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The FDA has granted breakthrough device designation to Abiomed’s Impella ECP, the world's smallest heart pump. This designation accelerates its regulatory review process, enhancing its clinical study protocols and pre-market approval applications. The Impella ECP, designed to support coronary revascularization, demonstrated positive clinical outcomes in an early feasibility study involving 21 patients. Its small size enables more patients to receive hemodynamic support. The first patient treated, Robert Matthews, experienced significant recovery two days post-procedure.
Abiomed, Inc. (NASDAQ: ABMD) reported Q1 FY22 financial results with total revenue of $252.6 million, a 53% increase year-over-year. Impella heart pump product revenue reached $241.5 million, up 55%. U.S. sales were $197.5 million, marking a 56% rise. Despite strong operational metrics, GAAP net loss was $26.5 million due to the preCARDIA acquisition. The company forecasts FY22 revenue between $1,030 million and $1,050 million, reflecting 22-24% growth. Gross margin improved to 82.1%. The FDA approved Impella RP with SmartAssist for acute right heart failure treatment.
Abiomed, Inc. (NASDAQ: ABMD) will announce its financial results for Q1 FY2022 on August 5, 2021. A conference call led by CEO Michael R. Minogue and CFO Todd Trapp will take place at 8:00 a.m. ET to discuss the outcomes. Investors can access the live call via a webcast or by phone. A replay will be available later on the same day. The company specializes in medical devices for circulatory support, aiding heart function and blood flow. For further details visit www.abiomed.com.
Abiomed (NASDAQ: ABMD) has received FDA pre-market approval for its Impella RP with SmartAssist heart pump, an innovative device for treating acute right heart failure for up to 14 days. This device features dual-sensor technology, offering real-time management support and enabling remote monitoring. The update enhances patient outcomes and has shown significant survival improvements in critical cases, with 73% survival when used within 48 hours of cardiogenic shock onset. The rollout will follow best practice protocols at selected hospitals.
Abiomed (NASDAQ: ABMD) has acquired preCARDIA, a developer of a catheter system targeting acute decompensated heart failure (ADHF). This acquisition aims to enhance Abiomed’s offerings, providing a minimally invasive solution to manage ADHF-related volume overload, potentially improving patient outcomes and lowering healthcare costs. The preCARDIA system has received Breakthrough Device Designation from the FDA and shows promise in clinical trials, with significant reductions in cardiac filling pressures noted in a small early feasibility study.
Abiomed, Inc. (NASDAQ: ABMD) announced that CEO Michael R. Minogue will present at two upcoming virtual conferences. The first is the William Blair’s 41st Annual Growth Stock Conference on June 1st at 4:40pm CT, followed by the Jefferies Virtual Healthcare Conference on June 3rd at 2:00pm ET. The company designs medical devices to support circulatory health, allowing the heart to rest by enhancing blood flow. For more details, visit www.abiomed.com.
Abiomed reported a record fourth quarter fiscal 2021 revenue of $241.2 million, up from $206.7 million in the same period last year, due to increased patient support. For fiscal year 2021, total revenue increased by 1% to $847.5 million, with an operating income of $229.6 million. Impella heart pump revenue rose 17% in Q4 to $230.4 million. The company anticipates fiscal year 2022 revenue between $990 million and $1,030 million, projecting growth of 17% to 22% compared to fiscal 2021.
The National Cardiogenic Shock Initiative (NCSI) Study reveals a 71% survival to discharge rate and over 90% native heart recovery when utilizing the Impella heart pump before revascularization in acute myocardial infarction cardiogenic shock patients. Conducted across 80 U.S. sites with 406 patients, the study demonstrates that implementing a protocol-based approach can significantly enhance survival compared to historical rates. Findings indicate improved results for various SCAI stages, with a potential to save 20,000 lives annually if adopted nationwide.
Abiomed (NASDAQ:ABMD) announces the immediate appointment of Dr. Paula A. Johnson to its Board of Directors, enhancing its governance structure. Dr. Johnson, a recognized expert in healthcare and gender biology, will also contribute to the Governance and Nominating Committee. Her extensive background as the 14th president of Wellesley College and her leadership roles in women's health research will bring valuable insight as Abiomed aims to advance heart and lung recovery technologies. The board now consists of nine active directors, positioning Abiomed for its next growth phase.
Abiomed (NASDAQ:ABMD) announced patient enrollment in PROTECT IV, a large randomized controlled trial aimed at establishing clinical evidence for Impella support in high-risk percutaneous coronary intervention (HRPCI). Enrolled at Ascension St. John Hospital, the trial seeks to enroll 1,252 patients across over 100 sites in the U.S. and Europe. Its primary endpoint includes all-cause death, stroke, and myocardial infarction over at least one year. Building on previous studies, PROTECT IV could transform interventional cardiology practice for patients with complex coronary artery disease.
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