Navy Multi-Topic – Advanced Biomedical Product Development for Naval Operations

The Purpose of this multiple topic area (“multi-topic”) RPP is focused on the advancement of engineering and medical prototypes and knowledge products related to a broad range of medical technological needs. The Government will solicit a total of five Technology Focus Areas (which are: (1) Casualty Care; (2) Medical Logistics Enhancement; (3) Human Performance; (4) Prolonged and En Route Care; and (5) Operational Readiness). The research project award recipients were selected from the Offerors who responded to MTEC’s Request for Project Proposals (20-02-NavyMulti).

Phospholipid Nanoparticles in the Treatment of Septic Shock

Project Team: Vivacelle Bio

Award Amount: $5.33M

Project Duration: 28 months

Project Objective: Mortality from septic shock occurs when the blood pressure drops to an unsurvivable level. This occurs in spite of the use of high doses of vasopressors. We have designed a phospholipid nanoparticle-based fluid, VBI-S1, that elevates blood pressure to a survivable level without adverse effects and enables reduction of vasopressor dose. VBI-S1 is effective even when vasopressors and all other measures have failed. This improves the probability of survival and if used early could avert the onset of shock.

Mayo Clinic White Paper Topic Area 3a (Elucidating and Quantifying the Response of Down-Regulation Techniques on Physical and Cognitive Stress)

Project Team: Mayo Clinic

Award Amount: $1.67M

Project Duration: 35 months

Project Objective: The objective of this work is to deliver training modules to Human Performance Program (HPP) training personnel tasked with training SOF operators. In order to ensure the utility and validity of the training modules, the project plans to collect quantitative, scientific evidence that down-regulation can mitigate the psycho-physiologic response to stress. In contrast to civilian applications of down-regulation, this work will focus on techniques which can be leveraged quickly during operations, while still providing the necessary bio-feedback for optimal performance. Once those skills are in place, implementing maintenance strategy for learned skills (in this case, down-regulation) is critical for long-term adoption and success. 

Mayo Clinic White Paper Topic Area 3f (Lightweight End Cryptographic Unit for Wearables: LECUW)

Project Team: Mayo Clinic

Award Amount: $7.16M

Project Duration: 35 months

Project Objective: This effort covers designing an end cryptographic unit (ECU) to handle classified PSM information which will pass the U.S. Government Information Assurance evaluation process. Successful government evaluation ensures that the ECU design meets stringent criteria that prevent leakage of unencrypted data. The goal of the effort is the design of an encoder and decoder ECU ASIC accounting for size, weight, energy consumption, interfaces, data rate, block size, and key usage KPPs developed in collaboration with NAMD Program Officer and U.S. Government SMEs that is tailored for PSM CONOPs in operational and classified environments. The milestones for the proposed phase of effort are (i) architecture design for the encoder ASIC, (ii) architecture design for decoder ASIC, (iii) encoder ASIC hardware design, (iv) decoder ASIC hardware design. The Contractor will work with NAMD Program Officer and U.S. Government SMEs to ensure that the ECU hardware will meet Information Assurance evaluation process requirements.

Biofilm Prevention and Treatment through Continuum of Care

Project Team: Rochal Industries

Award Amount: $1.99M

Project Duration: 36 months

Project Objective: In addition to biofilm prevention or treatment, any therapeutic developed for military use would ideally be widely efficacious against multiple microbial families, shelf stable, easy to carry and administer, fast-acting with prolonged functionality, transparent for wound visualization, and safe. BIAKŌS Antimicrobial Wound Cleanser (AWC) and Gel (AWG) meet many of the requirements listed above. The AWC and AWG have undergone extensive safety and biofilm eradication testing with superior results, but the existing tests and clinical studies have been performed to address chronic wounds in the civilian population. Given successful results in previous chronic wound clinical testing, there is an expectation they will perform similarly in acute infection. However, additional stability work under austere conditions, pre-clinical testing in military-relevant wound infection models, and clinical testing in acute wounds is required to prove effective translation into military use.

Wearable AI-Assisted Doppler Ultrasound Blood-Flow Sensor

Project Team: Flosonics Medical

Award Amount: $0.97M (additional cost share = $484K)

Project Duration: 13 months

Project Objective: A wearable, wireless, Doppler ultrasound system is an entirely new type of physiological sensor that has, preliminarily, demonstrated itself to be more sensitive at detecting declining cardiac output than traditional vital signs, or combinations thereof (e.g. shock index). This Doppler sensor is a new and sensitive data source that, in combination with artificial intelligence, will afford better detection, triage and management of hemorrhage across the continuum of care – from the site of injury, to prolonged transport, to the hospital and intensive care unit.

Electroceutical Technology Against Wound Microbial Biofilm Infection

Project Team: Indiana University

Award Amount: $1.81M (additional cost share = $249K)

Project Duration: 24 months

Project Objective: We propose a randomized open label clinical study to demonstrate the efficacy of EDT treatment protocol in a relevant environment i.e., infected trauma/surgical wounds. The primary objective of the study is to demonstrate the ability of optimized EDT dressing protocol to prevent biofilm infection compared to standard of care (SoC) treatment.

Pravibismane Suspension as a Topical, Broad Spectrum Anti-Infective

Project Team: CUBRC

Award Amount: $2.15M (additional cost share = $2.37M)

Project Duration: 35 months

Project Objective: The objective of this proposal is to evaluate a novel, broad-spectrum antibiotic, pravibismane, formulated as a topical suspension (MBN-101) in a proof-of-concept (POC) Phase 2 clinical trial for the treatment of chronic wounds in patients with moderate to severe diabetic foot ulcer infections (DFI).

Clinical Development of a New Antimicrobial Agent to Treat and Prevent Biofilm Formation in Wounds

Project Team: Soft-Ox Solutions

Award Amount: $1.98M (additional cost share = $2.14M)

Project Duration: 38 months

Project Objective: Combat wounds are prone to infections, and hence pose a threat to the life of wounded soldiers and civilians. Biofilm formation and antibiotic resistance development are of particular concern. Our technology is based on hypochlorous acid (HOCl) and acetic acid, which are natural chemicals and jointly maximize the antimicrobial effect of our solution. Recent data show that our technology is non-toxic, well tolerated, and with no adverse effects on normal wound healing. Our aim is to develop a range of stable, long-lasting, and effective antimicrobial products for infection prevention and control in combat wounds. Here, we will conduct a phase I/II clinical trial that will enable us to proceed to a phase III clinical trial.

Developing an Ideal Wound Care Platform: Transforming Powder Dressing

Project Team: ULURU

Award Amount: $2.90M

Project Duration: 36 months

Project Objective: Transforming Powder Dressing provides a simple, cost-effective portable solution that is easy to administer as close to the site of injury as possible, prevents infections and complications, and enables early healing. Its drug delivery capacity enables its use as a flexible, customizable platform for wound healing across various wound etiologies and stages of a wound’s evolution.