Helius Medical Technologies Inc (HSDT)

[tykundegex]

Quick summary of Helius Medical:

first and only solution indicated for mmTBI
pilot studies for MS, CP, stroke..all with similar results across all symptoms
350k Canadians with mmTBI
1.5MM Americans
120k new cases every year in USA
product stimulates trigeminal nerve via tongue
IP whitespace (tongue-based brain stimulation entirely unexplored before today)
60 patents covering method and utility
increases blood supply to brain
neuromodulation combined with phsy/cog therapy leads to brain rebuilding itself (neurplasticity)
shown efficacious on patients who have undergone every other available therapy, and are no longer improving, even after an average of 4 years since last treatment
study was patients who are all treatment resistant and min 1 year later (chronic symptoms set in, lifetime affliction virtual certainty)
120 person trial
50% of them regained normal balance after the trial
efficacy retained 3mo after last use of device, proving the remedy is permanent
Cleared in Canada, commercialization underway
cleared in Russia (partners in place)
EU clearance submission filed in Dec 2018
AU submitted in May 2019
expect AU verdict in summer 2019
FDA rejected "de novo" classification, so back to FDA around Sept to get detailed guidance
not waiting.. generating a random PT-only trial now
Canada alone is "multi-billion dollar business" just for mmTBI indication
device sales is focus, partners and clinic drive service
2 founding clinics in CA
3 more clinics in CA just signed (now over 50% of population have access)
*data due in summer about patient outcomes*, prelim is encouraging

PoNS is a platform tech
peer-reviewed studies on MS
AU publication on stroke
other neurological conditions likely
$19MM in cash at the end of Q1
$700k in revenue last year
2019 guidance: $1.6-2MM in revenue from the 2 initial CA clinics alone (though they already signed 3 more)
early Aug will report Q2 numbers and update guidance

JMP Conference webcast from June 2019: http://wsw.com/webcast/jmp39/hsdt/index.aspx
Latest Investor deck: https://heliusmedical.com/images/pdf/Presentation/2019/HSDT_Company_Public_Presentation_v_2.1_MLR_Approved_5232019.pdf
Video supposedly showing one child's result from PoNS treatment in Russia: https://vimeo.com/181665292
and to offer an alternative perspective, a bearish SA article from Jan: https://seekingalpha.com/article/4234256-helius-medical-failed-clinical-trial-redacted-data-questionable-leadership-points-ineffective