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Management attributed the second quarter's flat revenue to the voluntary recall of the CGuard Prime 135 system, which necessitated $734,000 in customer credits that offset underlying U.S. sales growth.
International business grew 21% year-over-year, serving as a strategic proof point for the CGuard implant's clinical efficacy and physician demand despite domestic regulatory setbacks.
The company implemented a 20% workforce reduction to align its cost structure with near-term regulatory priorities, aiming to preserve cash while maintaining a lean commercial core for relaunch.
Management emphasized that the CGuard implant itself remains the foundational value driver, with the recall being a 'well-defined and manageable' issue isolated to the delivery system rather than the stent technology.
#cguard #recall #system #international
Management attributed the second quarter's flat revenue to the voluntary recall of the CGuard Prime 135 system, which necessitated $734,000 in customer credits that offset underlying U.S. sales growth.
International business grew 21% year-over-year, serving as a strategic proof point for the CGuard implant's clinical efficacy and physician demand despite domestic regulatory setbacks.
The company implemented a 20% workforce reduction to align its cost structure with near-term regulatory priorities, aiming to preserve cash while maintaining a lean commercial core for relaunch.
Management emphasized that the CGuard implant itself remains the foundational value driver, with the recall being a 'well-defined and manageable' issue isolated to the delivery system rather than the stent technology.
#cguard #recall #system #international
1 day ago
