Welcome to our dedicated page for Third Harmonic Bio SEC filings (Ticker: THRD), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
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Helius Medical Technologies (HSDT) filed an 8-K announcing topline results from its Stroke Registrational Program (SRP) for the Portable Neuromodulation Stimulator (PoNS).
- Three aligned trials (1 double-blind RCT, 1 single-arm sponsor study, 1 investigator-initiated RCT) enrolled 159 chronic-stroke patients; 130 completed 12-week treatment and 12-week follow-up at 10 U.S./Canadian sites.
- The pivotal double-blind RCT met its primary endpoint, delivering statistically significant gait/balance improvement versus sham, both alone and when pooled with open-label data adjusted for baseline differences.
- Multiplicity-controlled secondary endpoints confirmed durability at 12 weeks and reduced fall risk; all studies reported minimal adverse events and good tolerability.
Based on these data, Helius intends to submit a marketing application to the U.S. FDA under its existing Breakthrough Device Designation for a stroke-related gait and balance indication.
The filing reiterates forward-looking risks, including capital requirements, reimbursement access, manufacturing, IP protection and the outcome of regulatory review.
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