InspireMD initiated cost-reduction actions expected to generate approximately $9 million of annual savings as it prepares for an anticipated U.S. CGuard platform relaunch, while its CGUARDIANS II study reported 100% acute device success across all 50 patients evaluated with the CGuard Prime 80 cm implant in TCAR procedures.
The clinical results included no reported deaths, strokes or myocardial infarctions within 30 days, no stent thrombosis and complete stent patency at 30 days among evaluable subjects.
InspireMD is pursuing regulatory pathways for both the CGuard Prime 80 cm implant for transcarotid artery revascularization and its original CGuard platform for traditional carotid artery stenting. Management continues to anticipate FDA decisions on both products during 2026.
The savings program was initiated after the end of Q2 and is intended to consolidate resources, improve operating efficiency and align the company’s expense structure with its nearer-term commercial and regulatory priorities. The restructuring includes streamlining its commercial organization ahead of the anticipated U.S. relaunch.
InspireMD is simultaneously working to return its CGuard Prime 135 cm delivery system to the U.S. market following a voluntary recall in May. The company has implemented design changes and expects to submit the modified system to the FDA before year-end.
The recall substantially affected Q2 financials. Total revenue was nearly unchanged at $1.77 million, but U.S. net revenue was negative $351,000 because $734,000 of recall-related customer credits exceeded gross U.S. product sales before the recall. International revenue increased 21% to $2.12 million.
The quarter produced a gross loss of $774,000 after a $612,000 inventory impairment and $734,000 in customer credits. Excluding those recall-related items, adjusted gross profit was $572,000.
Net loss totaled $14.3 million, compared with $13.2 million a year earlier. InspireMD ended June with $30.4 million of cash, equivalents and marketable securities, down from $54.2 million at the end of 2025, increasing the importance of the planned $9 million annual cost reduction as multiple regulatory programs progress.
KEY QUOTES:
“Following the end of the second quarter, we executed a series of steps designed to consolidate resources and better align our global operations with our near-term commercial and regulatory priorities, including streamlining our commercial organization to more effectively support our anticipated U.S. platform re-launch. We continue to engage in a productive dialogue with FDA regarding our pending regulatory submissions for our CGuard Prime 80 cm implant for TCAR procedures, as well as our original CGuard platform for traditional carotid stenting procedures. We continue to anticipate FDA decisions on both products later this year.”
“At the same time, the design improvements that we are making to the CGuard Prime 135 cm delivery system, which we voluntarily recalled last quarter, are progressing as planned, with an FDA submission anticipated before year-end. Subject to receipt of the necessary regulatory approvals, we expect to return to the U.S. market with both TCAR and CAS delivery systems. We believe that this would strengthen our ability to compete in the carotid stenting market, and support increased adoption of the CGuard platform, expanded market penetration and future revenue growth, leveraging what we believe is a best-in-class implant in the carotid stenting space.”
Marvin Slosman, Chief Executive Officer of InspireMD
