On 1/29/19 we sent a letter to the FDA urging them to reject Helius Medical’s (HSDT) marketing application for their PoNS device. It’s proven to be a safe device, but efficacy has not been proven in our opinion.
The following is our letter we sent to the FDA along with our report on HSDT:
Information-Medical Devices / Radiation Products
Division of Industry and Consumer Education
CDRH-Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
January 29, 2019
Re: Helius Medical Technologies, Inc. 510K Submission; DUNS Number 079853934
To Whom It May Concern:
We urge the FDA to reject the PoNS device 510(k) submission from Helius Medical Technologies (stock symbol: HSDT) that is currently going through an FDA review. The analysis from our attached report shows that the results of the clinical studies are significantly affected by a placebo effect and we believe the patient improvements are in actuality coming from the accompanying physical therapy sessions, not the device. We believe approving the PoNS would mislead people suffering from chronic balance deficit into using this ineffective and expensive device.
We hope that the information in our report will aid in your decision process of whether to approve or reject the marketing application of the PoNS device.
Sincerely,
White Diamond Research
Head Analyst Adam Gefvert, CFA