U.S. Army Medical Research & Development Command - Medical Technology Transfer Office (MTT)

U.S. Army Medical Research and Development Command seeks additional licensees for the Body Cooling System; a lightweight portable apparatus that reduces a person's core temperature by transferring heat through the hands and forearm into cold water.

The Body Cooling System can be used in high risk heat environments to decrease the incidence of heat-related illnesses by reducing the body’s core temperature, therefore extending heat tolerance and increasing total work time. It is ideal for local and professional sports teams, athletic/endurance events such as marathons, training situations, firefighting, and any strenuous activity commonly performed in hot environments.

Benefits

• Reduces core body temperature 1.0°C in 3-10 minutes
• Minimizes heat-related illnesses (Exertional Heat Stroke is usually among the top 3 causes of death in athletes)
• Allows for easy transportation, setup, and storage
• Accommodates 6 adults at a time
• Integrated thermometer monitors water temperature
• Assembly and use instructions stenciled on the waterproof, flexible fabric
• Holds up to 48 gallons of water, equaling 6 inches of water in the reservoir
• Legs adjust to provide ideal height for users
• Inexpensive to manufacture
• Successfully implemented in military settings

The U.S. Army seeks patent licensees for an antimicrobial decapeptide system that augments our natural immune responses to prevent and disrupt biofilm formation. This invention is especially well suited for the prevention and treatment of plaque-related oral diseases. In Phase 2a clinical trials Plaktak™ gum demonstrated safety and efficacy against plaque after 2-4 weeks of treatment in people with gingivitis. Background & Technology KSL-W is a member of a decapeptide family with demonstrated effectiveness to prevent biofilm formation on teeth, inhibit the growth of oral microorganisms, and reduce the development of plaque. KSL-W mimics the body’s own defense system – namely it exhibits selective toxicity for prokaryotes. The result is efficacy against supragingival plaque bacteria, but little effect on normal oral flora and low potential for drug resistance. KSL–W is readily adsorbed to tooth-like materials and effectively desorbed over time; this peptide also has good stability in saliva. The U.S. Army has formulated this peptide into an antiplaque chewing gum (Plaktak™) for sustained and improved delivery in the mouth. KSL-W readily degrades in gastro-intestinal environments causing no harm to the intestinal flora. Double-blind, randomized, controlled, dose escalation clinical trials of Plaktak™ demonstrated:

Phase 1 single dose safety and tolerability, and

Phase 2a multiple doses safety, tolerability, and proof of concept efficacy against plaque after

2-4 weeks of active treatment in a gingivitis population.

No serious adverse events occurred in both single and multiple doses trials.

Benefits

Augments natural defense:

KSL-W acts in a manner similar to the body’s defenses and augments those systems in a manner that targets threats while maintaining beneficial oral flora.

Broad Spectrum Effectiveness:

Efficacious against the following:

Plaque-causing bacteria: Actinomyces, Fusobacterium

Cariogenic bacteria: Streptococcus mutans, S. sobrinus, and Lactobacillus acidophilus

Fungi: Candida albicans Virus: Herpes simplex virus (preliminary data) Plaktak™ may also have anti-inflammatory capabilities by sequestering endotoxins associated with Gram-negative periodontal pathogens.

CoWEDA is a software tool designed to assist in the selection of clothing ensembles for different levels of cold exposure using menus of clothing items. By integrating a thermoregulatory model, physiological criteria, and clothing algorithms into a user-friendly application, it relates the clothing items to the physiology consequences at anticipated activity and environmental conditions.

The Need
Cold stress degrades performance, potentially resulting in injuries and casualties. Proper selection of cold weather ensembles is the primary prevention strategy. At present, the evaluation and selection of cold weather ensembles are often based on anecdotal experiences, or simple charts and tables which do not fully address the need for cold protection.

Benefits

• CoWEDA allows users to build their own ensembles from their clothing inventory (e.g., jacket, gloves and boots), and then interprets their selection in the context of cold exposure risks.
• It guides users to select the most appropriate clothing items to optimize human performance and mitigate risks of frostbite and hypothermia.

EC Temp utilizes a mathematical process to calculate the change in core body temperature based on heart rate time series data. No temperature sensor is needed. Talk to licensing agent charles.b.sajonia.ctr@mail.mil if thermoregulation, core body temperature, heat illness and performance enhancement technologies matter to you.  EC Temp utilizes a mathematical process to calculate the change in core body temperature based on heart rate time series data.  

Heat stroke is one of the most preventable deaths in our athletic population. Field testing has demonstrated accurate temperature estimates using ECTemp even when operated 24/7 for several days. With this new capability, an athlete or worker can be alerted if and when a predicted core body temperature exceeds a predetermined threshold, thus avoiding potential heat illness or undue stress that would impact future performance.

Benefits:

• Easy to implement algorithm can be incorporated in commercial heart rate monitors to provide a value added feature in the otherwise crowded market;
• Provides valuable data to help athletes, coaches, workers, and supervisors optimize performance and better manage work-rest cycles;
• Core body temperature can be displayed in real time on many devices, such as wrist worn displays, smartphones, or heads up displays;
• Can be used during activity for real-time data and/or post activity for analysis.

The current prototype includes an acuity task, contrast sensitivity task, glare discomfort task, and target detection task. The prototype device was designed for testing the impact of various glare conditions on healthy subjects. Talk to licensing agent charles.b.sajonia.ctr@mail.mil if vision and performance enhancement and technologies matter to you.

The Glare Testing Device measures visual performance and discomfort under various glare conditions. The invention includes broader applications. For example, it could be used to identify pre‐cataract glare related issues which would warrant intraocular lens surgery. The device could be useful in investigating the side‐effects of refractive surgical procedures and identifying suitable candidates for different refractive surgeries. It also could be useful in identifying glare‐related performance issues in drivers and pilots, both for civilian and military screening and licensing procedures. 

 

The invention encompasses intravenous pharmaceutical compositions containing omega-3 fatty acids and methods of treating traumatic brain injury (TBI), traumatic spinal cord injury, and stroke as described in issued US Patent 9,675,572

Benefits:
• Mitigation of symptoms associated with TBI, spinal cord injury, and/or stroke by administration of omega-3 fatty acid compositions
• Omega-3 fatty acids are effective agents in reducing the neuronal damage, and reducing brain oxidative stress.

Applications:
• Therapeutic intervention to prevent secondary neuronal damage and enhance recovery in TBI and spinal cord injury patients
• Therapy is effective in all types of TBI including mild TBI often labeled as “concussions” which constitute approximately 80% of all cases

Laboratory Reference: USUHS 12-23

The technology provides evidence that gene therapy using an AAV8 vector containing a paraoxonase 1 variant has the potential to protect soldiers and medical personnel against G-type nerve agents and threats during medical and military operations. The tech will also protect agricultural workers from organophosphate compound toxicity without the side effects of inorganic chemical therapies. Contact Dave Humphrey, david.h.humphrey7.civ@mail.mil or 301-619-6975, for more information.

The Market Need
Nerve agents are colorless, tasteless, and odorless organophosphate compounds used as invisible chemical weapons. They are known to inhibit acetylcholinesterase (AChE) and disrupt the normal functioning of the central nervous system inducing seizures and causing rapid death by respiratory paralysis. There are a few inorganic chemical therapies/antidotes available for protection against nerve agents. However, the potential antidotes of G series nerve agents cannot prevent brain damage due to their inability to cross the blood-brain barrier and often come with undesired side-effects such as difficulty breathing and behavior abnormalities. Pesticides, which also contain organophosphate compounds, are less toxic than nerve agents but are believed to be responsible for nearly 250,000 deaths in developing countries each year. Therefore, identification of new therapeutic approaches with safe and broad-spectrum efficacy is essential to offer complete protection against organophosphate nerve agents.

The Technology
RICD inventors developed an adeno-virus 8 (AAV8)-mediated paraoxonase 1 variant gene therapy that has increased catalytic efficiency against G-series nerve agents. This therapy provides safe, long-term protection against nerve agents. Based on the results obtained from a mouse model system, just one intramuscular shot of a therapeutic formulation given to a subject three days before going to the battlefield will offer complete protection against G-type nerve agents from 6 months to potentially the life-span of the animal. 

Highlighted Benefits

• Technology is a viable option for the abundant expression of recombinant paraoxonase 1 variant, a promising catalytic bioscavenger that hydrolyzes Gtype nerve agents in the blood stream.
• In a mouse model, one intramuscular administration provides protection for 6 months to potentially the entire life span of the animal with no signs of toxicity Stage of Development A single injection of liver-specific AAV8 viral particles loaded with paraoxonase 1 variant gene in mice resulted in expression and secretion of recombinant protein in milligram quantities which has the ability to break down G-type agents into biologically inactive products. Mice containing milligram concentrations of recombinant paraoxonase 1 variant in their blood displayed no clinical signs of toxcity based on blood and serum chemistry profiles. The circulating recombinant protein may be able to protect humans against G-type nerve agents for several weeks to months with a single administration, a significant improvement over existing, post exposure therapies.

Stage of Development
A single injection of liver-specific AAV8 viral particles loaded with paraoxonase 1 variant gene in mice resulted in expression and secretion of recombinant protein in milligram quantities which has the ability to break down G-type agents into biologically inactive products. Mice containing milligram concentrations of recombinant paraoxonase 1 variant in their blood displayed no clinical signs of toxcity based on blood and serum chemistry profiles. The circulating recombinant protein may be able to protect humans against G-type nerve agents for several weeks to months with a single administration, a significant improvement over existing, post exposure therapies.

This smartphone app uses sleep-wake history and caffeine consumption along with measurements of past performance as inputs to predict future alertness and cognitive performance levels. If sleep, alertness and performance enhancement technologies matter to you, contact licensing agent charles.b.sajonia.ctr@mail.mil.  

Sleep loss impairs alertness and cognitive performance. 2B-Alert Smartphone App is fully functional software available to companies that want to incorporate this app into their software product. Past and current performance are measured using a psychomotor vigilance task (PVT) test for accurate, objective assessment.

The system’s user-friendly interface allows for user evaluation of the effects of caffeine consumption and/or nap schedules to optimize future performance at the desired times. The app includes a visual reaction time PVT test, which is the gold standard for estimating cognitive performance. An intuitive graphical user interface allows the user and, if desired, others such as a supervisor or safety officer, to view predicted cognitive performance levels at desired future times.

Applications:

• Consumer Products — added functionality for existing activity tracking and sleep monitoring devices (e.g., alertness test and nap/caffeine planning tool);
• Transportation Industry — safety tool for airlines, railways, etc.;
• Coffee Industry — promotional item for demonstrating benefits gained; Clinic/Research — tool for pharma to study dosage impact on alertness and cognitive performance, tool for collecting additional objective data for sleep labs, etc.

Benefits:

• User-friendly, intuitive software available for transfer to a commercial partner;
• Built-in PVT test for accurate, objective assessment of current alertness;
• User can identify schedule of caffeine and/or nap to achieve peak alertness and cognitive performance at desired time; Includes a caffeine optimization algorithm 

 

The Nutrient Delivery System, is a simple add-on to personal hydration systems (PHS) that provides nutrition on-the-move. The user has on-demand access to a beverage mixed to their current personal taste. This system eliminates cumbersome mixing. An important aspect of the invention is to introduce the additive of choice into a personal water supply in such a way as to prevent contamination of the water reservoir by the additive. The invention enables the user to consume the additives necessary for their chosen activity while maintaining a reservoir supply of uncontaminated water. The composition of the additives is highly versatile and may include those specific to exercise such as electrolytes, flavoring, carbohydrates, vitamins, etc. Additionally, the device may be used to administer oral medications or dietary supplements.

The Market Need
Personal hydration systems (PHS) are ergonomically designed water bladders with carriers that can be worn individually or integrated with load-bearing equipment or web harness systems. These systems are widely used by soldiers, outdoor recreationists, athletes, and others to proactively maintain hydration levels. While additives, such as electrolytes, flavoring, and carbohydrates are desirable, this can result in the growth of mold and bacteria if added to the reservoir/bladder directly.

Applications
For use with any personal hydration systems

Competition/Collaborators
Numerous gels, powders, and solids are sold in the market space as hydration additives. These are used without an NDS by consuming the product directly from its packaging or by placing the product in a gel flask or water bottle that is separate from the NDS.

Highlighted Benefits

Simple add-on component that can be used with any PHS

Provides nutrition on-the-move

On-demand control of water-to-additive mix ratio

Eliminates cumbersome mixing or package opening

Keeps water reservoir/bladder clean

The PAC hydrogel system has applications in burn and wound healing as well as soft tissue regeneration. Greater stiffness allows for greater durability and easier product application, while controlled degradation rates allow for improved timing of released materials. Because the two layers of the gel remain distinct, this allows for separate functions within a single gel. For example, the alginate domain can be loaded with an antimicrobial agent for sustained release in vivo and subsequent infection control, whereas the plasma domain can be loaded with therapeutic stem cells to enable cell proliferation and tissue remodeling. Contact Barry Datlof, 301‐619‐0033 or Barry.M.Datlof.civ@mail.mil

The Market Need
At the heart of tissue engineering is the challenge to optimize scaffolding material with cellular constructs. Blood plasma-based biomaterials have been extensively explored, as they mimic in vivo clots that form after any injury and are therefore a natural choice for stem cell delivery or to initiate regenerative processes, notably angiogenesis. However, they cannot be used to deliver exogenous materials and are limited by their sub-optimal degradation rates, mechanical properties and insufficient durability. Alginate gels are well known for their rigidity and controlled release properties. But they lack the molecular domains to enable proper cell adhesion and growth necessary for cell delivery and tissue engineering applications.

The Technology
The inventors have developed a plasma alginate composite (PAC) matrix that, combined, address the limitations of each material alone. In the presence of calcium and without added thrombin, a plasmaalginate composite gel is formed into a combined product with separate gel domains. Optimizing the timing and order of component mixing for the PAC composite gels is the key to this invention.

Competition
Genetic Engineering & Biotechnology News (GEN) estimated a $9 billion "tissue engineering" marketplace and identified 49 companies, of which 21 were currently selling products. Some of those companies include Allergan, CryolifeMiMedx Group, RTI Surgical and Vericel. (February 2019, Vol. 39 No. 2). Technologies that address skin regeneration and wound healing are complex and rapidly evolving. There are 4 main approaches to delivering the cells and growth factors necessary to replicate and repair damaged tissues – topical spray, direct injection, systemic delivery and cell-seeded scaffolds.

Highlighted Benefits

• Decouples degradation rates and stiffness, allowing for constants degradation despite an order of magnitude increase in stiffness, leading to easier manipulation for clinical applications Adipose Stem Cells (ASC) cultured within the PAC gels remain similar in behavior to plasma-only gels.
• ASCs cultured in the PAC gels do not undergo significant differentiation, and stemness markers are maintained, allowing induced differentiation in in vitro or in vivo applications.
• PACs exhibit improved mechanical properties and benefit from facile fabrication