Advanced Tissue Sciences Announces Successful FDA Reinspection; Appoints Vice President of Quality
LA JOLLA, Calif., Sept. 28 /PRNewswire/ -- Advanced Tissue Sciences, Inc. (Nasdaq: ATIS) reported it has successfully completed a reinspection by the U.S. Food and Drug Administration (FDA) of its manufacturing facility and quality systems for compliance with Good Manufacturing Practices and other applicable regulations. Deficiencies noted by the FDA in an inspection earlier this year have been corrected and enhancements have been made which provide the Company with systems that address both biologics and device regulations. Separately, the Company announced it has appointed Charles E. Anderson to the new position of Vice President of Quality.
Commenting on the reinspection, Dr. Gail K. Naughton, President and Chief Operating Officer, said, "We have worked aggressively over the last several months to enhance our quality systems and organization while continuing to manufacture and ship both TransCyte(TM) and Dermagraft(R) in the U.S. and to several international markets. We are very pleased with the successful outcome of our reinspection. We are also delighted with the addition of Charlie Anderson to our management team. His extensive experience in biologics will help us address the unique requirements of manufacturing our pipeline of tissue engineered products."
Mr. Anderson joins Advanced Tissue Sciences with 20 years of comprehensive experience in quality control and quality assurance. His background in biologics includes his tenure at Genzyme Corporation where, as Vice President of Quality Assurance, he has been responsible for the quality assurance activities for products manufactured both in U.S. and European facilities. Prior to joining Genzyme in 1995, Mr. Anderson was Vice President of Quality Assurance and Quality Control at XOMA Corporation.
Advanced Tissue Sciences is a tissue engineering company utilizing its proprietary core technology to develop and manufacture human-based tissue products for tissue repair and transplantation. The Company currently has two products on the market, TransCyte (formerly known as Dermagraft-TC(R)), a temporary covering for full and partial-thickness burns, and Dermagraft, a living, permanent dermal replacement for the treatment of diabetic foot ulcers (currently available in Canada and the United Kingdom) through a joint venture with Smith & Nephew plc. The Company is conducting a multi-center clinical trial for Dermagraft for diabetic foot ulcers in the United States, and is preparing to pursue additional indications for Dermagraft in venous and pressure ulcers through the joint venture with Smith & Nephew. The Company is also developing products for cartilage and cardiovascular applications.
SOURCE Advanced Tissue Sciences, Inc.
CO: Advanced Tissue Sciences, Inc.
ST: California
IN: MTC
SU: PER
09/28/98 08:52 EDT prnewswire.com
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