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Orchestra BioMed Gets FDA Nod for BackBeat Study

By Dean Seal


Orchestra BioMed has gotten the go-ahead from federal regulators to start a study examining BackBeat, its atrioventricular interval modulation therapy for treating hypertension in pacemaker patients.

The biomedical company said Tuesday that the U.S. Food and Drug Administration has granted approval of an investigational device exemption that will allow the study to move forward.

Orchestra BioMed partnered with Medtronic on development and commercialization of the therapy in July 2022.

The company plans to begin enrollment in the BackBeat study before the end of this year.


Write to Dean Seal at


(END) Dow Jones Newswires

September 19, 2023 08:09 ET (12:09 GMT)

Copyright (c) 2023 Dow Jones & Company, Inc.

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