ATLANTA, Jan. 4, 2012 /PRNewswire/ -- CryoLife, Inc. (NYSE: CRY), a leading tissue processing and medical device company focused on cardiac and vascular surgery, announced today that it has promoted David C. Gale, Ph.D., to the position of Vice President, Research and Development; and David P. Lang to the newly created position of Vice President, Market Development Surgical Adhesives and Starch Medical Relations. Dr. Gale will report to Steven G. Anderson, President and Chief Executive Officer and Mr. Lang will report to Gerald B. Seery, Senior Vice President, Sales and Marketing.
"We are extremely pleased to make these significant additions to our leadership team," said Steven G. Anderson, President and Chief Executive Officer. "Dr. David Gale brings more than 15 years of research and development experience, holding over 30 issued U.S. patents covering material, processing and designs of medical devices. We will continue to call upon his wealth of experience as he oversees the important activities supporting the advancement of our product pipeline, which includes new products in both our core tissue processing segment and within our higher growth, higher margin medical devices segment."
Mr. Anderson added, "David Lang brings 35 years of marketing and business development experience in the medical device industry. He will continue to play a critical role in the growth of BioGlue, BioFoam and PerClot, particularly as we work to gain and leverage new regulatory approvals for these products."
David C. Gale, Ph.D. joined CryoLife in 2009 as Senior Director of Research and Development. Prior to joining CryoLife, he was Vice President, Research and Development of Sinexus Inc., a manufacturer of drug-eluting (or releasing) stents located in Palo Alto, California. He previously worked in research and development of bioabsorbable polymers and stents at Abbott Laboratories and Birmingham Polymers. David Gale has a B.S. in Chemistry and an M.S. in Instrumentation and Analysis from the University of Manchester in England. He also holds an M.S. in Chemical Engineering from Auburn University and a Ph.D. in Materials Science from the University of Alabama, Birmingham.
David P. Lang joined CryoLife in 2010, as Vice President of PerClot Market Development, CryoLife International in Munich, Germany. Prior to joining CryoLife International, David Lang was President and then consultant to Starch Medical, Inc. His senior management positions include three resident assignments in Paris, Munich, and Shanghai. He was a founder of the first Sino-American medical electronics joint venture in China in 1985. David Lang received a B.A. in Economics from Harvard University.
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, through its subsidiary Cardiogenesis Corporation, specializes in the treatment of cardiovascular disease and the sale of 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). CryoLife distributes PerClot®, an absorbable powder hemostat, in the European Community. 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.
Statements made in this press release that look forward in time or that express management's beliefs, expectations or hopes are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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 our work to gain and leverage new regulatory approvals for BioGlue, BioFoam and PerClot, the advancement of our product pipeline, which includes new products in both our core tissue processing segment and within our higher growth, higher margin medical devices segment, the reference to our products as key growth drivers, the description of our medical devices segment as a higher growth, higher margin segment, and the implication that the promotions of Mr. Lang and Mr. Gale may help further our efforts in their respective areas. These future events may not occur as and when expected, if at all, and, together with the Company's business, are subject to various risks and uncertainties. These risks and uncertainties include that the regulatory approval process for our products and the development of new products can be time consuming and costly, and may not ultimately prove to be successful. Even if new regulatory approvals are obtained for BioGlue, BioFoam and/or PerClot, or new products are developed, these developments may not lead to increased sales or revenue growth for a number of reasons, including those discussed below. Based on changing conditions in our Company and in the economy generally, management may decide to terminate its pursuit of regulatory approvals for certain products or the development of any products in our pipeline at any time, and our current plans and timeline for regulatory approvals and the development of new products may be altered. Also, even if the requisite regulatory approvals are obtained for our products, the products may not provide the anticipated medical benefits, may not ultimately be accepted by physicians and patients, and competing products and solutions may be developed or may already exist that gain market footholds and adversely impact future sales of our products. The potential market for any of our products could also be impacted by a number of other factors, including the effectiveness and relative cost of competing products, the impact of future surgical innovations and medical breakthroughs and the perceptions of surgeons and other medical professionals. Continuing negative economic conditions could accentuate the impact of price on the ability of our products to compete. Past experience and trends regarding the growth and/or margins related to any of our products are not necessarily reflective of future performance, and sales and margins may decline due to any of the factors discussed above, as well as any increases in the cost of manufacturing or distributing our products, particularly within our medical devices segment. Personnel changes and promotions may not directly lead to increased sales, new regulatory approvals or the development of new products for a number of reasons, including those discussed above, regardless of the skill or talent of the individuals involved. For additional risks impacting the Company's business, see the Risk Factors section of the Company's Annual Report on Form 10-K for the year ended Dec. 31, 2010, and the Company's subsequent Form 10-Q filings. The Company does not undertake to update its forward-looking statements.
For additional information about the company, visit CryoLife's website:
D. Ashley Lee
Executive Vice President, Chief Financial Officer and Chief Operating Officer
The Ruth Group
Nick Laudico / Zack Kubow
646-536-7030 / 7020
|SOURCE CryoLife, Inc.|
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