InspireMD — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total revenue for the three months ended September 30, 2026, was $2,242,000, a decrease of 11.1% ($281,000) compared to $2,523,000 in the prior-year period.
• International revenue for the quarter was $2,210,000, an increase of 9.1% ($184,000) year-over-year, while U.S. revenue was $32,000 compared to $497,000 in the prior year.
• Gross profit for the quarter was $240,000 (10.7% of revenue), down from $864,000 (34.2% of revenue) in the prior year, driven by the U.S. recall impact and lower average sales prices in international markets.
• Total operating expenses for the quarter were $10,193,000, a decrease of 26.7% ($3,722,000) from $13,915,000 in the prior year, including $1,074,000 in restructuring expenses.
• Net loss for the quarter was $9,762,000 ($0.12 per share), improving from a net loss of $12,708,000 ($0.17 per share) in the prior year.
• For the nine months ended September 30, 2026, total revenue was $7,411,000, an increase of 27.1% ($1,581,000) from $5,830,000 in the prior period.
• Gross profit for the nine-month period was $153,000 (2.1% of revenue), down from $1,469,000 (25.2% of revenue) in the prior period.
• Net loss for the nine months was $37,775,000 ($0.45 per share), compared to $37,025,000 ($0.64 per share) in the prior period.
• Cash and cash equivalents and marketable securities totaled $19,246,000 as of September 30, 2026, down from $54,211,000 as of December 31, 2025.

Guidance and Future Outlook:

• The company expects to commence U.S. sales of CGuard Prime for TCAR promptly in the fourth quarter of 2026.
• The company anticipates submitting a PMA supplement to the FDA for the enhanced CGuard Prime for CAS in December 2026, with a potential relaunch expected in the first half of 2027.
• Management anticipates the introduction of a proprietary micro puncture kit to support vascular access.
• Forward-looking statements indicate expectations regarding the size of the addressable market for CGuard Prime for TCAR, which is expected to expand by over 35,000 procedures annually.

Business Segments and Product Lines:

• Received FDA approval for CGuard Prime for TCAR, marking the return of the platform to the U.S. market with data from the CGUARDIANS II trial showing 100% acute device success and zero adverse events at 30 days.
• Successfully implemented design changes to the delivery system for CGuard Prime for CAS, currently undergoing final validation and performance testing.
• Continued enrollment in the CGUARDIANS III pivotal trial for the SwitchGuard neuroprotection system for use with CGuard Prime for TCAR.
• Advancing the original CGuard carotid stent system for CAS procedures through the FDA regulatory review process.
• Appointed Kathleen Kennedy as Senior Vice President of Global Sales and Marketing ahead of the U.S. launch and CAS relaunch.
• Announced upcoming scheduled talks at the VEITH symposium 2026 featuring the CGuard and CGuard Prime platforms.

Market and Competitive Landscape:

• The FDA approval for TCAR expands the company's addressable market opportunity by over 35,000 procedures annually.
• The company aims to establish CGuard Prime as a leading platform for carotid intervention with best-in-class evidence.
• The company faces intense competition from competitors with substantially greater financial, technological, and marketing resources.

Risks and Challenges:

• The voluntary recall of the CGuard Prime delivery system in May 2026 significantly impacted U.S. revenue and gross margins.
• Risks include potential claims and lawsuits, including class action product liability lawsuits, and regulatory actions associated with the recall.
• The company has a history of recurring losses and negative cash flows, with substantial doubt regarding its ability to continue as a going concern.
• There is a need to raise additional capital, which could be costly, dilutive, or difficult to obtain.
• Dependence on a single manufacturing facility and risks related to foreign currency fluctuations, geopolitical instability in the Middle East, and regulatory compliance in multiple jurisdictions.

Management Commentary and Tone:

• CEO Marvin Slosman described the FDA approval of CGuard Prime for TCAR as a "transformative milestone" enabling the launch of a next-generation carotid implant.
• Management expressed confidence that the product supports their mission to "treat the lesion" and strengthens their competitive position.
• Management emphasized a commitment to building a comprehensive carotid intervention platform with a broad range of solutions for physicians.

Other Key Points:

• The company incurred $1,074,000 in restructuring expenses and related termination costs associated with a workforce reduction during the third quarter.
• U.S. revenue for the nine months ended September 30, 2026, was $859,000, compared to $551,000 in the prior period, reflecting the impact of the recall.
• The company's common stock is quoted on Nasdaq under the ticker symbol NSPR.
• A conference call and webcast were scheduled for November 12, 2026, at 4:30 pm ET to review results and provide updates.