InspireMD Announces FDA Approval for CGuard Prime TCAR System and Q3 2026 Financial Results

On November 12, 2026, InspireMD, Inc. reported the receipt of U.S. Food and Drug Administration (FDA) approval for the CGuard Prime TransCarotid Stent System (CGuard Prime for TCAR). This approval marks the return of the platform to the U.S. market and is supported by data from the CGUARDIANS II pivotal trial, which reported 100% acute device success and zero death, stroke, myocardial infarction, or stent thrombosis at 30 days. The company anticipates commencing U.S. sales promptly in the fourth quarter of 2026.

The filing details the company's financial performance for the three and nine months ended September 30, 2026. Total revenue for the third quarter of 2026 was $2,242,000, a decrease of $281,000, or 11.1%, compared to the same period in 2025. International revenue for the quarter was $2,210,000, an increase of 9.1% year over year, while U.S. revenue was $32,000, a significant decline from $497,000 in the prior year. This U.S. sales comparison reflects the impact of a voluntary recall of the delivery system for the CGuard Prime for CAS in May 2026.

Gross profit for the third quarter of 2026 was $240,000, or 10.7% of revenue, compared to $864,000, or 34.2%, in the prior year. Total operating expenses for the quarter were $10,193,000, a decrease of $3,722,000, or 26.7%, compared to 2025. This reduction included $1,074,000 in restructuring expenses and termination costs associated with a workforce reduction. As of September 30, 2026, cash and cash equivalents and marketable securities totaled $19,246,000.

For the nine months ended September 30, 2026, total revenue increased by 27.1% to $7,411,000. Gross profit for the period was $153,000, or 2.1% of revenue. The company reported a net loss of $9,762,000, or $0.12 per share, for the third quarter of 2026, and a net loss of $37,775,000, or $0.45 per share, for the first nine months of the year.

In other developments, InspireMD announced the appointment of Kathleen Kennedy as Senior Vice President of Global Sales and Marketing. The company also stated that the enhanced CGuard Prime for CAS delivery system is undergoing final validation and that a premarket approval (PMA) supplement is expected to be submitted to the FDA in December 2026. Additionally, InspireMD continues to advance the CGUARDIANS III pivotal trial for its SwitchGuard neuroprotection system.