University of Rochester Medical Center Among Four Nationally to Participate in Clinical Trial of World's First Synthetic Surgical Sealant

Trial is testing surgical sealant designed to eliminate air leaks that arise in approximately 80 percent of the surgeries performed on the lungs

July 28, 1998

Dr. David W. Johnstone, Assistant Professor of Surgery, is the principal investigator at the University of Rochester Medical Center for the U.S. clinical trial of FocalSeal(r)-L surgical sealant, the world's first synthetic, absorbable, liquid surgical sealant. FocalSeal-L surgical sealant is designed to seal air leaks that commonly occur on the lungs following surgery. The University of Rochester Medical Center is among a select group of participating medical centers that includes Massachusetts General Hospital (Boston, Mass.), Johns Hopkins Medical Center (Baltimore, Md.) and University of Pennsylvania (Philadelphia, Pa.).

Approximately 260,000 lung surgery procedures, primarily for the treatment of lung cancer resulting from years of smoking, are performed worldwide each year. It is estimated that 80 percent of these procedures result in air leaks. As air leaks from the lung, it accumulates in the plural cavity, making breathing difficult as the lung cannot expand and contract normally. As a result, patients require insertion of chest drainage tubes to vent accumulated air. These chest tubes reside in the patient until the air leaks stop, limiting patient mobility and contributing to post-operative pain. Patients must remain hospitalized until the air leaks are resolved. Prolonged hospitalization and additional surgical procedures needed for some patients with persistent air leaks result in additional health care costs.

"FocalSeal Sealant proved to be a highly innovative, effective new product for surgery," said Dr. Johnstone. "Surgeons have long considered leaks an unavoidable part of surgery because sutures and staples, the primary products available to close surgical wounds, do not have inherent sealing capabilities. FocalSeal was effective in providing a complete, air-tight seal to surgical wounds and offers the potential to decrease the risk of infection and potentially life-threatening complications which can occur as a result of leaks. I envision Focal's unique proprietary polymer technology becoming a major contributor to the next generation of surgical wound closure products."

Using a simple application technique, a surgeon applies FocalSeal Sealant as a liquid directly to a suture or staple site during surgery. Visible light from a specially designed light source quickly transforms the liquid into an adherent sealant that creates a leak-proof seal over the wound, protecting it from leaks and allowing tissue healing. The sealant dissolves naturally in the body.

The current U.S. clinical trial focuses on the effectiveness of FocalSeal surgical sealant in sealing air leaks that arise in lung surgery. However, future formulations of the sealant are designed to be applicable to cardiovascular surgery, gastrointestinal surgery and other surgical applications. Focal expects to submit a Premarket Approval (PMA) application for FocalSeal-L surgical sealant to the U.S. Food and Drug Administration (FDA) for lung surgery indications by the end of 1998.

David W. Johnstone, M.D. is an Assistant Professor of Surgery in the Division of Cardiothoracic Surgery at the University of Rochester Medical Center. Dr. Johnstone received his Bachelor's Degree from Yale University and later received his Medical Degree from the Northwestern University Medical School. Dr. Johnstone is a member of various associations including: the American Medical Association, the American College of Surgeons, the General Thoracic Surgical Club and the Society of Thoracic Surgeons. Dr. Johnstone has contributed to four books and five journal articles and has been an invited speaker at several conferences.

About Focal:

Focal Inc. develops, manufactures and commercializes synthetic absorbable, liquid surgical sealants based on the Company's proprietary polymer technology. The Company's FocalSeal-L and FocalSeal-S surgical sealant products are currently being developed for use inside the body with or without sutures and staples to seal leaks resulting from pulmonary surgery, neurosurgery, cardiovascular, and gastrointestinal surgery. FocalSeal-L surgical sealant is currently available in the European Union through Ethicon, Inc., a Johnson & Johnson Company (NYSE:JNJ), under the tradename AdvaSeal.

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