Helius collapses after FDA turns down Pons

Helius Medical Technologies has vowed to continue its quest to obtain de novo 510(k) clearance of its neuromodulation device, but having lost two thirds of its value yesterday when the FDA declined its application the path ahead will not be easily navigated. The portable neuromodulation stimulator, or Pons for short, is intended for patients with balance disorders caused by traumatic brain injury. It sends electrical impulses to the tongue via an electrode array that the patient holds in their mouth; according to Helius, this stimulates cranial nerves and then the brain stem, which controls sensory perception and movement. Helius said the FDA turned Pons down for lack of evidence that the system, rather than physical therapy, was responsible for patients’ approvals in clinical trials. The silver lining, such as it is, is that Helius raised $18.3m in a share offering last November, and with $25.6m in the bank at the end of fiscal 2018 it could theoretically try again. That said, its net loss in 2018 was $28.6m. There is a small amount of revenue coming in, since the device is approved in Canada. A CE mark application is pending.

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