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Monday, August 21, 2023

Orchestra BioMed Q2 update

 

  • U.S. Food and Drug Administration (“FDA”) granted Investigational Device Exemption (“IDE”) approval with conditions for Virtue SAB® coronary in-stent restenosis (“ISR”) U.S. pivotal study (in collaboration with Terumo Corporation (“Terumo”)); study expected to start before the end of 2023

  • BackBeat CNT™ global pivotal study in hypertensive pacemaker patients (in collaboration with Medtronic) on track for initiation in the second half of 2023

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