Orchestra BioMed (Nasdaq:OBIO) announced today that it received a second FDA breakthrough device designation for its AVIM therapy.
AVIM (atrioventricular interval modulation) uses conduction system pacing to immediately, substantially and persistently reduce blood pressure. The patented bioelectronic therapy comes through a standard dual-chamber pacemaker. New Hope, Pennsylvania–based Orchestra won its first FDA breakthrough device designation for AVIM therapy last year.
Today, the company says the FDA granted a breakthrough nod for AVIM therapy specific to patients with uncontrolled hypertension despite the use of anti-hypertensive medications, and an indication for a pacemaker.
Orchestra’s two breakthrough designations cover indications that encompass the broader population of patients with uncontrolled hypertension despite medication and increased cardiovascular risk, along with the specific pacemaker-indicated population with uncontrolled hypertension under evaluation in the BACKBEAT trial.
The company is conducting BACKBEAT in collaboration with Medtronic. If approved, Medtronic has exclusive global rights to commercialize AVIM-enabled pacing systems for this target population. Under their agreement, Orchestra BioMed shares in the revenues generated by these technologies.
This additional breakthrough designation supports strategic optionality for clinical, regulatory and commercial reimbursement strategies. Orchestra said it supports potential future expansion populations with uncontrolled hypertension and increased cardiovascular risk.
David Hochman, chair and CEO of Orchestra BioMed, said:
“We are pleased to receive this additional breakthrough device designation from the FDA. We believe it is directly aligned with the patient population being studied in our ongoing BACKBEAT Trial which we are executing in collaboration with Medtronic. Continued alignment from the FDA, alongside our strategic relationship with Medtronic and accelerated enrollment in the BACKBEAT Trial, puts us in a strong position to advance AVIM therapy to pivotal trial results.”
