In Brief: Biomatrix
This article was originally published in The Gray Sheet
Executive SummaryBiomatrix: Patient enrollment is under way for multi-center U.S. clinicals of Hylagel Uro following FDA approval of an investigational device exemption. Designed to treat urinary incontinence, the viscoelastic gel device is "injected intramuscularly to augment the soft connective tissue between the sphincter and the muscles of the urethra". Biomatrix anticipates its hylan B-based product will compete directly with Collagen's Contigen, a collagen-based urinary incontinence treatment approved in 1993 ("The Gray Sheet" Oct. 4, 1993, p. 1). Biomatrix expects to meet with FDA soon to discuss resubmission of its premarket approval application for its Hylaform viscoelastic gel for use in removing depressed scars and facial wrinkles, which was recently withdrawn. "The Gray Sheet" (Jan. 5, In Brief) incorrectly reported that the company would discuss with FDA the need for additional skin test data on allergic reactions and labeling changes. Biomatrix says there have been no reports of allergic reactions to Hylaform...
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