By Omar Ford
Helius Medical Technologies Inc. (Newton, Pa.) reported it is making progress with its attempts to bring a neuromodulation device to market that can help treat symptoms in multiple sclerosis (MS) patients. On Monday, the company said a pilot study evaluating its investigational portable neuromodulation stimulator (Pons) used to help treat the symptoms of MS, met all of its study objectives. A total of 14 subjects (seven-active and seven-sham control) received treatment with the non-invasive brain stimulation technology and concomitant physiotherapy.
The independent trial took place at the Montreal Neurological Institute and Hospital and Concordia University's Perform Center (all Montreal). The study objectives were to explore the potential beneficial effects of the Pons device and to provide data to be used for the design of future studies to support requests for marketing authorization. The study included the use of functional MRI (fMRI) to measure the effect of Pons while performing tasks with, and without, stimulation.
The Pons device is a non-invasive means for delivering neurostimulation through the tongue.
"The results by far exceeded our expectations," Philippe Deschamps, president/CEO of Helius told Medical Device Daily. "This is the first tangible and physical scientific proof that we are doing something to the brain through the tongue, which is obviously a major finding for us."
The results show fMRI results were significantly different between the active group (who manifested brain function comparable to healthy subjects following treatment) and the control group. (p<0.02).The Pons stimulation group showed a statistically significant improvement (p<.001 in balance as measured by the Sensory Organization Test) scores, which were compared at baseline and week 14. The change in the control group did not reach the same level of statistical significance (p >.05). Other results suggest the Pons device may be facilitating neural plasticity.
The company plans to use the results to help craft and develop a trial that would inevitably lead it to obtaining a nod from the FDA for an MS indication. Factors to improve recruitment, screening, randomization and execution were identified and will be considered in the design of future MS studies. The results included a power analysis suggesting a sample size of 128 subjects (64 active, 64-sham) would be suitable for a definitive MS study.
Other uses for the technology
But the company isn't settling for just one indication.
Back in August, Helius revealed its partnership with the U.S. Army Medical Research and Materiel Command (USAMRMC) to investigate the safety and effectiveness of the Pons device for the treatment of balance disorder in patients with mild-to-moderate traumatic brain injury (Medical Device Daily, Aug. 13, 2015).
The purpose of the partnership with the military is to demonstrate that cranial nerve noninvasive neuromodulation, which combines the Pons device with a physiotherapy regiment, could provide new rehabilitative opportunities for patients suffering from chronic symptoms.
Deschamps gave an update on the company's bid for the indication.
"We've begun the registrational trial and we're recruiting patients as we speak," he said. "We expect the trial will be completed by the end of April or possibly early May. We expect maybe this time next year we would be cleared for marketing in U.S. for the traumatic brain injury indication in the U.S."
The seeds for the company and the device were planted in the '90s when Paul Bach-y-Rita founded the Tactile Communication and Neurorehabilitation Laboratory (TCNL) at the University of Wisconsin-Madison. He was joined by Kurt Kaczmarek, Mitchell Tyler and Yuri Danilov. This team pioneered work in neuroplasticity and expanded research into the development of sensory substitution devices.
According to the company's website, by the late 2000s, TCNL had analyzed the first pilot data to support cranial nerve noninvasive neuromodulation (CN-NINM) and found that whole-tongue electrotactile stimulation without sensory substitution significantly improves the effectiveness of therapeutic exercises in people with vestibular disorders. As a result, the team developed and built the Pons device, the active factor in CN-NINM intervention, and tested approximately 100 units.
Kaczmarek, Tyler and Danilov organized Advanced Neurorehabilitation LLC (ANR; Madison, Wis.) to manage neurorehabilitation technologies developed at TCNL. In 2013, ANR and MPJ Healthcare formed a joint venture called Neurohabilitation Corporation to develop and commercialize the Pons device. Through a reverse merger in 2014, Helius acquired Neurohabilitation as a wholly owned division, according to its website.
'I'm pleased about where we stand today," Deschamps said. "We've reached about all of our milestones thus far and the most important work we're doing now is to complete the clinical trial work and to do fantastic and high end science to demonstrate this technology has a very valid medical outcome."
Shares of Helius (OTCMKTS:HSDT) were up 36.72 percent trading at 83 cents on Monday.
If the company is successful with commercialization of its device then it would compete in a quickly growing neuromodulation market. The neuromodulation space is projected to reach $6.20 billion by 2020, at a CAGR of 11.2 percent during the forecast period, according to a report from Research and Markets.
Medtronic (Dublin), Boston Scientific (Marlborough, Mass.), St. Jude Medical (St. Paul, Minn.), Synapse Biomedical (Oberlin, Ohio), Nevro (Menlo Park, Calif.), Neurosigma (Los Angeles), Neuropace (Mountain View, Calif.), Neuronetics (Malvern, Pa.), Cyberonics (Houston) and Biocontrol Medical (Minneapolis) are all prominent players in the neuromodulation space. //
Published November 3, 2015