2026-05-04, 2:06:42 p.m.
MIAMI, May 4, 2026 — Leads & Copy — InspireMD, Inc. (Nasdaq: NSPR) announced its financial and operating results for the first quarter ended March 31, 2026, reporting $3.4 million in revenue, a 122% increase year-over-year.
The company, which develops the CGuard® Prime carotid stent system, also received IDE approval from the FDA to begin the CGUARDIANS III clinical trial for its SwitchGuard neuro protection system for use in TCAR procedures.
InspireMD anticipates FDA approval of the original CGuard delivery system in Q3 2026 and remains on track for expected FDA approval of the CGuard Prime 80 cm for TCAR procedures in H2 2026. The approval of CGuard Prime 80 cm could potentially double the company’s addressable market.
According to Marvin Slosman, Chief Executive Officer of InspireMD, the first quarter results reflect strong demand and clinical outcomes for the CGuard carotid stent implant in the U.S. and internationally.
InspireMD supported over 625 cumulative carotid procedures using CGuard Prime across more than 100 U.S. hospitals and integrated delivery networks since its launch.
The company has filed for FDA approval of the original, clinically proven CGuard stent delivery system, expected in Q3 2026. The company also initiated a voluntary recall of the CGuard Prime 135 cm carotid stent delivery system to improve user experience and delivery system performance.
Slosman stated the TCAR program is unaffected by the voluntary action, and the company received FDA approval to initiate the CGUARDIANS III clinical trial with its SwitchGuard NPS.
The company expects this delivery system approval to allow physicians to have multiple options to deliver the best implant to their patients. The delivery system has been successfully used in over 70,000 implants globally.
U.S. revenue for the first quarter of 2026 was $1.2 million, a 36% increase compared to the fourth quarter of 2025. International revenue was $2.2 million, a 48% increase compared to the first quarter of 2025.
Gross profit for the first quarter of 2026 was $0.7 million, or 20.2% of revenue, compared to $0.3 million, or 19.1% of revenue, for the same period of 2025. Adjusted gross profit was $1.2 million, or 34.1% of revenue, excluding an inventory impairment charge of $0.5 million.
Total operating expenses for the first quarter of 2026 were $14.7 million, an increase of $2.9 million, compared to $11.8 million for the first quarter of 2025. Financial income, net, for the first quarter of 2026 was $0.3 million, roughly flat with the first quarter of 2025.
Net loss for the first quarter of 2026 was $13.7 million, or $0.16 per basic and diluted share, compared to a net loss of $11.2 million, or $0.22 per basic and diluted share, for the same period in 2025.
The company expects the financial impact of the U.S. recall of CGuard Prime to include a reserve for customer returns of approximately $700,000 and a reserve for inventory impairment and remediation costs of approximately $650,000.
Management hosted a conference call at 4:30 pm ET today, May 4th, to review financial results and provide an update on corporate developments.
InspireMD seeks to utilize its proprietary MicroNet™ mesh technology to make its products the industry standard for carotid stenting. 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.
Source: InspireMD, Inc.
