Friday, August 1, 2008

Cryolife Q2 Biofoam and Hemostase MPH

CryoLife, Inc. (NYSE: CRY), a biomaterials, medical device and tissue processing company, announced today that revenues for the second quarter of 2008 increased 18 percent to $27.2
million compared to $23.0 million in the second quarter of 2007.
During the Cryolife Q2 results mention was made of Biofoam which is being made with the help and funding of the Dept. of Defense (DOD). Biofoam is an expandable version of bioglue which expands to about 4 times its size as it leaves the syringe. BioFoam® Surgical Sealant (BioFoam) is a two-component surgical sealant composed of purified bovine serum albumin (BSA) solution with sodium bicarbonate and glutaraldehyde solution with acetic acid. The two components of BioFoam are contained in a dual chambered syringe and, at the point of delivery, are mixed in a specially designed applicator tip. Indications are for both Trauma and Surgical use. It appears suited to abdominal resections or lacerations and is ready to commence filing for regulatory submission. CE submission is planned for November 2008 and approval is expected late in Q1 2009 and product launch is expected 2-3 months after that, FDA IDE submission is planned for Q4 2008.
Sales of Hemostase MPH licensed from Medafor in early May have been "encouraging" and contributed $320,000 in the first 3 months including most of July. Steven G. Anderson, president and chief executive officer stated that internationally Hemostase MPH has had some success in the UK and Germany with launches in France and Canada set for September 1. Distribution throughout the rest of Europe, the America's, Australia and Asia-Pacific is scheduled for January 1 2009.
Analyst Matt Dolan enquired how long the sales force had sufficient product quantities to commence sales and was told orders only commenced in mid May but the US sales team now had full access to product. Cryolife also said new accounts and re-order rates are moving well for Hemostase MPH.
BioGlue(R) Surgical Adhesive revenues were $13.0 million for the second quarter of 2008 compared to $10.9 million in the second quarter of 2007, an increase of 19 percent. BioGlue revenues were $24.9 million for the first six months of 2008 compared to $22.1 million in the first six months of 2007, an increase of 13 percent.
U.S. BioGlue revenues were $9.1 million and $7.7 million in the second quarter of 2008 and 2007, respectively. U.S. BioGlue revenues were $17.7 million and $16.0 million in the first six months of 2008 and 2007, respectively. International BioGlue revenues were $3.9 million and $3.2 million in the second quarter of 2008 and 2007, respectively. International BioGlue revenues were $7.2 million and $6.1 million in the first six months of 2008 and 2007, respectively.
Other implantable medical device revenues for the second quarter of 2008 were $308,000, compared to $226,000 in the second quarter of 2007. Other implantable medical device revenues for the first six months of 2008 were $401,000 compared to $458,000 in the first six months of 2007. Other implantable medical device revenues in the second quarter and first six months of 2008 included $177,000 for Hemostase MPH(R), which was added to the CryoLife product portfolio in the second quarter of 2008.