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`Edwards Lifesciences to Acquire Percutaneous Valve Technologies, Inc. for $125 Million
`
`• New Technology Expands Market With Interventional Alternative for Patients With Heart Valve Disease
`
`IRVINE, Calif., Dec. 15-- Edwards Lifesciences Corporation (NYSE: EW), a global leader in medical technologies to treat
`advanced cardiovascular disease, and the world's number-one heart valve company, announced today that it has entered into a
`definitive agreement to acquire Percutaneous Valve Technologies, Inc. (PVT), a privately held medical technology company
`based in Fort Lee, NJ with a subsidiary in Caesarea, Israel, and a leader in the development of an innovative, catheter-based
`(percutaneous) approach for replacing aortic heart valves. Under terms of the agreement, Edwards would pay $125 million in
`cash upon completion of the transaction, plus up to an additional $30 million in payments upon the achievement of key
`milestones. The transaction is expected to close in the first quarter of 2004, subject to customary closing conditions. Edwards
`has the right to terminate the agreement for a payment of up to $15 million.
`
`"This transaction will allow Edwards to accelerate the development of a breakthrough technology for patients with heart valve
`disease, particularly the many individuals who do not receive surgery today," said Michael A. Mussallem, Edwards' chairman and
`CEO, who noted that sales of catheter-based valve repair and replacement products could exceed $1 billion over the next
`decade.
`
`"Edwards has been developing its own unique percutaneous heart valve therapy platform, and this transaction enables the
`company to provide percutaneous technology to clinicians much sooner," Mussallem said. "Although the safety and efficacy of
`these technologies is not yet established, we believe this transaction should provide a path to leadership in minimally invasive
`alternatives for patients with heart valve disease. We are very excited about combining Edwards' decades of experience in
`successfully pioneering the treatment of heart valve disease, with PVT's unique capabilities, clinical experience and strong
`intellectual property."
`
`Edwards expects to take an initial in-process research and development (IPR&D) charge related to this transaction in the first
`quarter of 2004, estimated between $60 million and $90 million ($1.00 to $1.50 per share). Excluding this charge, the company
`believes that the range of dilution related to additional costs will be between $0.10 to $0.15 per share on the current 2004 First
`Call mean earnings per share estimate of $1.77.
`
`"This decision to marry the capabilities of PVT and its technologies with the breadth and depth of Edwards' global heart valve
`therapy experience provides the needed expertise and resources to assure successful commercialization. We are eager to
`become part of the Edwards organization so that we can focus our combined expertise on meeting the needs of thousands of
`patients worldwide," said Stanton Rowe, PVT president and CEO.
`
`PVT's technology is a proprietary combination of balloon-expandable stent technology integrated with a percutaneously delivered
`tissue heart valve. Unlike conventional open-heart valve replacement surgery, this less-invasive procedure is designed to be
`performed in a cardiac catheterization laboratory under local anesthesia.
`
`The first human implant of PVT's valve was performed in April 2002 by Dr. Alain Cribier, who has treated 14 patients to date and
`is conducting a prospective clinical trial in France. U.S. clinical trials are pending approval of an IDE filing expected early next
`year. PVT also plans to file for a Humanitarian Device Exemption (HDE) with the U.S. Food and Drug Administration in 2005,
`which would allow for commercial use in a limited number of patients. CE Mark also is anticipated in Europe in 2005.
`
`"This technology continues to be very promising for patients, particularly those who are not candidates for conventional heart
`valve surgery today," said Martin Leon, MD, president and CEO of the Cardiovascular Research Foundation in New York, and a
`PVT co-founder. "When fully developed, this therapy could revolutionize heart valve replacement procedures. Patients could avoid
`the invasiveness of open-heart surgery, and the recovery period would be dramatically shortened."
`
`"The acquisition of PVT represents an important complement to Edwards' existing heart valve pipeline," added Mussallem, who
`noted that Edwards is also actively pursuing three of its own percutaneous heart valve development programs, including two
`approaches for mitral valve repair, and a unique approach for aortic valve replacement.
`
`Endovascular Devices Intended for a New and Growing Population
`
`Each year, an estimated 300,000 people worldwide undergo heart valve replacement or repair surgery. Edwards expects the
`number of surgical heart valve procedures to continue growing, due in part to the overall increasing incidence of cardiovascular
`disease, compounded by an aging global population.
`
`Current surgical treatments of heart valve disease offer excellent long- term outcomes as biological valve technology and
`surgical techniques have improved. However, there is a population of patients who are not being treated today. The goal of
`percutaneous heart valve therapies is to provide catheter-based alternatives to patients who are not candidates for heart valve
`surgery.
`
`"We believe that more than one million patients worldwide suffer from symptomatic aortic heart valve disease," Mussallem said.
`"Only a small portion of patients undergo surgery today, and the promise of percutaneous procedures would be to provide new
`treatment options for the large number of patients whose heart valve disease remains largely unaddressed."
`
`About PVT
`
`PVT, located in Fort Lee, NJ, with a subsidiary in Israel, is a privately held medical technology company developing an innovative,
`percutaneous approach for delivering heart valves to treat late-stage aortic stenosis. PVT was founded by Stanton Rowe and
`Stanley Rabinovich, the company's executive vice president and chief operating officer, along with Martin Leon, MD, president
`and chief executive officer of the Cardiovascular Research Foundation in New York, and Alain Cribier, MD, chief of Cardiology of
`
`ENDOHEART AG, EX. 2019 Page 1
`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
`Case No.: IPR2016-00300, U.S Patent No. 8,182,530
`
`

`
`University Hospital in Rouen, France.
`
`About Edwards Lifesciences
`
`Edwards Lifesciences, a leader in advanced cardiovascular disease treatments, is the number-one heart valve company in the
`world, and the global leader in acute hemodynamic monitoring. Headquartered in Irvine, Calif., Edwards 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. Additional company information can be found at www.edwards.com.
`
`Conference Call and Web Cast Information
`
`Edwards Lifesciences will be hosting a conference call today at 9:00 a.m. EDT to discuss this transaction. To participate in the
`conference call, dial (877) 407-8037 or (201) 689-8037. The call will also be available via live or archived Web cast on the
`"Investor Information" section of the Edwards' Web site at http://www.edwards.com/ or http://www.edwards.com/conferencecalls.
`A telephonic replay can be accessed for 72 hours by dialing (877) 660-6853 or (201) 612-7415 and using account number 2995
`and passcode 85388.
`
`Edwards Lifesciences and Edwards are trademarks of Edwards Lifesciences Corporation. Carpentier-Edwards, Cosgrove-
`Edwards, Swan-Ganz and Fogarty are trademarks of Edwards Lifesciences Corporation and are registered in the U.S. Patent
`and Trademark Office.
`
`This news release includes forward-looking statements that involve risks and uncertainties, including those related to the
`success of animal and clinical studies of percutaneous heart valve replacement, the potential size of the catheter-based heart
`valve repair and replacement market, the potential for Edwards to provide these technologies to non-surgical candidates even
`sooner, the ability of this transaction to further strengthen the company's global leadership, and, more generally, the ability to
`consummate targeted technology investments and acquisitions; timing or results of pending or future clinical trials, actions by
`the U.S. Food and Drug Administration and European Union technological advances in the medical field, product demand and
`market acceptance, the effect of changing economic conditions, the impact of foreign exchange, and other risks detailed in the
`company's filings with the Securities and Exchange Commission. These forward-looking statements are based on estimates
`and assumptions made by management of the company and are believed to be reasonable, though are inherently uncertain
`and difficult to predict. Actual results or experience could differ materially from the forward-looking statements.
`
`Contact Information:
`Media, Barry R. Liden, +1-949-250-5070, or Investors, David K. Erickson, +1-949-250-6826, both of Edw ards Lifesciences Corporation
`
`Nous Contacter | Mentions légales | Déclaration de confidentialité | © 2016 Edwards Lifesciences Corporation. All rights reserved.
`
`ENDOHEART AG, EX. 2019 Page 2
`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
`Case No.: IPR2016-00300, U.S Patent No. 8,182,530