InspireMD, Inc. Q1 FY2026 earnings call

• CEO Marvin Schlossman addressed the pause in commercialization of C-Guard Prime 135 delivery system, stating it's not related to safety/performance of C-Guard stent. It was a proactive decision to enhance technical performance. They aim to reenter U.S. market with original C-Guard delivery system approved by FDA in Q3 2026. • Anticipate FDA approval of C-Guard Prime 80 system for TCAR procedures in H2 2026, which could double U.S. addressable market. • Received FDA approval to initiate C-Guardians III clinical trial for next-gen switchguard neuroprotection system with Seaguard Prime 80 for TCAR. • Team focused on approval of original Seaguard 135, Seaguard Prime 80 with TCAR indication, completion of design changes for C-Guard Prime 135, and enrollment of C-Guardians 3 study. • CFO Mike Lawless discussed Q1 financials, including revenue growth driven by U.S. launch of Seaguard Prime and international growth. Impact of voluntary action on U.S. commercial activity and withdrawal of full-year 2026 revenue guidance. • CCO Shane Gleason discussed commercial aspects, including customer receptivity to C-Guard stent, engagement with prospective customers, and receptivity to relaunch of products.

First quarter revenue was $3.4 million, up over 120% from Q1 2025. U.S. revenue for Q1 was $1.2 million (36% sequential growth from Q4 2025), international revenue was $2.2 million (48% annual growth from Q1 2025). Gross profit was $0.7 million (20.2% of revenue), with a $473,000 impairment charge related to excess inventory. On a non-GAAP basis, adjusted gross profit was $1.2 million (34.1% of revenue). Total operating expenses were $14.7 million, an increase from $11.8 million in Q1 2025. Net loss was $13.7 million.

• Withdrew full-year 2026 revenue guidance due to temporary pause in U.S. commercialization and need for clarity on FDA approval timing. • Expect no commercial activity in U.S. market until expected FDA approval of original C-Guard stent system in Q3 2026, with revenue from international markets during that time. • Anticipate positive U.S. customer response to original C-Guard system following FDA approval.

• Temporary pause in U.S. commercialization of C-Guard Prime 135 delivery system could impact revenue. • Uncertainty around timing of FDA approval for original C-Guard stent system and C-Guard Prime 80 system. • Impact of impairment charge related to excess inventory. • Potential impact of ongoing conflict in Tel Aviv on operations and expenses.

Q: Clarification around process to get Seagard Prime back on market, timeline for resolution, resubmission, and expedited review.

A: Already begun remediating technical challenges, completing V&V testing, resubmitting to FDA. Timeline for approval of changes is statutory, but confident in solving issue and getting back to market early 2027 or sooner.

Q: How quickly can relaunch new delivery system after approval, revenue comeback.

A: Once approved, ready to launch original Seaguard, full steam ahead on manufacturing capacity, expect to relaunch as quickly as possible with plan in place, anticipating August approval.

Q: OPEX trending through transition period and retaining key talent.

A: Expect OPEX to continue to increase slightly, investments in R&D with CYARDIANS III clinical trial, selling and marketing in GNA relatively stable, pause on headcount investment until clarity on FDA approval timeline.

Q: Existing customer base of C-Guard Prime, grandfathering in with original system.

A: Team in field staying close to it, many customers look forward to gaining access as soon as available, process varies by center but expect receptivity to plug back in.

Q: Impact to prospective customers while not selling in U.S.

A: Can discuss clinical data, results, but not specific pricing until products approved, can remain engaged with customers following rules of each site.

Q: Decision to voluntarily recall in U.S. and effect on European business, labeling changes.

A: European business continues to grow nicely, decision was necessary for short and long term to achieve objective. Changes are design and technical, no changes to use of product IFU.

Q: Why issues with delivery system weren't picked up earlier.

A: Limited user experience in PMA trial, combination of new user experiences and different accessory devices led to learning curve, controlled launch was done to address details early.