PULSE of Innovation
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APRIL 2021

THE CHANGING MILITARY SCENARIO

A Note from MTEC President Bill Howell

Many of you participated in the recent MTEC Annual Meeting. Though virtual, we were able to bring several of the military leaders and portfolio managers onto the screen between directed discussion and more than 290 one-on-one meetings. Two full days were dedicated to military speakers, and their participation in the Annual Meeting demonstrates how the military views its relationship with MTEC: as one of value and viability.

There is now a closeness between MTEC and our military partners that enables freer exchange of information and responsive action. This is advantageous because we are able to share pertinent information with our members, in turn improving their understanding of military needs and situational conditions. While I hope many of you took full advantage of the opportunities to hear directly from our sponsors during the meeting, MTEC is prepared to support this exchange of information year-round as solicitations are developed or questions are submitted. We are using our educational webinars to highlight such information as well.

I want to emphasize one aspect of the meeting that I hope everyone caught, but I will reiterate it here: the military strategy is changing. Instead of fighting the same wars we have been involved in over the past decade, the focus will shift away from smaller, peacekeeping type missions. The military is focusing more heavily on future threats, including possible larger challenges between near peers. This type of scenario means greater lethality, less control of the battlespace and, to the medics, a far greater number of casualties who will be harder to move around the battlefield. It focuses on different areas of the world, each with their own environmental and disease threats. Literally, we are seeing a large shift in military medical needs for the future, and when that happens, the money eventually follows.

Dr. Mark Dertzbaugh, Principal Assistant for Research and Technology and the individual Joint Planning Committee (JPC) leaders all referenced these changes and the effect they are beginning to have on their portfolio needs. Human performance maximization, far forward resuscitative and stabilization care, robotics and automated assistance, and wound infections all are areas of increased importance. Though not especially new, these areas are receiving priority over areas that may have been pursued during the last decade. This is a watershed event, and MTEC members need to pay close attention. It does not happen frequently, but about once each decade, the impetus for R&D funding makes large changes to accommodate the new envisioned battlefield.

The newly released MTEC Military Prototype Advancement Initiative (MPAI) solicitation was built around many of these changes, and it offers a mechanism for members to provide their ideas and technologies related to this evolving landscape. I am certain that over the next year, we will see more specific solicitations in many of the areas I described above, especially as things become better defined.

Even as we await new solicitations in these areas, there are opportunities for our members to assist the military in developing their solutions for the new battlefield. We are getting you in on the ground floor of this change.

Dan Hathorn Photo
Keynote Speaker Dan Hathorn

Annual Meeting Highlights

MTEC Board Chairman, Dr. Lester Martinez-Lopez and keynote speaker Dan Hathorn kicked off the MTEC 6th Annual Meeting on March 22nd with a compelling message of military medical innovation purpose and imperative. Dan, a former Navy Seal, shared his experience of being severely injured while serving. He came precipitously close to losing an arm and more. He motivated all of us to press on to innovate and serve. There is much yet to be done. He set the tone for the meeting, for MTEC and for the military medical enterprise.

MTEC Board Chairman, Dr. Lester Martinez-Lopez and keynote speaker Dan Hathorn kicked off the MTEC 6th Annual Meeting on March 22nd with a compelling message of military medical innovation purpose and imperative. Dan, a former Navy Seal, shared his experience of being severely injured while serving. He came precipitously close to losing an arm and more. He motivated all of us to press on to innovate and serve. There is much yet to be done. He set the tone for the meeting, for MTEC and for the military medical enterprise.

Again,  congratulations to MTEC Prototype of the Year awardees, Centivax and Kitware, USAMRDC Sponsor Recognition awardees, MIDRP,  TATRC and MOMRP, and MTEC’s 2021 Impact Awardee, the BrightFocus Foundation. Learn more about these awards here.

And a special thanks to ATI for hosting one of the largest turnouts yet for an MTEC Annual Meeting, with a record 480 registrants. Kathy Zolman, MTEC’s Director of Program Operations, and Tracy Schwerin, ATI events coordinator met this challenge professionally and adeptly. We are all grateful to them for a job very well done.

Note:  The slides and recordings noted above can be accessed on the MTEC Members Only Site.

Membership Growth: 2016- 86, 2017- 154, 2018- 276, 2019- 336, 2020- 461, 2021:436; 436 Small & Large business, academia and nonprofit member organizations. 120 Project Awards; $390 Million in government funding. $58.3 Million in cost share.

PROJECT HIGHLIGHTS

2021 is off to a great start! More and more MTEC projects are beginning to achieve major milestones in their work plans. In fact, Centivax and Kitware were both awarded with Prototype of the Year Awards at MTEC’s 6th Annual Membership Meeting in March 2021. Below is a sampling of other notable projects from the last quarter of business.

Vivacelle Bio: Open Clinical Trial for the Evaluation of Novel Phospholipid Nanoparticles for the Treatment of Septic Shock

Graphic depictions of a Micelle and Liposome. Phospholipid nanoparticle technology treats septic shock.

Vivacelle Bio was recently cleared by the FDA to proceed with its Phase IIa clinical trial for evaluation of the safety and efficacy of VBI-S—an intravenously injected cardiovascular support fluid containing phospholipid nano-micelles and liposomes—to treat septic shock. Septic shock is a potentially fatal condition that results from the body’s systemic response to infection and leads to critically low blood pressure and organ dysfunction. The beneficial action of VBI-S occurs through its unique ability to redistribute nitric oxide, a gas that is overproduced in septic shock and causes potentially fatal hypovolemia, hypotension, and organ damage. Recruiting for the Phase IIa clinical trial is currently underway. This project was funded through MTEC-20-02-NavyMultiTopic.

NOCTEM: Optimizing the Scalability of Evidence‐Based Behavioral Sleep Medicine Practices

NOCTEM has begun enrolling healthcare providers and patients for their clinical effectiveness and implementation trial to evaluate a new software solution that provides personalized insomnia treatment to military service members. Insufficient sleep and insomnia affect between 40% and 70% of military service members, which compromises readiness, performance, health, productivity, and safety. NOCTEM’s new software solution aims to upskill existing providers with clinician decision support algorithms, increase their capacity to monitor service members’ sleep and compliance in real time, and deliver personalized evidence-based sleep optimization recommendations to hundreds of service members remotely. The software solution uses cloud and mobile architectures to provide near-instantaneous and secure messaging between healthcare providers and service members. This clinical trial has begun enrolling providers and patients. This project was funded through MTEC 19-02-Tele-Sleep.

Tele-Sleep Decision Assist Tool for personalized insomnia treatment.

Lumen Bioscience: Ultra-Rapid, Low-Cost Neutralizing Antibody Therapeutic for COVID-19

Harvest spirulina semi-continuously; only minerals, light, water and air are needed. BHH framework is highly expressed in spirulina and is protease resistant.

Lumen Bioscience has started rapid development of a low-cost, orally delivered cocktail of antibodies against SARS-CoV-2 (the virus that causes COVID-19) to prevent and treat infection of the gastrointestinal (GI) tract. The GI-targeted therapy to may help to reduce overall viral burden, inhibit disease progression, and accelerate viral clearance. Early results demonstrate strong resistance to GI proteases and high-yield in Lumen’s ultra-low-cost cGMP manufacturing system. The program is now working through final antibody cocktail assembly in live-virus neutralization assays. Lumen Bioscience is preparing an Investigational New Drug (IND) application, with plans for a treatment/prophylaxis Phase 2 clinical trial later this year. This project was funded through MTEC-20-09-COVID-19_Treatment_MIDRP.

Institute for Behavior Resources (IBR): Management of Sleep and Fatigue Using the SleepTank™ Smartwatch App

Maintaining vigilance in the military operational environment and in civilian 24/7 operations requires appropriate sleep planning and management. The Institutes for Behavior Resources, Inc. (IBR) has developed a Fitbit-smartwatch app, an iOS mobile app, and a web-based dashboard that provides sleep feedback using SleepTank™. SleepTank™ is a proprietary sleep debt algorithm that provides the wearer with long-term sleep health information and actionable recommendations for additional sleep, which will optimize sleep opportunities and increase overall sleep duration. The SleepTankTM app is now available for beta testing. Moreover, the efficacy of SleepTank™ for improving sleep hygiene and reducing fatigue in operations is being investigated in populations of shift-working nurses, helicopter emergency medical services pilot-technicians, and U.S. Air Force Service members. This project was funded through MTEC-17-08-Multi-Topic.

SleepTank Smartwatch App to manage sleep and fatigue.

To enjoy the previous highlights, click here. If you have any questions regarding these research efforts, please reach out to Dr. Lauren Palestrini, MTEC Director of Research.

COMMERCIALIZATION HIGHLIGHTS

The MTEC Education Webinar series is in full swing! The schedule for next quarter has been finalized, and we are adding plans for later in the year. Examples of topics include:

  • – April 14, 1 pm EST – Military laboratory capabilities and how to partner
  • – May 19, 1 pm EST – Cost proposals and managing an award (register here)
  • – June 22, 1 pm EST – Introduction to Medtech investment
  • – July 20, 1 pm EST – Sourcing smart, non-dilutive capital

We continue to build a network of subject matter experts and service providers that will represent our Venture Corps to assist members with business, technical, and regulatory strategies as technologies in the portfolio mature. MTEC has begun discussions for teaming agreements with four groups to offer services to members in support of procurement, clinical and regulatory, licensing, and business development services.

The Commercialization Readiness Assessment (CRA) tool is being refined as we seek feedback from our commercialization and investment support network. The CRA will be completed by members interested in pitching to the military, industry, and investors. Watch for further news about this tool, including invitations to schedule company pitches in the third and fourth quarter of this year.

– Rick Satcher, MTEC Director of Commercialization

ACTIVE SOLICITATIONS

21-06-MPAI – Military Prototype
Advancement Initiative (MPAI)

  • – Aims to solicit for a broad range of medical prototype technological solutions [medical techniques, knowledge products, and materiel (medical devices, drugs, and biologics)] related to prolonged field care, medical readiness, emerging technologies, and maximizing human potential. Enhanced White Papers may be submitted anytime between April 20th and June 17th.

View the Solicitation

21-07-iACT – interoperable Algorithms
for Care and Treatment (iACT)

  • – Focused on providing soldiers and military medic personnel with Artificial Intelligence (AI) and Machine-Learning based decision support software to enhance their ability to provide short and long-term patient care in all domain operation (ADO) environments. White Papers are due on April 27, 2021.

View the Solicitation

21-08-iMCCS-J – interoperable Medical
Command and Control System – Joint (iMCCS-J)

  • – Focused on the development of a prototype that supports the integration of medical data with the Air Force Research Laboratory (AFRL), Tactical Assault Kit (TAK) suite of software and hardware in support of an interoperable Medical Command and Control System – Joint (iMCCS-J). Full proposals due on April 29, 2021.

View the Solicitation

21-09-iFH - interoperable Field Hospital (iFH)

  • – Focused on the development of a prototype to create a deployed interoperable field hospital environment that will integrate existing Department of Defense (DoD) tactical networks, systems and medical devices via a Local Area Network (LAN) within deployed Medical Treatment Facilities (MTF). Full proposals due on April 26, 2021.

View the Solicitation

UPCOMING SOLICITATIONS

 The following topics have not been officially pre-announced but have the potential to become active funding opportunities in 2021 (subject to change):

Military-Civilian National Disaster Medical System (NDMS)
Interoperability Study (MCNIS) Pilot Implementation Program

  • – Focuses on the development and implementation of the National Disaster Medical System (NDMS) Pilot Program (“Pilot”). The Pilot is a congressionally required prototype, which will serve as a proof of concept to inform nationwide changes to the NDMS. The purpose of the Pilot is to strengthen interoperable partnerships of the NDMS to care for our Nation’s combat casualties by increasing medical surge capabilities and capacities at five regional sites. This will be achieved through a collaborative network of federal and civilian NDMS partners. The current Pilot Phase I activities (currently underway during Year 0) will be transitioning (as of September 30, 2021) to Phase II (Pilot Implementation). This upcoming RPP is specifically focused on the activities associated with Phase II, which include conducting further NDMS studies, systematically implementing recommended changes, measuring intervention outcomes, and iteratively making improvements to optimize Pilot performance at the five sites. The information generated in Phase II (which will include tasks awarded under the upcoming MTEC RPP) will inform system-wide changes for nationwide implementation in Phase III.

View the Solicitation Pre-announcement

If you have any questions, please reach out to Dr. Lauren Palestrini, MTEC Director of Research.

AWARDS

So far, 2021 has been a promising year for MTEC. Funding sponsors and military participation continues to grow. We have 119 projects on award and forecast more than $120 million in available funding for calendar year 2021. We look forward to delivering even more military medical solutions to our government sponsors this year. To view a complete list of our projects, click here.

– Kathy Zolman, MTEC Director of Program Operations 

FOUNDATION HIGHLIGHTS

MTEC Foundation Relations Program

Astrocyte Pharmaceuticals has been recommended to receive the first MTEC and BrightFocus Foundation co-funded award for $500,000 to advance the development of drug treatments for repeated mild traumatic brain injury (mTBI). The funding will support preparation for and submission of an IND application, as well as preparation for clinical studies. This award is exciting, not only for the research it will foster, but also because it represents a milestone for MTEC in coupling significant philanthropic funds with government funding to further our research objectives and impact.

BrightFocus Foundation, a leading funder of scientific research on diseases of mind and sight, manages a global portfolio of 220 grants representing $50M in research investments. It partnered with MTEC to address a critical need in brain research and drug development. Despite numerous clinical trials on potential therapies, there is no FDA approved drug therapy for the treatment of TBI. Veterans who have experienced repeated mTBIs have been found to be at two to three times the risk of Alzheimer’s and other forms of dementia.

We look forward to keeping you appraised of our foundation relations throughout the year.  For additional information, please contact Kate Golden at kate.golden@mtec-sc.org.

– Kate Golden, Changing Our World

INDUSTRY PARTNERS PROGRAM

In 2021, MTEC is dedicating resources to work more closely and strategically with our industry and investor partners. MTEC Senior Advisor, Dave Hood moderated an introductory session on Day 4 of the MTEC Annual Meeting with partners J&J Innovation JLABS, Philips Healthcare, and Sanofi Pasteur. Brittany Trelly represented JLABS as its Senior Business Development Operations Manager. Rich Wilmot represented Philips as its Head of Venture Investment. Dr. Mark Parrington represented Sanofi Pasteur as its Senior Director and Head of External R&D for the Americas. All three speakers outlined their respective corporate areas of investment and interest, all of which you can find on the MTEC Members Only site.

MTEC Chief Operating Officer (COO), Jill Sorensen moderated a second session on Day 4 of the Annual Meeting, featuring representatives in the MTEC investment network, namely Corey Ritter of ARCH Venture Partners, Tico Blumenthal of Life Science Angels, Noel Jee of Illumina Ventures, and Amy Salzhauer of Good Growth Capital. The panel explored access to capital and financing issues for medical technology companies, including when, where, and how to identify investment partners, as well as different types of capital, insights on what these investors seek, and how to prepare for communicating with investors. Panel slides can be found in the MTEC Members Only site.

The MTEC Industry Partners Program is growing teaming, collaboration, business development, and investment opportunities for MTEC members in service to our military sponsors. For input on any of these topics, contact Jill Sorensen, MTEC COO, at jill.sorensen@mtec-sc.org. 

Jill Sorensen, JD, MTEC COO

EVENTS

UPCOMING:

MTEC Webinar Series:
Cost Proposals and Managing an Award

May 19, 2021 1pm EST

Understanding cost requirements for proposals is critical for a successful application to MTEC. The May MTEC Educational webinar will review common challenges and frequently asked questions from proposers. We will also discuss contracts management from the perspective of the Government Agreements Officer/Army Contracting Shop and MTEC, describe the difference between the base agreement and the Research Project Award, and review some of the key agreement clauses.

Moderator:
Rick Satcher, Director of Commercialization, MTEC

Panelists:
Lisa Kuhns, Contracts specialist, USAMRAA
Erinbeth Massie, Sr. Contracts Manager, MTEC
Randall Fernandez, Contracts Administrator, MTEC

MTEC Members can register here: https://ati.zoomgov.com/webinar/register/WN_VOgRpcggT0-TKmuhwbTlKw

Introduction to Medtech Investment

June 22, 2021 1pm EST

Overview of investing in medical technology (med-tech) from dilutive and non-dilutive sources, including the budget process and accounts, key timelines, sources of government funding, ways to access decision-makers, advocacy tools, case studies, rewards and risks of venture capital investment, including screening and due diligence, terms sheets.

Sourcing Smart, Non-dilutive Capital

July 20, 2021 1pm EST

Information on foundation relations, CDMRP, SBIR-STTRs, angel networks and grant tracking.

PAST:

Webinar Series:
Getting to Know Your Military Sponsor

January 26, 2021

Understanding and responding to the technical requirements for a Request for Project Proposal (RPP) from the Army is critical to receiving an award.  This webinar will provide an overview of technical requirements and present insights into the factors that go into proposal evaluations.  Panelists will also describe common technical, budgeting, and contracting challenges they see when reviewing proposals and offer suggestions that may help members craft proposals that address all military needs.

Moderator:
Lauren Palestrini, MTEC Director of Research

Panelists:
Kimberly Pope, CDMRP
Jeff Bartlett, USAMRAA
Thomas Dunn, Naval Advanced Medical Development

MTEC Members can find slides and speaker notes from the webinar on the Members Only site.

Introduction to DoD Cybersecurity Awareness

February 23, 2021

Cybersecurity is the practice of defending computers, servers, mobile devices, electronic systems, networks, and data from malicious attacks. Breaches have caused $100s Billion’s worth of economic loss to the US and given our adversaries secrets and insights into our technology and security plans.  The Department of Defense is ramping up efforts to ensure Federal Contract Information (FCI) is protected.  This webinar will review what information is at risk, who is behind the cyber breaches, and how to protect FCI from being hacked, which is a fundamental requirement for DoD contractors.

Panelists:
Sam Wyman, Co-Lead Spectrum Risk Management Solutions, The Spectrum Group
Gillian Jaeger, Co-Lead Spectrum Risk Management Solutions, The Spectrum Group

MTEC Members can find slides and speaker notes from the webinar on the Members Only site.

Collaboration Opportunities with Military Laboratories

April 14, 2021 1pm EST

This webinar will present an overview of the USMRDC laboratories available for collaboration and partnerships, the use of cooperative research and development agreements (CRADA) to enable collaboration, and examples of partnerships that helped advance medical technologies.

Speakers:
Sara Langdon, Program Manager, U.S. Army Medical Research and Development Command (USAMRDC)
Dan Coffman, Director, Office of Research & Technology Applications, U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID)

MTEC Members can find slides and speaker notes from the webinar on the Members Only site.