Business Wire

Abiomed Expands Product Portfolio with Acquisition of Cardiopulmonary Support Technology (ECMO) to Improve Outcomes for Patients

Share

Abiomed (NASDAQ: ABMD), maker of the Impella heart pump, has acquired Breethe, developer of a novel extracorporeal membrane oxygenation (ECMO) system that will complement and expand Abiomed’s product portfolio to more comprehensively serve the needs of patients whose lungs can no longer provide sufficient oxygenation, including patients suffering from cardiogenic shock or respiratory failure such as due to ARDS, H1N1, SARS, or COVID-19. ECMO has also been utilized as a primary method of oxygenation and hemodynamic support for pediatric patients.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200429005975/en/

The Breethe system has an integrated oxygen concentrator removing the need for bulky, heavy tanks and multiple wires enabling easier patient mobility. (Photo: Business Wire)

The Breethe system has an integrated oxygen concentrator removing the need for bulky, heavy tanks and multiple wires enabling easier patient mobility. (Photo: Business Wire)

Patients who require ECMO therapy have a severe and life-threatening illness that stops their lungs from working properly. The system is connected to patients through tubes (cannulae) and is an external respiratory assistance device that takes venous blood, removes carbon dioxide and adds oxygen, much like a human lung. Oxygenated blood is then sent back to the patient. Each year, more than 20,000 patients receive ECMO therapy in the United States.

Abiomed recognizes the need for ECMO therapy for patients in need of oxygenation and has supported approximately 10,000 ECMO plus Impella (ECPella TM) patients with cardiogenic shock over the past 10 years. In Japan, more than half of Impella patients receive ECPella for hemodynamic and oxygenation support.

Breethe’s product is a first-of-its kind, easy-to-use compact ECMO system with an integrated oxygen concentrator that eliminates the need for bulky oxygen tanks to promote easier patient ambulation. It has a novel design that is intuitive for health care providers to set up, manage, and monitor. Abiomed invested in Breethe in mid-2019. Breethe has applied for 510(k) clearance by the Food and Drug Administration (FDA).

Breethe’s founder and the Hales Distinguished Professor of Surgery at University of Maryland School of Medicine, Bartley Griffith, MD, is a renowned leader in multiple areas of adult cardiac surgery including mechanical circulatory support. Dr. Griffith has collaborated with Abiomed for a number of years and served as the principal investigator of RECOVER I. With decades of experience, Dr. Griffith and his team designed the cutting-edge Breethe system to improve patient outcomes, improve quality of life and reduce total cost of care by changing the way oxygenation is delivered.

“Abiomed is the best positioned company to build on the legacy of what we started,” said Dr. Griffith. “I am confident that the addition of Breethe’s technology into Abiomed’s product portfolio will further enhance Abiomed’s ability to improve outcomes for their patients and serve a new patient population.”

“This acquisition is a natural progression toward improving patient care,” said Matthew D. Bacchetta, MD, associate professor, Department of Thoracic Surgery at Vanderbilt University. “Breethe’s compact and all-in-one technology aims for improved patient ambulation, which can improve outcomes and promote active rehabilitation for patients with cardiopulmonary diseases.”

“Breethe will integrate with Abiomed and our manufacturing, quality, sales, engineering and research capabilities, including Abiomed’s best-in-class Clinical Support Center,” said Michael R. Minogue, Abiomed’s Chairman, President and Chief Executive Officer. “This acquisition aligns with our principles of leading in technology and innovation, putting patients first and striving to continually improve outcomes. Physicians have asked Abiomed to bring this technology into our portfolio because of our ability to support patients, teach best practices, and collect critical data for research. This ECMO technology will allow us to treat cardiogenic shock patients who are already being supported with Impella, add pediatric offerings and treat a new patient population with respiratory failure.”

This acquisition provides Abiomed with the opportunity to innovate traditional ECMO technology, focusing on patient ambulation and recovery from acute respiratory failure. For many patients in cardiogenic shock, Impella is the optimal technology because it unloads the left ventricle, perfuses end organs and allows the heart to rest and recover. Abiomed recognizes patients in cardiogenic shock may also need oxygenation. ECMO perfuses the end organs but does not unload the left ventricle, which increases the oxygen demand of the myocardium (heart muscle) in these patients. For patients in cardiogenic shock, Impella with ECMO (ECPella) work together to unload the heart and oxygenate the body.

Multiple studies support the association of ECPella therapy to improve outcomes for patients who are suffering from cardiogenic shock and require oxygenation. The European Journal of Heart Failure, ASAIO, and the Journal of the American College of Cardiology have published studies that examine a combined 4,126 patients and conclude use of ECPella was associated with increased survival rates, as compared to patients who were treated with ECMO only. (See figure 1.) In addition to higher survival, the study in the European Journal of Heart Failure by Pappalardo et al. found higher rates of heart recovery with ECPella use than with ECMO only (62% vs 36%; p=0.048).

Terms of the acquisition are not being disclosed at this time.

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, DTU STEMI Study and SmartAssist are pending trademarks of Abiomed, Inc.

ABOUT BREETHE

Breethe has filed for, but not received, 510 (k) clearance for its OXY-1 System. The materials contained herein about Breethe’s future products are intended for investor information purposes only and should not be used for the purposes of providing medical treatment. Nothing herein should be construed as a claim of safety or efficacy with respect to future products or indications.

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 the scope, scale and duration of the impact of the COVID-19 pandemic, 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 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. 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.

Contact information

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

About Business Wire

Business Wire
Business Wire



Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Newmont Publishes 2019 Sustainability Report1.6.2020 15:00:00 CESTPress release

Newmont Corporation (NYSE: NEM, TSX: NGT) (Newmont or The Company) today announced the publication of its 2019 Sustainability Report, Beyond the Mine, a transparent and comprehensive disclosure of the Company’s environmental, social and governance (ESG) performance. “Our sustainability report provides investors and other stakeholders a transparent and detailed look at look at our safety, environmental and social performance,” said Tom Palmer, President and Chief Executive Officer. “In 2019, we completed two transformative transactions whilst enhancing our ESG performance to align with our position as the world’s leading gold company.” Newmont’s 2019 sustainability highlights include: Achieving no workplace fatalities and conducting a global safety culture review, which identified several opportunities to enhance Newmont’s Fatality Risk Management program and improve the way fatality risks are managed Further strengthening management of tailings, whilst enhancing transparency through a

New Western Union research provides insight into the future of international education1.6.2020 15:00:00 CESTPress release

The Western Union Company (NYSE: WU), a leader in cross-border, cross-currency money movement and payments, today shares a new report on “The Future of International Education,” in partnership with The Future Laboratory. The white paper highlights five new student profiles that will evolve from the shifting attitudes and behaviors of today’s youth. From Hybrid Thinkers to Greener Graduates, this new report predicts how academic institutions should adapt to meet these expectations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200601005162/en/ Meet the students of the future: new student profiles uncovered in “The Future of International Education” (Graphic: Business Wire) The findings come as universities and colleges worldwide are evolving to navigate COVID-19, from moving online, to delaying term dates. Institutions can use the report to ensure the new policies they introduce align with the needs and priorities of interna

Vivet’s Second Gene Therapy Product, VTX-803 for PFIC3, Receives US and European Orphan Drug Designation1.6.2020 13:00:00 CESTPress release

Vivet Therapeutics announced today that both the Food and Drug Administration (FDA) and the European Commission (EC) have granted Orphan Drug Designation (ODD) for Vivet’s second gene therapy product, VTX-803, for the treatment of Progressive Familial Intrahepatic Cholestasis type 3 (PFIC3). PFIC3 is a rare life-threatening and chronically debilitating condition due to progressive severe liver dysfunction, accompanied by jaundice, portal hypertension, hepatosplenomegaly and failure to thrive. The symptoms of the disease usually appear first in childhood with progressive cholestasis, evolving to hepatic failure, cirrhosis and need for liver transplantation. “We are very pleased to receive these designations which further validate Vivet’s efforts to treat rare inherited metabolic disorders. The FDA and EC have both recognized the unmet need for a safe and effective treatment of PFIC3 and the potential of VTX-803 to address such need. The field of Progressive Familial Intrahepatic Cholest

FDA Issues Emergency Use Authorization for Impella RP as Therapy for COVID-19 Patients with Right Heart Failure1.6.2020 13:00:00 CESTPress release

The United States Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for Impella RP to include patients suffering from COVID-19 related right heart failure or decompensation, including pulmonary embolism (PE). Abiomed (NASDAQ: ABMD) manufactures Impella RP. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200601005257/en/ Impella RP is now FDA indicated for COVID-19 related complications, including pulmonary embolism. (Photo: Business Wire) Impella RP is a temporary heart pump that provides circulatory support for patients who develop right side ventricular failure. Five years of pre- and post-market clinical studies support Impella RP’s safety and efficacy. In 2017, Impella RP received FDA approval as safe and effective for treating right ventricular failure in the setting of acute myocardial infarction and after cardiac surgery. Biventricular cardiac support can be provided when Impella RP is

Zynga Enters Into Agreement to Acquire Istanbul-based Peak, Creator of Top Charting Mobile Franchises Toon Blast and Toy Blast1.6.2020 13:00:00 CESTPress release

Zynga Inc. (Nasdaq: ZNGA), a global leader in interactive entertainment, today announced it has entered into a definitive agreement to acquire Peak, one of the most globally successful mobile gaming companies, for $1.8 billion. Peak brings a 100-person strong team and two Forever Franchises, Toon Blast and Toy Blast, that have consistently ranked in the top 10 and top 20 U.S. iPhone grossing games for over two years, respectively. These franchises add significant scale to Zynga’s live services and will be an additional driver of margin expansion over the coming years. Peak also enhances Zynga’s new game pipeline with additional projects in early development. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200601005142/en/ Zynga Enters Into Agreement to Acquire Istanbul-based Peak, Creator of Top Charting Mobile Franchises Toon Blast and Toy Blast (Graphic: Business Wire) Founded in 2010 by Sidar Sahin, Peak has developed the

bitFlyer Europe and Quazard Partner to Bring First Ever Trading Competition to Botwars Ultimate Trading1.6.2020 06:00:00 CESTPress release

Leading cryptocurrency exchange bitFlyer, is partnering with crypto-trading game developer Quazard, to bring the first ever gamified trading competition to the Botwars Ultimate Trading universe. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200531005005/en/ bitFlyer and Quazard bring the first gamified trading competition to the Botwars Ultimate Trading universe (Graphic: Business Wire) The competition, which launches today, allows Botwars players to compete in a free to enter crypto-trading simulator to win real Bitcoin. This is the first trading competition to launch on Botwars, and the only live trading competition of its type. In Botwars Ultimate Trading, players need to build an army of trading robots (each representing a trade) and lead them into battle to conquer the cryptocurrency markets. Botwars is a real-time, gamified currency trading experience where you will learn new trading skills, unlock powerful new tradin

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom