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HSDT

Helius Medical

$2.30

0.28 (13.86%)

06:23
04/16/19
04/16
06:23
04/16/19
06:23

Helius Medical downgraded to Neutral from Buy at BTIG

BTIG analyst Sean Lavin downgraded Helius Medical to Neutral following last week's FDA announcement denying the company the request for de novo classification and 510(k) clearance for its Portable Neuromodulation Stimulator, or PoNS device. The analyst notes that there was some risk around the decision, but sees the decision as surprising since he believes that contrary to the FDA thinking, the company's submission "did separate" the impacts of the device and physical therapy toward symptom improvements. Lavin contends that Helius Medical may now have to conduct a new prospective trial which would require a "good deal of time and capital", adding that "significant dilution may be necessary."

HSDT Helius Medical
$2.30

0.28 (13.86%)

03/05/19
OPCO
03/05/19
INITIATION
Target $10
OPCO
Outperform
Helius Medical initiated with an Outperform at Oppenheimer
Oppenheimer analyst Steven Lichtman started Helius Medical with an Outperform rating and $10 price target. While FDA approval of the company's Portable Neuromodulation Stimulator device is still pending and market development work remains, the "opportunity ahead is significant," Lichtman tells investors in a research note. He points out that 2.1M people in the U.S. suffer from chronic symptoms of traumatic brain injury with a primary complication of balance or gait disability. The analyst sees 2019 as a key year for Helius as it awaits FDA approval and begins a rollout in Canada.
04/11/19
OPCO
04/11/19
DOWNGRADE
OPCO
Perform
Helius Medical downgraded to Perform from Outperform at Oppenheimer
04/11/19
04/11/19
DOWNGRADE

Perform
Helius Medical downgraded to Perform on FDA PoNS update at Oppenheimer
As previously reported, Oppenheimer analyst Steven Lichtman downgraded Helius Medical to Perform from Outperform following the update on the FDA submission for the company's PoNS, with the agency declining approval and more data needed for resubmission. The next key milestones include the update on U.S. pathway following another expected FDA meeting and potential approvals in Europe/Australia, he contends.
04/16/19
BTIG
04/16/19
DOWNGRADE
BTIG
Neutral
Helius Medical downgraded to Neutral from Buy at BTIG

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F

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CLB

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