Helius enters clinical trial of its PoNS brain stimulation device to treat traumatic brain injury

Helius Medical Technologies is set to begin a Phase III clinical trial with the U.S. Army Medical Research and Materiel Command for its Portable Neuromodulation Stimulator (PoNS), which is designed to treat balance disorder for patients with traumatic brain injury.

The PoNS 4.0 device is a noninvasive brain stimulation treatment for patients with mild or moderate TBI that induces neuromodulation by stimulating the cranial nerves found in the tongue, the company said. The trial is expected to be the basis for the company to seek both Canadian and U.S. regulatory approval to market the device.

Researchers believe the tongue is a gateway to the brain and could be a natural, noninvasive approach to neural stimulation. The tongue is anatomically unique with thousands of nerve fibers that are interconnected to the brainstem by two cranial nerves.

"Traumatic Brain Injury (TBI) remains a serious public health problem both for the military and civilian populations for which there have been almost no new developments in treatment since the introduction of physical therapy several decades ago," Helius CEO Philippe Deschamps said in a statement. "There is also a large population of TBI patients who develop chronic symptoms, for which traditional physical therapy has proven ineffective."

The primary endpoint of the 7-month study is to demonstrate improvement in chronic balance deficit as measured by a sensory organization test. About 120 subjects are expected to participate in the study at two sites in the U.S. and one in Canada.

Earlier this summer, Helius raised $1.8 million in a private stock placement. Backers of the Newtown, PA-based company include television and radio personality Montel Williams, who was diagnosed with multiple sclerosis in 1999.

- check out the release