InspireMD, Inc.

For the second quarter of 2026, total revenue was $1.8 million, essentially flat versus Q2 2025. International revenue was $2.1 million, up 21% year over year, while reported U.S. revenue was depressed by recall-related credits, including a $734,000 credit for returned CGuard Prime 135 product. Gross profit was a loss of $0.8 million, or negative 43.7% of revenue, versus $0.3 million, or 17.6%, in Q2 2025; the decline reflected the $734,000 credit and a $612,000 inventory impairment. Operating expenses were $13.7 million versus $13.3 million a year ago, and net loss was $14.3 million, or $0.17 per share, compared with a $13.2 million loss, or $0.26 per share, last year. Cash and cash equivalents plus marketable securities were $30.4 million at June 30, 2026, down from $54.2 million at year-end 2025. Looking ahead, management still expects a fourth-quarter FDA decision for the original CGuard platform and for CGuard Prime 80 for TCAR, and said the redesigned CGuard Prime 135 platform remains guided to first-half 2027 market reentry, with possible earlier approval if testing and FDA review move faster.

Marvin Slosman framed the quarter as a period of managing the recall while strengthening the business for a U.S. return. He emphasized four priorities: improving the international business, advancing regulatory milestones, redesigning the Prime 135 delivery system, and aligning the organization and cost base. His tone was cautious but constructive, repeatedly saying the company is making meaningful progress and that the recall has become a defined, manageable issue.

Mike Lawless focused on the recall’s accounting impact and the company’s cost actions. He said the $734,000 customer credit and the $612,000 inventory impairment were the main drivers of the negative gross margin, and noted that adjusted gross profit would have been $0.6 million excluding those recall-related items. He also highlighted the workforce reduction of almost 20%, which should save about $9 million annually, with a restructuring charge of $900,000 to $1.2 million expected in Q3 and the new run rate mostly visible in Q4. Cash and marketable securities stood at $30.4 million at quarter-end.

Analysts pressed management on the slight shift in timing for the original CGuard approval, and Marvin said the move from Q3 to Q4 was simply a more realistic view of FDA timelines and review workload, not a change in the underlying progress. Questions on the redesigned Prime 135 centered on what remains before submission and what could pull approval earlier; management pointed to biocompatibility testing and the FDA statutory review process as the key variables, while saying the technical issue appears solved. Analysts also asked about the commercial relaunch and SwitchGuard enrollment, and management said customer enthusiasm remains high, the sales team has stayed intact, and early SwitchGuard enrollments have gone well.