AtriCure has revealed that it has entered into a definitive agreement to acquire SentreHeart. Under the terms of the acquisition agreement, the transaction consideration consists of an upfront payment of approximately US$40 million in cash and AtriCure common stock, plus additional contingent consideration based on the achievement of certain clinical and reimbursement milestones over the next several years, all of which are value-creating events.
Of the contingent consideration, US$140 million is based on milestones related to the aMAZE investigational device exemption (IDE) clinical trial, including premarket approval (PMA), and US$120 million is based on a milestone related to reimbursement for the therapy involving SentreHeart devices. All contingent consideration would be payable in a combination of cash and stock.
“We believe that SentreHeart is a strategic addition to AtriCure, significantly expanding our addressable markets with a product designed for electrophysiologists,” said Michael Carrel, president and chief executive officer of AtriCure. “With our pursuit of labelling based on the aMAZE Trial, we are deepening our commitment to provide the broadest possible offering of ablation and left atrial appendage management solutions to our customers and their patients.”
Carrel continued, “This transaction combines two companies dedicated to solving the challenges associated with Afib. We are confident that SentreHeart complements our current product portfolio and intellectual property, augments our commitment to clinical science with the aMAZE Trial, and will leverage our growing commercial channel into the electrophysiology market. We believe that upon FDA approval, use of the LARIAT® device will continue to advance AtriCure’s competitive position in the market.”
SentreHeart was founded in 2005 and is based in Redwood City, USA. The company’s technology is currently being studied in the aMAZE Trial, a US Food and Drug Administration (FDA)-approved, prospective, multicentre, randomised controlled trial evaluating the LARIAT Suture Delivery Device for LAA closure adjunctive to pulmonary vein isolation (PVI) catheter ablation for the treatment of persistent and longstanding persistent Afib. The objective of the aMAZE Trial is to demonstrate that the LARIAT device for LAA closure, plus a PVI ablation, will lead to a reduced incidence of recurrent Afib compared to PVI alone, with a high safety profile.
The aMAZE Trial is expected to enrol up to 600 total patients at 65 sites with one-year follow up. Primary endpoint measures are freedom from episodes of Afib greater than 30 seconds at one-year post treatment. To date, 535 patients have been enrolled in the trial, with full enrolment anticipated in early 2020.
Subject to customary closing conditions, the transaction is expected to close in the next several days. AtriCure shareholder approval is not required.