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Get filing alertsInspireMD reports 30-day clinical trial results for CGuard Prime 80 cm implant in TCAR
Filed June 11, 2026 · Period ending June 11, 2026 · ~1 min read
Key Changes
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Company disclosed 30-day results from CGUARDIANS II trial evaluating CGuard Prime 80 cm implant for transcarotid artery revascularization (TCAR) procedures, a minimally invasive stroke prevention treatment.
Item 7.01 verify on EDGAR → -
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Results released under Regulation FD, ensuring all investors receive clinical data simultaneously. Full trial outcomes and safety data are in the attached press release.
8-K: Reg FD Disclosure view on EDGAR →
Summary
InspireMD announced 30-day clinical results from its CGUARDIANS II trial testing the CGuard Prime 80 cm implant in TCAR procedures, a technique for preventing strokes in high-risk patients. The disclosure was made under Regulation FD rules, meaning the company is providing material clinical data to all investors at once rather than selectively. For a medical device company, clinical trial milestones are critical value drivers that can affect regulatory approval timelines and commercial prospects.
Retail investors should review the press release for key metrics: patient outcomes, adverse events, and whether results meet trial endpoints. Positive 30-day data could support the company's regulatory pathway and market positioning against competitors. Watch for follow-up disclosures on longer-term trial results (90-day, 1-year) and any FDA submission timelines, as these will determine whether CGuard Prime can reach commercial launch and generate revenue.
Section-by-Section Diff
Event · Item 7.01 — Regulation FD Disclosure
Item 7.01 — Regulation FD Disclosure filed; see Key Changes for terms.
Added in current filing · verify on EDGAR →
On June 11, 2026, InspireMD, Inc. (the “Company”) issued a press release titled “InspireMD Announces 30-Day Results from the CGUARDIANS II Clinical Trial of the CGuard Prime 80 cm Implant for Use in TCAR Procedures.”
The company disclosed 30-day results from its CGUARDIANS II clinical trial evaluating the CGuard Prime 80 cm implant for use in transcarotid artery revascularization (TCAR) procedures. This is a Regulation FD disclosure, meaning the information is being publicly released to ensure fair disclosure to all investors. The actual trial results and their implications are contained in the press release exhibit, which is furnished but not filed with the SEC.
Event · Item 9.01 — Financial Statements and Exhibits
InspireMD filed an 8-K attaching a press release dated June 11, 2026; no material business event disclosed in the filing body.
Show 1 minor / wording change
Added in current filing · verify on EDGAR →
Press Release, dated June 11, 2026
The 8-K references an attached press release dated June 11, 2026 (Exhibit 99.1). The filing body itself contains no substantive disclosure about the press release content or the underlying corporate event.
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Figures/quotes linked to EDGAR · Narrative written by AI · Jun 11, 2026 · How we verify