InspireMD, Inc. NSPR
InspireMD, Inc. (Nasdaq: NSPR) is a cardio-renal-metabolic medical device company. Its next catalyst on record is CGuard EPS: Potential FDA PMA approval (H2 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: CGuard EPS — Potential FDA PMA approval (H2 2026). 3 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| CGuard Prime (PMA approved June 2025; US voluntary recall May 2026) | Carotid revascularization | — | NA_NON_THERAPEUTIC |
| CGuard EPS | Carotid revascularization (CE marked; US PMA submitted Q1 2026) | — | NA_NON_THERAPEUTIC |
| CGUARDIANS II (CGuard Prime 80 cm, TCAR) | Transcarotid revascularization | — | NA_NON_THERAPEUTIC |
| CGUARDIANS III (SwitchGuard NPS + CGuard Prime) | TCAR with flow-reversal neuroprotection | — | NA_NON_THERAPEUTIC |
Recent results and decisions
- Jun 11, 2026positive CGUARDIANS II pivotal single-arm 30-day results for CGuard Prime 80 cm in TCAR: 100% (50/50) acute device success, no deaths, strokes or MIs, no stent thrombosis.
Acute device success was achieved in 100% (50/50) of patients;
Filing - May 1, 2026n/a InspireMD initiated a voluntary U.S. recall of the CGuard Prime 135 cm carotid stent delivery system after technical success fell short of expectations; U.S. commercialization paused and 2026 revenue guidance withdrawn.
the Company has initiated a voluntary recall in the U.S. for its CGuard® Prime 135 cm carotid stent delivery system.
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other cardio-renal-metabolic companies
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- MiniMed Group, Inc. MMED
- Heartflow, Inc. HTFL
- iRhythm Holdings, Inc. IRTC
- Pulse Biosciences, Inc. PLSE
- AtriCure, Inc. ATRC
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.