Edwards Lifesciences Corporation (NYSE: EW - News) announced today that it has completed its acquisition of Percutaneous Valve Technologies, Inc. (PVT), a privately held medical technology company based in Fort Lee, NJ with a subsidiary in Caesarea, Israel. Edwards previously announced its intent to acquire PVT in December of 2003.
Under terms of the agreement Edwards is paying the shareholders of PVT $125 million cash, plus up to an additional $30 million in payments upon the achievement of key milestones. As previously announced, the company expects to take an initial in-process research and development charge related to this transaction in the first quarter of 2004, estimated to be between $60 million and $90 million ($1.00 to $1.50 per share).
Edwards Lifesciences said that the acquisition reinforced its leadership role in replacement and repair of heart valves through catheter-based technologies.
Edwards Lifesciences focuses on four main cardiovascular disease states: heart valve disease, coronary artery disease, peripheral vascular disease and congestive heart failure. The company's global brands, which are sold in approximately 100 countries, include Carpentier-Edwards, Cosgrove-Edwards, Swan-Ganz, and Fogarty.
PVT's technology is an innovative, catheter-based (percutaneous) approach for replacing aortic heart valves, a proprietary combination of a percutaneously delivered balloon-expandable stent technology integrated with a tissue heart valve. Unlike conventional open-heart valve replacement surgery, this less invasive procedure can be performed under local anesthesia, and is a breakthrough for patients who are not candidates for surgery today.
PVT was founded by CEO Stanton Rowe and COO Stanley Rabinovich, along with Martin Leon, MD, president and CEO of the Cardiovascular Research Foundation in New York, and Alain Cribier MD, chief of Cardiology of University Hospital in Rouen, France.
Edwards Lifesciences said that it estimated that total sales of catheter-based valve repair and replacement products could exceed $1 billion over the next decade.
"We are pleased at how smoothly this transaction has been completed, and we're looking forward to bringing this technology to market quickly," Edwards Lifesciences chairman and CEO Michael A. Mussallem said.
The first human implant of PVT's valve was performed in April 2002 by Dr. Cribier, who has treated 17 patients to date and is conducting a prospective clinical trial in France. Edwards Lifesciences plans to file for a humanitarian device exemption (HDE) with the FDA in 2005, which would allow for commercial use in a limited number of patients. Receipt of the CE Mark also is anticipated in Europe in 2005.
Published by Globes [online] - www.globes.co.il - on Wednesday, January 28, 2004