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Mentor
Receives European Approval for Hyalite™ Dermal Filler Product Based on
Hyaluronic Acid
(press release from Mentor Corporation)
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SANTA BARBARA,
Calif.--Aug. 11, 2004--Mentor Corporation (NYSE:MNT), a
leading supplier of medical products in the United States and
internationally, today announced that it had received CE Mark approval to
market its Hyalite™ dermal filler in Europe. Hyalite™ is the first product
in the Company's product development pipeline for facial rejuvenation and is
comprised of non animal-based, synthetic hyaluronic acid stabilized by
Mentor's unique and patented double-cross linking technology.
"We are pleased to bring this next generation dermal filler to the European
market and look forward to beginning the process required to gain U.S.
approval as well," commented Joshua H. Levine, President and Chief Executive
Officer of Mentor Corporation. "This approval represents the first milestone
in our strategic product development pipeline focused on facial aesthetics,
an area where we are increasing our level of activity now and in the
future."
Hyalite™ received European approval for soft tissue augmentation in the
correction of wrinkles and folds and for lip enhancement. Hyalite™ is a
pure, synthetic hyaluronic acid and does not have the risks of infection and
contamination associated with animal-based products. Hyalite™ is
manufactured through a unique and patented process that provides two
discrete cross-linking steps to improve product stability and increase
product persistence.
"Hyalite™ provides an important new choice for me to consider as I seek to
optimize patient outcomes," commented Nicholas Lowe, M.D, a thought-leading
dermatologist and cosmetic surgeon with practices in London, England, and in
Santa Monica, California. "I am pleased with the results of the product thus
far. Hyalite™ gives a very smooth injection resulting in a uniform filling
to the lips and lower face lines. I am hopeful that this new treatment
option will better meet patients' needs."
Mentor is planning to commence the U.S clinical development program in the
second half of 2004, which is required to be completed prior to seeking
approval to launch the product in the United States. Mentor acquired
Hyalite™ and the patented double cross-linking technology platform in August
2003 through its acquisition of A-Life Inc.
About Mentor Corporation
Founded in 1969, Mentor Corporation is a leading supplier of medical
products for the global healthcare market. The Company develops,
manufactures and markets innovative, science-based products for the
aesthetics and urologic specialties markets around the world.
The Company's Aesthetics franchise includes prosthetic mammary implants for
breast augmentation and reconstruction, and lipoplasty products for body
contouring. Mentor's Urologic Specialties franchise includes surgical slings
for the treatment of urinary stress incontinence, brachytherapy seeds for
the treatment of prostate cancer, prosthetic implants for the treatment of
erectile dysfunction and disposable medical devices for the treatment and
care of urinary incontinence and other urological conditions.
Mentor employs approximately 2,000 people around the world and is
headquartered in Santa Barbara, California, with manufacturing and research
operations in the United States, France, the Netherlands and the United
Kingdom. The Company's website is: www.mentorcorp.com
Safe Harbor Statement
All statements included or incorporated by reference in this release, other
than statements or characterizations of historical fact, are forward-looking
statements. These forward-looking statements are based on our current
expectations, estimates and projections about our industry, management's
beliefs and certain assumptions made by us. Forward-looking statements can
often be identified by words such as "anticipates," "expects," "intends,"
"plans," "predicts," "believes," "seeks," "estimates," "may," "will,"
"should," "would," "could," "potential," "continue," similar expressions,
and variations or negatives of these words. In addition, any statements that
refer to expectations, projections, or other characterizations of future
events or circumstances, including any underlying assumptions, are
forward-looking statements. These forward-looking statements speak only as
of the date hereof and are based upon the information available to us at
this time. Such information is subject to change, and we will not
necessarily inform you of such changes. These statements are not guarantees
of future results and are subject to risks, uncertainties and assumptions
that are difficult to predict. Therefore, our actual results could differ
materially and adversely from those expressed in any forward-looking
statement as a result of various factors.
The Securities and Exchange Commission filings of Mentor, including, without
limitation, its Annual Reports on Form 10-K, subsequent quarterly reports on
Form 10-Q, and recent Current Reports on Form 8-K, discuss important risk
factors that could contribute to such differences or otherwise affect its
business, results of operations and financial condition. Mentor undertakes
no obligation to revise or update publicly any forward-looking statement for
any reason.
Contacts
Mentor Corporation
Peter R. Nicholson, (805) 879-6082
***********
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