Orchestra BioMed Holdings, Inc. announced on Tuesday that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation (BDD) for its innovative atrioventricular interval modulation (AVIM) therapy. The company's shares responded positively to the news, rising more than 25% in pre-market trading.
The breakthrough designation applies to a pacemaker delivering AVIM therapy designed to reduce blood pressure in a specific patient population: those with increased ten-year atherosclerotic cardiovascular disease (ASCVD) risk, preserved left ventricular systolic function, and uncontrolled hypertension despite anti-hypertensive medications or who have medication intolerance.
Significance of the Breakthrough Designation
The FDA's Breakthrough Device Designation provides Orchestra BioMed with accelerated regulatory engagement and review processes. This status is reserved for technologies that offer more effective treatment for life-threatening or irreversibly debilitating conditions. Beyond expediting development, the designation supports potential pathways for securing higher reimbursement for AVIM-enabled devices in the future.
David Hochman, Chairman and Chief Executive of Orchestra BioMed, emphasized the importance of this development: "Patients at higher risk for mortality and morbidity associated with high blood pressure are the core of the population we are actively enrolling in the Backbeat global pivotal study of hypertensive pacemaker-indicated patients in collaboration with Medtronic."
Market Potential and Clinical Development
Orchestra BioMed estimates that over 7.7 million patients in the United States meet the criteria for device use as described in the FDA's designation. This represents a significant market opportunity for the New Hope, Pennsylvania-based company.
The AVIM therapy is currently being evaluated in the BACKBEAT pivotal study, conducted in partnership with Medtronic, a leading manufacturer of pacemakers. This strategic collaboration combines Orchestra BioMed's innovative therapy with Medtronic's established presence in the cardiac device market.
How AVIM Therapy Works
AVIM therapy utilizes an implantable pacemaker with conduction-system pacing to address uncontrolled hypertension. The technology represents a novel approach to blood pressure management for patients who have not achieved adequate control through traditional pharmacological treatments or who cannot tolerate anti-hypertensive medications.
The therapy targets the atrioventricular interval, a critical timing component in the cardiac cycle, to modulate blood pressure. This approach could provide an important alternative for patients with limited options for hypertension management.
Market Response
Following the announcement, Orchestra BioMed's stock demonstrated significant movement. After closing at $2.85 on Monday, shares rallied approximately 30% to $3.70 in pre-market trading on Tuesday. The company's stock has traded in the range of $2.49-$8.87 over the past year.
Addressing an Unmet Clinical Need
Hypertension remains a significant public health challenge, contributing to cardiovascular morbidity and mortality worldwide. For patients with uncontrolled hypertension despite multiple medications, or those who cannot tolerate pharmacological treatments, device-based approaches like AVIM therapy may offer new hope.
The FDA's decision to grant Breakthrough Device Designation acknowledges both the innovative nature of Orchestra BioMed's approach and the substantial unmet need in this patient population. As the BACKBEAT study progresses, healthcare providers and patients will be watching closely to see if this technology can deliver on its promise to address a challenging clinical problem.
