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Enrollment in Clinical Study with FocalSeal Surgical Sealant Completed LEXINGTON, Mass., Feb. 3, 1997 -- Focal, Inc., today announced that it has completed enrollment in a 60 patient clinical study, aimed at evaluating the Company's FocalSeal(TM) surgical sealant in patients experiencing air leaks following lung surgery. The randomized, controlled study, being conducted at two leading centers in Europe, is designed to evaluate the ability of FocalSeal sealant to create a leak-proof seal over sutures, staples and other sites traumatized during lung surgery. "We designed this study to evaluate our liquid surgical sealant product in the most challenging environment possible," indicated Mary Lou Mooney, Vice President of Clinical, Regulatory & Quality for Focal, Inc. "Our belief is that if FocalSeal sealant can work on an expanding, dynamic organ like the lung, it will prove to be broadly effective in sealing fluid leaks in many other areas of surgery. We expect the final study results will support our plans to rapidly bring this product to the marketplace," added Mooney. FocalSeal sealant is a synthetic absorbable, liquid surgical sealant that is being developed to seal air and fluid leaks which frequently occur during operations involving the lung and other vital tissues and organs. Using a simple procedure, a surgeon can apply FocalSeal surgical sealant to the target area, and in minutes, create an air-tight, fluid-tight seal that permits tissue healing. The sealant subsequently dissolves and is cleared by the body. Focal recently announced that Ethicon, Inc., a Johnson & Johnson company will distribute the product internationally. Both companies expect Focal's technology to be broadly applicable for sealing leaks in a wide range of surgeries. Focal is a privately-held medical device and drug delivery company specializing in the development of surgical sealants and site-specific drug delivery. In addition to developing FocalSeal surgical sealant, the Company, in collaboration with corporate partners Novartis (formerly Ciba-Geigy Corporation) and Chiron Corporation, is developing a drug delivery system to prevent restenosis, the re-closure of arteries following balloon angioplasty. E-mail this page to a friend or colleague! To print, use this version