Orchestra BioMed Gets FDA Nod for BackBeat Study
September 19 2023 - 7:24AM
Dow Jones News
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 dean.seal@wsj.com
(END) Dow Jones Newswires
September 19, 2023 08:09 ET (12:09 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.
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