Abiomed's acquisition of Impella CardioSystems AG opens the interventional cardiology market to the ventricular support device company.

"For the first time, Abiomed will be able to provide a product that promotes heart recovery starting in the cath lab within a few hours of treatment following the [acute myocardial infarction]," Abiomed President and CEO Michael Minogue explained during an April 27 conference call.

"This acquisition reemphasizes our focus to recover the heart and will provide us a platform for sales in every hospital worldwide that utilizes the cath lab or surgery suite," he said. "Our customer base has now more than doubled between the cardiologists and the surgeons."

The call was scheduled to announce the signing of a definitive agreement whereby Abiomed will acquire the Aachen, Germany firm for more than four million shares, $1.8 mil. in cash, and milestone payments approaching $29 mil. based on stock price performance, unit sales and FDA approvals. Abiomed's stock closed at $10.15 on April 29. The total price of the deal could reach $75 mil., Abiomed estimates.

Venture capital-backed Impella has 30 European and international patents related to tiny pumps with integrated motors and sensors that can be implanted in the heart through a catheter.

The firm currently has CE marks for the Recover 5.0 and Recover 2.5 second-generationmicro-pumps. More than 400 patients at 60 European centers have been treated with Recover pumps, including roughly 200 treated with Recover 2.5 since it received CE mark in late 2004.

Recover 2.5 delivers up to 2.5 L of blood per minute from the left ventricle into the ascending aorta and is intended to be used in "critical" situations, according to Abiomed. Recover 5.0 provides 5 L of flow per minute to support the right ventricle and is intended for "conventional post-cardiotomy cardiogenic shock and cardiomyopathy patients," Minogue explained.

Abiomed is planning U.S. trials for both Recover devices. A six-center, 11-patient pilot trial of Recover 5.0 has been completed and will be submitted to FDA this summer to support IDE approval for a pivotal trial.

The firm has submitted an IDE study proposal to FDA for the Recover 2.5 and is currently answering questions from FDA. Abiomed expects to begin a five-center pilot study on the device later this summer.

Minogue could not provide an exact timeline for FDA approval of the Impella devices except to say that the firm does not expect approval until after 2006. More detail on the firm's financial projections will emerge during its May 31 quarterly earnings call.

"Consequently, we do not expect to be profitable in fiscal year '06 as a company, based on this transaction," he stated. However, he argued: "The potential for the company in the top-line growth is greatly enhanced."

Danvers, Mass.-based Abiomed currently markets the AB5000 circulatory support system and the BVS5000 biventricular support system. Both provide temporary in-hospital support of a failing heart that could recover.

While Abiomed's current devices require surgical implantation, Impella's pumps can be implanted percutaneously and are therefore more suitable for "cath lab" patients receiving a coronary stent and/or angioplasty after AMI, including patients who have gone into cardiac shock, Minogue explained.

"We know that early reperfusion and mechanical support are essential to heart recovery following the AMI," he observed. "Well, currently only 1% of AMI patients are referred to surgery for [ventricular assist device] implantation."

"With Impella's devices, we will be able to provide an option for cardiologists to provide minimally invasive left-ventricular support before referring the patient to surgery if that's needed," the CEO explained.

The Impella devices can also be used during interventional coronary procedures in patients without AMI. The devices are designed to support the patient's heart and keep the patient out of shock during a "crisis," much in the same manner that intra-aortic balloon pumps are used in some cardiac surgeries, Minogue noted.

Abiomed plans to bring Impella's devices into the U.S. market while expanding its European sales force. The firms says it will incorporate Impella's 50 employees, including its three-member sales force.

Abiomed Acquires German Micro-Pump Maker Impella for Nearly $75 mil.

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