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.
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CONTACT:
Jack D. Strube, Executive Director, Finance,
of Advanced Tissue Sciences, Inc., 619-450-5802
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