"Edwards' primary strategy is to create valuable therapies that transform patient care. We believe the acquisition and integration of CardiAQ will advance our development of a transformational therapy for patients with mitral valve disease who aren't well-served today," said Michael A. Mussallem, Edwards' chairman and CEO. "While still early in the development of this therapy, the progress of the team of employees and clinicians working on our FORTIS mitral replacement system has reinforced our confidence in a catheter-based approach. We believe the experiences and technologies of FORTIS and CardiAQ are complementary and that this combination will enable important advancements for patients."
CardiAQ has received a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval to conduct an early feasibility study of up to 20 patients, and also plans to initiate a CE Mark study in Europe.
"CardiAQ is proud of our pioneering efforts in the early development of this transcatheter mitral valve therapy conceived by cardiac surgeon Arshad Quadri, M.D. We believe our technology, which incorporates multiple delivery approaches with a single valve, shows great promise for patients," said Rob Michiels, chief executive officer of CardiAQ.
"We look forward to joining Edwards, whose experience and leadership as a developer of breakthrough therapies for heart valve disease will advance our work," said J. Brent Ratz, co-founder, president and chief operating officer of CardiAQ.
The purchase price is up to $400 million, including $350 million in cash at closing, and the remainder payable upon achievement of a European regulatory milestone. The transaction remains subject to customary closing conditions. Edwards expects that this acquisition will be slightly dilutive to 2015 earnings per share. The company will provide updated financial guidance for 2015 when second quarter earnings are released on July 28.
As an update to the temporary pause in the FORTIS program, working closely with its global clinical investigators, Edwards recently completed its review and has reached agreement on protocol revisions to re-start enrollment.
The CardiAQ and FORTIS valve systems are not approved for sale in any country.
About Edwards Lifesciences
Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring, enabling them to save and enhance lives. Additional company information can be found at www.edwards.com.
About CardiAQ Valve Technologies
Privately held CardiAQ, headquartered in Irvine, Calif., has developed a proprietary transcatheter mitral valve (TMV) implant that can be delivered through multiple delivery systems. Through its unique anchoring mechanism that engages and utilizes the patient's native mitral valve anatomy, physicians will be able to implant a new mitral valve within a beating heart without circulatory support, thus avoiding open-heart surgery. OrbiMed led the series B financing and is CardiAQ's largest shareholder. Other venture investors include Broadview, Advent and Versant.
This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements include, but are not limited to, statements by Michael Mussallem, Rob Michiels and J. Brent Ratz regarding the timing and status of the transaction, and the timing, impact and success of clinical development of mitral valve replacement technologies. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement.
Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors including but not limited to unexpected impediments or delays in closing the transaction, unexpected outcomes after more expanded clinical experience with the devices, unexpected changes or delays related to product supply, potentials for unexpected regulatory or quality developments, competitive dynamics, global economic conditions and customer acceptance. These factors are detailed in the company's filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2014.
Edwards, Edwards Lifesciences, the stylized E logo, Edwards FORTIS and FORTIS are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.
Contact Information :
Media Contact: Sarah Huoh, 949-250-5070;
Investor Contact: David K. Erickson, 949-250-6826
Caution: Federal (United States) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.
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