BARD REQUESTS IDE FOR HYLAGEL-MUSCLE
BARD REQUESTS IDE FOR HYLAGEL-MUSCLE RIDGEFIELD, N.J., Feb. 18 /PRNewswire/ -- Biomatrix, Inc.
(NASDAQ: BIOX) reported today that the Bard Urological Division of C.R. Bard, Inc. submitted a request for an Investigational Device Exemption (IDE) to the Food and Drug Administration (FDA). This submission requests authorization to commence human clinical trials on Hylagel(R)- Muscle, an injectable gel for the treatment of urinary incontinence, manufactured by Biomatrix, Inc.
Urinary stress incontinence is a condition which is estimated to affect over three million people in the U.S. alone. Hylagel-Muscle consists of hylan gel, a chemically cross-linked form of a naturally occurring carbohydrate, called hyaluronan. Hylagel-Muscle is injected directly into the urinary sphincter in order to increase pressure on the urethra and stem the uncontrolled flow of urine. Currently available treatment alternatives include corrective surgery or adult diapers. Based on contractual agreements between the companies, Bard will fund and direct the clinical trials. Biomatrix will manufacture the product and receive a royalty on sales. Bard has exclusive marketing rights to the product on a world-wide basis. Biomatrix develops advanced biomaterials for use in therapeutic medical applications and skin care products based on hylan technology. Hylans, patented by Biomatrix, are chemically modified forms of hyaluronan. The company is headquartered in Ridgefield, N.J. -0- 2/18/92 /CONTACT: Melissa Mack of Howard J. Rubenstein Associates, Inc., 212-489-6900, for Biomatrix/ (BIOX) CO: Biomatrix Inc. ST: New Jersey IN: MTC SU:
KD-KW -- NY074 -- 9981 02/18/92 13:19 EST
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|Date:||Feb 18, 1992|
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