Abiomed

Abiomed is a publicly-traded medical devices company that develops and manufactures external and implantable circulatory support devices. The company is headquartered in Danvers, Massachusetts and has three additional offices, two in Germany in the cities of Berlin and Aachen, and another in Tokyo, Japan. Michael R. Minogue is Chairman, CEO & President of the company, with Dr. Thorsten Siess as Chief Technology Officer, Dr. Chuck Simonton as Chief Medical Officer and Dr. David M. Weber as Chief Operating Officer. According to Bloomberg, the company "engages in the research, development, and sale of medical devices to assist or replace the pumping function of the failing heart. It also provides continuum of care to heart failure patients". As of 2019, the company had secured five FDA approvals and 715 patents with 622 pending. For fiscal year 2019, Abiomed reported $769.4 million in revenue and reported diluted earnings per share was $5.61 for the year.
History.
Abiomed was founded in Danvers, Massachusetts by David M. Lederman in 1981 as Applied Biomedical Corporation. That year, the company commenced the development of an artificial heart. Funded by federal research grants, Lederman partnered with The Texas Heart Institute to develop the AbioCor, a grapefruit-sized electromagnetic device with an internal battery that completely replaces the heart without wires or tubes passing through the skin. In July 2001, AbioCor became the first artificial heart successfully implanted in a patient, where it pumped more than 20 million times. Fourteen of the AbioCor devices were implanted, during clinical trials from 2001 to 2004, with the longest-living recipient surviving 512 days. The AbioCor won FDA approval in 2006 for patients who are near death and do not qualify for a heart transplant.
In 2004, Michael R. Minogue became president and CEO of Abiomed. In 2005, Abiomed purchased ventricular assist device company Impella CardioSystems AG of Aachen, Germany, maker of the Impella heart pump, developed by Thorsten Siess, who is now the Chief Technology Officer at Abiomed. After Abiomed acquired Impella the company's focus shifted from heart replacement to heart recovery.
In July 2014, Abiomed acquired German heart pump maker ECP in a deal worth up to $30 million. The deal included a nearly $2.8 million buyout of AIS GmbH Aachen Innovative Solutions, which owns some of the patents licensed to ECP.
In May 2018, Abiomed was added to the S&P 500 index. During the S&P's rise from 2000 to 3000, Abiomed was the index's top performing stock.
In 2018, Abiomed built a $17 million Innovation Center to facilitate research and product development. The 29,800-square-foot facility features laboratories for blood, optical, software, mechanical and electrical research, plus a production line.
In 2019, "Barron's" ranked Abiomed the 4th best stock of the 2010s, with total return of 1,983%. while "Fortune" ranked Abiomed 19th on the magazine's list of 100 fastest-growing companies.
In April 2020, Abiomed acquired Breethe, developer of a novel extracorporeal membrane oxygenation (ECMO) system.
Impella products.
Impella is the world's smallest heart pump. It sits in the heart, spinning up to 50,000 revolutions per minute, sending blood throughout the body, allowing the heart to recover. It is inserted through a minimally invasive procedure and guided through an artery to the heart. In 2007, the Impella 2.5 heart pump was among 35 healthcare products to receive a 2007 Medical Design Excellence Award. As of August 2020, the Impella heart pump products include the Impella 2.5, Impella 5.0/LD, Impella CP with SmartAssist, Impella 5.5 with SmartAssist, Impella RP and Impella Connect.
Since 2005 when Abiomed acquired the Impella technology, the heart devices have received a series of FDA approvals. Notably, in 2015, Abiomed received FDA approval to use the Impella 2.5 heart pump during elective and urgent high-risk percutaneous coronary intervention procedures. In 2016, the Impella RP system became the first percutaneous single-access heart pump designed for right-heart support to receive FDA approval. The FDA approval was based on the PROTECT II randomized controlled trial, which found high-risk percutaneous coronary intervention (PCI) patients who underwent PCI with Impella had fewer major adverse events at 90 days, compared to patients who underwent PCI with the intra-aortic balloon pump (IABP).
A 2020 study of 21,848 non-emergent, high-risk patients who underwent PCI with percutaneous ventricular assist devices (PVADs), including Impella, demonstrated the PVAD patients had a lower rate of mortality and complications than patients who underwent PCI with IABPs. As of 2020, the Impella heart pump is the most studied mechanical circulatory support device in the history of the FDA with more than 14 years of studies, clinical data on more than 140,000 patients, and more than 650 peer-reviewed publications.
Leadership.
Michael R. Minogue, Chairman, CEO & President, took over as chief executive in 2004 when Abiomed's founder, David Lederman, stepped down. Minogue is a former Army Ranger and Operation Desert Storm veteran with an engineering degree from West Point and an MBA from the University of Chicago. Prior to Abiomed, Minogue spent eleven years with General Electric Healthcare. Minogue helped found the Medical Technology Veterans Program (MVP), a career training and mentorship initiative designed to help veterans entering the civilian workforce transition into jobs in the medical device and life sciences industries, and also serves on the boards of directors for the medical device industry association AdvaMed, Insulet Corporation, and the Medical Device Innovation Consortium.