CryoLife Announces First Human Implants of BioDisc(TM) Spinal Disc Repair System
2005年9月6日 - 10:45PM
PRニュース・ワイアー (英語)
ATLANTA, Sept. 6 /PRNewswire-FirstCall/ -- CryoLife, Inc.
(NYSE:CRY), a biomaterials and biosurgical device company,
announced today that BioDisc(TM) Spinal Disc Repair System, a
nucleus pulposus repair device, was successfully implanted in two
patients. These patients underwent a discectomy approximately 6
weeks ago, to treat a herniated disc in the lumbar spinal area. The
BioDisc implant material was easily delivered into the void space
as a simple additional step at the completion of the discectomy
procedure. The early clinical course of both patients is proceeding
as expected for discectomy patients. These initial two patients are
part of a BioDisc feasibility study being conducted in the United
Kingdom and the Company expects to enroll an additional eight
patients in this study over the next several months. "We are
pleased with the early preliminary results in these first BioDisc
patients. We believe BioDisc is an innovative treatment that has
the potential to benefit thousands of patients who suffer from back
and leg pain resulting from herniated discs," stated Steven G.
Anderson, President and Chief Executive Officer. The spinal disc is
comprised of the nucleus pulposus and the surrounding fibrous
tissue, known as the annulus. The nucleus pulposus is composed of a
gelatinous-like material that acts as a cushion or shock absorber
to the spinal column. Through either the natural process of aging
or an injury, the spinal disc may weaken, resulting in a
herniation. The herniation may occur adjacent to a nerve, resulting
in debilitating back or leg pain. The herniation may be removed via
a surgical procedure known as a discectomy, which leaves an empty
void within the spinal disc. The implantation of BioDisc into this
void may prevent or reduce spine instability, preserve disc height,
and prevent recurrent disc herniation. Presently, over 300,000
discectomies are performed in the U.S. each year and approximately
120,000 are performed in Europe. About CryoLife 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(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
Economic Area and approved in Canada for use in soft tissue repair
and approved in Australia for use in vascular and pulmonary sealing
and repair. 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 despite expectations,
the Company may face difficulties in enrolling additional patients
for the BioDisc study, that actual results of the study may not
meet expectations, that BioDisc may not prove beneficial to
thousands of individuals suffering pain attributable to herniated
discs, that BioDisc may not prove beneficial in preventing or
reducing spine instability, preserving disc height, or preventing
recurrent disc herniation, that CryoLife's 2005 revenues and
expenses may not meet its expectations, the possibility that as a
result of its recent inspection of the Company's facilities 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 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 other 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, 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/ 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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