Growing Shareholder Value

Press Releases

Planet abiomed Inc.
Dec 21,2020

First Patients, Including a COVID-19 Patient, Treated with Abiomed’s Innovative ECMO Technology

DANVERS, Mass.--(BUSINESS WIRE)--Dec. 21, 2020-- Abiomed (NASDAQ: ABMD) announces the first two patients in the world have been treated with the Abiomed Breethe OXY-1 System, a compact cardiopulmonary bypass system. The advanced ECMO technology pumps, oxygenates, and removes carbon dioxide from blood for patients whose lungs can no longer provide sufficient end organ oxygenation.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201221005403/en/

The first patient in the world treated with the Abiomed Breethe OXY-1 System easily walked around the hospital while on support. (Photo: Business Wire)

The first patient in the world treated with the Abiomed Breethe OXY-1 System easily walked around the hospital while on support. (Photo: Business Wire)

The system can help provide oxygenation to patients suffering from cardiogenic shock or respiratory failure from ARDS, H1N1, SARS, or COVID-19. When used with the Impella heart pump, it can unload the heart and oxygenate the body, a combination therapy known as ECpella.

The first patient is a 21-year-old woman at the University of Maryland Medical Center who sustained a lung injury and was placed on V-V ECMO with the Breethe system. She immediately began to improve and was able to ambulate daily, as seen in this short video.

After eight days, the patient was successfully weaned off Breethe support and is no longer in the ICU. The patient was treated by Bartley Griffith, MD, the Hales Distinguished Professor of Surgery at University of Maryland, School of Medicine and Daniel Herr, MD, chief surgical critical care services and medical director cardiac surgery ICU at University of Maryland Medical Center.

The second patient is a 51-year-old woman being treated at HUMC/Hackensack Meridian Health for respiratory failure due to COVID-19. After 24 hours of V-V ECMO support with the Breethe system, she is stable and improving. The patient was treated by Mark Anderson, MD, chief of the division of cardiac surgery and cardiothoracic surgeon at the Heart and Vascular Hospital at HUMC/Hackensack Meridian Health.

“Breethe is an important new option for patients with COVID-19 who require ECMO therapy. It is simple and intuitive to use, highly portable and a very promising therapy with the potential to help many patients,” said Dr. Anderson.

“This revolutionary technology will change the way we think about extracorporeal life support therapy by enabling physicians to easily mobilize their patients in turn promoting a faster recovery,” said Dr. Griffith. Dr. Griffith helped develop the Breethe technology and currently serves as an Abiomed advisory board member. “I am pleased to be a part of this milestone”

“The Breethe system significantly facilitates early mobilization and physical rehabilitation, which is critically important in the recovery of our patients,” said Chris L. Wells, PhD, PT, CCS, ATC, associate professor at the University of Maryland, School of Medicine, EBP, and research coordinator in the department of rehab services at University of Maryland Medical Center. She is also member of the medical team who treated the first patient.

Breethe adds to Abiomed’s innovative portfolio focused on native heart and lung recovery. Abiomed now provides the treatment options of the catheter-based Impella heart pump, which unloads the left ventricle, perfuses end organs and allows the heart to rest and recover, Breethe, which provides oxygenation, and the combination therapy of ECpella, when Impella and Breethe work together to unload the heart and oxygenate the body.

The Breethe system received FDA 510(k) clearance in October. It is being rolled out through a controlled launch at select hospitals in the United States, with full U.S. commercial availability expected in calendar year 2021.

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.

ABOUT ABIOMED BREETHE OXY-1 SYSTEM

The Abiomed Breethe OXY-1 System™ is cleared by the U.S. Food and Drug Administration (FDA) to provide extracorporeal circulation. The OXY-1 System pumps, oxygenates and removes carbon dioxide from blood during cardiopulmonary bypass up to six (6) hours in duration.

Under guidance issued by FDA, on April 6, 2020, the Abiomed Breethe OXY-1 System is now permitted to be used temporarily in the U.S. for ECMO therapy greater than six hours. Therefore, it now has a limited indication modification for use longer than six hours in an extracorporeal membrane oxygenation (ECMO) circuit to treat patients who are experiencing acute temporary respiratory or acute cardiopulmonary failure. This limited indication modification for ECMO therapy greater than six hours has not been cleared or approved by FDA and is in effect only for the duration of the public health emergency related to COVID-19 as declared by the U.S. Department of Health and Human Services (HHS).

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements. Forward-looking statements are subject to risks and uncertainties such as those described in Abiomed's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

Media Contact:
Sarah Karr
Communications Manager
978-882-8211
skarr@abiomed.com

Investor Contact:
Todd Trapp
Vice President and Chief Financial Officer
(978) 646-1680
ttrapp@abiomed.com

Source: Abiomed

FORWARD-LOOKING STATEMENTS

This release contains forward-looking statements, including, without limitation, statements regarding development of Abiomed's existing and new products, the company's progress toward commercial growth, and future opportunities and expected regulatory approvals. All statements, other than statements of historical facts, may be forward-looking statements. These forward-looking statements may be accompanied by such words as “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,” “project,” “target,” “should,” “likely,” “will” and other words and terms of similar meaning. The company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including, without limitation: the scope, scale and duration of the impact of the COVID-19 pandemic, the company’s dependence on Impella® products for all of its revenues; the company’s ability to successfully compete against its existing or potential competitors; the acceptance of the company’s products by cardiac surgeons and interventional cardiologists; long sales and training cycles associated with expansion into new hospital cardiac centers; reduced market acceptance of the company’s products due to lengthy clinician training process; the company’s ability to effectively manage its growth; the company’s ability to successfully commercialize its products; the company’s ability to obtain regulatory approvals and market and sell its products in certain jurisdictions; enforcement actions and product liability suits relating to off-label uses of the company’s products; unsuccessful clinical trials or procedures relating to products under development; the company’s ability to maintain compliance with regulatory requirements; the failure of third-party payers to provide reimbursement of the company’s products; the company’s ability to increase manufacturing capacity to support continued demand for its products; the company or its vendors’ failure to achieve and maintain high manufacturing standards; the failure of the company’s suppliers to provide the components the company requires; the company’s ability to expand its direct sales activities into international markets; the outcome of ongoing securities class action litigation relating to our public disclosures, the company’s ability to integrate acquired companies into its operations and other risks and challenges detailed in the company's filings with the Securities and Exchange Commission (the “SEC”), including the most recently filed Annual Report on Form 10-K and the filings subsequently filed with or furnished to the SEC. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. Unless otherwise required by law, 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.