The U.S. FDA reported that the post-approval study (PAS) for the Impella RP by Abiomed Inc. of Danvers, Mass., demonstrated that the device performed well for patients who would have been eligible for the pivotal study, providing a 69.7% survival rate at 30 days after device explant.
Johnson & Johnson (J&J) agreed to acquire circulatory support device maker Abiomed Inc. for $380 per share in cash, corresponding to an enterprise value of $16.6 billion and a more than 50% premium on the share price as of the market close on Oct. 31. Abiomed shareholders will also receive a non-tradeable contingent value right that entitles them to $35 per share in cash, if certain milestones are met. That would bring the premium to 60%.
The 2022 Transcatheter Cardiovascular Therapeutics annual meeting highlighted mostly positive outcomes from major trials conducted by nearly all the big players in the cardiac device market. Here’s our round-up of the meeting’s high points, with updates from Abbott Laboratories, Abiomed Inc., Boston Scientific Corp., Edwards Lifesciences Corp., Inari Medical Inc., Medtronic plc and Recor Medical Inc.
Abiomed Inc., has worked the ventricular assist device (VAD) space for a number of years with its Impella series of VADs, and a study coming out of Japan seems to affirm investors’ confidence in these devices. This registry study demonstrated that the combination of Impella devices and extracorporeal membrane oxygenation (ECMO) provides a 30-day survival rate of more than three in four patients with cardiogenic shock, an outcome that is said to support the notion that the native heart tissue can recover from myocarditis, an especially salient consideration for those who contracted the SARS-CoV-2 virus.
Abiomed Inc. is one of a number of companies whose share prices took a hit in the early days of the COVID-19 pandemic, but the company has since rebounded, thanks in part to the news that the FDA has granted the company a breakthrough device designation for its Impella ECP device. The external counterpulsation (ECP) system may eventually make significant headway in the hemodynamic support space thanks to the small size of the device, a key feature for patients undergoing high-risk percutaneous coronary intervention (PCI) procedures.
Abiomed Inc. has won the U.S. FDA’s nod for its Breethe Oxy-1 device, an all-in-one, compact cardiopulmonary bypass system designed for easy mobility. The company plans a controlled release at U.S. hospitals between now and March of 2021, with widespread availability later that year.
The restrictions on elective surgeries as hospitals struggle to manage the unfolding global pandemic are hitting medical device companies particularly hard. Abiomed Inc., which specializes in a tiny, minimally invasive heart pump to support heart failure patients, saw its first fiscal fourth-quarter revenue flatten as procedures were postponed. Still, U.S. revenue remained stronger than Wall Street had expected, even as ex-U.S. revenue had deeper declines.
Campbell, Calif.-based startup Supira Medical Inc. scooped up $35 million in a series B financing led by Cormorant Asset Management. Also participating in the round were The Capital Partnership, 415 Capital, Amed Ventures and Shifamed Angels. The new capital is earmarked to advance the development and clinical evaluation of the company’s next-generation percutaneous ventricular assist device.
