CryoLife Receives FDA Approval of New Delivery System for BioGlue(R) Surgical Adhesive
May 17 2004 - 9:30AM
PR Newswire (US)
CryoLife Receives FDA Approval of New Delivery System for
BioGlue(R) Surgical Adhesive Disposable Syringe Provides Surgeons
with Improved Site Access and Ease of Use ATLANTA, May 17
/PRNewswire-FirstCall/ -- CryoLife, Inc., a human tissue processing
and surgical device company, today announced the FDA approval of a
new disposable delivery system for BioGlue Surgical Adhesive. The
new BioGlue Syringe is expected to provide clinicians with improved
convenience and ease of use. "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. The BioGlue Syringe provides
surgeons with an effective adhesive in an easier-to-use,
self-contained, disposable syringe. The BioGlue Syringe will be
available in 2ml and 5ml volumes. Since its introduction in Europe
in 1998, CryoLife has distributed over 225,000 units of BioGlue
worldwide. "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,"
said Steven G. Anderson. "As previously announced, we expect
continued strong growth in BioGlue revenues, which are expected to
increase by 19 to 26 percent to between $33 and $35 million in 2004
from $27.8 million in 2003." About BioGlue 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 and approved in Canada for use in soft tissue repair and
approved 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 the new BioGlue syringe delivery device
may not provide clinicians with improved convenience and ease of
use, that 2004 BioGlue revenues may not meet expectations, that the
Company's aggregate 2004 revenues and expenses may not meet its
expectations, that demand for CryoLife preserved tissues may not
return to prior levels, the possibility that the FDA could impose
additional restrictions on the Company's operations, require a
recall, or prevent the Company from processing and distributing
tissues or manufacturing and distributing other products, that the
Company's SG Model #100 bovine ureter product may not meet
expectations, that the Company's 510k application for SG processed
heart valves may require significant time and expense and may not
be cleared on a timely basis or at all, that FDA regulation of the
Company's CryoValve SG and CryoVein SG may require significant time
and expense, that the protein hydrogel products under development
may not be commercially feasible, that the Company may not have
sufficient borrowing or other capital availability to fund its
business, that present and future litigation may be resolved only
by substantial payments by the Company in excess of available
insurance coverage and amounts set aside for products liability
cases by CryoLife since the outcomes of products liability
securities class action and derivative cases are inherently
uncertain, that pending litigation cannot be settled on terms
acceptable to the Company, that the Company may not have sufficient
resources to pay punitive damages which are not covered by
insurance or liabilities in excess of 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 to pay the claims against it, 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 in CryoLife's Securities and Exchange
Commission filings, including CryoLife's Form 10-K filing for the
year ended December 31, 2003, and the Company's 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/ . Contact: Joseph T.
Schepers Vice President, Corporate Communications (770) 419-3355
DATASOURCE: CryoLife, Inc. CONTACT: Joseph T. Schepers, Vice
President, Corporate Communications of CryoLife, Inc.,
+1-770-419-3355 Web site: http://www.cryolife.com/
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