ATLANTA, July 9, 2015 /PRNewswire/ -- CryoLife, Inc. (NYSE: CRY), a leading medical device and tissue processing company focused on cardiac and vascular surgery, announced today that the Japanese Pharmaceuticals and Medical Device Agency (PMDA) has approved an expanded indication for BioGlue. BioGlue is now indicated for adhesion and support of hemostasis for aortotomy closure sites, suture/anastomosis sites (including aortic dissection and anastomosis sites with a use of a prosthetic graft), and suture sites on the heart. BioGlue was previously approved for aortic dissection procedures in Japan, which is estimated to be a $5 million market. The expanded indication potentially doubles the estimated BioGlue market opportunity in Japan to over $10 million.
CryoLife's marketing partner in Japan, Century Medical, Inc., is expected to begin selling BioGlue in the third quarter of 2015 for the expanded indications. BioGlue is the leading surgical adhesive used in cardiovascular surgery around the world and is used in a wide range of reconstruction procedures. To date BioGlue has been used in over 1 million surgical procedures with more than 300 pre-clinical and clinical papers discussing its safety, efficacy, and application techniques.
"In conjunction with our distributor, Century Medical, we have already achieved meaningful commercial success with BioGlue in Japan. The expanded indication potentially doubles our market opportunity in Japan to over $10 million, allowing us to leverage our existing relationships to broaden the use of BioGlue into all aortic, cardiac, and large vessel procedures," stated Pat Mackin, CryoLife Chairman, President, and Chief Executive Officer. "We will work with Century Medical to train their team on the expanded indication, and we anticipate that they will be prepared to begin selling in the third quarter."
About CryoLife, Inc.
Headquartered in suburban Atlanta, Georgia, CryoLife is a leader in the manufacturing, processing, and distribution of implantable living tissues and medical devices used in cardiac and vascular surgical procedures. CryoLife markets and sells products in more than 75 countries worldwide. For additional information about CryoLife, visit our website, www.cryolife.com.
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 the estimated market opportunity and timing of sales for the expanded BioGlue indication in Japan. The risks and uncertainties affecting these statements include that the market opportunity for the expanded BioGlue indication in Japan could be less than anticipated, and that sales with respect to the expanded indication may begin later and/or be less than anticipated. These risks and uncertainties include the risk factors detailed in our Securities and Exchange Commission filings, including our Form 10-K for the year ended December 31, 2014 and our subsequent filings with the SEC. CryoLife does not undertake to update its forward-looking statements.
D. Ashley Lee
Executive Vice President, Chief Financial Officer and Chief Operating Officer Phone: 770-419-3355
The Ruth Group
Nick Laudico / Zack Kubow
646-536-7030 / 7020
SOURCE CryoLife, Inc.