InspireMD, Inc.

What they do

InspireMD develops and commercializes carotid stent systems for the treatment of carotid artery disease. Its portfolio includes CGuard EPS, sold internationally through distributors, and CGuard Prime, which received FDA premarket approval in June 2025 and is sold directly in the U.S. The company is also developing SwitchGuard NPS, a neuroprotection system for transcarotid revascularization (TCAR) procedures, and evaluating its stent platform in TCAR and acute ischemic stroke indications.

Revenue drivers

• CGuard Prime (U.S. direct sales) — FDA-approved in June 2025, this is the primary U.S. growth driver. Q1 2026 U.S. revenue was $1.2 million, up 36% sequentially from Q4 2025, supported by over 625 cumulative procedures at 100+ U.S. hospitals.
• CGuard EPS (international distributor sales) — Marketed in over 30 countries outside the U.S. Q1 2026 international revenue was $2.2 million, up 48% year-over-year, contributing the majority of total revenue.
• Total revenue mix and pricing — U.S. direct sales carry a higher average selling price per unit than international distributor sales, improving gross margin when the U.S. mix increases.

Recent performance

For Q1 2026, revenue was $3.4 million, up 122% year-over-year from $1.5 million. Gross profit was $0.7 million (20.2% margin), including a $0.5 million inventory impairment charge; excluding that, adjusted gross profit was $1.2 million (34.1% margin). Net loss widened to $13.7 million, or $0.16 per share, from $11.2 million a year earlier. Operating expenses rose to $14.7 million, driven by U.S. commercial expansion. As of March 31, 2026, cash and equivalents were $11.4 million, with an accumulated deficit of $316 million.

Strategy

Management is pursuing a 'stent-first' approach to carotid revascularization, expanding U.S. commercialization of CGuard Prime while seeking FDA approval of the original CGuard delivery system (anticipated Q3 2026) to offer multiple delivery options. The company is investing in TCAR programs, including the CGUARDIANS II pivotal study (enrollment completed Q1 2026) and the newly approved CGUARDIANS III trial evaluating SwitchGuard NPS with CGuard Prime 80cm. It also continues clinical work in acute ischemic stroke with tandem lesions. Concurrently, management plans to raise additional capital to fund operations, noting substantial doubt about its ability to continue as a going concern.

Risks

• Going concern and liquidity — With $11.4 million in cash and negative operating cash flows, management states there are not sufficient resources to fund operations for the next 12 months and substantial doubt exists about the company's ability to continue.
• Voluntary recall of CGuard Prime 135 cm — The company initiated a voluntary recall of the 135 cm delivery system for technical enhancements, which will pause its U.S. commercialization and may impact near-term revenue.
• Dependence on regulatory approvals — U.S. growth relies on timely FDA approvals for the original CGuard delivery system (expected Q3 2026) and the CGuard Prime 80 cm for TCAR, both of which are subject to regulatory uncertainty and delays.
• History of losses and capital needs — The company has a history of recurring net losses ($48.8 million in 2025) and will likely need dilutive equity or debt financing, which may be costly or unavailable.

Outlook

Management expects continued U.S. growth from CGuard Prime direct sales and anticipates FDA approval of the original CGuard delivery system in Q3 2026. It also projects FDA approval of the CGuard Prime 80 cm for TCAR in H2 2026, which could double the addressable market. The company is executing the CGUARDIANS III trial for SwitchGuard NPS and expects to raise capital to fund operations, though success is not assured.