Helius Medical Kicks Off Clinical Trial to Investigate its Portable Neuromodulation Stimulator

Newtown, Pa.-based Helius Medical Technologies and the U.S. Army Medical Research and Materiel Command (USAMRMC) launched a Phase 3 clinical trial to investigate the safety and effectiveness of the Portable Neuromodulation Stimulator (PoNS) 4.0 device, a non-invasive brain stimulation device that is being developed for the treatment of balance disorder in patients with mild-to-moderate traumatic brain injury. The trial is intended to serve as the basis for seeking Canadian and U.S. marketing approvals of the PoNS, an investigational medical device that is designed to induce neuromodulation by stimulating the cranial nerves found in the tongue.

The trial, a double-blind, randomized, sham-controlled study of the safety and effectiveness of the PoNS device for cranial nerve noninvasive neuromodulation training in subjects with a chronic balance deficit due to moderate traumatic brain injury, is a seven-month study being conducted at three sites: the Montreal (Quebec, Canada) Neurofeedback Center; the Oregon Health & Science University (OHSU) Center for Regenerative Medicine in Portland; and the Orlando Regional Medical Center (ORMC) in Florida.

A total of 120 subjects will participate in the study. The primary endpoint at five weeks is improvement in chronic balance deficit as analyzed by the sensory organization test. The purpose of the study is to demonstrate that cranial nerve noninvasive neuromodulation, which combines the PoNS device with a unique physiotherapy regiment, may provide new rehabilitative opportunities for patients suffering from chronic symptoms.

“Together with our partners at the USAMRMC, we are very pleased to announce the launch of our pivotal Phase 3 mTBI trial today,” said Helius’ CEO, Philippe Deschamps. “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. There is also a large population of TBI patients who develop chronic symptoms, for which traditional physical therapy has proven ineffective.”

“We are excited to begin the clinical trials for the PoNS device as a potential treatment for symptoms of TBI in our wounded warriors,” said Kenneth Bertram, M.D., principal assistant for acquisition, USAMRMC. “We are committed to the laboratory and clinical research needed to improve the treatment of brain injury.”

The first site to begin recruitment and screening will be the Montreal Neurofeedback Center, a private, multi-disciplinary center offering neurofeedback and biofeedback training to reduce or eliminate everyday symptoms of stress, as well as brain based and functional disorders.

“TBI has always been an issue of high unmet need in Canada and in the United States, and we are proud and excited for the opportunity to lead the clinical development of this breakthrough technology,” said Alain Ptito, M.D., Ph.D., neuropsychologist and principal investigator of the study.

The Portable Neuromodulation Stimulator (PoNS) device is an investigational medical device being studied for the treatment of neurological symptoms caused by disease or trauma. The PoNS is currently being studied in the United States and Canada for the treatment of balance disorder for subjects with mild to moderate Traumatic Brain Injury , and in Canada for the treatment of gait and balance disorder for subjects with multiple sclerosis.

The PoNS device is a non-invasive means for delivering neurostimulation through the tongue. Researchers believe that use of the tongue as a gateway to the brain may be one of the most natural, non-invasive and direct ways to stimulate the brain. The tongue is anatomically unique, being richly innervated by thousands of nerve fibers and interconnected to the brainstem by two major cranial nerves.

Approximately 5.3 million Americans are living with a TBI-related disability, with an annual total cost in 2010 estimated at $76.5 billion, including $11.5 billion in direct medical costs and $64.8 billion in indirect costs including lost wages, lost productivity, and nonmedical expenditures. There are 1.7 million new TBI cases per year in the United States, 20-30 percent of which will have chronic disability associated with them.

The Department of Defense reports approximately 200,000 cases of TBI in troops between 2000 and June 2010.

According to the Brain Injury Society of Toronto, including concussions, 587,025 Canadians acquire a brain injury each year. The annual incidence of TBI in Canada is greater than that of multiple sclerosis, spinal cord Injury, HIV/AIDS and breast cancer combined.

Helius Medical Technologies is working on unique and noninvasive platform technologies that amplify the brain’s ability to heal itself. The company intends to file for U.S. Food and Drug Administration clearance for the PoNS device.

The Center for Regenerative Medicine at OHSU was created in 2012 and is dedicated to the translation of regenerative therapies from the bench to the clinic and battlefield. Its research is focused on developing novel biomaterials for the replacement of damaged tissues, perfecting cell-based therapies to regenerate a variety of damaged organs, and engineering enhancements to medical devices such as vascular stents.

The Orlando Regional Medical Center is a 808-bed tertiary hospital in downtown Orlando, Florida and is the flagship medical center of Orlando Health. ORMC provides a wide range of medical services to treat memory disorder, epilepsy and is home to specialty centers, including the Orlando Health Rehabilitation Institute (OHRI), which includes the Brain Injury Rehabilitation Program (BIRC) and outpatient surgery services.