This Company's Medical Device Could Be A Game Changer For The Military

For years, technology has been key to enhancing soldiers’ tactical ability by helping administer fast and effective medical care to military personnel — especially on the front line.

Access to cutting-edge, combat-compatible medical technology can very often be the deciding factor on the battlefield — making the critical difference in a medical case of life and death.

Technology has also proven to be highly effective in enhancing training in the intelligence, surveillance and reconnaissance (ISR) training environment.

Unlike conventional technologies, medical products for the military must meet a specific set of criteria. They must be portable, lightweight and easy to use as they may be used by nonmedical professionals during training and emergencies.

From combat injuries to migraines, several companies including ZOLL Medical Corp. ZOLL, Quick Tube Medical, North American Rescue, PerSys Medical and QB Medical have developed products that are enhancing training or saving lives on the front line.

Game Changer?

The recent selection of electroCore Inc.’s ECOR noninvasive vagus nerve stimulation product — gammaCore™ (nVNS) — for study by the U.S. Department of Defense (DOD) has thrown the spotlight on a new product that could potentially revolutionize the industry and join the military’s collection of high-performance medical and training products.

The U.S. Food and Drug Administration (FDA)-approved gammaCore™ nVNS has been selected for further study under the DOD’s Biotech Optimized for Operational Solutions and Tactics (BOOST) program.

The program, expected to run through September 2023, is funded through BOOST and the Defense Advanced Research Projects Agency (DARPA).

The BOOST research program will be conducted under the leadership of the 711 Human Performance Wing, the U.S. Air Force’s performance optimization branch, in an effort to optimize and validate the ability of nVNS to enhance training in the ISR training environment.

The BOOST program hopes to build upon completed work by electroCore, which reported that preliminary studies have shown:

• nVNS therapy produced 20% acceleration in training.
• nVNS produced a 35% improvement in memory retention during ISR training.
• Participants exhibited a 25% improvement in attention and mood.

Should the BOOST Program confirm the initial findings, the project calls for electroCore to be prepared to provide field-ready devices to the Air Force in the second half of 2023.

electroCore also says that gammaCore™ nVNS has the potential to be used to enhance training for the Air Force, which would expand the utility of nVNS beyond its approved functions. This could potentially help launch electroCore into other branches of the military and government.

• gammaCore™ has been cleared by the FDA for the prevention and treatment of primary headaches in adults and adolescents.
• Cluster headaches and migraines are estimated to affect more than 39 million adults in the U.S.
• The gammaCore™ device is complementary to existing care; it is not a drug.
• This year, the FDA granted breakthrough device designation to gammaCore™ to help treat post-traumatic stress disorder (PTSD).
• electroCore was granted FDA Emergency Use Authorization for the use of gammaCore Sapphire™ CV for the acute treatment of asthma exacerbations in known or suspected COVID-19 patients.

Positive Findings?

A report published in the National Library of Medicine of the National Center for Biotechnology Information reports that gammaCore™ nVNS seems to back the product's efficacy.

The report said gammaCore™ nVNS has the potential to prevent migraine days in patients based on mechanistic rationale and pilot clinical data.

A multicenter study into the product included a four-week run-in period, a 12-week double-blind period of randomized treatment with nVNS or sham and a 24-week open-label period of nVNS.

With players like Tivic Health Systems Inc. TIVC, BioSig Technologies Inc. BSGM and Electromed Inc. ELMD fighting for a share of the market, the BOOST research program could present a unique opportunity for electroCore to expand its service offering.

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Featured photo by Israel Palacio on Unsplash