CryoLife Inc. (NYSE:CRY) said yesterday that it won expanded indications from the Japanese Pharmaceuticals and Medical Device Agency for its BioGlue surgical adhesive.
The glue is now indicated for use in adhesion and support of hemostasis for aortotomy closure sites, suture and anastomosis sites (including aortic dissection and prosthetic grafts) and heart suture sites, the Atlanta, Ga.-based company said.
“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. 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 3rd quarter,” CEO Pat Mackin said in a press release.
BioGlue was already indicated for use in aortic dissection procedures, which are an estimated $5 million market in Japan, the company said. The expansion of indications doubles the market opportunity for the product, the company added.
Late last month, CryoLife said it shifted to a direct sales model in the France, where the company said it made approximately $3 million in revenue over the last year from sales to its distributor.