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Pacertool has developed the PaCRTool system, a proprietary medical device and biomarker platform designed to improve outcomes in heart failure patients by enabling precision selection and optimization of candidates for cardiac resynchronization therapy (CRT). The company has completed an initial proof-of-principle study (~45 patients), demonstrating feasibility and safety. A larger "first demand" clinical trial enrolling up to ~50 guideline-selected CRT candidates began enrollment in late spring/summer 2024. The company aims to demonstrate improved patient selection and response rates using its technology, with the goal of reducing non-responder rates seen with current CRT approaches. No pivotal data or regulatory approvals have been announced as of June 2025. Regulatory strategy targeting US FDA 510(k) clearance. Device not yet cleared for use in any market.
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