Evalve(R) Completes $60 Million Series D Financing

Financing Provides Capital to Complete EVEREST Pivotal Study and Begin

European Commercialization

Investigators Continue to Build on Initial Data Showing Durability,

Efficacy & Safety of Evalve's MitraClip(R) Device for Percutaneous Repair

of Mitral Valve Regurgitation

    MENLO PARK, Calif., Nov. 27 /PRNewswire/ -- Evalve, Inc., the leader in
 the development of devices for the percutaneous repair of cardiac valves,
 announced today that it had successfully completed a $60 million Series D
 financing. BBT Fund LP led the round and was joined by current Evalve
 investors including, Delphi Ventures, New Enterprise Associates, Split Rock
 Partners and Abbott Laboratories.
 
     This financing will enable Evalve to begin preparations for
 commercialization of the MitraClip(R) device in Europe and continue to move
 toward U.S. approval of the product by completing enrollment in its EVEREST
 pivotal study. The MitraClip device is intended to treat mitral
 regurgitation (MR) by percutaneously repairing the mitral valve allowing
 patients to avoid the risks, trauma and costs associated with current open,
 arrested heart surgical treatment.
 
     "The strong interest from both new and existing investors indicates a
 high level of confidence in our clinical results to date, as well as
 enthusiasm for our potential to improve the continuum of care for patients
 suffering from structural heart disease and the expanding market this
 represents," said Ferolyn Powell, President and Chief Executive Officer of
 Evalve. "We are pleased that this financing will allow Evalve to progress
 toward commercialization of our MitraClip device for percutaneous mitral
 repair."
 
     Evalve also announced today changes to its board of directors. Ryan
 Perras, Principal at Apothecary Capital, will join the board while Dr.
 Thomas Fogarty will step down from his role as a director. Dr. Fogarty will
 continue his involvement with the company, joining as an investor in this
 round of funding through his new fund, Emergent Medical Ventures.
 
     "We welcome Ryan to the board where his expertise and experience will
 be an important resource for Evalve as we move forward toward
 commercialization," said Ms. Powell. "At the same time, we are pleased that
 Dr. Fogarty will continue to be involved with the company. His
 contributions have been a strong factor in our success throughout our
 history and in the development of the MitraClip device."
 
     EVEREST Study Continues Enrollment
 
     The EVEREST II study continues at more than 35 centers in North America
 with more than 300 patients enrolled and more than 300 MitraClip devices
 implanted to date. Investigators are currently enrolling patients in both
 arms of the EVEREST II study -- a randomized, controlled arm and a high
 risk registry arm -- with the goal of completing enrollment by the end of
 2008.
 
 
    Enrollment in the study is open to a range of patients:
 
     --  Patients with either degenerative or functional MR.
     --  Patients who are good surgical candidates and are open to the option
         of a less invasive approach.
     --  High risk patients who are not good candidates for surgery will be
         enrolled in the EVEREST High Risk Registry until enrollment is
         complete in this arm by the end of 2007.
 
     The EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy)
 randomized study is evaluating the safety and efficacy of the MitraClip
 device compared to surgical mitral valve repair or replacement. This
 prospective, randomized, multi-center study will enroll 279 patients at up
 to 42 sites in the United States and Canada. Patients are randomized 2:1 to
 receive the MitraClip device. Patients who are interested in participation
 in the study can call 1-877-MY-MR-FIX (1-877-696-7349). More information
 about the EVEREST II trial is available at
 http://www.mitralregurgitation.org.
 
     About Mitral Regurgitation
 
     Mitral regurgitation (MR), the most common type of heart valve
 insufficiency occurs when the heart's mitral valve does not close properly.
 Both the American Heart Association and the American College of Cardiology
 recommend open-heart surgery to repair or replace the mitral valve for
 patients who suffer from moderate-to-severe (Grade 3+) and severe (Grade
 4+) MR; open heart surgery is not recommended for patients with 1-2+ MR. An
 estimated four million people in the United States have significant
 (greater than 2+) MR, with an annual incidence of 250,000 newly diagnosed
 patients.
 
     About Evalve, Inc.
 
     Evalve, Inc. (Menlo Park, Calif.) was incorporated in 1999 to design,
 develop, manufacture, and market innovate devices to enable percutaneous
 repair of cardiac valves. The company's initial products are intended to
 reduce the risks, trauma and costs associated with current open, arrested
 heart surgical options. The company's present development and clinical
 efforts are focused on mitral valve repair. For more information about
 Evalve, Inc., and for an animated explanation of the Percutaneous Mitral
 Repair procedure using the MitraClip device, visit
 http://www.evalveinc.com. Evalve is the first portfolio company from the
 medical device company incubator, The Foundry (http://www.thefoundry.com).
 
     MitraClip and Evalve are registered trademarks of Evalve, Inc.
 
 
 

SOURCE Evalve, Inc.