Common Stock, $0.0001 par value per share
- Symbol
- NSPR
- Exchange
- NASDAQ
- Classification
- COMMON
- Status
- Current
Current Report · Items 7.01, 8.01, 9.01 · 8-K
InspireMD Inc.
NSPRNASDAQEQUITYCurrent
Regulation FD Disclosure · Other Events
Item 9.01 Financial Statements and Exhibits. (d) Exhibits. Exhibit Number Description ─────────────────────────────────────────────────────────────────────────────────────────────────── 99.1 Press Release, dated May 1, 2026 99.2 Press Release, dated May 1, 2026 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
Company context
InspireMD seeks to utilize its proprietary MicroNet ™ mesh technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free long-term outcomes. InspireMD’s common stock is quoted on Nasdaq under the ticker symbol NSPR. We routinely post information that may be important to investors on the Company’s website. For more information, please visit www.inspiremd.com.
Current securities
Registered securities in this filing
InspireMD, Inc. · 8-K · Filed 2026-05-01
Disclosure sections
Item 9.01Item 9.01 - Financial Statements and Exhibits
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits.
Exhibit Number Description
───────────────────────────────────────────────────────────────────────────────────────────────────
99.1 Press Release, dated May 1, 2026
99.2 Press Release, dated May 1, 2026
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
Filed exhibits (2)
EX-99.1 2 ex99-1.htm EX-99.1 Exhibit 99.1 InspireMD Initiates Voluntary U.S. Recall of CGuard® Prime 135 cm Carotid Stent Delivery System - Strong clinical demand continues in Q1 2026 with global year-over-year unit sales growth of 53% and quarter-over-quarter U.S. unit sales growth of 34% - - FDA approval anticipated with U.S. market availability of original CGuard delivery system in the third quarter of 2026 - - Continuing to anticipate FDA approval of CGuard Prime 80 cm for TCAR procedures during 2H 2026 - Miami, FL, May 1, 2026 - InspireMD, Inc. (Nasdaq: NSPR) (“InspireMD,” or the “Company”), developer of the CGuard ® Prime carotid stent system for the prevention of stroke, today announced that, in consultation with the U.S. Food and Drug Administration (“FDA”), the Company has initiated a voluntary recall in the U.S. for its CGuard® Prime 135 cm carotid stent delivery system. The Company acted after determining during a controlled launch that the technical success of the delivery system during carotid artery stenting (“CAS”) procedures has not met performance expectations. This action is voluntary with no implications for the safety of patients who have previously r…
Open exhibit ↗EX-99.2 3 ex99-2.htm EX-99.2 Exhibit 99.2 InspireMD Announces FDA Approval of Investigational Device Exemption for CGUARDIANS III Pivotal Study of the SwitchGuard Neuro Protection System Miami, FL - May 1, 2026 - InspireMD, Inc. (Nasdaq: NSPR) (“InspireMD” or the “Company”), developer of the CGuard® Prime carotid stent system for the prevention of stroke, today announced that the U.S. Food and Drug Administration (“FDA”) has approved the company’s Investigational Device Exemption (“IDE”) Application to initiate the CGUARDIANS III pivotal study of its SwitchGuard neuro protection system (“NPS”), including next generation enhancements from our prior IDE approval, for use with its CGuard Prime 80 cm stent platform, in transcarotid artery revascularization (“TCAR”) procedures. Patrick Geraghty, M.D., professor of surgery and radiology, section of vascular surgery at Washington University School of Medicine in St. Louis, MO, and Patrick Muck, M.D., program director and chief of vascular surgery at Good Samaritan Hospital in Cincinnati, OH, who previously led the CGUARDIANS II trial as co-lead investigators, will continue in the roles for the CGUARDIANS III trial. “The approval …
Open exhibit ↗