Healthcare Industry News: vascular graft
News Release - January 12, 2006
CryoLife Receives FDA Approval of New, Larger Delivery System for BioGlue(R) Surgical AdhesiveDisposable Syringe Provides Surgeons with Improved Site Access and Ease of Use
ATLANTA, Jan. 12 (HSMN NewsFeed) -- CryoLife, Inc., (NYSE: CRY ) a biomaterials and biosurgical device company, today announced that it has received approval from the Food and Drug Administration (FDA) for a new 10ml disposable syringe for BioGlue Surgical Adhesive.
The 10ml BioGlue Syringe provides surgeons with an effective adhesive in an easy-to-use, self-contained, disposable syringe, ideally suited for complex cardiovascular surgery procedures. Currently available in Europe, the 10ml BioGlue Syringe will be introduced to the U.S. market late in the first quarter of 2006. The BioGlue Syringe is already available in the U.S. in 2ml and 5ml volumes.
"Since its introduction in the U.S. in December 2001, BioGlue has seen a significant increase in acceptance and usage by surgeons as an integral part of their surgical practice," said Steven G. Anderson, President and Chief Executive Officer, CryoLife, Inc.
"Extensive clinical experience continues to demonstrate BioGlue's safety and effectiveness in a range of surgical procedures benefiting patients in the U.S. and internationally," Mr. Anderson added. "We expect the new 10ml syringe to be a catalyst of BioGlue sales growth in the U.S."
BioGlue is a two-component adhesive that creates a flexible, mechanical seal, independent of the body's clotting mechanism, within 20 to 30 seconds, and reaches its maximum bonding strength in two to three minutes.
The Company's BioGlue 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. In addition, BioGlue is approved in Canada for use in soft tissue repair and in Australia for use in vascular and pulmonary sealing and repair.
About CryoLife, Inc.
Founded in 1984, CryoLife, Inc. is a leader in the processing and distribution of implantable living human tissues for use in cardiovascular and vascular surgeries throughout the United States and Canada. The Company's BioGlue 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 for use in soft tissue repair and approved in Australia for use in vascular and pulmonary sealing and repair. The Company also manufactures the SG Model #100 vascular graft, which is CE marked for distribution within the European Community.
Statements made in this press release that look forward in time or that express management's beliefs, expectations or hopes are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These future events may not occur as and when expected, if at all, and, together with the Company's business, are subject to various risks and uncertainties. These risks and uncertainties include that future BioGlue revenues may not meet expectations since the new 10ml disposable syringe may not reinvigorate BioGlue sales growth in the U.S., provide clinicians with improved ease of use or prove to be ideally suited for complex procedures, that future clinical experience may not continue to demonstrate BioGlue's safety and effectiveness in a range of surgical procedures, that the Company's aggregate revenues and expenses may not meet its expectations, the possibility that as a result of its inspections of the Company's facilities or other events the FDA could impose additional restrictions on the Company's operations, require a recall, prevent the Company from processing and distributing tissues or manufacturing and distributing other products, or take other actions which the Company may not be able to address in a timely or cost-effective manner if at all, that the Company may not have sufficient borrowing or other capital availability to fund its business, that pending or threatened litigation cannot be settled on terms acceptable to the Company, that the Company may not have sufficient resources to pay punitive damages or other liabilities arising from litigation which are not covered by available insurance, the possibility of severe decreases in the Company's revenues and working capital, that to the extent the Company does not have sufficient resources, it may be forced to cease operations or seek protection under applicable bankruptcy laws, changes in laws and regulations applicable to CryoLife and other risk factors detailed CryoLife's Securities and Exchange Commission filings, including CryoLife's Form 10-K filing for the year ended December 31, 2004, its registration statement on Form S-3 (Reg. No. 333- 121406), CryoLife's most recent Form 10-Q, and its other SEC filings. The Company does not undertake to update its forward-looking statements.
For additional information about the company, visit CryoLife's Web site: http://www.cryolife.com
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