In a report issued on January 25, Sean Lavin from BTIG maintained a Buy rating on Helius Medical Technologies (HSDT – Research Report), with a price target of $14. The company’s shares closed on Friday at $7.13, close to its 52-week low of $6.72.
Lavin observed:
“Technologies announced that FDA sent the company a letter asking for more information on its PoNS device 510(k) submission and request for de novo classification. Importantly, management believes it has the needed information and emphasized confidence in ability to answer the questions. We believe the co. will be working with FDA to ensure satisfactory responses. This negative update is likely to delay potential PoNS clearance – we had anticipated an FDA decision in Q1. At this early stage, it is not clear to us how quickly HSDT will be able to turn in a response, but we now see Q2 or even Q3 potential clearance as more likely. We are disappointed and think this increases the likelihood of further FDA requests for new data or even a denial, but still think approval is more likely than not (no longer 85% without more data as we previously thought).”
According to TipRanks.com, Lavin is a 5-star analyst with an average return of 9.7%and a 58.4% success rate. Lavin covers the Healthcare sector, focusing on stocks such as Establishment Labs Holdings Inc, Tactile Systems Technology, and Obalon Therapeutics Inc.
The word on The Street in general, suggests a Moderate Buy analyst consensus rating for Helius Medical Technologies with a $14 average price target.
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The company has a one-year high of $13.20 and a one-year low of $6.72. Currently, Helius Medical Technologies has an average volume of 106.7K.
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Helius Medical Technologies, Inc. is a medical technology company, which engages in the development of products for the treatment of neurological symptoms caused by disease and trauma. It focuses on licensing and acquiring platform technologies that amplify the brain’s ability to heal itself.