Abiomed, Inc. - ABMD STOCK NEWS

Abiomed (NASDAQ: ABMD) announced successful results from the first-in-human early feasibility study of the preCARDIA system, aimed at treating acutely decompensated heart failure (ADHF). This multicenter study with 30 patients reported 100% freedom from major adverse events and significant reductions in right atrial and pulmonary capillary wedge pressures (34% and 27%, respectively). Urine output increased by 130%, indicating potential therapeutic benefits for approximately 300,000 patients annually who do not respond to diuretics. Further FDA authorization allows for expanding the study by 30 patients.

Abiomed (NASDAQ: ABMD) has received regulatory approvals for its Impella surgical products in the U.S., Japan, and Hong Kong. The FDA granted an Early Feasibility Study for Impella BTR, while Impella 5.5 with SmartAssist received approval from both Japan’s PMDA and Hong Kong’s MDD. The Impella 5.5 technology has reportedly improved survival rates in patients with acute heart failure, achieving a 74% survival to explant rate. The first patient for Impella 5.5 in Japan is expected to be treated soon, and the initial patient for Impella BTR in the U.S. is anticipated in March or April.

Abiomed, Inc. (NASDAQ: ABMD), a leader in heart support technologies, will present at the 40th Annual J.P. Morgan Healthcare Conference on January 12, 2022, at 1:30 PM ET. Michael R. Minogue, the company's Chairman, President, and CEO, will lead the discussion. Interested parties can access the webcast via the investor section of www.abiomed.com. Abiomed focuses on medical devices that support circulatory function, allowing the heart to rest and improving blood flow.

DANVERS, Mass.--(BUSINESS WIRE)--Abiomed, Inc. (NASDAQ: ABMD) announced that Michael R. Minogue, Chairman, President and CEO, will hold a fireside chat at the Stephens Annual Investment Conference on December 1, 2021, at 3:00pm ET, and at the Piper Sandler Virtual Healthcare Conference on December 2, 2021, at 11:00am ET. Abiomed is known for its heart support technologies, improving blood flow and performing heart pumping. For more information, visit www.abiomed.com.

The PROTECT III and Restore EF studies reveal improved clinical outcomes for high-risk PCI patients using Impella heart pumps. Presented at TCT 2021, the PROTECT III study shows a 31% relative risk reduction in major adverse cardiovascular and cerebrovascular events (MACCE) at 90 days compared to previous studies. The Restore EF study indicated significant improvements in left ventricular ejection fraction (LVEF), heart failure, and anginal symptoms. These advancements reflect the evolving use of Impella technology, enhancing patient care in various healthcare settings.

The 2021 guidelines of the European Society of Cardiology (ESC) elevate the recommendation for Impella heart pumps from Class IIb to Class IIa for treating patients in acute heart failure and cardiogenic shock. This update, the first in five years, reflects strong clinical evidence supporting Impella use in high-risk PCI and enhances its application to patients with mildly reduced left ventricular ejection fraction. The guidelines further emphasize mechanical circulatory support's role, particularly in unloading VA-ECMO patients.

Abiomed (NASDAQ:ABMD) highlights its Impella heart pumps at the Transcatheter Cardiovascular Therapeutics (TCT) 2021 conference, taking place in Orlando, Florida, from November 4-6. Key studies demonstrating the benefits of Impella in high-risk PCI and cardiogenic shock will be presented, including results showing improved patient outcomes through early unloading and complete revascularization. The FDA has approved Impella devices for several heart conditions.

Abiomed will offer demonstrations and discussions at their booth and conduct a pre-meeting workshop on November 3.

Abiomed, Inc. (NASDAQ:ABMD) reported Q2 financial results for the quarter ended September 30, 2021, revealing revenue of $248.1 million, an 18% increase year-over-year. Worldwide Impella® heart pump revenue reached $235.8 million, with U.S. sales at $189.8 million, up 16%. Gross margin improved to 82.3%. Non-GAAP net income rose 2% to $47.2 million, or $1.03 per diluted share. The company revised its fiscal year 2022 revenue guidance to $1,010 million to $1,030 million, reflecting a 19% to 22% increase compared to the prior year.

Abiomed, a leading provider of circulatory support medical devices, will release its second-quarter fiscal 2022 financial results on October 28, 2021. A conference call is set for 8:00 a.m. ET on the same day, hosted by CEO Michael R. Minogue and CFO Todd Trapp. Investors can tune in via webcast or by phone. A replay will be available from 11:00 a.m. ET on October 28 through 10:00 a.m. ET on November 4. The company highlights its focus on product development and commercial growth, but risks due to external factors remain.