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DANVERS, Mass.-- An analysis of over 2,000 patients from a U.S. database shows that non-emergent high-risk PCI using the Impella heart pump leads to better outcomes than the intra-aortic balloon pump (IABP). Key findings include significantly higher in-hospital survival (95.3% vs. 91.0%), reduced myocardial infarction (2.5% vs. 11.9%), and shorter hospital stays (3.1 days vs. 5.5 days). The study, published in The American Journal of Cardiology, supports previous research on Impella’s effectiveness. Both devices had similar safety profiles for bleeding and stroke.
Abiomed, Inc. (ABMD) will release its financial results for Q2 of fiscal year 2023 on November 1, 2022, with a conference call scheduled at 8:00 a.m. ET. CEO Michael R. Minogue and CFO Todd Trapp will host the call. Investors can listen via webcast or phone, with a replay available until November 8, 2022. Abiomed specializes in circulatory support and oxygenation technologies aimed at enhancing heart function and supporting respiratory health. The company emphasizes the importance of forward-looking statements subject to various risks.
Abiomed (ABMD) announced a 30-day survival rate of 77% for patients with cardiogenic shock due to myocarditis, based on a three-year study at 109 hospitals in Japan. This represents a significant improvement over the 48% survival rate for those receiving only VA ECMO support. The findings were presented at the 2022 Transcatheter Cardiovascular Therapeutics conference. The study involved 143 patients and was conducted by the J-PVAD registry, highlighting the potential of Impella support in enhancing heart recovery amidst rising myocarditis cases linked to COVID-19.
Abiomed's recent study highlights a significant advancement in treating AMI cardiogenic shock patients using Impella devices. Conducted across 109 hospitals in Japan, the study found a 30-day survival rate of 81% among 1,344 patients, a stark improvement from the historical rate of approximately 50%. Presented at the 2022 TCT conference, these results reinforce the efficacy of Impella in enabling heart recovery when combined with best practices. The findings align with similar studies, suggesting a consistent trend in improved survival rates with Impella usage.
A new analysis from the STEMI DTU pilot trial reveals a significant reduction in heart muscle damage in STEMI patients who underwent 30 minutes of left ventricular unloading with Impella CP before percutaneous coronary intervention (PCI). Results showed a lower infarct size normalized to the area at risk (47±16 vs. 60±16, p=0.02), representing a 22% relative and 13% absolute reduction. These findings, presented by Dr. Navin K. Kapur at the 2022 TCT conference, suggest that this approach could improve outcomes by minimizing myocardial damage and reducing heart failure risk.
The FDA has approved the RECOVER IV randomized controlled trial (RCT) for treating acute myocardial infarction (AMI) cardiogenic shock using Impella heart pumps. The trial aims to assess the efficacy of Impella support prior to percutaneous coronary intervention (PCI). Additionally, the FDA has closed the RECOVER III post-approval study, validating the Impella as a safe therapy. This regulatory approval highlights Impella as the only device with both pre-market and post-approval FDA designations for AMI cardiogenic shock, with significant implications for patient care and market positioning.
Abiomed (NASDAQ: ABMD) will showcase the benefits of Impella heart pumps for high-risk revascularization and heart recovery at the Transcatheter Cardiovascular Therapeutics (TCT) 2022 Conference from September 16 to 19 in Boston. Presenters will share data indicating that Impella improves survival rates for cardiogenic shock patients and enhances quality of life for those with heart failure. The company will also conduct hands-on training and preview future technologies, including preCARDIA and Impella ECP, aimed at advancing cardiac care.
Abiomed (NASDAQ: ABMD) announced positive results from its Restore EF study, demonstrating that Impella-supported high-risk PCI significantly improves left ventricular ejection fraction (LVEF) and reduces heart failure and angina symptoms. Conducted across 22 U.S. sites from August 2019 to May 2021, the study showed a 29% relative improvement in LVEF, a 76% reduction in severe heart failure symptoms, and a 97% reduction in severe angina symptoms at 90-day follow-up. These findings support the safety and efficacy of Impella in high-risk cardiac procedures.
ABIOMED, Inc. (NASDAQ: ABMD) reported financial results for the quarter ending June 30, 2022, showcasing a revenue increase of 10% to $277 million compared to the prior fiscal year. This growth is driven by a 6% rise in U.S. patient utilization and a significant 39% increase in Japan. Gross margin stood at 81.0%, while GAAP net income per diluted share improved to $1.19. The company continues to maintain its fiscal year 2023 revenue guidance of 10% to 14% growth. Additionally, a $200 million stock repurchase program was approved to further enhance shareholder value.
Abiomed, Inc. (NASDAQ: ABMD) will release its first-quarter fiscal year 2023 financial results on August 4, 2022. The conference call, hosted by CEO Michael R. Minogue and CFO Todd Trapp, is scheduled for 8:00 a.m. ET. Investors can listen via webcast or by dialing in. A replay will be available until August 11, 2022. Abiomed is known for its innovative medical devices that support heart function and improve blood flow. The company emphasizes growth opportunities, though faces industry and regulatory challenges.
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