NSPR Rallies After Hours On FDA Green Light for Key Stroke-Prevention Trial Despite Withdrawn Annual Guidance

• Vascular surgeons Dr. Patrick Geraghty and Dr. Patrick Muck — who led the earlier study — will head the new trial.
• Separately, the company also announced that it has initiated a voluntary recall in the U.S. for its CGuard Prime 135 cm carotid stent delivery system.
• The company also withdrew its full-year 2026 revenue guidance.

Shares of InspireMD (NSPR) jumped 30% after hours on Friday after the company announced that the U.S. Food and Drug Administration has approved its application to start the CGUARDIANS III pivotal study of the SwitchGuard Neuro-Protection System, overshadowing the pessimism around the firm dropping its 2026 financial guidance.

The trial will test the safety and effectiveness of SwitchGuard when used with the company’s CGuard Prime carotid stent during transcarotid artery revascularization or TCAR procedures. The device reverses blood flow to catch debris and help prevent strokes in patients with carotid artery disease.

Vascular surgeons Dr. Patrick Geraghty and Dr. Patrick Muck — who led the earlier study — will head the new trial.

“This is an important step toward offering a complete TCAR solution,” said CEO Marvin Slosman. The company hopes to launch SwitchGuard in the U.S. in 2027 if approved.InspireMD already won FDA approval for its CGuard Prime stent in June 2025.

Recall And Dropped Guidance

Separately, the company also announced that it has initiated a voluntary recall in the U.S. for its CGuard Prime 135 cm carotid stent delivery system.

The company said the delivery system did not meet technical performance expectations during a controlled commercial launch for carotid artery stenting (CAS) procedures. The recall applies only to the delivery system and does not affect the CGuard stent implant itself.

There are no safety concerns for patients who have already received the implanted stent. InspireMD is pausing U.S. sales of the 135 cm version while it makes design improvements. The company expects FDA approval for the original CGuard delivery system in the third quarter of 2026 and for the enhanced Prime version in the first half of 2027. As a result, it has withdrawn its full-year 2026 revenue guidance.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,” the company said.

More details will be provided at the company’s first quarter earnings on May 4, InspireMD added.

How Did NSPR Retail Traders React?

On Stocktwits, retail sentiment around NSPR stock stayed within the ‘bullish’ territory over the past 24 hours, while message volume remained at ‘normal’ levels.

A Stocktwits user expressed skepticism about upcoming dilution.

Another user dismissed the application news as nothing more than regular updates from biotech companies.

NSPR stock has fallen 56% over the past 12 months. 

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