The FDA Rejects a Therapeutic Device that Stimulates Cranial Nerves


Just one year ago David Chen, a forty-year-old policeman who lives in Toronto, was walking home after playing volleyball. According to a recent article in CBC Canada News, a car accident left him with severe brain damage that reduced his gait to a slow shuffle.

His doctor recommended a new therapy and although David and his family had some reservations about the program, he would do anything to be able to walk freely again. David recently began treatment that consisted of physiotherapy two times each day while using a new therapeutic device.

About The Portable Neuromodulation Stimulator (PoNS) 

The PoNS is non-invasive and improves walking and balance for people who have brain injuries. PoNS stimulates new neural connections in the brain (neuroplasticity) which allows the brain’s nerve cells to compensate for an injury.

The PoNS is held on the tongue emitting electrical impulses that stimulate cranial nerves in the tongue. It is used in conjunction with the patient’s physiotherapy routine. The duration of the program which takes place in Surrey and Montreal is fourteen weeks. The U.S. manufacturer of PoNS, Helius Medical Technologies, is planning to expand into other areas in Canada later this year.

The treatment is administered at a cost of $30,000 which is very seldom approved by general health systems or covered by other types of insurance.

Additional Evidence is Warranted

A neuropsychologist who is a consultant at a private Canadian clinic that participates in the program admits that it is still not known exactly how the device stimulates neuroplasticity in the brain.

Yet there is a serious need for improved therapy, as it is estimated that over 100,000 Canadians are coping with various degrees of brain injury.

The FDA reviewed the Helius application for a full seven months. It only took Health Canada one month to issue a license for PoNS. At the end of the seven months, the FDA rejected the application to license PoNS.

According to a spokesman for Helius, the FDA does not challenge the company’s evidence that study participants showed “significant” benefit from the treatment.

Helius Medical Technologies is Cooperating with the FDA

Helius issued a statement that the FDA did not find “sufficient information” to show whether improvement in a patient’s condition was the result of vigorous physiotherapy or as a response to PoNS.

Although a spokesman for the company admits that the FDA rejection was an unexpected setback, he referred to the success of their two studies with a total of 163 PoNS participants.

Clinical trials were also conducted using the device for people who had been affected by a stroke, and others who had cerebral palsy or multiple sclerosis. According to the company, all participants improved as a result of the treatment.

Helius is prepared to submit additional data to the FDA and is optimistic that PoNS will gain FDA approval.

Celebrities and Hockey Players

Montel Williams, a former TV host, has coped with multiple sclerosis for many years. At first, he was a little skeptical about using PoNS. After trying the device he was so impressed that he invested in the company. The device was featured on several TV shows after Montel began to promote its benefits.

Simon Jodoin, a former junior hockey league champion in Moncton, Canada, posted a GoFundMe page describing his many symptoms resulting from several head injuries. He explained that he is unable to work and cannot afford the $30,000 needed for PoNS treatment.

Simon was overwhelmed with the response that totaled well over $30,000. He hopes that he will soon be one of the many patients whose lives have been improved by the device.

The Right Call

Dr. Charles Tator, head of the Canadian Concussion Centre based in Toronto, believes that the FDA made the right decision in denying Helius a license. Dr. Tator explained that research into deep brain stimulation (neuromodulation) is still in its early stages. He commented that they are only beginning to understand it.

With this in mind, Dr. Tator mentioned Health Canada’s decision to approve a license for PoNS. He spoke of safety, efficacy and whether there was sufficient evidence to warrant a license.

As evidence that Canadians are serious about brain injuries that occur in various high-performance sports, Canada has recently adopted “concussion strategy” for these athletes.

Rose Duesterwald

Rose Duesterwald

Rose became acquainted with Patient Worthy after her husband was diagnosed with Acute Myeloid Leukemia (AML) six years ago. During this period of partial remission, Rose researched investigational drugs to be prepared in the event of a relapse. Her husband died February 12, 2021 with a rare and unexplained occurrence of liver cancer possibly unrelated to AML.

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