Clinical Track Record and Physician Demand
CGuard implant used in more than 70,000 cases globally with best-in-class clinical outcomes; management reports strong physician excitement and ongoing demand.
Regulatory and Clinical Milestones
Ongoing positive discussions with FDA; anticipate approval of original CGuard delivery system in Q3 2026 (August window) and expect CGuard Prime 80 TCAR indication in H2 2026; FDA cleared initiation of C-GUARDIANS III trial for SwitchGuard.
TCAR Strategy and Manufacturing Readiness
TCAR strategy remains on track and unaffected by U.S. delivery-system pause; management states manufacturing capacity is ready to support a relaunch with no current constraints.
Cash Position
Cash, cash equivalents and marketable securities of $41.6M as of March 31, 2026, providing runway while international sales continue.
Revenue Growth
Total Q1 2026 revenue of $3.4M, up 122% year-over-year from $1.5M in Q1 2025.
U.S. Launch Traction (Pre-Pause)
U.S. revenue of $1.2M in Q1 2026 driven by CGuard Prime, representing 36% sequential growth versus Q4 2025 during the controlled launch.
International Expansion
International revenue of $2.2M in Q1 2026, up 48% year-over-year vs $1.5M in Q1 2025; foreign exchange contributed ~11% of international growth.
Improved Gross Margins (Non-GAAP)
GAAP gross profit $0.7M (20.2% of revenue) vs 19.1% a year ago; adjusted (non-GAAP) gross profit $1.2M or 34.1% of revenue after excluding a $473k inventory impairment.