A NOTE FROM MTEC PRESIDENT BILL HOWELL
Dear MTEC members,
Another quarter has gone by, and it has been one of tremendous effort on the part of the staff to get things accomplished, especially the end of fiscal year awards. We will have placed more than $100M in awards this past month for a total of just over $200M, and we still have about $40+M to go in fourth quarter that is using non-expiring dollars.
Our Commercialization team just completed the annual cycle of commercialization grants. I want to congratulate the winners for when you complete your statements of work, you will be in a much better space to seek outside funding and in some instances other military funding. Although our awards help to foster partnerships, you should be reaching out anyway for the completion of necessary plans that will energize your development means and open your organizations to other funding opportunities.
Several members of our staff attended AdvaMed’s annual meeting in Anaheim. AdvaMed, is the largest medical technology association representing device, diagnostics and digital technology companies. This year’s meeting focused more on small companies and helping them grow and prosper until the large companies can license, acquire or merge. This reflects the industries greater reliance for pipeline from smalls rather than in house efforts. For example, there were reverse pitches where the strategics talked to their areas of interest to foster discussions with smalls. Also, seminars went into areas like due diligence performed by larges prior to agreements with smalls. A large portion of the agenda was focused on small and large interactions. A worthy effort from my standpoint. You will see some of this reflected in the upcoming months educational and consulting webinars to capture some of these topics for you.
MTEC sponsored 6 companies in their innovation center which allowed the strategics/larges to visit and see what they are developing. MedTech Innovator, a strong MTEC partner, had its own stage and introduced 60 companies, including MTEC members who are in both cohorts, to the general meeting participants. Also, they had their final competition winner selection ($350K prize), which happened to be Stroke DR which has a very applicable imaging device that is small, very portable, and can be used by almost anyone; otherwise stated, something clearly in military perspective for intercranial bleeds from penetrating or blast related trauma (vice their civilian application for early stroke diagnostics). A strong military candidate. Also, Neurotex, a nerve regeneration technology producer who is an MTEC member, made the final 5 and collected a small prize as well.
A good week for many, and I would highly recommend consideration next year. For those who were at our annual meeting, you may recall we had Patrick Brennan of ADVAMED as a panel member, so if you want to hook up, we have the network. I think the time is ripe for ADVAMED membership and attendance.
My best regards to all,
Bill Howell
MTEC President
MTEC BEATS
- MHSRS, August 14-17, was special this year. In addition to a record registration of 3,800, Dr. Lester Martinez-Lopez provided a keynote address at the opening plenary session. The discussions, posters, presentations, and meetings that followed were a whirlwind over the four days of the conference. MTEC was present in full force. Our reception on Tuesday evening was at capacity of 300. One-on-one meetings with Bill, Lauren, Kathy, Rick, Jill, and other professional staff were maxed out. This shows that there is a high demand for our time and attention, as well as appreciation for the services and resources MTEC offers our stakeholders.
- At the conference, MTEC also hosted poster sessions to provide members with increased visibility to the military ecosystem. 40 member companies participated and we invite you to check out their posters here: Member presentations from the MTEC Poster Session at MHSRS 2023 – MTEC | Medical Technology Enterprise Consortium (mtec-sc.org)
- MTEC has welcomed a new Vice President for Strategy and Business Development, Dr. Shawn J. Green, and MTEC’s newest Board Member, Michael Brown of GE Global Research.
Special thanks to Skip Auch and Ed Steiner for their years of service and dedication to MTEC as they roll off the board.
- MTEC is excited to host two State of the Technology Meetings in support of the U.S. Army Medical Research and Development Command’s (USAMRDC) Combat Casualty Care Research Program and the Biomedical Advanced Research and Development Authority (BARDA).
- Blood and Blood Products State of the Technology Meeting | November 29-30, 2023
This event is to inform the US Government and the greater scientific community of innovative research for blood and blood products, in support of current and future military and civilian blood needs for future large scale combat operations, as well as domestic mass casualty and disaster response. Additionally, the meeting will assist the US Government in identifying capability gaps and prioritizing efforts toward blood product development within DoD and across the inter‐agency enterprise. The meeting will give an opportunity for a dynamic exchange of ideas among all participants and provide support to identify and overcome challenges.
Registration is currently at capacity. Email any questions to [email protected]
- Blood and Blood Products State of the Technology Meeting | November 29-30, 2023
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- Neurotrauma Diagnosis, Monitoring, and Assessment State of Technology Meeting | March 12-13, 2024 in Washington D.C.
This event is to understand: i) better diagnose traumatic brain injury (TBI) at all levels of the continuum of care, ii) understand how to monitor patients already diagnosed with TBI, and iii) identify new potential products that could be developed into prototypes for the diagnosis, assessment and/monitoring of TBI. Content from the meeting will be organized into relevant conclusions and recommendations to inform the government of non-/minimally-invasive TBI diagnosis, monitoring, and assessment technologies research directions and priorities. This event is currently in the planning stage.
Save the Date will be emailed soon!
- Neurotrauma Diagnosis, Monitoring, and Assessment State of Technology Meeting | March 12-13, 2024 in Washington D.C.
MTEC is collaborating with the American Brain Coalition (ABC) in support of the psychological health and wellness of military medical service men and women. Check out ABC’s podcast with MTEC’s Chief Science Officer, Dr. Lauren Palestrini, MRDC’s Combat Casualty Care Neurotrauma portfolio manager, Dr. Kasey Moritz, and MRDC’s Military Operational Medicine area manager, Dr. Ronda Renosky-Vittori, on Wednesday, November 1.
The FDA is looking to solicit views from technical and scientific subject matter experts from diverse disciplines and backgrounds, including both women and men, members of all racial and ethnic groups, and individuals with and without disabilities, for this advisory committee and, therefore encourages nominations of appropriately qualified candidates from these groups.
For those interested in serving or nominating a representative to serve as a voting or non-voting member of the FDA’s Digital Health Advisory Committee, please either submit your nomination electronically by accessing the FDA Advisory Committee Membership Nomination Portal.
WELCOME NEW MTEC MEMBERS!
MTEC welcomes 40 new members as of September 30th! Click here for a full list of current members, totaling 615 members at the end of 2023 Q3!
Small Business
ERI Group
ExcelCoat Technologies, Inc.
Flambeau Diagnostics LLC
Global Military Expert Consulting And Instruction LLC dba Spotlight Labs
Legionarius LLC
Microbion Corp.
Molecular Rebar Design LLC
MY01, Inc.
Nurami Medical
OXOS Medical, Inc.
Peptilogics, Inc.
Pivot Path Solutions LLC
Precision Trauma LLC
Protinhi B.V.
Quorum Innovations LLC
Ragged Edge Solutions
Safeguard Surgical
Sibel Health, Inc.
Sophic Synergistics LLC
Stephenson & Stephenson Research & Consulting
Swaza, Inc.
U-Smell-It LLC
Vocxi Health, Inc.
Xheme, Inc.
Large Industry
Resilience Government Services, Inc.
SLSCO, Ltd.
Non-Profit
Phare Bio, Inc.
Academic (8)
Colorado State University
Georgia Southern University
University of California Los Angeles
University of Malta
University of Miami
University of Washington
Wayne State University
RESEARCH PROGRAM
A full list of MTEC’s active and upcoming solicitations can be found here.
OPEN FUNDING OPPORTUNITIES:
| Solicitation # | Topic | Sponsor | Important Dates |
|---|---|---|---|
| 24-03-Dental RPI | Military Dental Research – Seeking New Technologies and Development Partners | NAMD | Submissions due November 30, 2023 @ 12PM EST |
| E24-02-AutoDocPrize Demonstration and Prize Competition | Passive Data Collection using Autonomous Documentation (AutoDoc) Project | MTEC | Proposal Due: November 20, 2023 @ 12PM EST |
| 24-01-MPAI RPP | Fiscal Year 2024 Military Prototype Advancement Initiative | USAMRDC | Enhanced White Paper Due: January 15, 2024 @ 12PM EST
Proposers Conferences: See MTEC members only website for posted materials |
PROJECT HIGHLIGHTS
Several MTEC projects, including those from small businesses and academia, have reached major milestones over the last quarter of business.
Below is a sampling of several of these successful projects.
More projects can be found highlighted on our website: https://www.mtec-sc.org/project-highlights/
AWARDS
Projects Awarded since last newsletter through Sept 30th:
| Initiative # | Title | Company Name | Awarded Ceiling | Award Date |
| 21-06-MPAI-078 | Intravenous Agent for Hemorrhage Control | Cayuga Biotech, Inc. | $3,092,802.70 | 8/21/2023 |
| 22-02-MPAI-009 | An Inhaled ACE2-Targeting Therapeutic Prototype for Pandemic Preparedness | Inhalon Biopharma, Inc. | $5,693,201.00 | 8/23/2023 |
| 22-02-MPAI-071 | CorNeat KPro: A synthetic self-integrating artificial cornea: Accelerating FDA clearance for combat related corneal blindness indications | CorNeat Vision Ltd. | $2,192,848.46 | 7/27/2023 |
| 22-02-MPAI-093 | Identification of Risk Factors that Prevent Return to Duty and Predict Residual Disability after Knee ACL Reconstruction at Short and Long-Term Follow-up | The Geneva Foundation | $2,819,104.00 | 9/7/2023 |
| 22-02-MPAI-115 | A Modular, Portable Computed Tomography (CT) System for Triage and Surgical Support in Far-Forward, Austere Environments | Massachusetts General Hospital and Harvard Medical School | $2,881,311.91 | 9/25/2023 |
| 22-02-MPAI-136 | GelATA to prevent infection in traumatic penetrating injuries | University of Pittsburgh | $1,483,833.00 | 9/14/2023 |
| 23-03-Performance-001 | NC-COMP Technology Integration | Research Triangle Institute | $6,699,972.37 | 8/23/2023 |
| 23-02-MSKI-017 | Dynamic Gait-Synchronous Neuromuscular Electrical Stimulation Following Anterior Cruciate Ligament Reconstruction | The Henry M. Jackson Foundation for the Advancement of Military Medicine | $1,277,563.33 | 9/29/2023 |
| 23-04-AFIRM-004 | The Armed Forces Institute for Regenerative Medicine (AFIRM) | Wake Forest University Health Sciences | $38,884,300.00 | 9/21/2023 |
| 23-06-USAMRDC-MultiTopic-001 | BurRapid Intracranial Access Platform for Far Forward Traumatic Brain Injury Stabilization | Critical Innovations LLC | $1,174,447.00 | 9/26/2023 |
| 23-06-USAMRDC-MultiTopic-005 | BurRapid Intracranial Pressure Monitor Attachment for Far Forward Traumatic Brain Injury | Critical Innovations LLC | $449,321.00 | 9/27/2023 |
| 23-06-USAMRDC-MultiTopic-045 | Cellphire Therapeutics Freeze-dried Platelet-derived Hemostatic (“FPH”) product CLPH-211: Chemistry, Manufacturing and Controls (“CMC”) Good Manufacturing Practices (“GMP”) enabling development work, FPH product concentration optimization, and IND enabling Clinical and Regulatory Preparation. | Cellphire Therapeutics | $7,271,826.53 | 9/19/2023 |
| 23-06-USAMRDC-MultiTopic-091 | Pharmacological Modulation and Remote Measurement of Sleep-Driven Glymphatic Clearance | University of North Carolina – Chapel Hill | $2,583,792.31 | 9/27/2023 |
| 23-06-USAMRDC-MultiTopic-103 | Expanding Weapon Signature Database for Blast Exposure Estimation during Weapon Training | CFD Research Corporation | $799,911.05 | 9/26/2023 |
| 23-06-USAMRDC-MultiTopic-112 | Sex Steroid Suppression and Replacement on Musculoskeletal Resiliency and Adaptation to Multi-Stressor Training | University of Pittsburgh | $4,422,604.42 | 9/14/2023 |
| 23-06-USAMRDC-MultiTopic-113 | Smart insoles to Track and Treat over Use injuries (STATUS) | Applied Research Associates, Inc. | $2,505,728.87 | 9/22/2023 |
| 23-07-WWSDP-TASK1-006 | Applying the Delphi Method to Advance and Optimize a Benchmark for the Training and Matching of Service Dogs with Disabled Service Members and Veterans | California State University Long Beach Research Foundation | $12,000,007.00 | 9/28/2023 |
| 23-09-NDMS-Modular-002 | National Disaster Medical System (NDMS) Modular/Convertible Capability Pilot | Deloitte Consulting | $4,980,379.80 | 9/26/2023 |
| 23-09-NDMS-Modular-005 | A Modular, Scalable Alternate Care Facility for Patient Surge | University of Colorado Anschutz Medical Campus | $3,320,249.90 | 9/27/2023 |
View all Project Awards here.
– Kathy Zolman, MTEC Chief of Consortium Operations
SPOTLIGHT ON INDUSTRY
Enhancing Preparedness: Just in Time Micro-Simulation Trauma Training
Nearly thirteen years ago, while serving in the United States Army, I had the privilege of taking part in a NATO training event that aimed to assist Eastern European countries to prepare for the potential of a Russian invasion – an event that would be the largest attack on a European country since the Second World War. While it was always a possibility, it was never something I thought would happen in my lifetime, until now.
Today, the world is witnessing what we tried to prepare for and prevent – a Russian invasion. Members of the Armed Forces have always worked towards and trained to be ready for any possible situation. The motto of the U.S. Army has been “Train as you Fight” meaning to simulate the real event as much as possible during training. In the case of the war in Ukraine the phrase has unfortunately been changed to “Train while you fight.” This poses many challenges as the battles do not get placed on hold for training to take place, the challenges are enduring.
Ukraine has faced persistent challenges, including territorial conflicts and threats from various sources. In such an environment, it is crucial for the Ukrainian forces to be well-prepared not only in terms of combat but also in providing medical aid to their comrades in the field. Traditional training methods often fall short in replicating the chaotic and high-stress conditions of a real battlefield. This is where microsimulation trauma training comes into play as it can be quickly made adaptable to any environment.
In a rapidly evolving world of military tactics and technology, adaptability and the assurance of readiness and effectiveness of the armed forces is paramount. DLH has worked with industry partners to develop a Microsimulation Platform, Realtime Assessment and Personalized Instruction on Demand (RAPID). RAPID allows for the building of screen-based simulation training that is platform agnostic and can be operated in a low or no bandwidth environment thus allowing the training to take place “Just in Time,” and to be offered anywhere at any time.
DLH has authored various training simulations from Police engagement training to the application of new equipment training, but most importantly for this case medical training. Tactical Combat Casualty Care (TC3) has been the standard of care for U.S. forces for many years. In fact, the Secretary of Defense made TC3 training mandatory for all U.S. forces regardless of specialty. Based on this mandate DLH worked to author a training module to provide refresher training and screen-based simulation to allow for competency to be measured. This training module has been presented and demonstrated at multiple industry and military events and has been very well received.
Based on current world events and the perceived need for this type of training, DLH has seized the initiative by working to offer this microsimulation training in the Ukrainian language and in various dialects as needed. It is our hope that by providing this training additional lives will be saved as the conflict continues to evolve.
Benefits of Micro-Simulation Trauma Training
- Realism: The elevated level of realism in micro-simulation training helps soldiers experience the stress and urgency of real-life combat situations. This prepares them mentally and emotionally for the challenges they may encounter.
- Skill Development: Micro-simulation training allows soldiers to practice critical medical skills, including wound assessment, bleeding control, and airway management, in a safe and controlled environment.
- Teamwork: It promotes teamwork and communication among soldiers, as they must work together to provide effective medical care under pressure.
- Risk Mitigation: By providing realistic training without the risks associated with live exercises, micro-simulation training reduces the chances of injuries during training.
- Cost-Efficiency: Since RAPID is platform agnostic, micro-simulation training can be more cost-effective overall compared to traditional field exercises, which require extensive logistical support
- Environmental: Bringing the balance of skill learning and its application with the backdrop of the actual environment where those skills will be used will enhance the comfort of learning in an uncomfortable environment.
- Platform Agnostic: RAPID is not dependent on a specific system. Training will run on any device from a cell phone, tablet, PC, and in a virtual reality headset.
In a world where military preparedness is critical and skill application essential, microsimulation trauma training emerges as a valuable tool for Ukrainian forces. By offering a high-fidelity, realistic training experience, it prepares troops to deal with the physical and psychological challenges of combat. As Ukraine continues to adapt to evolving threats, embracing innovative training methods like microsimulation will evaluate and analyze behaviors and events in real-time and undoubtedly enhance its military readiness and effectiveness on the battlefield.
Frank J. Karluk, MA, PMP, NRP
Account Executive
Medical Modeling and Simulation
DLH Holdings Corporation
M-CORPS
The 2023 round of $50,000 Commercialization grant proposals have been awarded! 60 proposals in total have been evaluated and nine have been identified. This program encourages small business members to engage M-Corps Partners to advance their technology and business development efforts.
The award winners are….
| Company | Technology | TRL | Project | M-Corps Partner |
|---|---|---|---|---|
| Diagnostic Biochips, Inc. | Electrode implants, software and analytics to enable next generation Brain Computer Interfaces for a range of clinical applications including thought-to-speech conversion and control of prosthetic limbs and visual prosthesis. | 4 | FDA Regulatory Strategy for Deep Array Brain Computer Interface Electrodes | Convergent Clinical |
| Limax Biosciences, Inc | HEMOMax™ a fully degradable hydrogel-based material that has strong adhesion to difficult to attach biological surfaces | 5 | Regulatory landscape review and strategy. | Alira |
| Matregenix | MatriNova™ to enhance guided bone regeneration (GBR) procedures in oral and craniomaxillofacial surgeries. | 6 | Quality Management System Acquisition, Installation, and Training | Greenlight Guru |
| Moberg Analytics, inc. | Cloud-based AI platform for managing/analyzing data in moderate/severe brain injury to provide real-time guidance | 7 | The Medical Record for the Brain – Market Adoption Strategy | Cornerstone |
| NIRSense LLC | Argus that measure Pulses Oximetry (SpO2) and tissue oximetry (StO2) in the same location | 6 | US and European Transition Market Research | Latham |
| Purgo Scientific, LLC | Purgo Pouch drug delivery device that sustains local, high dose antibiotic therapy in a traumatic injury site including an open fracture | 4 | Customer Discovery Project for Purgo Scientific | TreMonti |
| Sense Diagnostics, Inc | NeuroHawk that uses radiofrequency (RF) to detect intracranial hemorrhage following 5 minutes of scanning. | 5 | Support Development of Sense Neuro Diagnostics’ US Go to Market Roadmap to Support the Launch of their NeuStat Platform | Alira |
| Sonogen Medical, Inc. | Low intensity pulsed ultrasound (LIPUS) bone growth stimulation (BGS) device that delivers an optimized multi-modal fracture healing signal that heals 30% faster than any technology on the market today. | 4 | Industrial Design and 3D Rendering for Ultrasonic Bone Fracture Healing Device | RPM Tech |
| Vistendo Inc | Detects early warning signs of injuries and illnesses, even before symptoms are noticeable. | TRL 9 commercial / TRL 6 military | Product Commercialization market Strategy and Plan Development | Conafay |
See the M-Corps page for a list of current partners.
Interested in joining the M-Corps? It’s free to MTEC for-profit service provider members in good standing who have signed the M-Corps Teaming Agreement. Partners must be experts in their field with an established record of excellence and expertise that can assist prototype developers in advancing commercialization readiness of their medical technology offerings. Contact Rick Satcher for more details.
Networking
Don’t forget about our member connect resources, including the Member Profiles site where you can describe your technology capabilities and collaboration interests for all members to see.
– Rick Satcher, MTEC Director of Commercialization
FOUNDATION HIGHLIGHTS
The Medical Technology Enterprise Consortium is pleased to announce that Sgt. Elizabeth Hernandez is the recipient of the inaugural MTEC Scholarship through the Association
of the United States Army National Scholarship Program. This year, AUSA issued 41 scholarships, totaling approximately $330,000.
A member of the Army National Guard, Sgt. Hernandez is currently completing the certification needed to become a paramedic. She will earn her master’s in physician assistant studies from Southern Illinois University.
MTEC partnered with the AUSA to issue this first-of-its-kind scholarship, which is supporting the continued academic work of an Army medic, solider or officer in a health care role who is pursuing a career in biomedical research or health care services.
Over fifty individuals applied for the MTEC scholarship; applications were reviewed by the AUSA Scholarship Committee and awardees were notified in early September.
For the last six years, Sgt. Hernandez has been a Combat Medic with the Army. Currently, she is working full-time for the Jackson County Ambulance Service to gain additional field experience before attending Southern Illinois University, where she will pursue her master’s in a two-year program.
MTEC is thrilled to partner with AUSA in helping to realize the ambitions of Sgt. Hernandez.
Says Hernandez, “I am very grateful for the opportunity this scholarship brings. It has been an honor to serve my country, and to choose to continue to serve my community outside of my military service. This scholarship offers an important financial opportunity and also the opportunity to achieve a greater dream. My goal once I obtain my Physician Assistant Degree is to continue to serve my country as an officer in the Army, but also to pay it forward by encouraging and educating others to do the same in becoming a service to their communities. British philosopher Francis Bacon once said, “knowledge is power” and the key to our success is well within our grasp. Thank you again. “
Sgt. Hernandez exemplifies the pursuit of knowledge and service to our country. We extend our heartfelt congratulations and best wishes for her bright future. Thank you, Sgt. Hernandez, for your dedication and inspiration!
– Kate Golden, MTEC Foundation Relations
UPCOMING WEBINARS & EVENTS
- M-Corps showcase: CUBRC is on November 8
- Defense Tech Connect in National Harbor is November 28-29
- State of the Technology Meeting: Blood & Blood Products in DC is November 29-30
All upcoming MTEC events can be found here.
All archived recordings and slide decks for webinars can be found on the member’s only site.
