Abiomed, Inc. - ABMD STOCK NEWS

Abiomed, Inc. (NASDAQ: ABMD) announced that CEO Michael R. Minogue will participate in a fireside chat at the virtual Stephens Annual Investment Conference on November 18, 2020, at 9:00 am ET. The company specializes in heart support technologies, aiming to improve blood flow and reduce cardiac workload. For further details about Abiomed's initiatives and progress, visit www.abiomed.com.

Abiomed reported Q2 FY2021 revenue of $209.8 million, up 27% sequentially and 2% year-over-year despite COVID-19 challenges. Worldwide Impella® heart pump revenue reached $199.7 million, marking a 29% increase from Q1 FY2021. Operating income rose to $61.3 million, while gross margin dipped to 81.5%. GAAP net income surged to $62.2 million or $1.36 per diluted share, benefitting from an investment gain. Third quarter FY2021 revenue is projected between $221 million and $230 million.

Abiomed (NASDAQ: ABMD) reports the successful treatment of its first two patients with the Impella ECP, the world's smallest heart pump. The device, measuring 9 French, is designed for less invasive cardiac procedures and can provide peak flows over 3.5 L/min. Treating physicians noted its effectiveness in high-risk percutaneous coronary interventions (PCI) for patients with severe coronary artery narrowing. This innovation is part of an FDA early feasibility study aimed at enhancing patient outcomes and may expand to more patients with FDA approval.

Abiomed has received 510(k) clearance from the FDA for its Breethe OXY-1 System™, an all-in-one cardiopulmonary bypass system. This system is designed for patients needing respiratory support, particularly those with cardiogenic shock or respiratory failure conditions like COVID-19. The Breethe system can pump, oxygenate, and remove carbon dioxide from blood for up to six hours. It can be combined with the Impella heart pump for enhanced patient treatment, known as ECpella therapy, and aims to improve patient outcomes and recovery processes.

Data from the TCT Connect symposium indicates that early detection and intervention in right heart failure significantly improve survival rates. Patients receiving the Impella RP device within 48 hours of cardiogenic shock onset had a survival rate of 73%, compared to 14% for those with delayed treatment (p<0.001). This study, along with others, emphasizes the importance of timely support for patients, particularly those in AMI cardiogenic shock, where right heart dysfunction can elevate mortality risk by eight times.

DANVERS, Mass. -- Two studies presented at TCT Connect reveal that placing the Impella device pre-PCI in acute myocardial infarction (AMI) cardiogenic shock patients significantly improves survival rates. The first study demonstrated an 18% relative increase in overall survival among patients who received Impella before PCI compared to those who received it afterward. The second study found that women experienced a remarkable 74% relative survival benefit with pre-PCI placement. These findings underscore the importance of adopting best practices in cardiogenic shock treatment.

Abiomed will host a virtual investor meeting on October 20, 2020, at 8:00 a.m. EDT, to discuss new clinical data from the PROTECT III and Restore EF studies presented at TCT Connect. The meeting features presentations by Dr. Chuck A. Simonton and an interactive Q&A with CEO Michael R. Minogue and CFO Todd Trapp. Investors can join via the company’s website. A replay will be available afterward. Abiomed focuses on circulatory support medical devices, notably its Impella product line.

Abiomed (NASDAQ: ABMD) released new interim data from the PROTECT III study that shows reduced rates of MACCE (major adverse cardiovascular and cerebrovascular events) when using the Impella device for high-risk PCI patients. Compared to the PROTECT II trial, PII-like patients in PROTECT III had improved 90-day MACCE rates (15% vs. 21.9%, p=0.035) and fewer bleeding complications (1.8% vs. 12.5%, p<0.001). The study included 1,143 patients across 45 sites. This data strengthens the understanding of Impella's safety and effectiveness, paving the way for the upcoming PROTECT IV trial, focused on complete revascularization.

The Restore EF Study showcases the efficacy of Impella in enhancing cardiac function for high-risk PCI patients. An interim analysis revealed significant improvements in left ventricular ejection fraction (LVEF), heart failure, and anginal symptoms. Key findings include:

• Median LVEF increased from 31% to 45% (p<0.0001).
• Heart failure symptoms reduced by 80% in NYHA classification III/IV (p<0.001).
• Anginal symptoms decreased by 99% in CCS classification III/IV (p<0.0001).

Sponsored by Abiomed, the study supports best practices for improved patient outcomes.