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NEW HOPE, Pa. - Orchestra BioMed Holdings, Inc. (Nasdaq:OBIO), a medical technology company with a market capitalization of $143.5 million and impressive gross profit margins of 92.7%, announced Thursday that a new study published in JACC: Advances demonstrates significant improvements in cardiac function among patients with hypertension and diastolic dysfunction who received atrioventricular interval modulation (AVIM) therapy. According to InvestingPro data, the company maintains strong liquidity with a current ratio of 2.1, though it faces challenges with cash burn.
The retrospective analysis of data from the MODERATO II study showed AVIM therapy reduced office systolic blood pressure by 12.1±12.8 mmHg and ambulatory systolic blood pressure by 8.3±9.7 mmHg over six months in patients with diastolic dysfunction, a key contributor to heart failure with preserved ejection fraction (HFpEF). These developments come as Orchestra BioMed’s stock trades at $2.66, down over 53% in the past six months, highlighting the volatile nature of early-stage medical technology investments.
Patients treated with AVIM also showed improvements in key measures of diastolic function, including increases in e′ from 5.9±2.0 to 8.8±3.4 cm/sec and E/A ratio from 0.86±0.39 to 1.60±0.84, indicating improved myocardial relaxation and diastolic compliance.
"There is a clear clinical link between long-standing hypertension, diastolic dysfunction, and the eventual development of HFpEF, yet few interventions are available that effectively target this pathway," said Dr. Marat Fudim of Duke Health, the publication’s primary author, according to the press release.
AVIM therapy is designed to be compatible with standard dual-chamber pacemakers and is currently being evaluated in the BACKBEAT global pivotal study in collaboration with Medtronic to support potential U.S. regulatory approval for use in pacemaker-indicated patients with uncontrolled hypertension.
The therapy previously received Breakthrough Device Designation from the FDA for the treatment of uncontrolled hypertension in patients with increased cardiovascular risk.
Hypertension is the leading cause of diastolic dysfunction and the most common comorbidity in older patients indicated for a pacemaker, according to the company’s statement. With earnings scheduled for August 19 and analysts maintaining a bullish consensus, investors can access detailed financial analysis and 8 additional key insights through InvestingPro’s comprehensive coverage of OBIO’s growth prospects and market position.
In other recent news, Orchestra BioMed Holdings, Inc. announced that the U.S. Food and Drug Administration has approved a protocol update for its BACKBEAT global pivotal study. This update significantly expands the patient eligibility criteria, increasing the potential eligible patient pool by more than 24 times compared to the original design. Additionally, Orchestra BioMed has commenced an underwritten public offering of its common stock and pre-funded warrants. The company plans to grant underwriters a 30-day option to purchase up to an additional 15% of shares and pre-funded warrants sold in the offering.
In a separate development, Ocean Biomedical, Inc. disclosed that it will be delisted from The Nasdaq Stock Market following a decision from the Nasdaq Listing and Hearing Review Council. The delisting will be effective at the opening of business on April 24, 2025, after the company’s appeal was denied. The initial decision to delist was made by the Nasdaq Hearings Panel on April 22, 2025. Ocean Biomedical had appealed this decision to the Listing Council, which has now affirmed the delisting.
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