Genzyme Tissue Repair Files 510(k) for Approval of Quick Tack(TM)
Thursday July 6, 9:14 am Eastern Time
Company Press Release
SOURCE: Genzyme Tissue Repair
CAMBRIDGE, Mass., July 6 /PRNewswire/ -- Genzyme Tissue Repair (Nasdaq: GZTR - news) announced today that it has submitted a 510(k) filing to the U.S. Food and Drug Administration (FDA) for clearance to market its Quick Tack(TM) periosteal fixation system.
Quick Tack is a small device designed to replace the use of sutures during the Carticel® implant, currently an open-knee procedure. It is expected to simplify the procedure and decrease the time needed for surgery by as much as half. Quick Tack is also the first step toward an arthroscopic (closed knee) Carticel procedure.
``Meeting this important milestone illustrates our commitment to growing the Carticel business,'' said Russell H. Herndon, president, Genzyme Tissue Repair. ``Quick Tack is a significant incremental step in reaching our ultimate goal of a next-generation Carticel and we look forward to working with the FDA as the submission moves ahead.''
Carticel employs a patient's own cartilage cells to repair symptomatic, damaged cartilage on the thigh bone part of the knee caused by acute or repetitive trauma, in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure.
Formation of Genzyme Biosurgery
Under an announced merger plan, Genzyme Tissue Repair will be combined with Genzyme's surgical products division, Genzyme Surgical Products (Nasdaq: GZSP - news), and merged with Biomatrix Inc. (NYSE: BXM - news) to form a new publicly-traded division of Genzyme Corporation called Genzyme Biosurgery. The transaction is expected to close in the third quarter of 2000.
The merger will create one of the leading businesses in the rapidly emerging market for sophisticated biotechnology products, including biomaterials and biotherapeutics, used to enhance or replace conventional surgical and medical procedures.
Upon formation, Genzyme Biosurgery will have approximately 1,300 employees; six dedicated manufacturing facilities; global clinical and regulatory capabilities; an extensive intellectual property portfolio; several established sales organizations in focused surgical markets in both the United States and Europe; and marketing and distribution agreements with a number of large, multinational health care companies.
Genzyme Tissue Repair is a leading developer of biological products for the treatment of orthopedic injuries such as cartilage damage, and severe burns. It is a division of Genzyme Corp. and has its own common stock intended to reflect its value and track its performance.
This press release contains forward-looking statements, including statements concerning the expected benefits of Quick Tack, the anticipated development of an arthroscopic Carticel procedure, the formation of Genzyme Biosurgery, the future growth and success of Genzyme Biosurgery and the timing for the formation of Genzyme Biosurgery. Actual results may differ materially depending on many factors including, the actual benefits of Quick Tack, the ability to successfully complete development of an arthroscopic Carticel procedure, the likelihood of regulatory and other approvals of the planned acquisition of Biomatrix and the formation of Genzyme Biosurgery, including shareholder approvals, the accuracy of information about the biosurgery market, the competitive environment for the biosurgery market, the operation integration associated with the formation of Genzyme Biosurgery, other risks generally associated with transactions and the risks and uncertainties described in Genzyme's filings with the Securities and Exchange Commission under the Exchange Act of 1934, as amended, including Exhibit 99.2 to Genzyme's Annual Report on Form 10-K for the year ended December 31, 1999.
Genzyme's releases are on the World Wide Web at genzyme.com. They are also available from Genzyme's fax-on-demand service at 1-800-436-1443 within the United States or 1-201-521-1080 outside the United States.
SOURCE: Genzyme Tissue Repair |
