Healthcare Industry News: PS3 System
News Release - November 3, 2006
AGA Medical and Ample Medical to Collaborate on the Development of Innovative Treatment for Congestive Heart FailurePartnership includes Investments by AGA Medical and Aberdare Ventures
MINNEAPOLIS, and FOSTER CITY, Calif., and SAN FRANCISCO, Nov. 3 (HSMN NewsFeed) -- AGA Medical Corporation ("AGA"), Ample Medical Corporation ("Ample") and Aberdare Ventures ("Aberdare") today announced the signing of an investment and joint development agreement. AGA has committed to additional investment through joint development programs for the clinical development and commercialization of Ample's PS3 System(TM), a novel percutaneous system used to treat mitral valve regurgitation associated with congestive heart failure.
As part of the agreement, AGA will make an immediate investment in return for equity in Ample with the potential for additional investments based on successful completion of milestones. Aberdare, the majority shareholder in Ample, has also agreed to increase its investment in Ample. Terms of the agreements were not disclosed.
The PS3 System is an investigational device for the treatment of mitral valve regurgitation ("MR") associated with congestive heart failure ("CHF"). The device is introduced through a catheter and when fully deployed the system is designed to reshape the mitral valve. An AGA occlusion device is a key component of the system.
Mitral valve regurgitation - or mitral regurgitation (also known as mitral insufficiency or incompetence) - is a condition in which the mitral valve does not close tightly, and allows blood to flow backward in the heart. The consequences of MR can accelerate CHF. As many as four million people over the age of 55 have some degree of mitral valve regurgitation associated with their CHF. An estimated 500,000 patients in the US are candidates for the PS3 System with an equal number in international markets.
"We are excited about the opportunity to invest in Ample Medical and collaborate with them on the development of the PS3 System," said Franck Gougeon, President and CEO of AGA Medical, "the system not only incorporates AGA technology but addresses a large potential market where no good therapeutic solution currently exists. We are impressed with the Ample team and believe our teams complement one another and that we will be able to effectively accelerate the development of a commercial version of the system. If we are successful, this system will further expand our acknowledged leadership position in the transcatheter repair of structural heart defects." As part of the agreement Mr. Gougeon will join the Board of Directors of Ample.
"The investment and development partnership with AGA will greatly accelerate the development of the PS3 System," added Robert Chang, President and CEO of Ample Medical. "We look forward to collaborating with their experienced team to quickly advance our innovative technology and provide a therapeutic option to the many patients suffering from this debilitating condition."
"AGA will be a great partner and collaborator," says Paul Klingenstein, Managing Partner of Aberdare Ventures, "they share our commitment to the development of the PS3 System, and bring an enormous amount of commercial experience and technical sophistication in interventional cardiac devices. Aberdare welcomes them aboard."
ABOUT AGA MEDICAL: AGA Medical Corporation, based in Golden Valley, Minnesota (just outside Minneapolis) is the leader in developing interventional devices to treat structural heart defects. As a result of the many contributions and creative genius of Dr. Kurt Amplatz, the Company has developed and commercializes a series of devices that have revolutionized the treatment of the most common congenital "holes in the heart" such as atrial septal and patent foramen ovale defects. Over 500 articles have been published in peer reviewed medical publications that support the benefits of AGA Medical devices including improved patient outcomes, reduced length of stay and accelerated recovery times for the patient, AGA Medical devices have received regulatory approval and are marketed in over 90 countries with over 200,000 devices shipped to date. For more information visit www.amplatzer.com
ABOUT AMPLE MEDICAL: Ample Medical, Inc. is a global technology leader in the design, development and manufacturing of endovascular medical devices for repairing heart valves. The Company's first product, the PS3 System, targets percutaneous repair of mitral valve regurgitation associated with congestive heart failure (CHF). Ample Medical is a privately held company based in Foster City, CA.
ABOUT ABERDARE VENTURES: Aberdare Ventures oversees over $270 million of committed capital dedicated to investments in healthcare technology companies. Aberdare's team consists of Managing Partner Paul Klingenstein, Partners Sami Hamade, Dan Kisner and Jake Odden, Principals Vince Kim and Naheed Misfeldt, and Associate Darren Hite. The firm is located in San Francisco, CA.
Source: AGA Medical
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