(206) 545-1478
Terrance Goan
DHP12-004      Awarded: 2/1/2013
Title:Bridging the Gap to Universal Health Information Exchange with Community-Driven Terminology Mediation
Abstract:The most critical obstacle to the seamless exchange of healthcare information is the translation from the proprietary medical ontologies of private providers to a universal reference language (i.e., the 3M Health Data Dictionary). Stottler Henke proposes to develop a new system, called Bridge, which will directly address this challenge through three primary techniques. First, we employ a novel approach to ontology mapping in which a community of domain and subdomain experts can work together to create more comprehensive and precise mappings with benefits including: higher dynamicity and up-to- dateness to changes over time, a reduction in errors and incomplete mappings through consensus reaching, and avoiding placing too high of a burden on any individual user. Second, we will enhance mapping accuracy by pairing these community contributions with a “committee” of complementary automated ontology mapping systems. Finally, we will incorporate an active learning module to recognize when ambiguity resolution by a human- in-the-loop can have a cascading effect throughout the automated mapping process and thereby prioritize user operations that can profitably constrain/direct the process with little effort. Phase I development of a limited prototype will provide a solid foundation for the complete implementation of Bridge in Phase II and its eventual commercialization.

SYSNET International, Inc.
2930 Oak Shadow Drive
Oak Hill, VA 20171
Phone:
PI:
Topic#:
(703) 855-2029
Odysseas Pentakalos
DHP12-004      Awarded: 1/14/2013
Title:Prototype, Open-Source, Universal Healthcare Exchange Language
Abstract:Use of information technology within the U.S. healthcare system has made considerable strides forward in the past few years but to fully realize the full benefits of an Electronic Health Record - including higher quality and safety of care through access to the patient’s complete health record at the point of care, increased participation by patients in their healthcare through access to a shared Patient Health Record, considerable advancements in public health and evidence-based treatment, and increased efficiency in the healthcare system, the current interoperability issues must be resolved. The PCAST recently issued a report to the President where they propose that the way forward to realizing the full potential of information technology in healthcare is through the implementation of a Universal Healthcare Language Service. SYSNET International proposes to conduct during Phase I of this SBIR an in-depth study of the recommendations put forward by the PCAST report and produce both, a detailed architecture document of an effective implementation of those recommendations, and a prototype that demonstrates the feasibility of the proposed architecture for a specific domain of health data sharing.

Charles River Analytics Inc.
625 Mount Auburn Street
Cambridge, MA 02138
Phone:
PI:
Topic#:
(617) 491-3474
Terry Patten
DHP12-005      Awarded: 2/7/2013
Title:Health Online through Language – a Medical Exchange System (HOLMES)
Abstract:The amount of information available from medical journals, patient records, and the cloud has increased beyond the point where clinicians can manage it using traditional means. Many clinical decision support systems (CDSS) have been created to manage this complexity, but these systems are often narrowly focused on a domain, quickly grow stale as new treatments become available, and do not account for variation in terminology. To address these needs, we are pleased to offer Health Online through Language – a Medical Exchange System (HOLMES), a system for predicting provisional diagnoses, providing clinical decision support, and improving outcomes for patients with mild traumatic brain injury (TBI) and posttraumatic stress disorder (PTSD). Like IBM’s Watson, HOLMES takes a natural language query, retrieves relevant information, performs inference with this information, and returns an answer along with an associated probability and pointers back to the information it used to draw its conclusion. HOLMES offers on-the-fly information retrieval without the requirement of a supercomputer to maintain and operate a huge data store.

Intelligent Automation, Inc.
15400 Calhoun Drive Suite 400
Rockville, MD 20855
Phone:
PI:
Topic#:
(301) 294-5214
Kaizhi Tang
DHP12-005      Awarded: 2/13/2013
Title:A Virtual PTSD Clinical Assistant with Cloud Computing and Mobile Interface: VPCA
Abstract:To provide better healthcare to PTSD patients, there is a strong need to develop a powerful PTSD CDSS based on evidence-based treatment strategies, acting as an anytime virtual assistant for PTSD professionals, Primary Care Physicians (PCP) and residents. To address this critical need, Intelligent Automation, Inc., proposes to develop an innovative Virtual PTSD Clinical Assistant with Cloud Computing and Mobile Interface: VPCA. The key innovation of VPCA is the utilization of Hadoop Ecosystem with scalable data storage and processing capability to enable the evidence based clinical decision support empowered by Watson-like predictive analytics across different domains for PTSD patients. VPCA consists of a set of indispensable components that are grouped in four sub-systems. The first sub- system is for knowledge and rule authorization. The purpose of this sub-system is to transform the PTSD decision guidelines, already recognized by PTSD professional in practice, will be transformed into business rules. The second sub-system is for data integration and warehousing that can include as many as possible clinical data for Watson- like predictive analytics. The third sub-system is for knowledge and rule discovery that can continuously improve the reasoning potential. The fourth sub-system is for online clinical decision support.

Lifecom Inc.
2828 SW Corbett Street Suite 122
Portland, OR 97201
Phone:
PI:
Topic#:
(503) 288-2393
Stephen J. Datena
DHP12-005      Awarded: 2/14/2013
Title:Prototype Application of Mobile, Cloud-based, Watson-Like Technologies for TBI/PTSD Clinical Decision Support and Predictive Analytics
Abstract:The goal of this Phase I project is to develop an engineering plan and to create a prototype for a mobile, cloud-based expert system to aid in diagnosis, decision support and predictive analytics to improve clinical outcomes for veterans, soldiers, and their families with traumatic brain injury (TBI) and posttraumatic stress disorder (PTSD). Lifecom, Inc. is a health information technology company with over ten years of experience enhancing the quality and safety of health care through improving the accuracy and timeliness of medical diagnosis and management. Lifecom has developed clinical decision support and predictive analytics technology based on its Adaptive Knowledge Engine (AKE), a novel, general-purpose, platform agnostic, and nonlinear decision engine. The AKE, in conjunction with its modular data ontology and industrialized content development process, uniquely positions Lifecom to successfully meet the requirements of this SBIR Phase I project. While initially focused on TBI and PTSD, Lifecom’s engineering plan, supporting technology, and underlying clinical ontology will be capable of providing a template for the development and implementation of a range of future expert systems with semantic search capabilities that can serve any commercial or Department of Defense requirements, medical or otherwise.

SentiMetrix, Inc
6017 Southport Drive
Bethesda, MD 20814
Phone:
PI:
Topic#:
(240) 498-5285
Vadim Kagan
DHP12-005      Awarded: 1/23/2013
Title:Clinical Online PTSD and TBI Analysis for Decision Support (COPTADS)
Abstract:Epidemiological estimates indicate that at least 20 percent of the forces deployed in or returning from the Iraq and Afghanistan wars suffer PTSD or major depression. The number of veterans receiving mental health care has increased from 900,000 to 1.2 million in the past four years. Last year over 400,000 were diagnosed with PTSD, and studies indicate that not all cases of PTSD, depression, and contemplations of suicide are identified using post- deployment mental health assessments. In order to ensure effective and timely treatment, we propose to develop the Clinical Online PTSD and TBI Analysis for Decision Support (COPTADS) system featuring: • Highly Accurate Detection of Symptoms within a diversity of natural language based medical records • Highly Accurate Classification of Patients as very likely to have PTSD/TBI (or not) • Compelling Explanations of why certain patients are believed to have PTSD or TBI • Mobile Access so that doctors anywhere can get COPTADS assessments on a 24/7 basis • Scalability to ensure real-time processing of millions of medical records The SentiMetrix team has worked extensively on the analysis of natural language documents in order to predict whether subjects of blogs have either PTSD or TBI with 80% accuracy

Vcrsoft LLC
2310 Bamboo Drive STE J303
Arlington, TX 76006
Phone:
PI:
Topic#:
(817) 213-6184
VC Ramesh
DHP12-005      Awarded: 2/13/2013
Title:Cloud-Based Predictive Analytics for TBI/PTSD
Abstract:Existing clinical decision support systems (CDSS) for TBI/PTSD are not well integrated with clinical pathways, terminologies/codes, and/or electronic medical records. Further, these CDSS do not leverage the latest computing technologies such as cloud computing, speech recognition, mobile computing and NLP. In particular, latest advances in machine learning / predictive analytics are not utilized. We propose to design and implement a TBI/PTSD CDSS that addresses these shortcomings.

Big Computing, LLC
1 Bradley Road Suite 404
Woodbridge, CT 06525
Phone:
PI:
Topic#:
(203) 936-8244
Martin Schultz
DHP12-006      Awarded: 1/23/2013
Title:Cohort Builder for Healthcare Quality Assurance and Comparative Health Effectiveness Research
Abstract:We propose to carry out a three-phase R&D project leading to a scalable, easy-to-use Cohort Builder software tool making it possible for clinical practitioners and quality assurance personnel to carry out comparative health research studies quickly and effectively, without the need for in-depth data or analytics expertise. In Phase I, we will investigate strategic, operational, and technical issues that must be resolved to develop a suitable cohort building and analysis tool for MHS, and we will create and assess a prototype tool design. This work will include assessments of a number of current GOTS or COTS products, with the joint aims of determining (a) the degree to which they have required cohort-building capabilities, (b) the feasibility and difficulty of integrating them with the varied array of MHS data system frameworks, and (c) the feasibility and difficulty of integrating them with suitable modules for data analytics. Based on our investigations and on consultations with MHS personnel, we will develop a detailed architectural design for a scalable, easy-to-use cohort builder/analytics tool that would meet the needs of MHS and be consistent with the MHS’s current and planned transactional, data-mart, registry, and data-warehouse systems.

Commonwealth Informatics, Inc.
19 Woodbury Street
Gloucester, MA 01930
Phone:
PI:
Topic#:
(617) 277-1287
David Fram
DHP12-006      Awarded: 1/9/2013
Title:Cohort Builder for Healthcare Quality Assurance and Comparative Health Effectiveness Research
Abstract:The goal of this project is to field an easy-to-use but highly capable cohort builder, integrated with Military Health System (MHS) data resources, that will enable clinicians, nurses and QA personnel to efficiently conduct clinical quality assurance and comparative effectiveness research studies, and to identify groups of chronically ill patients for whom there are opportunities for care remediation. Such a tool must effectively bridge the substantial gap between the end user’s formulation of a problem and the underlying computations required to provide an epidemiologically valid answer. A promising approach may be to create a graphical "data flow" environment which allows users to build up complex cohort definitions by composition from a set of familiar and easy-to-understand building blocks. Phase 1 will explore the feasibility of this approach by evaluating existing GOTS/COTS products, creating a prototype user interface, rounding out the list of required and desirable features, and planning for Phase 2. Commonwealth Informatics has assembled collaborators from Harvard Medical School Department of Population Medicine, Cleveland MetroHealth System, University of Maryland’s Human-Computer Interaction Lab (HCIL), and Stottler Henke Associates. Phase 1 deliverables include requirements and design documents, an implementation plan, and a comprehensive discussion of the relevant issues.

Knowledge Based Systems, Inc.
1408 University Drive East
College Station, TX 77840
Phone:
PI:
Topic#:
(979) 260-5274
Madhav Erraguntla
DHP12-006      Awarded: 2/13/2013
Title:Cohort Development and Analysis Toolkit (CDAT)
Abstract:We propose to design and develop a Cohort Development and Analysis Toolkit (CDAT) that will assist clinicians, practice administrators and public health professionals in comparing the effectiveness of different clinical practices, including preventive and treatment modalities. The overall goal of CDAT is to facilitate comparative effectiveness research and evidence- based practice without the necessity for advanced expertise in biostatistics and databases. The proposed CDAT will in addition provide a mechanism for the implementation of findings to improve practice and quality of care directly to the study population. The proposed CDAT will allow clinicians, practice administrators, preventive medicine professionals and Quality Improvement (QI) personnel to: (1) Quickly and efficiently define cohorts and conduct scientific and QI studies to compare and evaluate their morbidity and mortality, (2) Retrieve and recapitulate findings in the literature based on study goals, and (3) Collaborate and share results with stakeholders by publishing the data mining models, analysis results, and cohort models in a secure portal and facilitate re-use. Business applications of CDAT include chronic disease management, comparative health effectiveness research, design, evaluation and monitoring of practice-based quality improvement programs and interventions, and areas of opportunity like mortality and readmission, utilization, length of stay, avoidable delays, etc.

Barron Associates, Inc.
1410 Sachem Place Suite 202
Charlottesville, VA 22901
Phone:
PI:
Topic#:
(434) 973-1215
William T. Gressick
DHP12-007      Awarded: 3/21/2013
Title:Intelligent Automated Insect Collection System (IFICS)
Abstract:Flying insect vectors and the diseases they transmit continue to be a significant source of concern for United States service members deployed in field operations. In an effort to reduce contact between the vectors and humans, military entomologists are often required to perform surveillance to assess the prevalence of disease vectors and to evaluate the effectiveness of control measures. Surveillance relies heavily on the use of trapping devices such as the CDC light trap, which has long been the standard device used by military entomologists. The standard CDC light trap, however, lacks many of the features required for reliable and accurate assessment of adult insect populations. As such, there is now an urgent need for improved and more broadly effective surveillance. To meet these needs, Barron Associates and its subcontractor Virginia Tech propose the development of the Intelligent Flying Insect Collection System (IFICS), which combines proven insect attraction methods with innovative sensing and signal processing technology to create a broadly- effective, low-cost and energy-efficient solution for flying insect surveillance. Features attractive to a wide variety of insects are included, making the IFICS an ideal solution for the Army's needs and positioning it as a widely-applicable solution for commercial and research markets.

McQ Inc.
1551 Forbes St.
Fredericksburg, VA 22405
Phone:
PI:
Topic#:
(540) 373-2374
Robert Fish
DHP12-007      Awarded: 3/21/2013
Title:Novel Sampling Device for the Surveillance of Adult Flying Insect Vectors
Abstract:The Army Defense Health Program has a need for a novel freestanding device to sample and collect a broad spectrum of adult flying insects for the purpose of analyzing possible disease vectors. McQ proposes to develop a flying insect sampling device (FISDe) that utilizes a modular approach to allow the assembly of components necessary for the survey mission. This device will allow for the automatic counting and identification of flying insects along with autonomous reporting and aggregation of the survey data.

Physical Optics Corporation
Applied Technologies Division 1845 W. 205th Street
Torrance, CA 90501
Phone:
PI:
Topic#:
(310) 320-3088
Kang-Bin Chua
DHP12-007      Awarded: 4/2/2013
Title:Multi-Configurable Trap
Abstract:To meet the DHP’s need for a freestanding, lightweight, compact, portable trap to collect a broad spectrum of flying disease vectors, Physical Optics Corporation (POC) proposes to develop a Multi Configurable Trap (McTrap), based on a combination of trap features that have proven effective in collecting different species; a solar-powered internal rechargeable power source; and a lightweight CO^2 source that can operate continuously for multiple days. Modular design packages these features and components into an easily assembled/disassembled freestanding trap, keeping the stowed McTrap 2x the size and 3x the weight of a stowed CDC trap. This results in a portable, reliable, and effective trap for military entomologists to accurately characterize the threat of disease vectors, e.g. Anopheles, Aedes, Culex, Phlebotomus, and Lutzomyia, on deployments to remote locations and environments. When in use, it can be placed anywhere from ground level to a freestanding height of over 1.5 m. In Phase I, POC will design the McTrap and fabricate a prototype to operate for over 24 hours without an external power source. In Phase II, POC will design and fabricate a fieldworthy prototype for testing in laboratory and field environments, for efficacy in collecting a variety of disease vectors.

TDA Research, Inc.
12345 W. 52nd Ave.
Wheat Ridge, CO 80033
Phone:
PI:
Topic#:
(303) 261-1145
Brady Clapsaddle
DHP12-007      Awarded: 3/6/2013
Title:Novel Vector Survaillance Trap for Flying Insects
Abstract:Civilian and military organizations throughout the world perform surveillance to combat vector-borne disease. Of particular concern to the U.S. military are mosquito genera Anopheles, Aedes and Culex, which are important vectors for malaria, dengue and West Nile virus respectively, and sand fly genera Phlebotomus and Lutzomyia, both vectors for leishmaniasis. The trap most commonly used for by U.S. military staff performing vector surveillance is the CDC light trap, developed in the 1960s. Unfortunately, this trap is not effective against the complete range of vectors that threaten deployed forces, and has other deficiencies. Thus U.S. forces urgently require a highly versatile trap that efficiently captures multiple vector species, and is also lightweight, rugged, freestanding, compact for portability, and does not require an external power source. TDA Research, Inc. (TDA) proposes to design a versatile trap for flying insects that incorporates all these features. In developing the trap design, TDA and its team will integrate recent advances in understanding of vector behavior critical to trapping, as well as incorporate the latest materials and power sources. In Phase I we will produce a trap design and fabricate prototypes for initial tests in an enclosure and in the field.

TRITON SYSTEMS, INC.
200 TURNPIKE ROAD
CHELMSFORD, MA 01824
Phone:
PI:
Topic#:
(978) 250-4200
Kerrianne Mello
DHP12-007      Awarded: 5/8/2013
Title:Novel Sampling Device for Surveillance of Adult Flying Insect Vectors(1001-896)
Abstract:In this program Triton Systems will develop a novel freestanding, lightweight, compact, portable sampling device to collect a broad spectrum of adult flying insect disease vectors. The new trap will have a modular design with interchangeable parts for different vectors. The proposed trap will be nestable for easy transport, robust and energy efficient. The design will exploit known and available lures and baits. It will be adaptable with different options to attract a range of adult insects. The device will offer considerable advantages over the standard CDC trap and will also reduce the need for different surveillance devices in the field.

Creare Inc.
P.O. Box 71
Hanover, NH 03755
Phone:
PI:
Topic#:
(603) 643-3800
Anthony J. Dietz
DHP12-008      Awarded: 4/22/2013
Title:Integrated Sensors for Balance Augmentation
Abstract:Soldiers recovering from mild traumatic brain injury (mTBI) or relearning how to walk on a prosthetic lower limb often struggle with their balance. Of patients recovering from acute blast-induced mTBI, almost all (90%) report unsteadiness. These balance deficits affect ability to return to duty and ultimately quality of life. Recent research has shown that improvements can be made in upright standing balance by augmenting sensory information. For instance, sway-referenced tactile feedback improved patients’ balance. At present, there is a lack of systems capable of providing the measurements needed to apply these techniques to assist with balance during dynamic tasks such as walking. The potential to improve balance during walking and other more complex tasks would have an enormous impact on the quality of life for patients suffering from these sensory deficits and would provide a new tool to assist with rehabilitation. This project aims to create a system capable of providing the data necessary for augmenting sensory cues during dynamic tasks.

Ekso Bionics Inc
1414 Harbour Way South Suite 1201
Richmond, CA 94804
Phone:
PI:
Topic#:
(510) 735-8980
Tim Swift
DHP12-008      Awarded: 3/26/2013
Title:Multisegmental Sensor Integration for Balance Control
Abstract:With this Phase I SBIR project we intend to develop technical solutions to the primary issues limiting the feasibility of a stand-alone real-time balance feedback device. We intend to develop a technique that uses multiple sensors to estimate the orientation of the user’s body segments in the presence of real world disturbances. The effort will develop and validate techniques for accurate real-time estimation of center of mass (COM) and center of pressure (COP). The methods will be implemented on an existing hardware platform, our lower extremity exoskeleton Ekso. We will leverage Ekso as a platform to increase development speed while still being in a human centered application. This effort will also seek to develop a balance classification method that can score the balance of a user. We intend to implement this balance classification method in a stationary standing posture but will design an extension to dynamic walking for use in a later phase of the project.

Engineering Acoustics, Inc.
406 Live Oaks Blvd
Casselberry, FL 32707
Phone:
PI:
Topic#:
(407) 645-5444
Bruce Mortimer
DHP12-008      Awarded: 5/14/2013
Title:Multisegmental Sensor Integration for Balance Control
Abstract:Fall-related events are the leading cause for injury deaths among people 65 years and older. Blast related balance dysfunction is a significant problem the military. Recent advances in Micro-Electrical-Mechanical Systems (MEMS) have made accessible a variety of extremely small, rugged, reliable, low power consumption, and inexpensive sensors of acceleration and pressure. A collection of these devices should be capable of providing similar proprioceptive information that the distributed biological sensors of the human body provide the brain to carry out complex mobility tasks. This project aims to determine the minimal number, location and type of sensors required to provide real-time balance information for a wearable dynamic balance measurement system. We will develop new wearable sensors for determining key biomechanical parameters including; multiple segment, networked inertial sensors, shear sensors and environmental classification sensors.

Infoscitex Corporation
303 Bear Hill Road
Waltham, MA 02451
Phone:
PI:
Topic#:
(781) 890-1338
Anna Galea
DHP12-008      Awarded: 3/26/2013
Title:OMBA - On the Move Balance Assessment
Abstract:Balance disorders have a large negative impact on quality of life. Several methods have been developed that can help patients stay balanced, however these systems at present remain tethered to a gait lab or to a balance platform. A real time system that calculates the center of pressure and extrapolates the patient’s motions to determine stability during ambulation would enable these systems to become ambulatory devices that a patient can use at all times, dramatically increasing their usefulness to the patient population and opening new avenues for more intense training that may yield better results faster. The On-the-Move Balance Assessment (OMBA) system is designed to meet the noted needs. OMBA uses two different algorithms to robustly calculate whether the user is in danger of falling, providing predictive information in time for corrective action. OMBA is designed to be comfortable to wear and easy to use, with extremely low rate of false positives and no false negative alerts. Our team is well positioned to develop OMBA within the SBIR framework. We present a Phase I proposal aimed to address the novel aspects of the system, so that a complete system can be fabricated and tested in Phase II.

Liberating Technologies, Inc.
325 Hopping Brook Road suite A
Holliston, MA 01746
Phone:
PI:
Topic#:
(508) 893-6363
Jennifer Johansson
DHP12-008      Awarded: 3/26/2013
Title:Multisegmental Sensor Integration for Balance Control
Abstract:Falling and the fear of falling often lead to lack of independence and decreased mobility, followed by functional deficits and reduced quality of life. All these consequences of falling put a heavy burden on the healthcare system. Given the high cost associated with falling, research in this area has garnered much attention. Some research has identified that both vibrotactile trunk tilt feedback and vibrotactile foot pressure feedback significantly decrease fall risk in healthy elderly subjects as compared to no feedback. These technologies are currently being marketed as the Balance Belt™ and Walkasins™, respectively. Our approach entails using these existing technologies in a unique way to develop a multisegmental sensor system for balance control. We envision combining the proven technology of the Balance Belt™’s tilt sensor with commercial off-the-shelf Inertial Measurement Units (IMU) to obtain a reliable and extremely accurate measure of the Center of Gravity. We shall also combine the orientation of the hips and legs measured by the IMUs with the Walkasins™ demonstrated ability to determine the Center of Pressure (CoP) for each foot to determine the location of the whole body CoP during standing and the phases of gait that both feet are on the ground.

Benson Medical Instruments Company
310 4th Ave. S. Suite 5000
Minneapolis, MN 55415
Phone:
PI:
Topic#:
(612) 827-2222
Stephen Benson
DHP12-009      Awarded: 3/20/2013
Title:Ear Protection Validation System
Abstract:This proposal contains the description for a hearing protection device (HPD) fit-test instrument, the CCA-200fit. The CCA-200fit has the capability to determine if an individual is receiving effective noise protection from an HPD. The CCA-200fit also has training capabilities via a display, audio, and a touchscreen which will allow it to provide instruction, feedback, and results to the individual being tested. The instructions will be provided in the subject’s own language. A REAT (Real Ear At Threshold) fit testing algorithm utilizing either deep cavity headset or free field speaker will be used which will allow a fit-test to be conducted on a wide range of HPDs. The CCA-200 fit will be capable of both a highly automated mode that will test up to ten individuals at once and a highly interactive mode that will test a single individual. It will also have many additional features such as SQL Server database, reporting capabilities, import/export, SQL generation capabilities, and etcetera. Database capabilities include the ability to view, modify, sort, select, print, backup, restore records related to tables that contain subject, audiogram, fit-test, user-defined, company, and etcetera information.

Intelligent Automation, Inc.
15400 Calhoun Drive Suite 400
Rockville, MD 20855
Phone:
PI:
Topic#:
(301) 294-4630
Devendra Tolani
DHP12-009      Awarded: 5/15/2013
Title:Portable, Hearing Protection Device (HPD) Assessment System (PHAS)
Abstract:Good hearing is critical to understanding verbal communications, and to auditory situational awareness in military training and on the battlefield. Also, hearing protection is critical to the health and safety of those exposed to hazardous noise. In veteran’s compensation cases, Tinnitus and Hearing loss are the two most common disabilities awarded by the VA. Exposure to high noise levels, both hazardous and non-hazardous, may lead to excessive fatigue, reduced efficiency, headaches, sleep loss, muscle tension, high blood pressure, reduced reaction time and reduced concentration. (Army Hearing Program ST4-02.501, 2008). The effectiveness of hearing protection is dependent, not only upon the Noise Reduction Rating (NRR) of the devices, but also upon how they are fitted. The proposed research seeks to develop a portable, low cost, ruggedized, HPD Assessment System, which can be used in the field to validate levels of protection supported by HPDs at a personal level. The system will be capable of testing multiple users simultaneously, support a Field Microphone in Real Ear (F-MIRE) measurement method, provide a Personal Attenuation Rating (PAR) for each patient under test and provide data interfaces which are compatible with existing DOD systems such as the Defense Occupational and Environmental Health Readiness System (DOEHRS-HC).

KCF Technologies, Inc
336 South Fraser Street
State College, PA 16801
Phone:
PI:
Topic#:
(814) 867-4097
Richard Geiger
DHP12-009      Awarded: 3/27/2013
Title:Multiple-user Wireless Hearing Protection Device Validation and Training System
Abstract:KCF proposes to build a general wireless hearing protection device validation system with miniature, wireless in real ear microphones. The microphones will be battery-free to enable the reduction in size necessary to fit in the canal for testing with any hearing protection device. KCF has developed a low power wireless protocol that allows the microphones to run on small amounts of power that can be transferred wirelessly to them. Unlike commercial protocols, the protocol also includes multiple concurrent communication channels so that many users can be evaluated at once. The data from the in ear and external microphones will be passed wirelessly to a database, and finally to a handheld tablet computer such as an iPad.

Michael & Associates, Inc
2766 W. College Ave Suite 1
State College, PA 16801
Phone:
PI:
Topic#:
(814) 234-7042
Kevin Michael
DHP12-009      Awarded: 4/18/2013
Title:Ear Protection Validation System
Abstract:A new Field-Microphone in Real Ear (F-MIRE) Field Attenuation Estimation System (FAES) is proposed. The insertion loss measurements will utilize a sub-miniature microphone mounted deep in the ear canal. An ultra-thin flat flexible cable (FFC) will connect the microphone to the PC-based analysis module. Human subject and test fixture verification tests have been performed demonstrating that the FFC has no significant effect on insert- type hearing protector attenuation. The FAES system will be compatible with all types of hearing protection, including muffs, inserts, muffs plus inserts, and active noise control devices of either muff- or insert-type. The microphone will be encased in a proprietary, acoustically transparent, removable encasement that will maintain the microphone in a proper measurement position while preventing contact between the microphone and the delicate ear canal walls. The analysis hardware and software will present attenuation data in octave or third-octave band format. A single number Personal Attenuation Rating (PAR) will be generated from these octave band data, and other metrics such as predicted Time-Weighted Average (TWA) exposure, noise dose, and maximum allowable exposure.

Archinoetics, LLC
700 Bishop St. Suite 2000
Honolulu, HI 96813
Phone:
PI:
Topic#:
(808) 585-7439
Charles C. Martin
DHP12-010      Awarded: 2/25/2013
Title:Self Powered Biosensors
Abstract:In this project we will determine the feasibility of using motion from respiration to generate power for the circuits necessary to acquire and wireless transmit heart rate and respiration rate to a nearby receiver. Power generation will be based on electromagnetic induction. Circuitry will consist of a rectifier, a power conditioner, a system on a chip (SOC) and a wireless transmitter. Each subsystem will be designed to minimize power consumption. This work will provide the foundation for a comfortable, rugged, waterproof, low maintenance cardio/pulmonary strap.

MaXentric Technologies LLC
2071 Lemoine Avenue Suite 302
Fort Lee, NJ 07024
Phone:
PI:
Topic#:
(858) 848-0273
Paul Theilmann
DHP12-010      Awarded: 2/12/2013
Title:Self Powered Biosensors
Abstract:In response to the DHP 12-010 self powered biosensor solicitation, MaXentric proposes the VitalH system. Acknowledging the difficultly in creating a completely self-powered bio- sensor system that wirelessly transmits vital sign information, MaXentric has developed a solution which is extremely power efficient and minimally invasive. The VitalH garment continuously senses full ECG waveforms in a comfortable contactless manner. The ECG data is wirelessly transmitted to a display device (smart phone, tablet, etc…) which uses the VitalH software to calculate, store and display heart rate, respiratory rate and full ECG waveform data. Using ultra-low duty cycle transmission, power consumption of the wireless transceiver is minimized. This technique reduces power requirements to levels at which operation of the entire system can be sustained via harvested power. Power for system operation is harvested from respiratory effort. This is an important advantage of the VitalH system. Since power is provided by one of the vital signs being measured, the system ensures that energy will always be available to process and transmit sensed data. Through the use of advanced software and hardware techniques the VitalH system is free of many of the issues that plague ECG sensor systems.

CCL Biomedical Inc.
224 N. Washington Street
Havre de Grace, MD 21078
Phone:
PI:
Topic#:
(410) 939-9356
Nina M. Lamba
DHP12-011      Awarded: 2/27/2013
Title:High Performance Antimicrobial Textiles
Abstract:The goal of this Phase I SBIR proposal is to develop and evaluate a new antimicrobial coating to augment infection control in medical care settings. Laboratory and clinical studies have shown that bacteria can survive for weeks on items found in hospital patient rooms. Such items and are believed to play a role in the transmission of infectious agents. Reducing the number of microorganisms surviving on clothing and furnishings may be an important route to reducing the number of opportunistic infections. Infections lead to increased treatment time, costs, and mortality. CCL Biomedical will use its novel patented biocides and application processes to advance the current state of antimicrobial textiles. During this Phase I program, we will synthesize, characterize and bond patented biocides to natural and synthetic fabrics. Laboratory evaluation will include chemical, physical and microbiological characterization of the finished fabrics. The biocidal performance of these compounds is expected to supersede currently available antimicrobial technologies, leading to Phase II and III activities that assess additional microbiological characteristics, as well as durability and scalability for large-scale manufacture. In addition to medical textiles, additional product applications including soldier uniforms with improved biodefense capabilities are anticipated.

Medetech Development Corp.
12527 Mukilteo Speedway suite 103
Lynnwood, WA 98087
Phone:
PI:
Topic#:
(425) 442-5246
zhengbing cao
DHP12-011      Awarded: 2/27/2013
Title:Durable and rechargeable antimicrobial textiles
Abstract:For soldiers in the field, there are limited opportunities for normal hygiene. Showers/bathing facilities are limited, as is the ability to launder uniforms, underwear and bedding. A lack of clean water can make even basic hygiene difficult-- in addition to the obvious problem of unsanitary drinking water. Also, the infection-control challenges the military faces in field hospitals and in combat medical procedures are far greater than the infection-control problems faced by civilian hospitals and emergency responders. The typical infection-control methods used in civilian hospitals often cannot be applied in field medical shelters during combat. It is therefore imperative that exposure to pathogens on clothing, on surfaces and during medical treatment of wounds be minimized. Antimicrobial textiles have been used to reduce odor and risk of infection. Currently, there are numerous products on the market. However, not one of these products can come close to meeting DoD needs. The ultimate objective of this proposed project is to provide antimicrobial functions to uniforms and undergarments for soldiers to control body odor and reduce the risk of infection, and to provide medical textiles with antimicrobial functions for medical shelters and military hospitals to help prevent the transmission of pathogenic bacteria under field conditions.

NanoScale Materials, Inc.
1310 Research Park Drive
Manhattan, KS 66502
Phone:
PI:
Topic#:
(785) 537-0179
Shyamala Rajagopalan
DHP12-011      Selected for Award
Title:Natural Essential Oils and Nanocrystalline Oxides based Antimicrobial Coatings
Abstract:Improved hygiene standards and the threat of infectious diseases demand materials with properties that inhibit the survival and proliferation of pathogenic microbes. In particular, recent United States and multi-national military missions have demonstrated the need for antimicrobial textiles that are not only cost effective but also deliver a strong performance in protecting the lives of personnel in a high risk infectious environment. The purpose of the proposed project is to demonstrate the feasibility of combining biologically active Natural Essential Oils with highly porous Nanocrystalline Oxides to produce a composite coating (NEON OAC) which is effective against a range of pathogens. A standard battery of tests will be used to screen candidate formulations, and promising formulations will be fine-tuned to enhance performance. Further bench scale testing of these formulations will be done with NEON OAC treated cotton fabrics, using accepted industry test methods. The goal of the project is to produce textile coatings that show 4 log reduction or greater of several infectious organisms by the required protocols, and balance cost, toxicity, and high efficacy rate at room temperature without degrading the properties of the substrate.

Physical Sciences Inc.
20 New England Business Center
Andover, MA 01810
Phone:
PI:
Topic#:
(978) 689-0003
Dorin V. Preda
DHP12-011      Awarded: 1/15/2013
Title:Novel Dendrimers for Antimicrobial Textile Finish
Abstract:The US Department of Defense identified a continuing need for antimicrobial textiles to provide a range of capabilities such as integration in Soldier uniforms to control odor or in medical textiles to control the transmission of pathogenic bacteria. Physical Sciences Inc. (PSI) proposes to functionalize fabrics with novel antimicrobial dendrimers. These compounds will be used as a textile finish in a one-step process and will provide a high concentration of the antimicrobials on the surface of the fabric thus increasing the biocidal effectiveness. In addition, the proposed process will prevent leachable materials from being produced and will not lead to degradation of fabric properties. On a potential Phase II program, PSI will expand the use of this technology for multiple fabrics and will provide additional characterization of the finish. In addition, PSI will investigate the scale up of this technology to design high throughput process that will allow large volumes of fabrics to be treated with the antimicrobial finish.

Infoscitex Corporation
303 Bear Hill Road
Waltham, MA 02451
Phone:
PI:
Topic#:
(781) 890-1338
Vladimir Gilman
DHP12-012      Awarded: 2/22/2013
Title:Biosensor and Controller for Closed Loop Anesthesia Delivery System
Abstract:A sensor for rapidly and reliably measuring the blood concentration level of an intravenously –administered analgesic/anesthetic medication is proposed, providing a key feedback element for closed loop target controlled infusion analgesia/anesthesia (TCIA) systems. The addition of direct measurement of analgesic/anesthetic concentration to existing physiological/neurological feedback will address FDA concerns regarding closed loop TCIA systems and thereby facilitate approval. In the context of forward surgical care and medical evacuation of injured solders, the potential benefits of closed loop TCI are greatly multiplied, where medical personnel are stretched thin, conditions are hostile, and rapid changes in patient status are frequent. The proposed sensor achieves high signal to noise ratios, when measuring propofol, nalbuphine, and other phenolic compounds (e.g., opioids), thereby enabling accurate measurement of analgesia/anesthesia concentration with minute volumes of blood. Moreover, it is inherently small, suggesting that it can be designed for deployment for forward or EnRoute care, where size, weight and power are key considerations. Accordingly, Phase I will include (1) proof-of-principle testing in the laboratory, (2) planning and preparation for Phase II testing of prototype sensors in which sensor performance will be verified, and (3) development of a sensor design that is suitable for military deployment.

Infusense
6415 River Tide Drive
Memphis, TN 38121
Phone:
PI:
Topic#:
(865) 566-3912
Chuck Witkowski
DHP12-012      Awarded: 3/28/2013
Title:Biosensor and Controller for Closed Loop Anesthesia Delivery System
Abstract:Microfabricated chemical and biological sensors serve as an interface between biologic and electronic systems. Previously, through TATRC-funded research grants (W81XWH-05-2- 0064, W81XWH-10-1-0358), we have investigated the behavior and detection of propofol using electrochemical (EC) methods. Using these analytical methods, we have quantified the oxidation of propofol well below therapeutic concentrations in reagents and in serum, and have designed and fabricated several prototype biosensors using; 1) carbon fiber microdisc electrodes, 2) carbon nanofiber electrodes, and 3) organic membrane-coated carbon electrodes. We have previously tested and reported on sensor performance, signal sensitivity and stability, biofouling, and biological interference ex vivo to model clinical performance and validated sensor performance in pilot clinical studies. We have also developed a prototype preclinical platform feedback control loop (including controller design elements) for closed- loop infusional propofol anesthesia to automate drug delivery in real-time in vivo, using small infusion systems. The goal of this Phase I SBIR is to integrate our biosensor prototypes and EC methods with current TCI pump technology and complete controller design testing of the small platform closed loop device to deliver real time (<1 second) sensing of propofol levels.

Physical Optics Corporation
Applied Technologies Division 1845 W. 205th Street
Torrance, CA 90501
Phone:
PI:
Topic#:
(310) 320-3088
Ninad Patnekar
DHP12-012      Awarded: 5/16/2013
Title:Intelligent Sensor for Closed-Loop Anesthesia Delivery System
Abstract:To address the Army Medical Research and Material Command’s need for closed-loop anesthesia system Physical Optics Corporation (POC) proposes to develop a new Intelligent Sensor for Closed Loop Anesthesia Delivery (iSCAD) system based on a novel optical spectroscopy technique and a multisensor fusion–based control algorithm. The key innovation in the iSCAD is its novel system design that allows accurate detection of propofol in blood which does not result in any discomfort to the patient, making it suitable for field environment and hospital use. iSCAD’s novel processing of sensor information to generate a measure of depth of anesthesia enables better control of anesthesia delivery resulting in improved therapeutic outcome in terms of reduced pain, faster recovery, and reduced side effects to the warfighter. In Phase I, POC will develop an iSCAD system model, perform analysis and develop a bench-top prototype. We will perform feasibility testing on this TRL 3- 4 prototype to evaluate performance metrics such as sensitivity, accuracy and detection limits. In Phase II, we plan to build and validate a complete clinically fieldable, TRL-5 system on an animal model to determine its clinical safety and efficacy as well as evaluate its productization.

Infoscitex Corporation
303 Bear Hill Road
Waltham, MA 02451
Phone:
PI:
Topic#:
(781) 890-1338
Vladimir Gilman
DHP12-013      Awarded: 1/11/2013
Title:Tissue Specific Topical Treatment for Peripheral Neuropathy
Abstract:Peripheral neuropathy (PN) is condition in which a single nerve, nerve groups, or nerves become damaged. Neuropathic pain can be difficult to manage. Mild pain can be treated with over the counter analgesics. In cases when the pain is persistent and more severe, injections of, or topical patches containing local anesthetics, can be used. In order to provide a safe and no adverse side effect PN pain relief, the topical application and neuronally specific delivery of painkillers is an important strategy. Iontophoresis is a medication delivery method that can be used to reduce the risk of systemic side effects as opposed to oral medications by delivering a greater concentration of medication to a local area with a very low systemic dose. The result is a noninvasive drug delivery method with high patient acceptability. Nano-formulated compositions are promising means for transdermal tissue specific drug delivery, as they allow both long-term drug stability and sustained on demand release of the active drugs. Infoscitex Corporation (IST) and Northern Kentucky University (NKU) developed a concept that combines both of the above methods to result in a highly efficient, biocompatible, and topically administered and tissue specific PN treatment.

Lynntech, Inc.
2501 Earl Rudder Freeway South
College Station, TX 77845
Phone:
PI:
Topic#:
(979) 764-2200
Anjal Sharma
DHP12-013      Awarded: 12/21/2012
Title:Epicutaneous Gel for Delivery of Targeted Therapeutic to Treat Peripheral Neuropathy
Abstract:Peripheral Neuropathy (PN) is a painful debilitating condition caused by progressive subcutaneous nerve damage due to diabetes, chemotherapy or as a result of traumatic combat injuries. Systemic or topical administration of existing therapeutics alleviates pain but does not address progressive nerve damage. High dosages requisite for therapeutic effect increase long-term toxicity risk. Lynntech, Inc. proposes a biocompatible epicutaneous gel system to (a) topically deliver a therapeutic which may mitigate pain and halt or reverse nerve damage, (b) directly target receptors on neurons to reduce dosage and decrease long term toxicity risk and (c) be easily administered due to its familiar topical gel format. Phase I will provide proof-of-concept for improved neuronal targeted delivery of the therapeutic as directly compared to delivery of a currently utilized NSAID using an appropriate in vitro 3D skin equivalent model. Phase II will further optimize the topical gel system and therapeutic for improved skin barrier penetration and increased neuronal targeting ability which will be demonstrated using an appropriate in vivo model of PN. This innovative epicutaneous gel system is of direct relevance to the missions and goals of the USAMRMC as it may significantly improve the quality of life of our soldiers with PN.

Physical Optics Corporation
Photonic Systems Division 1845 W. 205th Street
Torrance, CA 90501
Phone:
PI:
Topic#:
(310) 320-3088
Gregory Zeltser
DHP12-013      Awarded: 1/10/2013
Title:Nano-Therapeutics for Peripheral Neuropathy
Abstract:To address the DHP need for a controlled, target-specific delivery system for topical treatment of peripheral neuropathy (PN), Physical Optics Corporation (POC) proposes to develop Nano Therapeutics for Peripheral Neuropathy (NATPEN). The NATPEN will include a nanocarrier (NC) loaded with specific drugs, a biocompatible gel to contain the NC, and a microneedle patch for transdermal delivery of the therapeutic. The innovations in the NATPEN as a topical treatment modality will enable minimally invasive, extended, targeted delivery of drugs to the peripheral terminals of the sensory neurons. The NATPEN modality has minimal toxicity and is easy to administer. In Phase I, POC will demonstrate the feasibility of the NATPEN concept by developing a prototype of a topical drug delivery system capable of transporting the therapeutic through skin and having nerve targeting capability and controlled release of the drug. In Phase II, POC plans to optimize, demonstrate, and validate the therapeutic modality in animal models of PN. The FDA approval pathway will be outlined and considered at each developmental stage.

Physical Optics Corporation
Photonic Systems Division 1845 W. 205th Street
Torrance, CA 90501
Phone:
PI:
Topic#:
(310) 320-3088
Hans-Peter Brecht
DHP12-014      Awarded: 5/14/2013
Title:Pelvic Model with multi-Sensory Data Acquisition
Abstract:To address the DHP need for a biometric model to address dismounted complex blast injury of the pelvis, abdomen, and genitals, Physical Optics Corporation (POC) proposes to develop a new Pelvic Model with multi-Sensory Data Acquisition (ELVIS). This proposed model is based on the combined development of a numerical model for blast effect prediction for different impact forces and an anatomically correct pelvic model with a number of physical sensors, which will be used to provide comprehensive information about the blast effect and to validate the numerical model. The innovation in the simultaneous development of a numerical model and an anatomically correct physical model that can be used for separate tests or numerical model validating will provide the medical research community with a superb tool for the dismounted complex blast injury study. In Phase I, POC will demonstrate the feasibility of ELVIS by developing a simplified numerical model and validating it against the sensor measurements from a physical prototype. In Phase II, POC plans to further develop the epidemiology study and develop a comprehensive injury prediction model for various blast effects.

AreteX Engineering
1050 Luminary Circle, No. 106
Melbourne, FL 32901
Phone:
PI:
Topic#:
(678) 886-6400
Behnood Gholami
DHP12-015      Awarded: 2/7/2013
Title:Objective Method for Pain Detection/Diagnosis
Abstract:Multiple studies have identified physiological and behavioral variables that are associated with pain intensity in critical care patients. In this phase of the research, we propose to investigate the feasibility of developing a multi-modality pain intensity detection algorithm predicated on physiological and behavioral indicators of pain as well as designing a plan to "calibrate" and validate the pain score provided by the algorithm. Specifically, we will use the physiological data generated by patient monitoring devices currently in use in the critical care environment as well as introduce the use of a number of sensors in order to complement the information provided by existing sensors. We propose to use machine learning to fuse the multi-modal sensor data and provide an objective assessment of pain intensity. Our proposed approach is adaptive in nature, and hence, can address challenges of intrapatient and interpatient analgesic state variability. In addition, the proposed sensor fusion framework is robust to sensor failure and incomplete sensor measurements making it especially appealing for combat critical care and combat evacuation. The emphasis of the approach will be on a portable objective pain detection device which can be utilized for monitoring nonverbal patients in the combat environment as well as in evacuation scenarios.

BIOLOGICAL COPROCESSORS, INC.
258 Elm Street Suite 200
Somerville, MA 02144
Phone:
PI:
Topic#:
(202) 256-2363
Newton Howard
DHP12-015      Awarded: 3/27/2013
Title:Objective Method for Pain Detection/Diagnosis
Abstract:In 2011, acute and chronic pain affected 116 million people in the United States and costs the U.S. economy $635 billion every year (Institute of Medicine). According to the NIH, 40% patients seeking medical attention do so because of pain. Biological Coprocessors Inc. (BCP) has identified an objective signature of pain in the brain. BCP seeks Phase I funding to validate the objective electroencephalography (EEG) signature of pain and its intensity and develop a pain detection algorithm software. Our long-term goal (Phase 2, 3) is to develop and commercialize a user-friendly brain wave sensing device that utilizes our pain detection algorithm software to be used by DoD, physicians, pharmaceutical companies as well as consumers. The expected cost savings of using our device is to better diagnose and monitor pain levels, to decrease trauma recovery time, and improve pain management strategies. BCP’s team includes top experts in pain, neurosurgery, electrophysiology, computational neuroscience, military defense studies and medical product commercialization in the field of neuroscience.

Biomarker Profiles Corporation
26442 Beckman Court
Murrieta, CA 92562
Phone:
PI:
Topic#:
(562) 440-7374
Leticia Cano
DHP12-015      Awarded: 2/1/2013
Title:Identification of Biomarkers for Pain Detection/Diagnosis
Abstract:We propose to identify biomarkers associated with pain and design a biomarker assay that can be used by scientists to study pain in many different diseases/conditions. Two biomarker discovery strategies will be used to identify candidate biomarkers in diseases associated with chronic pain. Diseases include fibromyalgia, rheumatoid arthritis and osteoarthritis. From a literature search, we have identified over 180 candidate biomarkers associated with pain. To verify each molecule using antibodies would be costly. Hence, we propose mass spectrometry based approaches that can identify hundreds of proteins from small sample sets. The first biomarker discovery strategy is the proteomic analysis of protein complexes isolated from plasma. We have been successful at identifying different protein sets from different diseases using this approach and think this is a feasible approach for this study. The second strategy is the proteomic analysis of small proteins isolated from plasma. We expect to find small neuropeptides known to be associated with pain using this approach. The proteomic data will be mined to look for biomarkers and protein modification. A biomarker database will be used to select the best candidates for pain and a high-throughput assay will be designed for biomarker verification/validation.

BioSensics LLC
165 Pleasant St., Suit 302
Cambridge, MA 02139
Phone:
PI:
Topic#:
(888) 589-6213
Bor-rong Chen
DHP12-015      Awarded: 5/8/2013
Title:Objective Method for Pain Detection/Diagnosis
Abstract:Pain is subjective and inherently difficult to quantify, yet appropriate pain management is predicated on adequate assessment. Whenever possible, pain is measured by the patient’s self-report. Patients who cannot reliably self-report are at significantly higher risk for inadequately managed pain. Therefore, there is a need for objective pain monitoring for noncommunicative patients. BioSensics LLC, in partnership with the University of Arizona, will develop a Multimodal Objective Pain Assessment Sensor System (MoPASS) consisting of two light, comfortable, wireless, wearable sensors (on the fingers and forehead) to monitor multiple indicators of pain and provide a single pain intensity score. This pain score will be based on proven pain correlates including behavioral parameters (restlessness and facial expression) and physiological parameters (electrocortical activity, heart-rate, skin conductance, and skin temperature). This system has broad applications ranging from rapid assessment in field-clinics to long-term monitoring of chronically noncommunicative patients. In Phase I we will develop the sensor system and perform a clinical feasibility study. In Phase II we will perform a comprehensive clinical study to examine the sensitivity and specificity of MoPASS. The results of this study will be used to pare down our system to the fewest possible sensing modalities for commercialization in Phase III.

KeraNetics, LLC
Richard Dean Research Building, Suite 391 Technology Way
Winston-Salem, NC 27101
Phone:
PI:
Topic#:
(336) 725-0621
Luke Burnett
DHP12-016      Awarded: 2/27/2013
Title:KeraStat(TM) Burn Gel and Halofuginone to Prevent Scar Contracture after Burn Injuries
Abstract:This Phase I project is relevant to the ultimate goals of this program announcement given the prevalence of the IED which often creates complex burn wounds on the face and skin that often form hypertrophic scars that often contract over time. Burn wound healing is a complex process that includes phases of inflammation, granulation tissue formation, re- epithelialization, and, finally, remodeling. Our proposed solution intends to intervene during the wound healing and remodeling phase to prevent hypertrophic scars from forming, thereby preventing scar contracture. In this initial proof of concept study, a keratin burn product KeraStat Burn Gel and a keratin + halofuginone product (Halogel, halofuginone is a Type I collagen synthesis inhibitor) will be assessed for contraction prevention by a standard commercially available fibroblast contraction assay. Additionally inflammatory and matrix gene expression will be examined by RT-PCR array in fibroblasts and keratinocytes after keratin and halofuginone exposure. Together these data will form the basis for a Phase II large and small animal efficacy study in models of burn scar contracture.

Physical Optics Corporation
Photonic Systems Division 1845 W. 205th Street
Torrance, CA 90501
Phone:
PI:
Topic#:
(310) 320-3088
Anya Asanbaeva
DHP12-016      Awarded: 4/24/2013
Title:Control of Scar Contracture After Burn Injury Topical Formulation
Abstract:The overall incidence of burns in current military operations has nearly doubled during the past few years and this type of injury remains a common component of armed conflicts. To address the need for prevention of scar contracture following burns, Physical Optics Corporation (POC) proposes to develop a new Control of Scar Contracture After Burn injury (SCAB) topical formulation. The SCAB is designed for application to burn-injured tissue after debridement during the critical initial stages of wound healing. Inhibition of contracture by SCAB is done by (1) stimulating the cells, thereby enhancing healing, and (2) controlling the stability of the collagen network. This dual action of the SCAB formulation on the cellular component and on the extracellular matrix constitutes the main innovation of the proposed solution. As a result, the SCAB formulation offers a safe and efficacious biomodulator of scar contracture supplied in a pharmaceutical delivery medium. In Phase I, POC will develop the SCAB formulation and demonstrate its efficacy in vitro and in a pilot animal study, validating the therapeutic effect of and setting the foundation for the formulation of the final product. In Phase II, further therapeutic efficacy characterization of SCAB will be performed with detailed animal studies.

Quick Med Technologies, Inc.
902 NW 4th Street
Gainesville, FL 32601
Phone:
PI:
Topic#:
(352) 379-0611
Bernd Liesenfeld
DHP12-016      Awarded: 5/13/2013
Title:Development of Technologies that Control Scar Contracture after Burn Injuries
Abstract:Current therapies to prevent scar formation and contracture of burns are minimally effective. QuickMed Technologies (QMT) proposes to develop an advanced therapy to enhance healing and prevent contraction of burn scars by combining the advanced prototype BURN- PLUS™ dressing with Endoform™ dermal template. BURN-PLUS is an occlusive island dressing with an adhesive apron bonded onto a super absorbent, microbicidal, pad that provides sustained release of two pre-loaded, FDA-cleared drugs: doxycycline and Kepivance™. Doxycycline is a broad spectrum antibiotic that also reduces inflammation through inhibition of tumor necrosis factor alpha (TNFa) converting enzyme (TACE) and inhibits contraction of collagen lattices by myofibroblasts through its inhibition of matrix metalloproteinases (MMPs). Kepivance is keratinocyte growth factor (KGF), which accelerates healing of skin wounds by directly stimulating proliferation and migration of epithelial cells. Endoform is a novel acellular matrix that has intact extracellular matrix (ECM) components (collagen IV, laminin, fibronectin) and growth factors (FGF2, VEGF) that increases vascularization and decreases irregular scar matrix in pig skin wounds. In this Phase I project, QMT will optimize design components of BURN-PLUS dressing and test its effectiveness alone and combined with Endoform matrix on enhancing healing and reducing scar formation and contracture of burn wounds in pigs.

Synedgen, Inc
1420 N. Claremont Blvd Suite 105D
Claremont, CA 91711
Phone:
PI:
Topic#:
(909) 447-6858
Shenda Baker
DHP12-016      Awarded: 5/30/2013
Title:Effective New Topical Treatment to Reduce Scar Formation in Burns
Abstract:Thermal injury is common in military conflicts due to primarily to the widespread use of explosive devices. Burns can produce scars that are excessive, physically debilitating and functionally damaging. There is a critical need for an effective product that can control bacterial contamination and prevent colonization, mitigate inflammation, and diffuse to or reach necrotic and damaged tissue resulting from a blast or traumatic thermal wound to reduce the formation of fibrotic scars. Synedgen has developed a biocompatible polysaccharide derivative (PAAG) that has been demonstrated in vivo and in vitro to reduce inflammation and provide enhanced healing with the reduction of scarring. This Phase 1 study will demonstrate the extent to which PAAG mitigates scar reduction in full thickness burns in a porcine model, and provide an opportunity to examine innate immune responses, inflammatory cytokines and healing pathways.

Washburn Therapeutics, Inc.
6743 Wilkins Ave.
Pittsburgh, PA 15217
Phone:
PI:
Topic#:
(412) 908-1309
Newell R. Washburn
DHP12-016      Awarded: 3/5/2013
Title:Reduction of Burn Progression and Scar Contracture with Cytokine-Neutralizing Gels
Abstract:Washburn Therapeutics Inc. is developing biologically active gels that control inflammation by selectively neutralizing pro-inflammatory cytokines based on a technology being licensed exclusively by the company from Carnegie Mellon University. Preliminary results demonstrated that conjugates of antibodies against tumor necrosis factor-alpha and hyaluronic acid were able to reduce secondary necrosis in a partial-thickness rat burn model by 70%. This SBIR Phase I will focus on treating partial-thickness burns to test of the safety and efficacy of the technology in preventing extensive tissue necrosis following burn and measuring subsequent scar contraction in the rat burn model. The hypothesis of this research program is that prevention of burn progression through local control of inflammatory responses will improve healing outcomes. Early therapeutic intervention could make a significant impact in burn treatment.