EXHIBIT 99.1
[CRYOLIFE COMPANY LOGO] [ENDOLOGIX COMPANY LOGO]
NEWS RELEASE
JANUARY 10, 2005
CRYOLIFE CONTACT: ENDOLOGIX CONTACTS:
Joseph T. Schepers Paul McCormick
VP, Corporate Communications President & CEO
(770) 419-3355 (949) 595-7200
ENDOLOGIX INVESTOR CONTACTS:
Lippert/Heilshorn & Associates
Bruce Voss/Jody Cain
(310) 691-7100
CRYOLIFE AND ENDOLOGIX SIGN DEVELOPMENT AGREEMENT FOR BIOFOAM
ENDOLOGIX TO DEVELOP CRYOLIFE'S INNOVATIVE,
SELF-EXPANDING SEALANT AS A FILLING AGENT FOR AORTIC ANEURYSMS
ATLANTA, GA. AND IRVINE, CALIF. (JANUARY 10, 2005) - CRYOLIFE, INC. (NYSE: CRY)
AND ENDOLOGIX, INC. (NASDAQ: ELGX) today announced the signing of a development
and marketing agreement for the percutaneous or endovascular delivery of
CryoLife's BioFoam(TM) as a self-expanding sealant for endovascular aortic
aneurysm grafts. Under the agreement, Endologix will be responsible for
preclinical, clinical, and regulatory activities and costs, and CryoLife will
manufacture BioFoam for clinical use and commercial sale and receive a royalty
on potential future product sales.
BioFoam is a protein hydrogel adhesive in preclinical development. The product
contains an expansion agent, which has the potential to rapidly fill and seal
internal body cavities, such as aneurysm sacs, and provide hemostasis in
penetrating wounds and severe trauma. BioFoam is based on the same platform
technology as CryoLife's BioGlue(R), which is FDA approved to control bleeding
as an adjunct to sutures and staples in the open surgical repair of large
vessels. BioGlue is CE marked in the European Community and approved in Canada
for use in soft tissue repair.
"BioFoam represents an outstanding business opportunity for Endologix, using a
well-described and often-used predicate in open surgical procedures in a market
that Endologix currently serves," said Paul McCormick, Endologix president and
chief executive officer. "Endoleaks, or blood flow into an excluded aneurysm
sac, are a significant factor for mid- and long-term failure of endovascular
aneurysm repair. Our near-term focus will be on developing BioFoam as an
effective agent for percutaneous treatment of endoleaks, irrespective of stent
graft manufacturer, while longer-term, BioFoam has the potential to make
minimally invasive treatment of abdominal aortic aneurysms (AAA) a more durable
procedure."
-more-
"BioFoam is an innovative and versatile product that should prove effective in
multiple medical applications," said Steven G. Anderson, CryoLife president and
chief executive officer. "Through agreements with companies with specialized
skills and market access, such as Endologix, we expect to improve the value of
this asset with application-specific development and to receive a royalty on
product sales and earn a manufacturing margin. We are delighted to enter into
this agreement with Endologix, and look forward to moving BioFoam into clinical
development."
Endologix intends to begin preclinical development of BioFoam during the first
quarter of 2005, and to start clinical testing for the treatment of type 2
endoleaks in mid-year 2006.
"With our Powerlink(R) System, we are addressing the failings of
first-generation endoluminal stent grafts (ELG), and with BioFoam, we are
addressing the entirety of the ELG procedure to make this approach the standard
of care," added Mr. McCormick. "We are pleased to further establish our position
of industry leadership and product innovation."
ABOUT CRYOLIFE
Founded in 1984, CryoLife, Inc. is a leader in the processing and distribution
of implantable human tissues for use in cardiovascular and vascular surgeries
throughout the United States and Canada. CryoLife'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. CryoLife also manufactures
the SG Model #100 vascular graft, which is CE marked for distribution within the
European Community. For additional information about CryoLife, visit CryoLife's
web site: www.cryolife.com.
ABOUT ENDOLOGIX
Endologix, Inc. develops and manufactures minimally invasive treatments for
vascular diseases. Endologix's Powerlink System is an endoluminal stent graft
for treating abdominal aortic aneurysms (AAA). AAA is a weakening of the wall of
the aorta, the largest artery in the body, resulting in a balloon-like
enlargement. Once AAA develops, it continues to enlarge and, if left untreated,
becomes increasingly susceptible to rupture. The overall patient mortality rate
for ruptured AAA is approximately 75%, making it the thirteenth leading cause of
death in the United States. In October 2004, Endologix received approval to
market the Powerlink in the U.S. Additional information can be found on
Endologix's web site at www.endologix.com.
CRYOLIFE SAFE HARBOR STATEMENT: Statements made in this press release that look
forward in time or that express CryoLife's 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 CryoLife's business, are
subject to various risks and uncertainties. These risks and uncertainties
include that BioFoam may not prove effective for percutaneous treatment of
endoleaks or make minimally invasive treatment of AAA a more durable procedure,
that the licensed use for BioFoam may not prove commercially feasible, that the
proposed use may not receive appropriate regulatory approval, that the proposed
use may infringe the proprietary rights of third parties, that royalties and
manufacturing margins on product sales from the agreement may not meet
expectations, that the Company's 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 CryoLife's operations, require a recall, or prevent CryoLife from
manufacturing and distributing BioFoam, that to the extent CryoLife 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
the company's Securities and Exchange Commission filings, including Form 10-K
filing for the year ended December 31, 2003, and other SEC filings. CryoLife
undertakes to update its forward-looking statements.
ENDOLOGIX SAFE HARBOR STATEMENT: Except for historical information contained
herein, this news release contains forward-looking statements, the accuracy of
which are necessarily subject to risks and uncertainties, including risks
related to the development, clinical success and regulatory approval of a new
medical device product, and the risks related to intellectual property rights
surrounding new technology, all of which are difficult or impossible to predict
accurately and many of which are beyond the control of Endologix, all as more
fully described in the risk factors and other matters set forth in the Company's
Annual Report on Form 10-K for the year ended December 31, 2003, and the
Company's other filings with the SEC.
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