Wednesday March 29, 8:41 am Eastern Time
Company Press Release
SOURCE: Biomatrix, Inc.
Biomatrix Receives FDA Approval to Market
Surgical Adhesion Prevention Product
RIDGEFIELD, N.J., March 29 /PRNewswire/ -- BIOMATRIX, INC. (NYSE: BXM - news) today announced that the
company has received Section 510(k) pre-market notification approval from the U.S. Food & Drug Administration (FDA) to
market HylaSine©. HylaSine is the company's viscoelastic gel device that is injected into anatomical compartments of the sinus
during and following sinus surgery to coat surgically altered tissue, to still intra-operative and post-operative bleeding, to reduce
post-surgical scarring and adhesions, to minimize patient discomfort and to shorten the patient post-operative rehabilitation
period. Intra-operative and post-operative complications appear in almost all of the 300,000 sinus surgical procedures that are
performed annually in the United States.
Dr. Endre A. Balazs, M.D., Biomatrix' chief executive officer and chief scientific officer, commented, ``Obtaining FDA
approval to market HylaSine marks an important milestone for Biomatrix in commercializing our family of adhesion prevention
products. The market potential for an effective anti- adhesive product for this otolaryngological indication is very promising, as
it could be used in most sinus surgeries to improve the outcome of the procedure, benefit the patient, and save the healthcare
system from the expense of costly re-operations.'
Dr. Balazs continued, ``This approval comes at a particularly exciting and opportune time in Biomatrix' development. The
commercialization of HylaSine contributes significantly to the development of our hylan technology platform and complements
the anti-adhesive technology program of our proposed merger partners, Genzyme Surgical Products and Genzyme Tissue
Repair. The combination of these innovative technologies should enable the new company to emerge as the preeminent global
leader in adhesion prevention.'
Biomatrix, Inc., headquartered in Ridgefield, New Jersey is an international biomedical company that develops, manufactures
and commercializes elastoviscous products used in therapeutic medical applications and in skin care products, and which are
made from proprietary biological polymers called hylans. Hylans are developed from hyaluronan, the ubiquitous polysaccharide
of the intercellular matrix of the human body. HylaSine is made of the company's viscoelastic hylan gel which mimics the human
body's own intercellular matrix and thus serves to strengthen, augment or replace diseased intercellular matrices of the body.
This therapeutic paradigm, called Intercellular Matrix Therapy, was pioneered by the company's scientists and consists of
products used for a broad variety of preventative, corrective, and curative applications.
Genzyme Corp. and Biomatrix, Inc. recently announced their agreement to form a new company, a division of Genzyme that
will be composed of Biomatrix, Genzyme Tissue Repair (Nasdaq: GZTR - news), a leading developer of biological products
for the treatment of orthopedic injuries and severe burns, and Genzyme Surgical Products (Nasdaq: GZSP - news), which
develops and markets medical devices, biomaterials, and biotherapeutics for cardiothoracic and other surgical markets, and is a
leader in developing biomaterials to prevent post- surgical adhesions.
Certain statements in this press release are forward-looking statements that involve risks and uncertainties including, but not
limited to, the regulatory approval process, obtaining and enforcing patents, reimbursement by private health care providers,
manufacturing capabilities, projected earnings and financial results, growing product demand, product liability, inventory levels
of our marketing partners, future product development, and other risks detailed in Biomatrix' reports filed under the Securities
Exchange Act, including Forms 10-Q and Biomatrix' annual report on Form 10-K for the year ended December 31, 1998. For
more information on Biomatrix, please visit the Company's web site at biomatrix.com.
Editor's note: HylaSine© is a registered trademark of Biomatrix, Inc.
SOURCE: Biomatrix, Inc. |
