CryoLife, Inc. Provides Update on ValveXchange. Investment
Published: Oct 13, 2011
ATLANTA, Oct. 13, 2011 /PRNewswire/ -- CryoLife, Inc. (NYSE: CRY), a leading tissue processing and medical device company focused on cardiac and vascular surgery, announced today that ValveXchange, Inc., a company in which CryoLife owns a minority interest, has completed the first three human implants with its novel Vitality two-part heart valve system.
The surgeries were performed in Asuncion, Paraguay and took place on Sept. 26 and 27, 2011. Three men aged 49, 62 and 72 received the Vitality heart valves. All have been discharged and are recovering normally.
The mission of ValveXchange is to bring the full, active lifestyle advantages of tissue heart valves to patients of all ages. Currently, bioprosthetic tissue valves are recommended only for older patients because the leaflet sets wear out every 10-15 years, requiring repeated open-heart surgeries. Younger patients today receive mechanical heart valves that do not wear out, but require lifelong doses of anticoagulation drugs that force a sedentary lifestyle with serious side effects.
The ValveXchange concept is a two-part valve with a permanently implanted base and an easily replaceable leaflet set. The leaflet set is designed to be replaced transapically (through the apex of the heart), accessed by a small incision between the ribs and not requiring any future open-heart surgeries. ValveXchange is currently developing the tool set for the transapical leaflet replacement procedure. Leaflets can also be replaced using standard and minimally invasive surgical techniques that are faster and simpler than traditional valve replacement surgeries.
Steven G. Anderson, Chairman, President and Chief Executive Officer of CryoLife, said, "We are pleased that ValveXchange has successfully completed their First-in-Man procedures with the Vitality system. The unique bioprosthetic leaflet set design has the potential to bring the benefits of tissue valves to patients and eliminate the need for repeat open heart surgeries. This significant milestone reaffirms our belief in ValveXchange as an emerging cardiovascular technology company."
CryoLife acquired a 19 percent equity ownership in ValveXchange in July, as well as the right of first refusal to acquire ValveXchange during a period that extends through the completion of initial commercialization milestones and the right to negotiate with ValveXchange for European distribution rights.
Founded in 1984, CryoLife, Inc. is a leader in the processing and distribution of implantable living human tissues for use in cardiac and vascular surgeries throughout the U.S. and Canada. CryoLife's CryoValve® SG pulmonary heart valve, processed using CryoLife's proprietary SynerGraft® technology, has FDA 510(k) clearance for the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic pulmonary valves. CryoLife's CryoPatch® SG pulmonary cardiac patch has FDA 510(k) clearance for the repair or reconstruction of the right ventricular outflow tract (RVOT), which is a surgery commonly performed in children with congenital heart defects, such as Tetralogy of Fallot, Truncus Arteriosus, and Pulmonary Atresia. CryoPatch SG is distributed in three anatomic configurations: pulmonary hemi-artery, pulmonary trunk, and pulmonary branch. CryoLife's BioGlue® Surgical Adhesive is FDA approved as an adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels. BioGlue is also CE marked in the European Community and approved in Canada and Australia for use in soft tissue repair and was recently approved in Japan for use in the repair of aortic dissections. CryoLife's BioFoam Surgical Matrix is CE marked in the European Community for use as an adjunct in the sealing of abdominal parenchymal tissues (liver and spleen) when cessation of bleeding by ligature or other conventional methods is ineffective or impractical. CryoLife distributes PerClot®, an absorbable powder hemostat, in the European Community. CryoLife, through its subsidiary Cardiogenesis Corporation, specializes in the treatment of cardiovascular disease and devices that treat severe angina. Its market leading FDA-approved Holmium: YAG laser system and single use fiber-optic delivery systems are used to perform a surgical procedure known as Transmyocardial Revascularization (TMR).
For additional information about CryoLife, visit CryoLife's website, http://www.cryolife.com/.
About ValveXchange, Inc.
ValveXchange, Inc. is an emerging technology company based in Colorado. Calling itself "The Lifetime Tissue Valve Company." ValveXchange is developing the first-of-its-kind "serviceable" bioprosthetic heart valve. By offering the possibility of periodic, minimally invasive exchange of the worn-out leaflet set, young and physically active patients can avoid the use of a mechanical valve and its associated lifetime of warfarin anticoagulation therapy. These design features are incorporated into its Vitality surgically implantable valves and are being designed into its Vanguard transcatheter valves and future pediatrics products.
ValveXchange was founded by Dr. Ivan Vesely, a PhD biophysicist internationally recognized for his research in the field of bioprosthetic heart valves. Chairman and CEO Larry Blankenship is a 30-year veteran of the medical device field and serial entrepreneur who has previously guided more than two dozen products into the marketplace, including heart valves. The company has ten patents covering various aspects of its heart valve and related technology, and ten additional patent applications in process.
Statements made in this press release that look forward in time or that express CryoLife's or ValveXchange's management's beliefs, expectations or hopes are forward-looking statements. Such forward-looking statements reflect the views of management at the time such statements are made and are subject to a number of risks, uncertainties, estimates, and assumptions that may cause actual results to differ materially from current expectations. These statements include those regarding the potential of ValveXchange technology to eliminate repeat open heart surgeries from the long-term wear complications associated with current biological valves, the belief that the system may resolve the long standing compromises between conventional mechanical and biological heart valves, the potential to make ValveXchange technology open to patients of all ages, and the implied expectation that CryoLife will ultimately reap benefits from its equity investment in ValveXchange. These future events may not occur as and when expected, if at all, and, together with CryoLife's and ValveXchange's business, are subject to various risks and uncertainties. These risks and uncertainties include that the ValveXchange technology may not be effective in eliminating repeat open heart surgeries from the long-term wear complications associated with biological valves and future testing or use by patients and physicians may prove otherwise, competitors may develop products that are more effective or better received by the marketplace, and long-term benefits of any new medical technology, including the ValveXchange technology and the ability of the system to resolve long standing compromises between conventional mechanical and biological heart valves, will not be able to be fully observed until the technology has been in use for an extended period of time. The ValveXchange technology may not be successfully implemented with patients of all ages, as the technology has only recently been tested in human patients, and younger patients in particular may respond differently to the technology than older patients. The initial human tests have only recently been performed and ultimate results may not meet expectations. The anticipated timing of additional procedures and testing related to the Vitality Exchangeable Heart Valve System may be delayed due to regulatory restraints and business considerations. The ability of ValveXchange to successfully distribute the Vitality Exchangeable Heart Valve System worldwide is dependent upon the technology's acceptance by patients and physicians and the marketing efforts of ValveXchange employees and distributors, as well as general global economic conditions. The benefits of the Vitality Exchangeable Heart Valve System may not ultimately prove to be permanent and the technology may not prove to be as beneficial to patients as expected, if at all. Also, the related leaflet sets may not last as long as expected and/or they may not retain the expected level of valve function for the entire life of the leaflet sets. The investment that CryoLife has made in ValveXchange may not be successful and it may take longer than expected for ValveXchange's technology to be accepted in the market and for CryoLife to reap the benefits of its investment in ValveXchange. Even with CryoLife's investment in ValveXchange, some or all of its products and systems may not be brought to market when expected, if at all. Business considerations, market forces or regulatory issues may impede distribution efforts. Regulatory approvals, in particular, are subject to testing results and the discretion of governmental and administrative agents, and there is no guarantee that ValveXchange will obtain the requisite approvals for its products and systems, or that the approval process will not be more time-consuming and costly than expected. ValveXchange is also subject to the general risks inherent in the medical device sector, including regulatory concerns, market acceptance of its products and technology, reliance on key persons, the possibility of lawsuits, and the ability to obtain sufficient insurance coverage and future funding, among other things. CryoLife's business is also subject to a number of risks and uncertainties, including the risk factors detailed in CryoLife's Securities and Exchange Commission filings, including its Form 10-K filing for the year ended December 31, 2010, its Form 10-Q filing for the quarter ended March 31, 2011, its Form 10-Q filing for the quarter ended June 30, 2011, and CryoLife's other SEC filings. CryoLife and ValveXchange do not undertake to update their forward-looking statements.
D. Ashley Lee
Executive Vice President, Chief Financial Officer
The Ruth Group
Nick Laudico / Zack Kubow
646-536-7030 / 7020
SOURCE CryoLife, Inc.