Healthcare Industry News: mitral valve
News Release - November 27, 2007
Evalve(R) Completes $60 Million Series D FinancingFinancing 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 (HSMN NewsFeed) -- 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® 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.
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