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Biotech / Medical : Biomatrix (BXM) Looking Great -- Ignore unavailable to you. Want to Upgrade?

To: James B. Barnes who wrote (301)	12/31/1997 10:04:00 AM
From: James B. Barnes	Read Replies (1) \| Respond to of 569

Biomatrix Reports Regulatory Update RIDGEFIELD, N.J., Dec. 31 /PRNewswire/ -- Biomatrix, Inc. (Nasdaq: BIOX) today announced that it has received regulatory approval to market its hylan B gel tissue augmentation product, Hylaform(R), for the correction of facial wrinkles and depressed scars, in Canada and Israel. The company also announced the intended withdrawal of its premarket approval (PMA) application for this product with the U.S. Food and Drug Administration. The company has come to the determination that a resubmission of the PMA for Hylaform will provide the best opportunity to continue the dialogue with U.S. regulatory authorities in support of its application. Hylaform has already received the CE mark, and is marketed by Collagen Corp. (Nasdaq: CGEN) in the 19 countries of the EEA. With these recent approvals, Hylaform is now approved in 21 countries, and has applications pending in another eight countries. Dr. Endre A. Balazs, Biomatrix' chief executive officer and chief scientific officer, commented, "European sales of Hylaform have been very strong throughout 1997, indicating the growing acceptance by European plastic surgeons and dermatologists. We are confident that Hylaform's success will continue as we enter other markets." Dr. Balazs continued, "We believe the steps we are taking with the FDA will strengthen the product's position in the United States long term." Biomatrix is the worldwide leader in the development, commercialization and manufacture of viscoelastic products for therapeutic medical applications and in skin care products. The company's lead product, Synvisc(R), for the treatment of osteoarthritis of the knee, received FDA approval in August 1997 and is marketed in the U.S. and certain European countries by Wyeth-Ayerst Laboratories (a division of American Home Products) and internationally through marketing and distribution agreements with a number of large multinational pharmaceutical companies including Boehringer Ingelheim, Hoffman La Roche, Rhone-Poulenc Rorer, and Bayer AG. In addition, Biomatrix manufactures and sells through distributors several other viscoelastic products: Gelvisc(R) Vet for the treatment of osteoarthritis in animals; two Hylashield(R) products for the protection of the surface of the eye from noxious environmental conditions, and several polymers for the skin care industry. 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, product liability, 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, 1996. For more information on Biomatrix, please visit the company's web site at biomatrix.com. SOURCE Biomatrix, Inc. CONTACT: Endre A. Balazs, M.D., Chief Executive Officer, or Rory B. Riggs, President, both of Biomatrix, Inc., 201-945-9550 Web Site: biomatrix.com