Zymogenetics - Recothrom Sales Climbing Q2 09

SEATTLE —ZymoGenetics, Inc. (NASDAQ:ZGEN) today reported financial results for the second quarter ended June 30, 2009. In the second quarter of 2009, the company’s net loss improved to $27.0 million, or $0.39 per share, from $37.4 million, or $0.54 per share, for the second quarter of 2008. The improvement primarily resulted from increased product sales of RECOTHROM and higher collaboration and license revenues.

Revenues for the second quarter of 2009 were $22.6 million compared to $12.6 million for the prior year quarter. The increase resulted from higher collaboration and license revenues and higher sales of RECOTHROM in the United States.

RECOTHROM net sales were $6.0 million for the second quarter of 2009 compared to $1.4 million for the second quarter of 2008. The increase was attributable to increased market share as additional hospitals converted from bovine thrombin to RECOTHROM and existing customers increased their purchase volumes of RECOTHROM. Second quarter 2009 RECOTHROM hospital unit demand also increased from first quarter of 2009, growing by approximately 24%. Costs of product sales rose in line with sales.

RECOTHROM^®Thrombin, topical (Recombinant)

End user demand for RECOTHROM continued to increase in the second quarter. Overall hospital demand increased by approximately 24% in the second quarter of 2009 versus the first quarter of 2009. The company’s partner, Bayer Healthcare, continues to pursue approval in Europe, Canada and Australia.

Results from the Phase 3b RECOTHROM clinical trial were published in the June issue ofJournal of the American College of Surgeons. This study analyzed the safety of RECOTHROM in surgical patients with confirmed or highly likely prior exposure to bovine thrombin. One out of six patients in the Phase 3b study had antibodies to bovine thrombin at baseline. None of the patients in the Phase 3b study developed antibodies to RECOTHROM after topical application of the product in surgery, and adverse events were consistent with those typically observed in surgical patients, suggesting that RECOTHROM can be safely used in patients with pre-existing antibodies to bovine thrombin.

CryoLife Receives CE Mark Approval for BioFoam(R) Hemostatic Technology

ATLANTA, Aug. 4 /PRNewswire-FirstCall/ -- CryoLife, Inc., (NYSE: CRY) an implantable biological medical device and cardiovascular tissue processing company, today announced it has received CE mark approval for its BioFoam((R)) Surgical Matrix (BioFoam). The CE mark allows immediate, unrestricted commercial distribution of BioFoam 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. BioFoam is the second product from the Company's protein hydrogel technology platform to receive a CE mark. CryoLife plans a controlled clinical launch of BioFoam at up to six centers in the United Kingdom, Germany, France and Italy to support its initial marketing efforts. Based on the number of liver and spleen procedures performed annually in the European Community, CryoLife estimates the annual European market opportunity for BioFoam to be approximately $30 million and more than $100 million on a worldwide basis. "We are excited about securing our first approval for the use of BioFoam in organ resection surgery and look forward to continuing our development efforts to bring BioFoam into the U.S. market," said Steven G. Anderson, CryoLife president and chief executive officer. "Over the past four fiscal years, the U.S. Department of Defense has allocated approximately $5.4 million to CryoLife for the development of products containing a protein hydrogel, which is the primary component of BioFoam." In December 2008, CryoLife received conditional approval from the FDA to conduct the feasibility phase of the company's BioFoam IDE submission for liver parenchymal sealing. The feasibility phase will enroll a total of 20 subjects at two investigational sites in the U.S. Before beginning this phase, the Company must receive final approval of the study protocol and related documents from the FDA and an additional approval of the study from the U.S. Department of Defense. CryoLife is in the final stages of this approval process.

About BioFoam

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. Upon delivery of the BioFoam, the sodium bicarbonate and acetic acid react with each other causing the material to foam to an approximate 5-fold expansion. The aldehyde groups of the glutaraldehyde react with the amine groups of the BSA and/or tissue surface proteins and generate chemical cross-links (covalent bonds). These chemicals cross-link together to form a mechanical seal at the site of application. The aldehyde groups are in slight molar excess over the amine groups, ensuring the cross-linking of the BSA molecules to each other and to the tissue at the application site. Polymerization of the BioFoam begins immediately upon application, sets up within 15-20 seconds and reaching full bonding strength within 2 minutes.