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Welcome to the MTEC Educational Webinar Series MTEC MEMBER PITCH SESSION June 25, 2020 For questions related to this session, please contact: Lauren Palestrini, PhD, MTEC Director Research, [email protected]

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Page 1: Welcome to the MTEC Educational Webinar Series · Virtual ‘Hardware Innovation 101’ Workshops Product Launch & Brand Strategy. Belay. AdhereTech. Dadi. ... Augmented/Mixed reality

Welcome to the MTEC Educational Webinar Series

MTEC MEMBER PITCH SESSIONJune 25, 2020

For questions related to this session, please contact:

Lauren Palestrini, PhD, MTEC Director Research, [email protected]

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1. Remote Health2. NuShores Biosciences3. Tomorrow Lab 4. Computer Technology Associates5. Sana Health6. Allvivo Vascular7. Design Interactive 8. Lumen Bioscience9. OLGS10. Bionica Labs 11. EchoNous12. NeuEsse13. Level Ex 14. IDRI

29. Vivonics30. MAE Group31. Trauma Insight32. Military & Health Research Foundation33. Iowa Technology Institute34. PPD35. Intelligent Automation 36. Thornton Tomasetti37. Sandstone Diagnostics38. Blue Cirrus Consulting39. Auxocell Laboratories40. Cherish Health41. ServiceNow42. Flosonics Medical

15. Bioflight16. Acuity Systems17. KaloCyte18. InnSightful19. Ashvattha Therapeutics20. SimX21. RTI International22. Nanowear23. Articulate Labs24. QUASAR25. IQVIA Government Solutions26. Promaxo27. Arizona State University28. Haima Therapeutics

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Remote Health LLC716 Grant Street Springfield Ohio 45504www.remotehealth19.com

Business Class: SmallStatus: Non-TraditionalMember since: <May 2020>

Prototype Description Desired Capabilities Sought from Other MTEC Members

• Description: Vitals 360 6-in-1 Mobile Diagnostic Device• Targeted Clinical Indication: Chronic- CHF, Diabetes, COPD,

Behavioral Health, Post-Surgical Eval, Pediatric Oncology, Field Exam• – Large/Small Animal Veterinarian Medicine Field Exam Use Cases• Current TRL: FDA 510K Filed-Product/Samples Available• Accomplishments to Date: Selected March 2020- Patient/Consumer

Facing Device Vendor to a national telehealth company serving FQHC’s -30+ million patient ecosystem

• December 2019 FCC Approval 17 Frequencies across multiple wireless carriers

• 2019 IFHA (Las Vegas) Top 50 Healthcare Product

Seeking additional Field Peripheral Devices/Software Development ideas for Clinical and Animal use casesBlockchain/Data Credentialing Gateway -Capacity Management/Physician Gap Coverage Services

Member Capabilities to Offer Others

Points-of-Contact Mobile Device Managers for Global Theater Scale Aggregated Clinical Services -- Direct to Consumer or Direct to Patient Remote Biometric Monitoring, EKG( 3 to 12 Lead), BP, Temp, Bo, BG, W, L, EEG, GPS Temp Mapping, Quarantine Monitoring, 1 to 100,000+ units per month, lease and financing programs available. Contact

Brian Easley, Managing Member, PH: 833-736-4334 Cell: [email protected] T. Easley MD, Medical Director, PH [email protected]

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NuShores Biosciences LLCLittle Rock, Arkansaswww.nushores.com

Business Class: SmallStatus: Non-TraditionalMember since: February 2019

Prototype Description Desired Capabilities Sought from Other MTEC Members• Description: NuCress™ bone void filler in the form of a solid,

osteoconductive, osteoinductive, highly porous scaffold in various shapes and sizes for extremities, spine and dental / CMF indications. Record-breaking 8.5 cm defects healed in goat tibia. NuCress™ scaffold demonstrated ability to generate proven neovascularization in as early as 3 weeks.

• Targeted Clinical Indication: NuCress™ bone void filler indicated for bony voids or gaps that are not intrinsic to stability of the bony structure. NuCress™ bone void filler is indicated for use in treatment of bony defects created surgically or through traumatic injury. Following placement into the bony void, NuCress™ bone void filler resorbs and is replaced with bone during the healing process.

• Current TRL: 6, for 510(K), info and data support production of final prototype and final testing in a military operational environment.

• Accomplishments to Date: Nearly 400 animals across 7 species tested with NuCress™ scaffold with no inflammation, infection or rejection due to scaffold.

• Imaging solutions: Both tools and expertise on in vivo, real time imaging for bone;

• Histology services;• Real-time live cell health monitoring tools (e.g. Incucyte Zoom);• Introductions to military orthopedic surgeon/ scientists interested

in working with / advising NuShores.

Member Capabilities to Offer Others• Extensive expertise in materials engineering for various biomedical

applications;• Entrepreneurial insights, SBIR, for medical device innovations,

manufacturing, quality systems lessons learned to date.

Points-of-Contact• Sharon C. Ballard, CEO, [email protected], 866.682.7377• Alex S. Biris, PhD, CTO, [email protected]

NuCress™ bone void filler scaffold

Record-breaking 8.5cm defect in goat tibia healed.

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TOMORROW LABNew York, NYhttps://tomorrow-lab.com

Business Class: SmallStatus: Non-Traditional

Member since: April 2020

Company Summary Desired Capabilities Sought from Other MTEC Members

● Description: Tomorrow Lab designs, develops, and scales first-of-their-kind hardware products including connected devices, distributed sensor networks & internet of things systems.

● Specialization: TL is industry agnostic but strong believers in our Holistic Innovation process, where we fuse technical development with human-centered design.

● TRL Levels: We can take products from TRL 1 to TRL 8.● Accomplishments to Date: We have designed & developed

more than 100 products, including:○ Belay helps families manage childhood food allergies○ AdhereTech is one of the first commercially-viable smart pill bottles

for drug compliance○ Dadi is an at-home kit for collecting and protecting sperm samples

with deployable preservative and thermally-regulated shipping box.

● Deep domain expertise in specific medical technologies (e.g. DNA sequencing, bioelectronics, chemical field-effect transistors).

● Owners of nascent technologies waiting to be productized.● Long-time experience in government contracting.● Existing business relationships with medical device

manufacturers and research groups.

Point-of-Contact Member Capabilities to Offer Others● [email protected]

Casey Rieder - Director of Business Development & Strategy● ~6 week Invention Sprints (TRL 1 to TRL 4)● ~6 month Product Development Scopes (TRL 4 to TRL 8)● Virtual ‘Hardware Innovation 101’ Workshops● Product Launch & Brand Strategy

Belay AdhereTech Dadi

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Computer Technology Associates (CTA)Ridgecrest, CACTA Healthcare URLhttps://vivacehealthsolutionsinc.com

Business Class: SmallStatus: Non-TraditionalMember since: Jan 2020

Prototype Description Desired Capabilities Sought from Other MTEC Members• Description: VFusion: Agile Early Warning (AEW) AI platform for

emergent disease progression using structured/unstructured EHR data and medical device waveforms. Key AI components include a multidisciplinary clinician-guided expert system combined with machine learning derived models for NLP, phenotype discovery and prediction.

• Targeted Clinical Indication: Disease agnostic, currently targeting life-threatening acute conditions: sepsis, AKI, ARDS, COVID-19

• Current TRL: 6. Tested/validated using > 500K hospital encounters• Accomplishments to Date: Using big data repositories from MedStar

Health, Children’s National, Beth Israel and community hospital, consistently demonstrate ES/NLP disease detection, meaningful disease subtypes and pre-onset probabilistic predictions with AUC > .9 for pre-COVID adult/pediatric sepsis and ARDS.

Enhanced VFusion Data Sources:• Remote Monitoring Devices• Bedside Labs/Sequencing Devices• De-identified EHR Data Registries• Third Party Applications/EHR Data Interface ToolsPotential VFusion Applications• Telemedicine/Telehealth Providers• Emergency Medical Services (EMS) Providers• Point of Care (POC) Clinical Decision Support Tools (CDS) • Artificial Intelligence (AI)/Healthcare Data Analytics (DA)• Evidence-based Medicine Dissemination Services/Collaborative

Knowledge Management (KM)• Clinical Workflow Robotic Process Automation (RPA)

Member Capabilities to Offer OthersPoints-of-Contact • Agile Cloud-based Disease Agnostic Clinical Decision Support

• Graph-based Semantic Enrichment of ML Training Data• Deep Learning and Vector-based NLP • Latent Class/Profile Clustering and Classification analysis• Free Text and Structured Clinical Time Series Machine Learning

• Tom Velez PhD, CEO, [email protected] 949-500-5883• Ron Garnett, PM, [email protected] 301-346-2045

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Sana Health Inc, Boulder Cowww.sana.io

Status: Non-Traditional (Afwerx Phase 1 only)Member since: June 2018

Prototype Description Desired Capabilities Sought from Other MTEC Members• Description: Wearable device for Sleep-on-Demand. Audio-visual

neuromodulation that produces sleep in an average of 10minutes, regardless of the stress level.

• Targeted Clinical Indication: We help with; 1) rapid acclimatization from travel. 2) fatigue mitigation in “reverse cycle” for SOF in training and deployment. 3) maintaining operating tempo 4) metal resilience in stressful environments

• Current TRL: TRL 8 (for commercial version, designing military spec version as well, so seeking input on requirements)

• Accomplishments to Date: 1) MedTech Innovator Grand Prize Winner 20182) 2020 trials with Mt. Sinai, Duke University and UPenn3) 2020 Winner, CES Proctor & Gamble Innovation Award4) 6 patents filed, 1 granted5) Afwerx SBIR Phase I awarded, Phase II MOA agreed with

AFSOC, supporting letter JSOCx

• Seeking collaboration with medical military institutions for clinical trials in:

• Anxiety• Depression• PTSD• Sleep and Fatigue Mitigation• mTBI and TBI

• Seeking Investors to close round

Member Capabilities to Offer OthersPoints-of-Contact • Ability to provide treatment in all of the above areas,

• in a drug free, non-significant risk device, • that can be used anywhere by anyone.Contact

• Richard Hanbury CEO – [email protected] +1 4156300467

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Lake Forest, CAwww.allvivo.com

Small BusinessNon-TraditionalMember since: March 2020

Antimicrobial Wound Treatments Capabilities Sought

• Key benefits:• Kills bacteria rapidly• Removes biofilm• Biocompatible• Provides moist healing environment

• Targeted Clinical Indications: Traumatic, chronic, burn and surgical wounds

• Current TRL: 4• Accomplishments to Date:

• Prototypes complete• Efficacy in large animal infected wound model• Compatible with end stage sterilization, ambient storage• Improved biocompatibility relative to silver• Issued and pending patents• NIH funding, CRADAs

• Animal model of hemorrhage• cGMP contract manufacturing• Subject matter experts

• Combat casualty care• Wound and burn care• Surgical and post traumatic infections

• Clinical trials

Capabilities Offered

Points-of-Contact • Antimicrobial technologies• Formulation and drug delivery• Antimicrobial coating• Medical device coating• Antimicrobial testing

• Jennifer Neff, PhD, CEO• [email protected]• (949) 939-2719

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Design Interactive, Inc.Orlando, FLwww.designinteractive.net

Business Class: Woman-owned Small Business Status: Non-traditionalMember since: Feb, 2018

Capabilities Description Desired Capabilities Sought from Other MTEC MembersDescription: We empower people with innovative technology with a full compliment of researchers, engineers, data modelers, designers and developers

• eXtended Reality: Augmented/Mixed reality medical training solutions

• Performance Augmentation: Automated performance assessment and effective performance feedback; great User Experience Design

• Biosignature Analytics: Algorithms that convert physiological data into objective measures of human state (vitals, cognitive, emotive states)

Accomplishments to Date: Five active MTEC awards ranging from empirical studies to training system development, and clinical trials (PTSD therapy tool)

• Physiological sensing / wearables hardware needing algorithms• Medical technologies that need associated training systems• Organizations seeking to reduce clinician burnout

Member Capabilities to Offer Others

Points-of-Contact • Human performance needs analysis• Training system development• Desktop, mobile, virtual/augmented reality design & development• Empirical research

• Luke DeVore, SVP – (910) 685-6088 – [email protected]

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Seattle, WAwww.lumen.bio

Business Class: SmallStatus: Non-TraditionalMember since: May 2020

Prototype Description Desired Capabilities Sought from Other MTEC Members• Description: Lumen makes ultra-low-cost biologics for site-specific

delivery to mucosal and topical tissues (i.e. GI tract, airways, skin). Usually the active biologics are antibodies, but other classes of biologic are also enabled — e.g. endolysins, enzymes, de novosynthetic proteins, and recombinant vaccines. Products are nearly always developed as cocktails comprised of 4-20 therapeutic proteins, which frequently generate surprisingly synergistic activity.

• Targeted Clinical Indications: Lumen has 4 publicly disclosed programs: (1) Covid-19 (MTEC-funded), (2) C. difficile infection, (3) traveler’s diarrhea (ETEC/campylobacter), (4) norovirus infection.

• Current TRL: Platform: TRL9 Lead program: TRL7• Accomplishments to Date: Human clinical trials (NCT04182490,

NCT04098263); cGMP production facility (~3kg drug material/week)

• Domain expertise in therapeutic areas of interest to DoD customers• Additional FDA regulatory bandwidth and financial backing to drive

programs through clinical development• Accounting and compliance infrastructure for engaging in large

programs of record with DoD agencies

Member Capabilities to Offer Others• Vertically integrated, on-site drug development infrastructure, from

discovery through cGMP manufacturing and FDA regulatory and clinical affairs

• Dedicated cGMP production facility (~3 kg/week)• Dedicated clinical operations and FDA regulatory affairs team• Purpose-built high-throughput strain engineering facility• Advanced protein engineering and optimization team• Large-scale AI/ML-enabled yield optimization facility

Points of Contact• Brian Finrow CEO & founder, [email protected]• Jim Roberts CSO & founder, [email protected]• Craig Behnke SVP, [email protected]

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OLGS, Inc. (One Less Gold Star)Pittsburgh, PAwww.olgs.biz

Business Class: Small Business (SDVOSB)Status: Non-TraditionalMember since: March 2020

Prototype Description Desired Capabilities Sought from Other MTEC Members

• Description: Developing an automated tourniquet system. A robotic device that works at the push of a button. An intuitive device that regulates pressure and can be equipped to provide additional vital sign data as well. Also can be a secure IOT device if desired. A similar concept to the AED, requires little or no user training.

• Targeted Clinical Indication: Trauma, Prolonged Field Care• Current TRL: TRL 5, proof of concept in simulated environment• Accomplishments to Date:

• Full qualification of all vendors required for manufacturing• Currently participating in AFWERX STTR program.• Partnered with University of Pittsburgh• Winners of SOFWERX Hackathon DEC 2017

• Currently have an initial investor, need co-investor.• Seeking co-investor to participate in convertible note.• Ideally co-investor will be able to participate in seed funding as well

and have experience in the medical device space.

Member Capabilities to Offer Others

Points-of-Contact • Advanced Manufacturing• SOF field medical experience• Robotics design and prototyping• Service Disabled Veteran Owned BusinessContact

• R. Wayne DuddingCEO, OLGS, [email protected]

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Bionica Labs LLCRichmond, Virginiawww.NIRSense.com

Business Class: SmallStatus: Non-TraditionalMember since: November 2018

Prototype Description Desired Capabilities Sought from Other MTEC Members

• Description: NIRSense, a wearable brain oxygen monitor (also works on skeletal muscles). Like in-clinic near infrared spectroscopy but patch form, wireless, and ruggedized.

• Targeted Clinical Indication: Trend monitoring of regional blood oxygenation in brain or other tissue. Intended to monitor reduced-flow or no-flow states.

• Current TRL: 5• Accomplishments to Date: Robust monitoring in high vibration

environments and reduced oxygen environments. Test to date show similar performance to FDA cleared devices.

• Clinical interest, additional indications (sleep, hemorrhage, etc.)• Integrators looking for new physiological monitoring capabilities• Regulatory expertise• CRO Capability

Member Capabilities to Offer Others

Points-of-Contact

• CEO Casey Boutwell, PhD/MBA [email protected] 757-749-5052• CTO Jason Strohmaier, MSEE [email protected] 919-268-5481• COO Callie Kimberly, MS [email protected] 719-362-7357

NIRSense Medtronic INVOS

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EchoNous, Inc.Redmond, WAhttps://kosmosplatform.com/

Business Class: SmallStatus: Traditional Member since: March 2020

Prototype Description Desired Capabilities Sought from Other MTEC Members

• Description: The KOSMOS system is a proprietary tablet-based ultrasound system that uses AI to significantly remove the barrier of initial training and subsequent sustainment training needed to become competent. The system will guide the operator to the appropriate image window, then grade the image for quality, as well as annotate the anatomy that is depicted in the image.

• Targeted Clinical Indication: Any deployable footprint or fixed facility that has a need to use ultrasound for trauma, point of care, or garrison care

• Current TRL: FDA approved and shippable • Accomplishments to Date: KOSMOS Received FDA approval on

March 26, 2020 and began shipping March 28th. To date placed over 200 systems with a significant opportunity pipeline in place

• We are open to investment opportunities to further our capabilities and to partnering with clinicians or organizations for pilot studies utilizing KOSMOS

Member Capabilities to Offer Others

Points-of-Contact • AI and deep learning expertise

• Name: Ron Dickson• Title: SVP, Military, Government, and Strategic Accounts• Email: [email protected]

Ph b 916 208 2055

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NeuEsse Inc.3805 Old Easton Road Doylestown, PA 18902www.neuesse.com

Business Class: Small Business Status: Traditional Member since: March 2019

Prototype Description Desired Capabilities Sought from Other MTEC Members

• Description: NeuEsse’s OmegaSkin is a human skin substitute occlusive dressing requiring no special handling for immediate treatment at any point of injury for wounds and burns to deployed Warfighters, non-active duty and veteran personnel.

• Targeted Clinical Indication: Wounds and Burns inflicted on Warfighters and Veterans alike

• Current TRL: 5• Accomplishments to Date:

• Published results prove full thickness wounds healed with intact hair follicles, sweat glands and minimal scarring.

• Head-to-head comparison to Oasis proved superior healing• Development of human clinical trial protocol at University of

Pittsburgh

• Regulatory guidance for FDA 510(k) device approval • Sterilization, stability testing• Packaging for hospital and austere environments• Manufacturing Scale-up using Commercial Electrospinning • Grant writing

Member Capabilities to Offer Others

Points-of-Contact • Wound and Burn dressing platform for other therapeutics delivery (i.e. stem cells, anti-hemorrhaging agents, etc.)

• Product Development, Launch• Handheld application device to complement sheets

Joseph P. Connell – CEO, [email protected], +1.910.233.0806

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Level ExChicago, ILhttps://www.levelex.com/

Business Class: SmallStatus: Traditional Member Since: April 2020

Prototype Description Desired Capabilities Sought from Other MTEC Members• Description: Mobile medical video games designed for

practicing clinicians to demonstrate their knowledge and skill and experientially learn about rare and challenging cases submitted by expert clinicians. We use the deep psychology behind games along with high fidelity, ultra-realistic, 3D, interactive virtual patients to create an engaging experience, all optimized for the mobile device in the clinician’s pocket. Our over 150 physician subject matter experts work closely with our in-house medical researchers, engineers, game designers, and art team to create our unique cases.

• Targeted Clinical Indication: Procedural and clinical decision-making games for clinical specialties across Cardiology, Pulmonology, Gastroenterology, Anesthesiology, and more.

• Current TRL: TRL Level 1• Accomplishments to Date: 4 mobile clinical applications live on

the App Store and Play Store with a user base of more than 600k Heath Care Providers and over 7 million cases played!

• Teaming opportunities for Government and Commercial contracts.

Member Capabilities to Offer Others• High-fidelity, ultra-realistic 3D virtual patient simulation that reach

provides across any specialty, anywhere• Facilitates rapid content generation and release in an existing platform• Utilizes a CME-accredited platform used by multiple leading medical

societies to disseminate best-practices and guidelines• Tracks all content engagement through robust analytics• Allows users to practice screening, diagnosis, and treatment on a range

of virtual patients

Points-of-Contact• Clifton Garner, Senior Project Manager

[email protected]

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IDRISeattle, WAhttps://www.idri.org/

Business Class: Non-ProfitStatus: Non-TraditionalMember since: March 2020

Prototype Description Desired Capabilities Sought from Other MTEC Members• Description:

• IDRI has among the world’s largest portfolio of immune-stimulating molecules (known as “adjuvants”) to enable more effective / prophylactic applications

• IDRI also has pioneered a novel RNA vaccine platform that can rapidly be deployed against a wide range of infectious targets and cancers, and has a potency nearly 1000-fold greater than current mRNA vaccines

• Targeted Clinical Indication: Infectious diseases, cancer• Current TRL: TRLs 7 through 2. Please see below.• Accomplishments to Date:

• TRL 7 / Phase II: Adjuvants GLA-SE (2,596 CPs) and SE (749 CPs)• TRL 6 / Phase I: Adjuvants GLA-AF (351 CPs), SLA-SE (93 CPs),

GLA-LSQ (52 CPs), CpG Alum (32 CPs), and 3M-052-AF/Alum (10 CPs).

• TRL 5 / GMP scaling: Adjuvants SLA-LSQ and 3M-052-SE and the self-amplifying / self-adjuvanting RNA platform

• TRL 2-4 / Preclinical: Adjuvants GLA-3M-052-LS and NanoAlum

• IDRI is interested in collaborating with vaccine and therapeutic developers that have products they wish to develop from preclinical through to GMP production and clinical trials.

• Access to a portfolio of adjuvants• Formulation development• Compatibility studies of IDRI adjuvants and 3rd party vaccine

antigen candidates• CMO services: GMP formulation and aseptic filling of drug product

candidates for pre-clinical and Phase I & II clinical studies• Clinical and regulatory assistance.

• CEO: Dr. Corey Casper, [email protected], 206.858.6054• Formulations: Dr. Christopher Fox, [email protected],

206.858.6027 • GMP: Erik Laursen, [email protected], 206.858.6068• Admin: Tre Argerious, [email protected], 206.858.6046

Member Capabilities to Offer Others

Points-of-Contact

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BIOFLIGHTAKRON, OHwww.bioflightvr.com

Business Class: smallStatus: Traditional Member since: April 2020

Prototype Description Desired Capabilities Sought from Other MTEC Members

• Description: XR enabled : Remote / distance learning hub• Targeted Clinical Indication: Medical simulation and training• Current TRL: Prototype of Platform - Commercially Deployed Pilots• Accomplishments to Date: XR solutions provider to:

○ Medicaid Ohio○ CAL State School of Nursing○ Case Western Reserve University SOM○ Duke University - SOO○ Children’s Hospital Los Angeles

• Scalable solutions architecture• Security and compliance• SME’s (Medical and non-medical)

Member Capabilities to Offer Others

Points-of-Contact • XR training and solutions, content and platform providers• Performance capture and analytics• Asset library and code base• XR consulting servicesContact

• Rik Shorten Co-Founder, • [email protected]• C:310-270-3806

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Herndon, VAhttps://acuitys.com/

• Member since: January, 2005

• Prototype Description • Desired Capabilities Sought from Other MTEC Members

• Description: Using Acuity’s advanced data science and analytics platforms and award winning application development, we seek to enhance early symptomatic detection of COVID-19 infection by advancing platforms and applications for wearable diagnostic solutions. Technologies utilized: Data Science, Ontology, Adaptive Learning, Information Management Systems, Machine Learning, Artificial Intelligence

• Targeted Clinical Indication: Prevention, Detection, Educational Gaming, Assessment systems,

• Current TRL: 7• Accomplishments to Date:

o Data2Decisions (D2D) is an enterprise data science and analytics solution that integrates and manages structured and unstructured data from hundreds of siloed data sources and provides analytics to support decision making

o AcuityNow framework creating enterprise class platforms that enable rapid deployment of applications and data science solutions.

• Acuity is interested in partnering with experts with access to/experience with Covid-19 testing strategies, health care and follow-up effects on individual health risks (risks of contracting, disease progressing and spreading the disease)

• This would include working on the after effects and health risks behaviors of those diagnosed with symptomatic and asymptomatic Covid-19 (experience with health management, health information, care and further health risks along all the steps of treatment cascade)

• Member Capabilities to Offer Others

• Points-of-Contact • Acuity has modern, secure and scalable capabilities integrated into a single complete solution that delivers comprehensive data management, advanced analytics, business process optimization, scalable storage, retention, data governance, privacy and security solutions, Artificial Intelligence/Machine Learning, Cloud, and Predictive Analytics

• Acuity is also interested in partnering with those organizations who are interested in rapid or near real time assessing and managing Covid-19 prevention information, testing, care (availability, accessibility, acceptability), analyzing and visualizing the effectiveness of prevention strategies on multiple levels – regional, institutional, populations.

• John Cofranceso, VP of Business Development, 407-342-5187, [email protected]

• Adrienne Gatanas, Capture Manager, 571-291-5656, [email protected]

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KaloCyte, Inc.Baltimore, MDwww.kalocyte.com

Business Class: SmallStatus: Non-Traditional Member since: July 2018

Prototype Description Desired Capabilities Sought from Other MTEC Members

• Description: Developing ErythroMer, bio-synthetic RBC substitute (nano-encapsulated human hemoglobin, freeze-dried for long-term storage at ambient conditions, universal option for all blood types)

• Targeted Clinical Indication: Oxygen carrier for treatment of severe hemorrhage when stored blood not available; combat casualty care

• Current TRL: 4• Accomplishments to Date:

• Pre-clinical POC and efficacy in hemodilution and shock models (non-inferiority to whole blood, superiority to colloid)

• Demonstrated human blood biocompatibility (min. complement activation, no interference with hemostasis, no NO consumption)

• Fabrication, characterization and lyophilization at lab scale • Awarded $5.4M NIH, DoD grants; raised >$1.4M investor funding

• CDMO: peptide-mimetic & lipid precursor synthesis, nanofabrication, lyophilization, sterilization, sterile packaging

• CRO: expertise in trauma trials, veterinary use, IND enabling tox, ex-vivo organ perfusion, cardiopulmonary bypass, blood products

• Animal models: canine trauma, hemorrhagic shock, military labs• Lab Assay: Evaluation of nanoparticle impact on blood panels, CBC• Investors: Seeking angel, family office, venture capital, and

corporate investors for upcoming Series A raise

Member Capabilities to Offer Others

Points-of-Contact • KaloCyte can provide small amounts of its oxygen carrier product for assessment:• Compatibility with blood components, devices, lab tests, etc.• Potential use as an oxygen carrier in the following settings:

veterinary (canine) hemorrhage, cardiopulmonary bypass, ex-vivo organ perfusion, COVID-19 ARDS, ARS, etc.

• Elaine Haynes, President & CEO: [email protected](410) 706-7095 or (314) 267-7344

• Darci Bartlett, Office and Program Manager: [email protected](410) 706-7066

Lyophilized forLong-term storageRBC

(7 microns)ErythroMer

(0.12 - 0.15 microns)

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Innsightful Inc.Sunnyvale, CAwww.innsightful.com

Business Class: SmallStatus: Non-TraditionalMember since: April, 2020

Prototype Description Desired Capabilities Sought from Other MTEC MembersDescription • Develop a technology platform that can diagnose, monitor and treat

behavior health issues, as well as monitor targeted physical illnesses.• Collect physiological signals using a wearable.• Verify data & collect additional information using a Dialog

System to product diagnosis.• Provide just-in-time and long-term therapy using Dialog System

and multimodal content.Targeted Clinical Indication • Behavioral health (focused on anxiety), Covid-19Current TRL: 4 Accomplishments to Date • Inexpensive wearable device to collect physiological data (Heart rate

variability, Sp02, etc.)• ML algorithm to detect instantaneous and overall physiological stress• Just-in-time therapeutic platform with content around Mindfulness,

mediation, ACT

• Test populations for Behavioral health• Test populations for Covid-19• RCT study for target populations• Wearable hardware capabilities

• Off-the-shelf best-of-breed clinical-grade wearable biosensor

• AI based symptom understanding and therapy recommendation engine

• Health care-based dialog agent• >11K Instagram Followers• Platform to determine biophysiological state (e.g. cough:

presence, intensity, quality) from biosignals and dialog capabilities

Member Capabilities to Offer Others

Points-of-Contact:

• Farzad Ehsani, [email protected], 650-279-8899

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ASHVATTHA THERAPEUTICSRedwood City, Californiahttp://avttx.com/

Business Class: SmallStatus: Non-TraditionalMember since: April 2020

Prototype Description Desired Capabilities Sought from Other MTEC Members

• Description: OcuPair is an ophthalmic sealant intended for temporary corneal repair/stabilization

• Targeted Clinical Indication: Corneal stabilization strategy for battlefield ocular wounds

• Current TRL: TRL 5• Accomplishments to Date: IDE-enabling studies are underway, along

with scale up manufacture and clinical trial design

• cGMP contract manufacturing organizations (CMOs) with the following capabilities:

• Small molecule synthesis, bioconjugation, characterization• Aseptic fill/finish for syringes

• Organizations with animal models of brain, ocular injuries, and wound healing, who would benefit from superior drug delivery

Member Capabilities to Offer OthersPoints-of-Contact • Targeted therapy approaches for ocular, brain, and lung disorders,

as well as wound healing• Proprietary hydroxyl dendrimer platform targets reactive

macrophages in >30 models in six species• Dendrimer-drug conjugates provide sustained treatment to target

cells, but are readily cleared through the kidney, showing remarkable efficacies in brain and ocular injury models

• Safe in humans when administered intravenously or subcutaneously

• Technology protected by >30 awarded and pending patents

• Jeffrey Cleland, Ph.D.• [email protected]• +1 (650) 505-5048 Rapid Wound Sealing Technology

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SimX - AR and VR Medical SimulationSan Francisco, CASimXAR.com

Business Class: SmallStatus: Non-traditionalMember since: December 2019

Prototype Description Desired Capabilities Sought from Other MTEC Members• Description: Developed by Emergency Medicine physicians at

Stanford and UCSF, SimX’s virtual reality medical simulation allows you to practice your skills on any patient, using any tools, in any environment. Wireless multiplayer capabilities mean you can work in teams in a “holodeck” like environment and interact with virtual patients the same way you would patients in real life.

• Targeted Clinical Indication: Training Physicians, nurses, medics, and general enlisted soldiers

• Current TRL: TRL 9• Accomplishments to Date: In use at 3 USAF bases, expanding to 10

more. Customers include Stanford, Mayo Clinic, Northwestern, University of Pennsylvania, and many others. Patented technology. Approaching $2M in revenue and >$1M in SBIR funding.

• 3D modeling• Unity Development• Military Business Development• Military contracting

Member Capabilities to Offer Others

Points-of-Contact • Can easily develop custom VR scenarios to run on our platform• Scenarios can extend beyond medical training into device repair,

interpersonal communication, patient education, and othersact• Ryan Ribeira MD, MPH - CEO - [email protected]• Karthik.Sarma MS - CTO - [email protected]

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RTI INTERNATIONALResearch Triangle Park, NChttps://www.rti.org/

Business Class: Non-ProfitStatus: Non-TraditionalMember since: November 2019

Prototype Description Desired Capabilities Sought from Other MTEC Members

• Description: Various Psychological Health (PH) Interventions• Targeted Clinical Indication: Prevention and treatment of PH

disorders to include suicide prevention, substance abuse and PTSD• Current TRL: Varying between TRL 3-6• Accomplishments to Date: Demonstrated effectiveness of Stellate

Ganglion Block for PTSD in Active Duty Service members• Description: Wearables, data management and analyses for various

health related issues to include respiratory diseases and TBI • Targeted Clinical Indication: Assessment and monitoring • Current TRL: TRL 4-6• Accomplishments to Date: Current DARPA project has shown flu

detection in asymptomatic and presymptomatic individuals

• Clinical Expertise in various disciplines to include, but not limited to respiratory health, psychological health, with a history of strong performance in the DoD

Member Capabilities to Offer Others

Points-of-Contact • Wide range of research capabilities to include epidemiology, health care delivery and assessment, data generation and analysis, economics, consulting and support, and community-based research• Dennis McGurk, [email protected], 919-541-7210/301-395-8886

• Rick Satcher, [email protected], 919-541-7418

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NanowearNew York, NYhttps://www.nanowearinc.com

Business Class: SmallStatus: Non-traditionalMember since: May 2020

Prototype Description Desired Capabilities Sought from Other MTEC Members• Description: Nanowear is a connected-care and remote diagnostic

platform built upon proprietary, FDA-cleared cloth-based nanotechnology. Nanowear’s product SimpleSENSE is * Non-invasive, gender-neutral, size adjustable garment w/ nanotechnology embedded * Captures and digitally transmits 15+ medical-grade electrical, hemodynamic, acoustic metabolic and activity biomarkers from basic skin contact* Cloud-based machine learning algorithms and digital alerts

• Targeted Clinical Indication: Non-invasive remote diagnostics of cardiovascular, pulmonary, and circulatory conditions

• Current TRL: > 6, < 7; • Accomplishments to Date:

* FDA 510(k) clearance* Decentralized Supply Chain Network of US-based ISO13485 manufacturers* Machine learning infrastructure built in partnership with Google

• Nanowear is hoping to build a partnership network of B2B channels for collaborative joint development and / or distribution of Nanowear’s technology and data services, for example, connected-care and remote diagnostic needs for:

1) Warfighter alert and readiness2) Warfighter injury and recovery3) Warfighter reaction to chemical or biological weapons or other varying physical stimuli such as elevation, humidity, etc.4) Other applications

Member Capabilities to Offer Others

Points-of-Contact • Nanowear offers clinical-grade cloth-based biomarkers1) Lung volume and lung capacity2) Multi-channel ECG, HR, HRV, Respiration rate3) Systolic and diastolic Blood Pressure4) Blood flow hemodynamics (eg., cardiac output), temperature

• Venk [email protected]+1 (718) 637-4815

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Articulate LabsDallas, TXwww.articulatelabs.com

Business Class: SmallStatus: Non-TraditionalMember since: March 2020

Prototype Description Desired Capabilities Sought from Other MTEC Members

• Description: Wearable medical devices that accelerate muscle strengthening and re-education through use of movement-synchronous neuromuscular electrical stimulation

• Targeted Clinical Indication: First application: speeding quadriceps muscle strengthening and re-education during everyday activity for those rehabilitating knees from injury or surgery

• Current TRL: 5; working prototypes tested in controlled conditions• Accomplishments to Date:

• Data showing 99% accuracy on stim timing and location• Developed light, form-fitting, highly-adjustable orthosis• Four US utility patents granted; one EPO recently allowed

• Seeking opportunities to test devices and generate efficacy and/or health economics data

• Soliciting more future use cases related to unresolved issues in physical medicine and rehabilitation

• Requesting introductions to ortho surgeons and physical therapists• Requesting introductions to potential investors and/or

opportunities for non-dilutive funding• Looking for assistance in early-stage medical device company

operations, sales, marketing, and trial planning

Member Capabilities to Offer Others

Points-of-Contact • Intellectual property planning and analysis• Digital signal processing• Real-time operating system development• Control system design

• Josh Rabinowitz, Co-Founder & CEO• [email protected]• O: (512) 366-3063• C: (248) 408-1503

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QUASAR, Inc. Sensing a World of Potential®

San Diego, CAwww.quasarusa.com

Business Class: SmallStatus: Non-TraditionalMember since: November 2017

Prototype Description Desired Capabilities Sought from Other MTEC Members• Description: Unobtrusive wearable biosignal sensor suite that provides

high signal quality in extreme/ambulatory military environments• Targeted Clinical Indication: Cognitive & physiological state

monitoring, for health, training, and augmented adaptive applications• Current TRL: Most QUASAR equipment is at TRL 6 or 7• Accomplishments to Date: Suite of sensors including dry electrode

EEG, through-fabric and underwater ECG, EMG, EOG, GSR, Skin Temp., Respiration, fNIR, hydration, 9D motion, integrated into various systems & validated in relevant military environments

• Medical or Training expertise in military environments• System integration into military systems• Prime contracting with DoD for acquisition• Complementary research interests and data analytics capabilities• Cognitive or physiological testing facilities for sensor validations in

military relevant environments including battlefield or flight simulations, healthcare, stress monitoring, underwater monitoring & related military medical research

Member Capabilities to Offer OthersWearable biosignal acquisition and data interpretation including:• Comprehensive high-fidelity wearable sensor suite• Cognitive state assessment for fatigue, stress, workload, …• Physiological monitoring underwater or during high motion• Training optimization through monitoring or neurofeedback• Brain-Computer Interface for augmented capabilities• Custom-designed hardware for specialized environments –

battlefield, underwater, high altitude etc. • Cognitive and physiological experimental design & execution

Points-of-Contact

• Dr. Walid Soussou, CEO, [email protected], 858 412 1820• Gayle Guy, Proposal Manager, [email protected], 858 412 1839• www.quasarusa.com & commercial partner www.wearablesensing.com

From left: EEG helmet & interior, standard EEG headset, ECG Body Armor, underwater ECG belt

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IQVIA Government Solutions, Inc.Falls Church, Virginiawww.iqvia.com

Business Class: LargeStatus: TraditionalMember since: June 2019

Prototype Description Desired Capabilities Sought from Other MTEC Members• Description: 1) Trial innovations (remote monitoring and data

collection with privacy considerations), 2) virtual trial technology, 3) R&D studies and 4) new forecasting models to improve health status

• Targeted Clinical Indication: All diseases, conditions, procedures, medication use and practice guidelines.

• Current TRL: 1) TRL 5, 2) TRL 4, 3) TRL 6 and 4) TRL 6• Accomplishments to Date: 1) Prototype underway self funded to

support COVID 19 trial self-identified patient recruitment, 2) Technology soon to be in integration phase with EHRs, 3) Being performed for commercial clients and 4) being performed for and with clients and academia partners

• New Bluetooth enabled wearable technology • Novel innovations in clinical studies• New vaccine development• EHR integration services for data exchange

Member Capabilities to Offer Others

Points-of-Contact • Global healthcare data curation and reporting• Drug supply chain understanding• Clinical trial, regulatory and safety support• Healthcare specific data management lifecycle & data privacy• Health related research and development support• Secure mobile platform with sensor/wearable integrations (support

for remote patient or employee monitoring/engagement portals)• Population health surveillance, modeling and analysis

Nandini SelvamVP, Government Solutions

(703) [email protected]

Wes WatkinsSr Dir, Strategic Health Insights

(703) [email protected]

Mike BruhnSr Dir, Real World Insights & Technology

(703) [email protected]

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PromaxoOakland, CAwww.promaxo.com

Business Class: SmallStatus: Non-TraditionalMember since: June 2020

Prototype Description Desired Capabilities Sought from Other MTEC Members• Description: The Promaxo platform uniquely combines MR imaging,

AI, and robotics to push the boundaries of medical imaging. The single-sided, portable, light weight MRI allows for patient comfort and goes beyond traditional usage scenarios of screening. The platform enables the use of MRI-guided robotics for needle-based interventions such as biopsies and treatment in an office setting.

• Targeted Clinical Indication: Live MRI-guided interventions • Current TRL: TRL 7• Accomplishments to Date:

• 60601-1 for EMC, general safety and essential performance• 60601-2-33 and NEMA tested for MR safety and performance• Clinical imaging – T1, T2 and DWI of prostate• American College of Radiology (ACR) phantom imaging• 64 issued and pending patents

• Potential co-development and cross-licensing opportunities for the following technologies:

• medical robotics• software defined radio (SDR)• image-guided procedures and drug delivery• machine learning• low-field MRIs• radio-frequency systems

• Collaboration with military institutions• Academic and clinical research collaboration • Contract research• Product industrial design and prototyping

Member Capabilities to Offer OthersPoints-of-Contact • Expertise in image-guided interventions, magnetic resonance

imaging, and robotics• Commercialization of medical devices• Strategic partnerships • Startup mentoring

• Amit Vohra, [email protected], 215-300-0525• Dinesh Kumar, [email protected], 510-770-6819• Poorvi Satya, [email protected], 408-833-4352

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Arizona State University Tempe, Arizonawww.asu.edu

Business Class: Academic Status: Traditional Member since: 2017

Prototype Description Desired Capabilities Sought from Other MTEC Members

• Description: Human Performance and Optimization • Targeted Clinical Indication: Identifying point of injury, disruptions in

biochemistry and developing interventions.• Current TRL: 2-6• Accomplishments to Date: Broad based public private partnerships

between ASU, Mayo Clinic, human performance centers, military and academia – applied research at the Human Performance Innovation Laboratory will examine professional athletes and military operators to better elucidate causal factors of injury, improve prevention, recovery, resilience and longevity – fueling higher performance and inspiring purposeful living.

• Interested in expertise within: Concussion and TBI, Genomics, Microbiome, Nutrition, Circadian rhythm and sleep, Hormonal balance, Muscle physiology, Exercise physiology, Motion analysis, Cognition and nootropics, Sport psychology, Physiologic monitoring, Regenerative medicine, Man-machine interface, Sport Medicine and orthopedics, Physical Medicine, and Physical training

Member Capabilities to Offer Others

Points-of-Contact • Recognized as the most innovative school in the country, 3500 faculty, 125,000 students, Largest engineering school in the nation, international presence, over 40 elite programs and more than $4.3B in economic impact.

• Drew Trojanowski, [email protected], 202.834.6515

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Haima TherapeuticsCleveland, OHwww.haimatherapeutics.com

Business Class: Small BusinessStatus: TraditionalMember since: July 2019

Prototype Description Desired Capabilities Sought from Other MTEC Members

• Description: SynthoPlate is a fully synthetic, intravenous hemostat that adheres to the site of injury and promotes platelet recruitment and aggregation to prevent and treat bleeding complications.

• Targeted Clinical Indication: IV administration during pre-hospital transportation after traumatic injury

• Current TRL: 4• Accomplishments to Date:

• Demonstrated efficacy in mouse liver laceration model• Demonstrated efficacy in rat liver laceration model• Demonstrated efficacy in pig femoral artery punch model

• We are seeking partners with an established animal model of uncontrolled hemorrhage in canines. CRO quality is desired.

• We are seeking partners with expertise in packaging lyophilized formulations for rapid reconstitution and administration

Member Capabilities to Offer Others

We are licensing and can manufacture an artificial platelet technology capable of targeting activated platelets and delivering packaged cargo.

Points-of-Contact

• Michael Bruckman, CEO & COO• [email protected] – 803-727-9487

• Anirban Sen Gupta, CSO• [email protected]

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Vivonics, Inc.Bedford, Massachusettswww.Vivonics.com

Business Class: Small BusinessStatus: Non-TraditionalMember since: June 2018

Prototype Description Desired Capabilities Sought from Other MTEC Members

• Wearable physiological monitoring systems for austere environment clinical decision support

• Continuous contactless physiological monitoring up to 10 meters away

• Traumatic brain injury device development: diagnosis – treatment – recovery monitoring

• Wearable transdermal stimulation: nausea, vestibular dysfunction, vestibular cueing, audio transmission, hearing loss

• Large Scale Commercialization Partners

• Austere Environmental Medicine Expertise

• Military Medicine Expertise

• Platforms Looking for Niche Solutions

Member Capabilities to Offer Others

Points-of-Contact • Bringing clinical application into austere/remote environments • GMP clinical manufacturing space• Clinical solution product roadmap development and execution• Wearable electronics and human factors expertise• Near-infrared spectroscopy device and algorithm development• Traumatic brain injury clinical device solution expertise• Transitioning academic research into clinical solutions

• Ryan Myers, Lead Scientist & Director of Business Development, [email protected], 781-373-1930 ext. 270

• Kristian DiMatteo, Sr. Director of Operations, [email protected], 781-373-1930 ext. 226

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MAE Group Manchester, New Hampshirewww.maeconsultinggroup.com

Business Class: SmallStatus: Non-TraditionalMember Since: January 2019

Service Description Desired Capabilities Sought from Other MTEC Members

• Description: Full service medical technology company that works with early-stage to large multi-national companies to bring lifesaving products to markets -globally

• Targeted Clinical Indication: Clinical Indication and Intended Use Agnostic

• Current TRL: Work with technologies at TRL3 and higher

• Medical Device, In Vitro Diagnostics, Combination, Companion Diagnostic design and manufacturing companies that do not have the regulatory, clinical, quality system infrastructure or bandwidth

• Start up, small, medium and large enterprises

Member Capabilities to Offer Others

Points-of-Contact • 510(k), PMA, BLA, IDE, De Novo, IND, Pre-Sub, Pre-IND, GLP, GMP

• Clinical Trials• Quality System, MDSAP• Software V&V Support• Design & Mfg Product/Process V&V Support

• Janet Kwiatkowski, [email protected] 603-340-7079

• Yashesh Rawal, [email protected], 603-340-7081

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Trauma InsightSan Antonio, TXTraumaInsight.com

Business Class: SmallStatus: Traditional Member since: 2018

Prototype Description Desired Capabilities Sought from Other MTEC Members

• Description: Trauma Insight is a clinical CRO that tests and commercializes novel medical technologies relevant to national security

• Targeted Clinical Indication: Military Relevant Products both Therapeutics and Devices

• Accomplishments to Date: Designed and executed over 30 clinical trials many at multiple military hospitals, Built strong relationships with SMEs within the DoD and other federal agencies, as well as track record for CRADA, IRB, MTA, and government contracts execution

• Seeking to partner with organizations that are looking to commercialize products and require CRO support.

Member Capabilities to Offer Others

Points-of-Contact • Clinical Trial Design and Execution• FDA Submissions • Study Start-up • Clinical Operations • Site Management • Study Safety Monitoring• Study Closeout• Medical Writing • Publication Strategy

• Teresa Evans, PhD, COO • [email protected]• (937) 213-2167• Dan Hargrove, JD, President• [email protected]• (210) 710-2867

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Military & Health Research Foundation8105 Crest RoadLaurel, MD 20723www.militaryhealthresearch.org

Business Class: 501 (c)(3) Non-ProfitStatus: Non-TraditionalMember since: 2018

Prototype Description Desired Capabilities Sought from Other MTEC Members

• Description: The Auscul –XV is a high-fidelity electronic stethoscope equipped with disposable wearable sensors that provides up to 72 hours of remote auscultation.

• Targeted Clinical Indication: Telemedicine for on-demand virtual listening and e-recordings without disturbing the patient; Infectious Disease – Keeping healthcare workers at a safe distance from patients while also conserving of PPE resources

• TRL: 6• Accomplishments to Date: Auscul-X (wired prototype) completed

and initial product assessment study to being at Ottawa Heart Institute in early July 2020. Protocol approved by Health Canada and OHI IRB.

• Clinical Trial partners• Prime or Sub partnering opportunities

Member Capabilities to Offer Others

Points-of-Contact • Technology transition from concept through commercialization• FDA subject matter expertise• Grant writing, submission and project management• Extremely low overhead ensuring research $’s to the Warfighter• Research design, planning, prototyping, test and evaluation• Licensing and Commercialization expertise• Effective and low cost staffing solutions

• Ramsey Taweel, President (240) 417-0417 [email protected]

• Elizabeth Stoops, Director of Contracts (210) 902-9372 [email protected]

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Iowa Technology InstituteIowa City, IAhttps://iti.uiowa.edu/Teammates: Titus Human Performance,

OPL, and Malum Technologies

Business Class: AcademicStatus: Non-TraditionalMember since: OCT 2018

Prototype Description Desired Capabilities Sought from Other MTEC Members• Description: Human Performance Optimization• Targeted Clinical Indication:

• Soft Tissue (MSK) Injury Prediction and Prevention (Malum)• Virtual human high-fidelity modeling & simulation (Santos)• Cognitive Load Assessment and Management (CATS)

• Current TRL: TRL 7-9• Accomplishments to Date:

• ONR Code 30 Three Year Research Effort (Malum)• Titus Human Performance Data Analysis (Malum)• Army SSTAF and ACFT modeling & development (Santos)• Brooke Army Medical Center prosthetic modeling (Santos)• Cognitive Assessment Tool Set (CATS)

- DATA toanalyze

- Use cases - Problems- STTR team- MSK-Injury- Readiness- Cognitive

Health- Human Per-

formance- Operator

Health- Austere En-

vironments

Member Capabilities to Offer Others

Points-of-Contact • MALUM AI Engine• Santos Virtual Human (Digital Twin) • Human Behavior Modeling Lab (Santos Digital Twin)• Titus Human Performance’s SPEAR Tactical Data Enterprise• Cognitive Assessment Tool Set (at OPL)• Live Flight T&E at the Operator Performance Laboratory (OPL)

• Director – Dr. Malek: [email protected]• Travis Klopfenstein: [email protected]• Iowa City, IA and Orlando, FL• https://iti.uiowa.edu/

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PPD Pharmaceutical Product Development Government and Public Health Services Wilmington, NCwww.ppd.com

Business Class: LargeStatus: Non-TraditionalMember since: February 2020

Company Description Desired Teaming Opportunities With MTEC MembersPPD’s dedicated Government and Public Health Services group (GPHS) is a small, agile project centric team with reach back to PPD’s global contract research organization (CRO) workforce and resources.

Experience: PPD brings near 30 years of experience leading single-, multi-, and full-service government-funded programs. PPD GPHS DOD experience over the last 7 years includes 70 DOD funded projects… • MPRD / Medical Product Research and Development Services • USAMRAA / Regulatory Submission and Biostat Support Services• USAMRAA / Regulatory Affairs Support Services • USAMRAA / Trials Consultation• USAMMDA / Two; PH III Clinical Trails

We are seeking prime and subcontracting partnering opportunities to support medical countermeasures technology research programs across many therapeutic areas… with a multitude of clients…

Member Capabilities to Offer Others

Points-of-Contact PPD is a leading global contract research organization (CRO) providing exceptional and unique capabilities to support the advancement of medical countermeasures technologies

• David Fisher, Associate Director Cell: 910.538.3963 Email: [email protected]

• Rebecca Harston, Senior Director Cell: 571.310.1951 Email: [email protected]

• Critical Care• Infectious Disease• Vaccines• Respiratory• Neuroscience • Transplant

• Government • Gov’t Contractor• Biotech / Biopharma• Medical Device• Non-Profit• Academic Research Org

• Development Consulting• Laboratories • Early Development• Phase II – IV Clinical Trials• Global Site Network

• Regulatory • Trial Design• Data Management • Medical Comms / Writing• Project and Quality

Management

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Intelligent Automation Inc. Rockville, Marylandwww.i-a-i.com

Business Class: SmallStatus: Non-TraditionalMember since: May, 2019

Member Capabilities to Offer Others• Technologies for providing field care

o Battlefield Dermatological Skin Condition Diagnostic Toolo Secure Wireless Architecture for Combat Casualty Care

• And moreo Non-intrusive markers of THC-based driving impairmentso Simulation & Training: Haptic-feedback based palpation trainer

• Over 20 NIH & DoD grants for healthcare and telehealth technologies

Points-of-ContactLee Brindel, MBA: [email protected] Cohen, PhD: [email protected]

Prototype Description Desired Capabilities Sought from Other MTEC Members• Hospital and clinic connections• Gathering (anonymized) patient data• EHR Integration• Regulatory expertise• Accelerating product testing, validation, and commercialization• Identifying new opportunities for innovation and collaboration

• Extensive experience in:o App Developmento Wearableso Machine Learning & AIo Transforming Data Into Actionable Insights

• mSMART: a proprietary HIPAA-compliant telehealth backend for:o Rapid app prototyping and data logging,o Collecting and analyzing data from all IAI’s apps

Neurological and Musculoskeletal Assessment and Rehabilitation

Sleep, Circadian Rhythm Regulation, and PTSD Sleep Aid

Remote Health and Cancer Patient and Monitoring

o Cognitive Impairmento Patient Symptomso Physiological Signs

Healthcare Platform and Apps

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Thornton TomasettiSanta Clara, CAhttps://www.thorntontomasetti.com/solution/life-sciences

Business Class: LargeStatus: Non-TraditionalMember since: June 2020

Prototype Description Desired Capabilities Sought from Other MTEC Members

• Description: Human centric simulation for medical device design, wearables, clinical diagnostics and treatment planning.

• Targeted Clinical Indication: 1. Cardiovascular and Neuro, 2. Orthopedics, 3. Respiratory Applications.

• Current TRL: 6-8 for in silico simulation support: FEA, CFD, Blast• Accomplishments to Date:

• Life Science group part of 120 person applied science practice: supporting DoD clients in M&S of blast, impact and shock effects for over 70 years.

• Device simulation for major medical device manufacturers• Contributions to Dassault Living Human Heart Model.• Developing improved model for Nitinol, parametric modeling

of human anatomy.

• Access to anatomical and other clinical data to determine use conditions.

• Experimental lab expertise: Benchtop, animal testing.• Access to clinical facilities and data bases, clinical trials, surgical

planning.• Software expertise to co-develop improved or novel capabilities for

in silico trials, surgical planning and diagnostics, e.g. AI/ML, simulation, image analysis and segmentation.

Member Capabilities to Offer Others

Points-of-Contact • Expertise in commercial and in-house FEA, CFD, FSI, electromechanical, ultrasound, image to simulation, material model development, VR/AR, AI/ML.

• Staff with previous experience at medical device manufacturers. Understanding the process of bringing medical devices to market.

• In Silico: Design, Simulation, to Data Management and Regulatory.

• Kristian Debus, VP, [email protected], +1.707.477.7412

• John Mould, Principal, [email protected], +1.650.230.0334

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Sandstone Diagnostics, Inc.Pleasanton, CAsandstonedx.com

Business Class: SmallStatus:Non-TraditionalMember since: Feb 2020

Prototype Description Desired Capabilities Sought from Other MTEC Members

TorqTM Zero Delay Centrifuge System• Description: Hand-portable, battery-powered blood sample

collection and stabilization tool • Targeted Clinical Indication: Enables blood-based diagnostics,

monitoring, or sample prep in remote, austere environments• Current TRL: 7• Accomplishments to Date:

○ Prototypes available now for trials/evaluations○ FDA 510(k) submitted (pending)

• CROs (virtual / remote trials)• Pharma/biotech (therapeutic development support)• Diagnostic providers (centralized or POC)• Remote triage and monitoring providers• Regenerative medicine providers (remote sample prep)

Member Capabilities to Offer OthersPoints-of-Contact • Remote sample collection and prep solutions

• IVD development• Hardware developmentContact

Greg Sommer, [email protected]

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Blue Cirrus ConsultingGreenville, SCwww.blue-cirrus.com

Business Class: WOSBStatus: Non-TraditionalMember since: 4/2020

Prototype Description Desired Capabilities Sought from Other MTEC Members• Description: Telehealth expertise in the areas of business planning,

technology selection, workflow redesign, clinical integration, return on investment and creation of a sustainable telehealth program.

• Targeted Clinical Indication: Telehealth integrated into the care delivery model in an outpatient and inpatient setting as well as commercial.

• Current TRL: TRL 9• Accomplishments to Date: Named a Top Telehealth Company to

Know by Becker’s Hospital Review, Certified by the Clear Health Quality Institute (now URAC), Industry speakers regularly at American Telemedicine Assoc. and Ctel, Vendor of Choice for notable organizations such as Intermountain Healthcare, Shriner’s Hospitals for Children, Christus Health, Adventist and Valley Health System as well as other commercial for profit entities.

• Highly technical skills in networking• Cloud computing• Custom development• Artificial Intelligence• International experience preferred

Member Capabilities to Offer Others

Points-of-Contact act• Michelle Hager – Managing Partner• 864-335-8070• [email protected]

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Auxocell Laboratories, Inc.Cambridge, MAwww.auxocell.com

Business Class: SmallStatus: Traditional Member since: March 2020

Prototype Description Desired Capabilities Sought from Other MTEC Members

• Description: A sterile, single-use, disposable tool to process solid tissue to release cells in a laboratory, outside of a patient setting Targeted Clinical Indication: Processing of Solid Tissue including but not limited to: Umbilical Cord, Placenta, Adipose Tissue, Liver, Kidney, Skin, Heart, Muscle, Pancreas.

• Current TRL: Commercially Available• Accomplishments to Date: AC:Px® is commercially available and

produces multiple products: Native Cellular Product, Minced Tissue Product, Decellularized ECM/Allograft/Secretome Product all without the use of an enzyme.

• Collaboration to develop specific indications for the use of the outputs from our technology.

• We produce Mesenchymal Stem Cells and other Decellularize ECM

Member Capabilities to Offer Others

Points-of-Contact • Single Use, Solid Tissue Processing systemCon• Kyle Cetrulo• [email protected]• 617-610-9000

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Cherish Health, Inc.Cambridge, MAwww.cherishhealth.com

Business Class: SmallStatus: Non-TraditionalMember since: May, 2020

Prototype Description Desired Capabilities Sought from Other MTEC Members

• Description: Ambient Sensing Platform for Independent Living• Targeted Clinical Indication: Falls; Respiratory Distress; Heart Rate

Elevation / Decline• Current TRL: Five functioning prototypes with first generation RF,

vision, audio subsystems functioning, data visualization functioning; Three more iterations to finalize for production; Industrial design concepts created.

• Accomplishments to Date: Five prototype units built for first iteration of hardware; Data from RF, Vision, Audio subsystems available for AI on-device; AI can detect heart rate, respiration rate from 7 meters away; Imaging data can be visualized in 3D space

• Radio Frequency / radar signal control and interpretation• Machine learning from RF signal• Machine learning from audio signal• Industrial design of consumer devices• Last-mile connectivity – cellular, starlink

Member Capabilities to Offer Others

Points-of-Contact • Digital Health • Healthcare workflows and processes• Healthcare interoperability• Healthcare financing• Care pathways and protocolsContact

• Sumit Nagpal, [email protected]+1-617-818-0000

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ServiceNowTyson’s Corner, Virginia www.ServiceNow.com; docs.servicenow.com

Business Class: LargeStatus: Non-Traditional Member since: June - 2020

Prototype Description Desired Capabilities Sought from Other MTEC Members• Description – ServiceNow is a robust open API development

platform at it’s core.• We typically serve as a target environment for the integration of

various point solutions into one comprehensive platform to aid in visibility, communication, and cross functional coordination across business units.

• FedRAMP HIGH/IL-4 Data Centers• Dedicated environment for MedCOI traffic• Workflow/Automation/AI Operations

• Enterprise Platform of Platforms for – VA, HHS, CMS, FDA, CDC, DHA, DISA, etc.

We provide technology that is foundational for the way organizations improve day to day operations.

We can integrate with nearly any technology that exists either through pre-built integrations on made available on our ServiceNow store or through a no, low, pro code approach

We would love to partner with any and everyone to leverage our out of the box functionality in areas that allow us to collaboratively increase time to value and also provide an enriched solution offering to the customer.

Member Capabilities to Offer Others

Points-of-Contact • IT Service Management• Customer Service Management• HR Service Delivery• IT Operations Management• Security Incident Response Management• Hardware/Software Asset Management• Dev-Ops• Application Portfolio Management • IT Business Management • Financial Management • Integrated Risk Management

• Ty McNeil –• [email protected]• 336-987-7108• Military Health Lead @ ServiceNow