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Helius Medical Technologies (HSM-T) could be on the verge of revolutionizing the treatment of brain disorders.
Capital Ideas Research talked with Phil Deschamps, the Canadian chief executive officer of Helius Medical, which is based in Newtown, Pa., about the company's flagship product and its potential.
CEO brings experience
Mr. Deschamps is a self-described "health care commercialization guy." Prior to joining Helius, he was the director of neuroscience marketing at Bristol Myers Squibb. Mr. Deschamps is applying his experience to help guide Helius to what he hopes will be U.S. Food and Drug Administration (FDA) clearance of its portable neuromodulation stimulator (PoNS) device, which was developed by scientists at the University of Wisconsin-Madison.
The FDA has deemed Helius' device "first-in-class" meaning there is a 100-per-cent unmet need for people suffering from a variety of brain disorders. The regulatory body has also ruled the company's PoNS is safe and is a non-invasive, "non-significant" risk to patients using it.
"That greatly simplifies the regulatory pathway," Mr. Deschamps says. "It's an efficacy review, it's not a safety review. That means you need much fewer patients. You just have to demonstrate that it works. They already deem it safe."
How PoNS works
When placed in the mouth, the Helius device stimulates cranial nerves in the tongue, in combination with cognitive or physical exercise, to achieve what's called neuroplasticity, which appears to allow the brain to learn or relearn certain bodily functions.
Mr. Deschamps says Helius is unique in that it's the only company researching and developing a treatment that is focused on the tongue's pathway to the brain's learning centres.
"The human body is an electrical appliance," he says. "People have been trying to shock the body for hundreds of years now. We just sort of perfected it by having the insight that the tongue might help be a pathway for communicating with the brain."
Plenty of patents
Mr. Deschamps was aggressive in locking up patents to the technology to prevent potential competitors from encroaching on Helius' territory.
"It wasn't about the device itself, it was about the pathway between the tongue and the brain," he says. "That's where the value is, that's the platform. So I patented the hell out of the tongue to brain pathway."
The tongue/brain relationship develops early
Here's how Mr. Deschamps describes the connection between the tongue and the brain:
"The tongue is very elegantly and naturally tied to the learning centres of your brain by the simple fact that it's your first learning organ so that everything within arm's distance of a baby goes straight into their mouth."
Talk show host says PoNS was life-altering
The apparent effectiveness of the treatment was given a public relations and financial boost when an initially sceptical Montel Williams used the PoNS device to treat his multiple sclerosis. The talk show host says the treatments changed his life. He was so impressed, he invested in the company that eventually became Helius.
How big is the market?
Mr. Deschamps believes there is a global addressable market for people with traumatic brain injury (TBI) or balance problems of about five million. He estimates that market could be worth $5-billion (U.S.). He also thinks the company's technology could be used to treat people with a wide range of diseases affecting the brain.
"Once we're cleared, the gloves are off," Mr. Deschamps says. "Then we can do Parkinson's, depression, post traumatic stress disorder, Alzheimer's, stroke. The number of people that could be treated, the math gets squirrelly. If this palpably works, there's no reason to believe that anybody can't benefit from that. From a potential standpoint, this could be revolutionary."
U.S. military has partnered with Helius
Helius has also caught the eye of the U.S. military, which every year sees about 30,000 of its active soldiers suffer some kind of brain trauma, according to Mr. Deschamps. The U.S. Army is collaborating with Helius on the clinical trial the company is conducting with the FDA. It's also injected $3-million into the project. Helius and the Army recently extended their contract agreement.
A binary result?
Capital Ideas Research contributor Fabrice Taylor owns shares in Helius, which has a market capitalization of about $150-million (Canadian), has met management and visited the company's laboratory in Madison, Wis.
"Helius offers massive upside and downside. We like the risk-reward equation, because our view of the probability of success weighted by the outcome suggests an intelligent bet. We expect the shares to move on anticipation of the results.The rating is speculative. Buy the stock accordingly," Mr. Taylor says.
Special to The Globe and Mail