The data supports a future FDA submission for PTSD, but no timeline given. Monitor for regulatory updates and peer-reviewed publication. The stock may see near-term momentum on the positive data but lacks a near-term catalyst without a formal FDA submission.
Price Chart
Executive Summary
BrainsWay presented positive real-world data showing 83.5% of comorbid PTSD/MDD patients responded to Deep TMS with a 52% mean symptom reduction. However, the therapy is not yet FDA-cleared for PTSD, limiting immediate commercial impact. The data strengthens the clinical evidence base but does not change near-term revenue or regulatory status.
Key Facts
- 83.5% of 462 comorbid PTSD/MDD patients responded to Deep TMS (≥50% symptom reduction).
- Mean PTSD symptom reduction of 52% (PCL-5).
- 66.6% depression response rate, 27.3% remission rate, mean 50% PHQ-9 reduction.
- Deep TMS is not yet FDA-cleared for PTSD; results are from a retrospective, real-world study.
- BrainsWay has three existing FDA clearances: MDD, OCD, and smoking addiction.
Financial Impact
No immediate revenue impact; potential future upside if FDA clearance for PTSD is pursued and obtained.
Risk Factors
- Deep TMS not FDA-cleared for PTSD; regulatory pathway uncertain.
- Data is retrospective and subject to peer review; may not replicate in prospective trials.
- Competing treatments (e.g., other TMS devices, psychotherapy) may limit market adoption.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3318863 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Sep 8, 2026 24d ago | 6-K | $14.16 $13.63 | ▼ −3.74% | ▼ −3.08% | $12.71 (−10.24%) |
Aug 27, 2026 5w ago | 6-K | $14.40 $14.51 | ▲ +0.76% | ▲ +0.50% | $12.71 (−11.74%) |
Aug 12, 2026 7w ago | 6-K | $16.47 $14.97 | ▼ −9.11% | ▼ −7.14% | $12.71 (−22.83%) |
Aug 12, 2026 7w ago | 6-K | $16.60 $15.17 | ▼ −8.61% | ▼ −8.17% | $12.71 (−23.43%) |
Aug 12, 2026 7w ago | Press Release | $16.60 $15.17 | ▼ −8.61% | ▼ −8.17% | $12.71 (−23.43%) |
Jul 20, 2026 10w ago | 6-K | $16.50 $15.97 | ▼ −3.21% | ▼ −2.79% | $12.71 (−22.97%) |
Jul 16, 2026 11w ago | 6-K | $14.84 $16.51 | ▲ +11.25% | ▲ +12.92% | $12.71 (−14.35%) |
Jun 29, 2026 13w ago | Press Release | $15.17 $16.02 | ▲ +5.60% | ▲ +4.22% | $12.71 (−16.22%) |
Jun 22, 2026 14w ago | 6-K | $14.38 $15.17 | ▲ +5.49% | ▲ +5.95% | $12.71 (−11.61%) |
May 18, 2026 19w ago | Press Release | $14.88 $15.89 | ▲ +6.79% | ▲ +5.17% | $12.71 (−14.58%) |
US Market Status
Subscribe to SecBot
Get Real-Time SEC Filing Intelligence
Comprehensive SEC filing analysis delivered the moment filings hit EDGAR. Sentiment scoring, impact analysis, and actionable insights for every material event.
Try SecBot Free Coming soon: SecBot Pro with alerts, watchlists, and API access