Abiomed’s Response to the COVID-19 Pandemic

DANVERS, Mass.--(BUSINESS WIRE)--Mar. 25, 2020-- Abiomed (NASDAQ: ABMD), maker of the Impella heart pump, is taking a number of steps to aid the global medical community and contribute to improved patient care during the COVID-19 outbreak. Impella heart pumps are FDA approved to provide circulatory support to allow the heart to rest and recover for patients suffering from cardiogenic shock, including AMI, right heart failure, cardiomyopathy and myocarditis, or for patients with advanced heart failure undergoing PCI.

During these challenging times, Abiomed has focused our Patients First mission on three guiding priorities:

1. Clinically supporting patients and physicians on-site, on-call and online
2. Manufacturing and supplying Impella heart pumps to hospitals
3. Keeping our employees and their families healthy and safe

As a medical device manufacturer that provides on-site support to hospitals, Abiomed is taking the following steps:

1. Continuing to manufacture and support patients. Our manufacturing, shipping and patient support teams are taking additional precautions as they continue to manufacture and ship Impella heart pumps and provide clinical support to patients in need of the Impella platform. We are also minimizing the spread of COVID-19 by instituting a work-from-home policy for all employees worldwide who are not involved in manufacturing, shipping or patient support.
2. Maintaining appropriate levels of inventory to supply hospitals needing Impella heart pumps during the COVID-19 crisis. Abiomed has several months of inventory available to ship to hospitals. Production continues with strict controls at Abiomed’s redundant manufacturing facilities in the United States and Germany.
3. Proactively moving inventory to depot sites in our major markets of the United States, Germany and Japan. This will help hospitals maintain access to Impella heart pump inventory, even if coronavirus-related shipping issues arise.
4. Using online virtual meeting platforms to communicate as needed to employees and customers. Abiomed implemented Skype more than a year ago and has transitioned all operational reviews to this virtual format.
5. Supporting clinical cases 24 hours a day, 7 days a week with Abiomed’s field-based, in-hospital clinical support team, augmented by the existing on-call phone support team from the Clinical Support Center. These field and on-phone support resources in the United States, Europe and Japan provide expertise in utilizing Impella to treat many of the sickest patients in the hospital. This on-site and on-phone support is a service provided by Abiomed for free as part of our commitment to improving patient outcomes.
6. Accelerating the Impella Connect rollout to provide online remote patient monitoring. Impella Connect allows Abiomed personnel to remotely monitor the Impella console and interact with medical providers appropriately on hemodynamic management, alarms and weaning. During the COVID-19 crisis, this online, HIPAA compliant monitoring service is being provided at no cost to help medical providers manage patients 24x7. In FY21, Abiomed will transition the majority of our patients and hospitals to the Impella Connect platform.
7. Pausing the FDA STEMI-DTU Randomized Controlled Trial in light of the tremendous challenge to medical providers to treat patients with the COVID-19 pandemic. Abiomed plans to restart the study in approximately eight weeks when physicians and hospitals have the ability to enroll patients and record clinical metrics.
8. Facilitating a COVID-19 physician advisory board through our global physician network. The advisory board is evaluating lessons learned in the use of all types of treatment, including the use of mechanical circulatory support (MCS) in COVID-19 patients. Additionally, Abiomed is tracking patient outcomes of COVID-19 patients who receive Impella, using the Impella Quality (IQ) Database.
9. Expanding existing online, interactive training opportunities to enable greater remote learning opportunities for medical providers. Hundreds of hours of education and online training are already available through Abiomed’s online physician community at ProtectedPCI.com, Abiomed Academy and the Impella app. The online training may be especially useful for physicians and nurses who are newly transitioned to patient care areas requiring competence with Impella use. In the April quarter, Abiomed will launch Coronary Artery and Myocardial Protected (CAMP) PCI, the largest online and interactive education and training endeavor in the company’s history, led by a faculty of experts in the field of circulatory support.
10. Maintaining product development and regulatory submissions. Abiomed is financially sound with $600 million in cash and no debt and will continue to invest in innovation and selectively hire for critical business objectives.

“Abiomed has always put patients first and we continue to do so during these challenging times for the world’s healthcare systems,” said Michael R. Minogue, Abiomed’s Chairman, President and Chief Executive Officer. “Abiomed would like to thank the medical community for all they are doing to support patients and provide much needed medical care during the COVID-19 health emergency. May God bless them and all the patients and families suffering around the world.”

ABOUT IMPELLA HEART PUMPS

The Impella 2.5^® and Impella CP^® devices are U.S. FDA PMA approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI) such as stenting or balloon angioplasty, to re-open blocked coronary arteries. The Impella 2.5, Impella CP, Impella CP with SmartAssist^®, Impella 5.0^®, Impella LD^®, and Impella 5.5™ with Smart Assist^® are U.S. FDA approved heart pumps used to treat heart attack or cardiomyopathy patients in cardiogenic shock, and have the unique ability to enable native heart recovery, allowing patients to return home with their own heart. The Impella RP^® is U.S. FDA approved to treat right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery. Impella is the most studied mechanical circulatory support device in the history of the FDA with more than 10 years of FDA studies, real world clinical data on more than 140,000 patients and more than 650 peer-reviewed publications.

In Europe, the Impella 2.5, Impella CP and Impella CP with SmartAssist are CE marked for treatment of high-risk PCI and AMI cardiogenic shock patients for up to 5 days. Impella 5.0 and Impella LD are CE marked to treat heart attack or cardiomyopathy patients in cardiogenic shock for up to 10 days. The Impella 5.5™ with Smart Assist^® is CE marked to treat heart attack or cardiomyopathy patients in cardiogenic shock for up to 30 days. The Impella RP is CE marked to treat right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, open-heart surgery, or refractory ventricular arrhythmia.

To learn more about the Impella platform of heart pumps, including their approved indications and important safety and risk information associated with the use of the devices, please visit www.impella.com.

ABOUT ABIOMED

Based in Danvers, Massachusetts, USA, Abiomed, Inc. is a leading provider of medical devices that provide circulatory support. Our products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart. For additional information, please visit www.abiomed.com.

Abiomed, Impella, Impella 2.5, Impella 5.0, Impella LD, Impella CP, Impella RP, and Impella Connect are registered trademarks of Abiomed, Inc., and are registered in the U.S. and certain foreign countries. Impella BTR, Impella 5.5, Impella ECP, CVAD Study, and SmartAssist are pending trademarks of Abiomed, Inc.

FORWARD-LOOKING STATEMENTS

This release contains forward-looking statements, including statements regarding development of Abiomed's existing and new products, the company's progress toward commercial growth, and future opportunities and expected regulatory approvals. The company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including uncertainties associated with development, testing and related regulatory approvals, including the potential for future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, litigation matters, future capital needs and uncertainty of additional financing, and other risks and challenges detailed in the company's filings with the Securities and Exchange Commission, including the most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. The company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.