- 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, May 01, 2026 (GLOBE NEWSWIRE) -- 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 received the CGuard stent.

This voluntary action pertains specifically to the CGuard Prime 135 delivery system, and does not include the CGuard stent implant, which continues to generate unmatched clinical outcomes, including the lowest major adverse event rates and most durable stroke prevention among CAS carotid interventions.

InspireMD anticipates FDA approval for its original CGuard stent delivery system for CAS procedures in the U.S. in the third quarter of 2026. The delivery system has been successfully used in over 70,000 cases worldwide, including the majority of clinical study cases in the CGUARDIANS clinical trial.

      

The Company is also implementing design improvements to the CGuard Prime stent delivery system and anticipates FDA approval in the first half of 2027.

"Our continued strong unit sales growth worldwide in the first quarter 2026 reflects significant demand for this novel stent technology with our best-in-class CGuard implant," stated Marvin Slosman, Chief Executive Officer.

"However, the controlled launch of CGuard Prime in the U.S. has revealed opportunities to improve the technical performance of the delivery system," continued Mr. Slosman. "As a result, we have taken the proactive step to pause commercialization of the CGuard Prime delivery system to implement the necessary enhancements. This voluntary action reflects our unwavering commitment to providing our customers with the highest quality carotid stent platform on the market, while minimizing market disruptions and achieving the optimal physician satisfaction and patient safety for which we are known."

TCAR Initiatives On-Track

InspireMD anticipates FDA approval later this year for its CGuard Prime 80 cm carotid stent delivery system for transcarotid artery revascularization ("TCAR") procedures, designed to be compatible with neuroprotection systems that are already in use. With approximately 35,000 TCAR procedures annually in the United States, an approved TCAR indication could potentially double the size of the addressable market for the CGuard stent implant. The technical performance of the CGuard Prime 80 cm version meets all technical expectations. Additionally, the Company anticipates potential FDA clearance of its SwitchGuard neuroprotection system for TCAR procedures in the second half of 2027.

2026 Financial Guidance

Concurrent with today's announcement, the Company is withdrawing its prior full year 2026 revenue guidance. Management believes this is the most prudent step given the impact of the temporary discontinuation of commercial activity in the U.S. pending the anticipated FDA approval of its original CGuard stent delivery system in the third quarter of 2026.

Management intends to provide a full company update on this and other recent developments during its conference call for the results of the first quarter of 2026 on May 4th.