CryoLife Receives CE Mark Approval for Distribution in the European Union of a New Delivery System for BioGlue(R) Surgical Adhes
May 19 2004 - 3:00AM
PR Newswire (US)
CryoLife Receives CE Mark Approval for Distribution in the European
Union of a New Delivery System for BioGlue(R) Surgical Adhesive
Disposable Syringe Provides Surgeons with Improved Site Access and
Ease of Use ATLANTA, May 19 /PRNewswire-FirstCall/ -- CryoLife,
Inc., a human tissue processing and surgical device company, today
announced the CE mark approval for distribution in the European
Union 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. On Monday, May 17, 2004,
the company announced the FDA approval of the same delivery system
for distribution in the United States. "Since its introduction in
Europe in 1998, 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. "International BioGlue sales
increased 24% in the first quarter 2004 compared to the same period
in 2003. Twenty percent of total BioGlue revenues are derived from
outside the United States." 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 1998, CryoLife has
distributed over 225,000 units of BioGlue worldwide. 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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