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FDA Requests Additional Information from Helius for MS Device

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FDA's query for additional information includes requests for additional analysis of clinical data and proposes certain labeling modifications.

Helius Medical Technologies has received a request from FDA for additional information for the Portable Neuromodulation Stimulator (PoNS).

The Newton, PA-based company is positioning PoNs as a potential treatment for gait deficit due to symptoms of Multiple Sclerosis (MS), to be used as an adjunct to a supervised therapeutic exercise program in patients over 18 years of age.

FDA granted the company breakthrough designation for PoNs in May. Helius then submitted its de novo classification and clearance of the device August 4. The company noted FDA’s request for additional information was received about 75 days from the submission date, which is consistent with FDA’s expected timing for review of a Breakthrough Designated product, such as the PoNS device.

The federal agency’s query for additional information includes requests for additional analysis of clinical data and proposes certain labeling modifications.

“As we continue to work towards our goal of bringing our PoNS technology to the aid of U.S. patients suffering from gait deficit due to MS-related symptoms, Helius is committed to preparing and submitting our response to FDA’s request for additional information as thoroughly and efficiently as possible, so that the Agency can resume its review process,” said Dane Andreeff, Interim President and CEO of Helius. “Importantly, we believe the PoNS device’s Breakthrough Designation status will provide Helius with the opportunity to work efficiently with the Agency as we address the request and plan our formal response.”

FDA’s request comes hot on the heels of Helius announcing the formation of an MS scientific advisory board. Helius’s board has nine members that include researchers, clinicians, and medical doctors with a body of work in MS and neurorehabilitation. The main purpose of the board is to advise the company on aspects of its commercial, reimbursement, and market access strategies for PoNs.

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