CryoLife's BioGlue Shown Effective in Pituitary Tumor Surgery

February 4, 2003 at 9:20 AM EST

Surgical Adhesive Eliminates Fluid Leak, Reinforces Bony Structure, Says Study in Journal of Clinical Neuroscience

ATLANTA, Feb 4, 2003 /PRNewswire-FirstCall via COMTEX/ -- CryoLife(R), Inc. (NYSE: CRY), a human tissue processing and medical device company, today announced that a paper published in the Journal of Clinical Neuroscience reported that using BioGlue(R) Surgical Adhesive in pituitary tumor removal may eliminate cerebrospinal fluid (CSF) leak following surgery.

BioGlue, a bovine serum albumin and glutaraldehyde tissue adhesive, was used in the 32 patient study to reinforce and seal the bony structures underneath the pituitary gland, preventing CSF leak in all 32 consecutive patients undergoing transsphenoidal surgical procedures for reconstruction of the sellar floor.

The study, published by Professor Andrew H. Kaye, MB, BS, MD, FRACS and colleagues at The Royal Melbourne Hospital's department of surgery, was entitled "Reconstruction of the Sellar Floor Using BioGlue Following Transsphenoidal Procedures" and appeared in the journal's January issue. These procedures involve crossing the sphenoid sinus in the front of the skull in order to remove a tumor from the pituitary gland. Patients in this study had a small bone graft secured in place and sealed with BioGlue to reconstruct the bony "floor" where the pituitary gland resides.

By preventing CSF leak, patients in this study avoided potential complications such as allergic rhinitis, meningitis, localized nodular inflammation, and trapped air inside the cranium. BioGlue was found to be biocompatible for this use and did not interfere with post-operative imaging studies, according to the authors.

Steven G. Anderson, president and chief executive officer of CryoLife, noted, "Transphenoidal surgery can be particularly intricate, with ramifications on a patient's post-surgical quality of life. It is both exciting and gratifying that BioGlue can be used to effectively eliminate many of the most troubling complications."

BioGlue was approved by the U.S. Food and Drug Administration (FDA) in December 2001 for repair of large vessels as an adjunct to sutures and staples. BioGlue is indicated in Europe and other parts of the world for a wider variety of soft-tissue repairs, including liver, spleen, hernia, brain and lung surgeries.

Founded in 1984, CryoLife, Inc. is a leader in the processing and distribution of implantable living human tissues for use in surgeries throughout the United States and Canada. The Company's BioGlue(R) Surgical Adhesive is FDA approved as an adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels and is CE-marked in the European Community and approved in Canada and Australia for use in vascular and pulmonary sealing and repair. The Company also manufactures the SynerGraft(R) vascular graft, the world's first tissue-engineered vascular replacement, which is CE-marked for distribution within the European Community. The human grafts processed by CryoLife using the SynerGraft technology are distributed in the U.S. under the trade names CryoValve(R)SG and CryoVein(R)SG.

Statements made in this press release that look forward in time or that express management's beliefs, expectations or hopes regarding future occurrences are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These future events may not occur when expected, if at all, and are subject to various risks and uncertainties. Such risks and uncertainties include the possibility that future BioGlue performance with respect to soft tissue pituitary tumor surgical procedures will prove less encouraging than current results, that surgeons will not accept and use BioGlue in soft tissue or other procedures, that additional regulatory requirements may be imposed by the FDA or other regulatory agencies, competition from other wound closure products and other risk factors detailed in the Company's Securities and Exchange Commission filings, including the Company's Form 10-K for the year ended December 31, 2001. For additional information about the company, visit CryoLife's web site: http://www.cryolife.com .

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