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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): May 27, 1998
GLIATECH INC.
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(Exact Name of Registrant as Specified in its Charter)
DELAWARE 0-20096 34-1587242
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(State or Other Jurisdiction (Commission (IRS Employer
of Incorporation) File Number) Identification Number)
23420 Commerce Park Road, Cleveland, Ohio 44122
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (216) 831-3200
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N/A
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(Former Name or Former Address, if Changed Since Last Report)
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Item 5. Other Events.
GLIATECH ADCON(R)-L RECEIVES FDA APPROVAL
-- FDA APPROVED TREATMENT TO INHIBIT SCARRING AND ADHESIONS
FOLLOWING LUMBAR SURGERY --
Cleveland, Ohio, May 28, 1998 -- Gliatech Inc. (Nasdaq: GLIA) today announced
that ADCON(R)-L was approved for marketing in the United States by the U.S. Food
and Drug Administration (FDA). ADCON(R)-L is designed to inhibit postsurgical
scarring and adhesions following lumbar surgery.
"The introduction of ADCON(R)-L in the U.S. is a major step forward for
Gliatech," said Thomas O. Oesterling, Ph.D., President and Chief Executive
Officer of Gliatech Inc. "This is our first product launch in the U.S. and we
are very excited about the prospects for ADCON(R)-L. ADCON(R)-L addresses a
major unmet medical need and is an important advance in the area of inhibition
of postsurgical scarring and adhesions."
Based on the most recent statistics available, in 1995, approximately 450,000
lumbar disc surgeries were performed in the United States. Scarring and
adhesions occur as part of the natural healing process but can be problematic
after surgery if the adhesions form around the tissues, nerves and organs
causing them to bind and tether to each other and the surrounding tissues.
Results from the European clinical trial for ADCON(R)-L demonstrated that:
* ADCON(R)-L statistically significantly reduced the incidence of
postsurgical scarring and adhesions.
* ADCON(R)-L statistically significantly reduced the incidence of
postoperative activity- related pain.
"Patients benefit from ADCON(R)-L treatment through reduced scarring and
adhesions resulting in less activity-related pain. ADCON(R)-L is a much-needed
product in this area," said Joseph C. Maroon, M.D., investigator in the
ADCON(R)-L study and Chairman of the Department of Neurosurgery at Allegheny
General Hospital in Pittsburgh, Pennsylvania.
ADCON(R)-L Adhesion Control in a Barrier Gel is a proprietary resorbable gel,
classified as a medical device, that provides a physical barrier to postsurgical
adhesions involving the nerve roots of the spine. The product is applied by the
surgeon at the surgical site and is naturally resorbed by the body.
To date, ADCON(R)-L has been used in approximately 12,000 surgeries worldwide
and is available in 29 countries outside of the U.S.
Gliatech is a healthcare company engaged in the discovery, development and
commercialization of therapeutic products based on the properties of glial
cells, a major component of the nervous system. The Company applies its core
glial research to developing innovative products for major unmet human health
care needs.
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Certain statements in this Current Report on Form 8-K constitute "forward
looking statements" that are subject to risks and uncertainties which may cause
the actual results of the Company to be different from such statements. Such
factors include, but are not limited to, uncertainty of market acceptance of the
Company's products, delays in product development of ADCON(R) products, the
potential market size for ADCON(R) products, and the uncertainty regarding
regulatory approvals.
ADCON(R) is a registered trademark of Gliatech Inc.
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SIGNATURES
Pursuant to the requirements of Section 12 of the Securities Exchange
Act of 1934, the registrant has duly caused this registration statement to be
signed on its behalf by the undersigned, hereunto duly authorized.
GLIATECH INC.
Date: May 28, 1998 By: /s/ Rodney E. Dausch
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Name: Rodney E. Dausch
Title: Vice President, Chief Financial
Officer and Secretary
