The Japanese Pharmaceuticals and Medical Device Agency has approved an expanded indication for CryoLife’s BioGlue. BioGlue is now indicated for adhesion and support of haemostasis 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 US$5m market. The expanded indication potentially doubles the estimated BioGlue market opportunity in Japan to over US$10m.
CryoLife’s marketing partner in Japan, Century Medical, 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 one million surgical procedures with more than 300 pre-clinical and clinical papers discussing its safety, efficacy, and application techniques.
“The expanded indication potentially doubles our market opportunity in Japan to over US$10m, 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.”