PRESS-RELEASE ·Filed May 1, 2026
Press release · FDA
Actionable Insight ▲ Bullish
The IDE approval is a positive regulatory milestone, but the stock has historically underperformed after similar events. Monitor enrollment updates and interim data; financing needs may cause dilution.
Final — all horizons settled through T+60d ⚠ clustered
NSPR ▼ -42.73% at T+60d
LONG call ✗ call lost -42.73% · α vs SPY -44.58% · entry $1.17 → $0.6701
T+1d
0.00%
call 0.00% · α -0.80%
$1.17
settled 6mo ago
T+5d
+6.84%
call +6.84% · α +3.90%
$1.25
settled 6mo ago
T+20d
-15.38%
call -15.38% · α -21.03%
$0.9900
settled 5mo ago
T+60d
-42.73%
call -42.73% · α -44.58%
$0.6701
settled 3mo ago
Price Chart
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Executive Summary
InspireMD received FDA IDE approval for its CGUARDIANS III pivotal study of the SwitchGuard neuro protection system, advancing its TCAR tool kit with the CGuard Prime stent platform. The company targets U.S. commercial launch in 2027 if approved.
Key Facts
- FDA approved IDE for CGUARDIANS III pivotal study of SwitchGuard NPS
- Study will use next-gen enhancements with CGuard Prime 80 cm stent platform
- Co-lead investigators from CGUARDIANS II will continue
- Targets U.S. commercial launch in 2027, if approved
- Company has history of losses and going concern risk
Financial Impact
No immediate revenue; potential future revenue if approved and commercialized
Risk Factors
- Clinical trial failure or delays
- Need for additional capital raises, causing dilution
- Going concern risk due to negative cash flows
- Historical stock weakness post-filing
Market Snapshot
Exchange
Nasdaq
Sector
Surgical & Medical Instruments & Apparatus
Analyst Consensus
89% bullish (9 analysts)
Investment Themes
Healthcare & Medical Devices
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3286201 |
19 reports for NSPR
63% Hit rate @ T+5 Went positive at some point 7 of 8 best @ T+60▲ +54.19%
Filters
Rows
| Type | Now | ||||
|---|---|---|---|---|---|
Sep 21, 2026 5w ago | 8-K | $0.7500 $0.6895 | ▼ −8.07% | ▼ −7.05% | $0.4500 (−40.00%) |
Sep 21, 2026 5w ago | Press Release | $0.7500 $0.6895 | ▼ −8.07% | ▼ −7.05% | $0.4500 (−40.00%) |
Aug 17, 2026 10w ago | 8-K | $0.8798 $0.8699 | ▲ +1.13% | ▼ −0.07% | $0.4500 (+48.85%) |
Aug 17, 2026 10w ago | Press Release | $0.8798 $0.8699 | ▲ +1.13% | ▼ −0.07% | $0.4500 (+48.85%) |
Aug 10, 2026 11w ago | Press Release | $0.8500 $0.8816 | ▲ +3.72% | ▲ +4.12% | $0.4500 (−47.06%) |
Jul 29, 2026 12w ago | 8-K | $0.6718 $0.7222 | ▲ +7.50% | ▲ +3.88% | $0.4500 (−33.02%) |
Jul 23, 2026 13w ago | 8-K | $0.6835 $0.6718 | ▲ +1.71% | ▲ +2.09% | $0.4500 (+34.16%) |
Jul 2, 2026 16w ago | 8-K | $0.6990 $0.7121 | ▲ +1.87% | ▲ +0.94% | $0.4500 (−35.62%) |
May 21, 2026 22w ago | Insider Cluster | $1.00 $0.9900 | ▼ −1.00% | ▼ −2.66% | $0.4500 (−55.00%) |
May 15, 2026 23w ago | Insider Cluster | $1.05 $0.9500 | ▼ −9.52% | ▼ −11.14% | $0.4500 (−57.14%) |
Showing 10 of 19
US Market Status
Market Closed — Opens in 5h 4m
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