CryoLife and Endologix Sign Development Agreement for BioFoam
January 10 2005 - 4:10PM
PR Newswire (US)
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 and IRVINE, Calif.,
Jan. 10 /PRNewswire-FirstCall/ -- 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." "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:
http://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
http://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. 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 DATASOURCE:
CryoLife, Inc. CONTACT: Joseph T. Schepers VP, Corporate
Communications of CryoLife, +1-770-419-3355; or Paul McCormick,
President & CEO of Endologix, +1-949-595-7200; or Endologix
Investors, Bruce Voss or Jody Cain of Lippert- Heilshorn &
Associates, +1-310-691-7100 Web site: http://www.cryolife.com/
http://www.endologix.com/
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