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NEW HOPE, Pa. - Orchestra BioMed Holdings, Inc. (NASDAQ:OBIO), a clinical-stage biotech company with a market capitalization of $141 million and impressive gross profit margins of 93%, announced Tuesday that a study published in the Journal of the American College of Cardiology: Clinical Electrophysiology demonstrated favorable hemodynamic effects of its atrioventricular interval modulation (AVIM) therapy in patients with uncontrolled hypertension who require pacemakers.
The pressure-volume loop analysis, involving 16 hypertensive pacemaker-indicated subjects, showed AVIM therapy significantly reduced systolic blood pressure by an average of 17.1 mmHg with right ventricular pacing and 19.2 mmHg with conduction system pacing, compared to 1.7 mmHg with standard dual-chamber pacing. According to InvestingPro data, the company’s stock has declined 46% over the past six months, trading near $2.60, despite maintaining strong liquidity with a current ratio of 2.1.
The therapy also improved left ventricular hemodynamics by decreasing end-diastolic volume, end-systolic volume, and end-diastolic pressure, while reducing cardiac workload with minimal impact on stroke volume.
"These results provide powerful insights on the impact of AVIM therapy to both decrease blood pressure and favorably impact ventricular end-diastolic volume without compromising cardiac output or increasing workload," said Daniel Burkhoff, Director of Heart Failure, Hemodynamics, and MCS Research at Cardiovascular Research Foundation and a study author.
AVIM therapy is currently being evaluated in the BACKBEAT global pivotal study, conducted in collaboration with Medtronic (NYSE:MDT). The therapy has received FDA Breakthrough Device Designation for treating uncontrolled hypertension in patients with increased cardiovascular risk.
Orchestra BioMed estimates that over 750,000 patients who receive pacemakers worldwide annually also have hypertension, representing a significant potential market for the therapy. While analyst price targets range from $12 to $20, suggesting significant upside potential, InvestingPro subscribers have access to 10+ additional exclusive tips and detailed financial metrics to better evaluate the company’s growth prospects.
The company stated in its press release that the consistent results across different pacing lead locations demonstrate the versatility of AVIM therapy and its potential to deliver clinical benefits for hypertension patients.
In other recent news, Orchestra BioMed Holdings, Inc. has announced a public offering of its common stock and pre-funded warrants, with plans to grant underwriters a 30-day option to purchase an additional 15% of the shares and warrants. This move follows the U.S. Food and Drug Administration’s approval of a protocol update for Orchestra BioMed’s BACKBEAT global pivotal study, which significantly expands the patient eligibility criteria by more than 24-fold. Additionally, a new study published in JACC: Advances highlights the promise of Orchestra BioMed’s atrioventricular interval modulation (AVIM) therapy, showing significant improvements in cardiac function among patients with hypertension and diastolic dysfunction. Meanwhile, BTIG has downgraded Orchestra BioMed’s stock rating from Buy to Neutral, citing concerns over recent dilutive equity financing and strategic funding arrangements that could impact future profitability. The downgrade reflects apprehensions about the company’s recent decisions and timeline delays. In related developments, Ocean Biomedical, Inc. is set to be delisted from the Nasdaq following the denial of its appeal to the Nasdaq Listing and Hearing Review Council. This decision follows a previous ruling by the Nasdaq Hearings Panel to delist and suspend trading of the company’s shares.
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