This Report on Helius Medical Tech Threatens Treatment for Cerebral Palsy (T.HSM)

I am writing to express my disbelief at the recklessness of Mackie’s November 9th research piece, written by Andre Uddin, on Helius Medical Technologies (HSM/HSDT). Helius Medical is a U.S. company pioneering development of a portable neurostimulation device (PoNS) which is showing dramatic promise to significantly improve outcomes of children and adults with brain injury and brain disease, conditions which, until now, have had little to no hope for meaningful improvement. In particular, the PoNS device appears to be an effective treatment for improving gait and balance deficits. In short, it appears to improve ability to walk in people with brain injuries.

I am the mother of a young boy, who has severe cerebral palsy as the result of a compressed umbilical cord at birth resulting in significant oxygen deprivation. Cerebral palsy is an umbrella term for a movement disorder which originates as the result of brain injury. Nearly 800,000 people in the US and 17 million people globally have cerebral palsy; about 40% of those people cannot walk. Currently, about 8,000 babies and infants are diagnosed with the condition each year. While the injury to the brain occurs before the time of birth, the outcomes of the injury often worsen over time, caused by gravity and mechanical forces of an atypically functioning body. There has been no available treatment for brain injuries. Parents of children with cerebral palsy are told that there are interventions, like physical therapy, medications and surgeries, but that nothing can be done to treat the underlying condition.

At eight years old, my son is unable to walk, talk, sit up, or use his hands. He has a tracheostomy, which is a tube in his neck that he uses to breathe, and eats 100% of his food through a tube in his stomach. Despite this, he is a bright and happy boy, who goes to school and communicates on a computer that he controls with his eyes. He is a wonderful little boy trapped in a body that doesn’t work. Like many people with cerebral palsy, my son requires extensive nursing care, many expensive medications and has frequent hospital stays in the intensive care unit due to pneumonias caused by not walking. His annual cost of care is somewhere between $500,000 and $1 million, depending on hospitalizations and surgeries in a given year. My son’s lifetime cost of care is estimated at $14 million, a figure which reflects a fact that I don’t like to think about: his life expectancy is significantly reduced because he does not walk — being confined to a wheelchair is very hard on a child’s heart and lungs.

When I came across the results of the Helius Medical’s pilot study in Russia for children with cerebral palsy on the internet a few months ago, I could not believe what I was seeing. As I looked through the company’s materials and early data, for the first time since my son was born, I felt hope that there might be some treatment to improve his function, and not only his function, but his quality of life and most importantly, his life expectancy. The only way that my son can gain access to the PoNS device is if the FDA approves the device for commercial use and the device is then manufactured for such use.

I had been waiting for months to hear about the release of Helius’ clinical trial data from its traumatic brain injury (TBI) study at the University of Wisconsin. I listened to the company’s call at 8 am EST on November 9th and as I heard the absolutely stunning results, tears rolled down my face. The results were so overwhelmingly positive, that I truly believed my son was one step closer to having a chance to walk.

In summary, the clinical trial data showed that using the PoNS device at high frequency with physical therapy for five weeks resulted in approximately three times the standard improvement seen over a 9 month period using physical therapy alone. A 12 week wash out period showed lasting improvement of the gains. The results of this study are groundbreaking and offer the first glimmer of hope to my family and millions of other families around the world who are affected by cerebral palsy and other types of brain injury.

I was devastated to learn, later in the day, that a research report was published by Andre Uddin, a Mackie analyst, which research report was published fifteen minutes prior to the Helius research presentation call, wherein he announced that Mackie had terminated coverage because Helius’ “pivitol trial failed”. To support his position, Mr. Uddin cherrypicked a minor point in the overall context of the study: the fact that Helius did not meet the primary endpoint in their study, a point which Helius addressed on its November 9th call and about which it gave a credible and scientifically valid reason. However, later in the piece, Mr. Uddin concedes that he believes the FDA will still clear the device, he just thinks the sales of the device might be poor because of the “negative” study results. It is almost impossible to believe that anyone could have reached the conclusion contained is Mr. Uddin’s report, having reviewed the data presented by Helius. One cannot help but wonder what Mr. Uddin had to gain by writing such a piece. It certainly wasn’t the truth.

In thinking about the millions and millions of people whose chances at brain injury rehabilitation have just been capriciously jeopardized by Mr. Uddin’s piece, I can only hope that other market analysts, who are better skilled in analysis of scientific data, will take the time to review the recent Helius clinical trial results and offer a more reasonable and reasoned analysis of the conclusions.