InspireMD, Inc. Q3 FY2025 earnings call

• The company achieved $2.5 million in total revenue in the third quarter with 39% Y/Y growth and over 40% sequential growth. Growth was driven by strong U.S. momentum post FDA approval of CGuard Prime and continued demand for CGuard stent platform internationally.
• Over 100 cases of CGuard Prime have been completed in the U.S., with many in large IDNs. Globally, nearly 70,000 stents sold as carotid interventional market shifts to stent-first approach.
• Introduced new Chief Medical Officer Dr. Peter Soukas to oversee clinical and medical topics. Progress on clinical trials: C-GUARDIANS II on track to complete enrollment by end of 2025 with potential approval in mid-2026; C-GUARDIANS III expected to launch in mid-2027; tandem lesion early feasibility study over 50% complete.
• Highlighted the massive gap in carotid artery disease treatment globally and CGuard Prime's aim to redefine success by lowering stroke risk.

In the third quarter of 2025, total revenue reached $2.5 million, representing a year-over-year growth of 39% and sequential growth of over 40% from the last quarter. U.S. revenue for the quarter was $497,000, driven by the launch of CGuard Prime. International revenue was $2.0 million, an increase of $223,000 or 12% compared to the third quarter of 2024. Gross profit for the third quarter of 2025 increased by $450,000 or over 100% to $864,000. Gross margin increased to 34.2% of revenue during the third quarter of 2025, up from 22.9% in the third quarter of 2024, driven by favorable revenue mix and volume leverage of fixed operating costs.

• For the fourth quarter, expected sequential growth in U.S. sales and steady international demand, resulting in revenue of approximately $2.5 million to $3.0 million.
• Will share 2026 growth expectations informed by insights from an additional quarter of U.S. launch progress when reporting fourth quarter 2025 results.

Q: Congrats on the progress. Would love to hear more about initial physician feedback on U.S. customers using CGuard Prime and how CGuard is used in doctors' armamentariums.

A: Marvin Slosman and Shane Gleason mentioned enthusiastic physician response, CGuard Prime is envisioned as a workhorse product meeting both open cell and closed cell stent needs for various anatomies.

Q: Hoping to go deeper into U.S. launch, share metrics like device ASP vs volume, number of accounts implanted, and onboarding in Q4.

A: Shane Gleason stated CGuard Prime has a modest premium to market, over 100 cases done since launch, ~a dozen reps in the field opening several accounts per rep, with over 30 in the U.S. commercial organization exiting the year with most in the field.

Q: Follow up on U.S. launch, parsing Q4 guidance, OUS vs U.S. in revenue.

A: Michael Lawless said guidance consists of stable international sales with expectations for growth in U.S. market in Q4.

Q: Deeper into U.S. launch, metrics on product ordering, how accounts are stocking shelves.

A: Shane Gleason mentioned goal is to be present in cases as launching, not stocking shelves and leaving products without training, primarily running cases with reps present to ensure training and familiarity before leaving products on shelves.

Q: Gross margin commentary on where gross margins can go with scale.

A: Michael Lawless stated increasing mix of U.S. sales will be the clear driver, expecting higher margin mix of U.S. sales to approach typical medical device type margins as volumes grow.