SAN DIEGO, May 5, 2004 (PRIMEZONE) -- Cell Bio-Systems, Inc. (Pink Sheets:CBSI), a biotechnology company seeking to manufacture and distribute patented, disposable technologies for cosmetic surgery, biopsy, orthopedic surgery and other living tissue procedures, announced today that it has selected TECSA Technical Services to provide quality assurance and regulatory consulting services.
As part of the agreement, TECSA will manage Cell Bio-Systems' ISO/CE compliance, FDA regulatory submissions, GMP Guidance and training, and development protocols from biocompatibility to sterilization. TECSA also will provide a broad range of ancillary services, as Cell Bio-Systems brings its patented technology to market.
"TECSA has more than ten years' experience in providing regulatory and quality assurance guidance and training to medical device companies," said Marc Pilkington, president and CEO of Cell Bio-Systems. "The Cell Bio-Systems management team feels TECSA is the ideal candidate to help us navigate the complex regulatory environment."
Cell Bio-Systems recently announced the completion of its first set of production tools for the manufacture of the company's flagship instrument, the Super-Luer, a patented connection system and the centerpiece component for the company's bio-device kits utilized in procedures ranging from liposuction and fat re-injections to gene therapy technologies and stem cell research.
The Super Luer will be adapted to manufacture the first affordable, disposable cannula, an enclosed tubular device, currently made from stainless steel, that looks much like a large needle and has been popularized by its use to insert or extract tissue during liposuction and collagen implant procedures. Though re-sterilized, steel cannulas are reused in hundreds of procedures, typically for as long as two years or more. Despite safety concerns and complications regularly ascribed to steel cannulas, no comparable, disposable device currently exists.
About Cell Bio-Systems
Based in San Diego, California, Cell Bio-Systems is the exclusive licensee of two patented syringe connection products that it plans to adapt as disposable devices for liposuction and other Living Tissue Management(TM) procedures. The company is developing an affordable, disposable product line that will fill this void in the cosmetic surgery and living tissue marketplace. The company's patented, groundbreaking technology will increase patient safety and enhance procedural outcomes. Most notably, Cell Bio-Systems devices can be adapted for a variety of procedures, ranging from fat transfers to biopsies to stem cell research. The company ultimately will develop a complete living tissue management system. For more information, please visit www.cellbiosystems.com.
About TECSA
TECSA provides regulatory-affairs and quality-assurance consulting services to medical device manufacturers. Services include development and implementation of quality systems to meet FDA and ISO requirements; GMP system audits by an ASQC-certified quality auditor; FDA 510(k), PMA, and IDE submissions; and assistance with regulatory compliance, design control, ISO 9000, and training.
Legal Notice Regarding Forward-Looking Statements: "Forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 may be included in this news release. These statements relate to future events or our future financial performance. These statements are only predictions and may differ materially from actual future results or events. CBSI disclaims any intention or obligation to revise any forward-looking statements whether as a result of new information, future developments or otherwise. There are important risk factors that could cause actual results to differ from those contained in forward-looking statements, including, but not limited to risks associated with changes in general economic and business conditions (including in the information technology and financial information industry), actions of our competitors, the extent to which we are able to develop new services and markets for our services, the time and expense involved in such development activities, the level of demand and market acceptance of our services, and changes in our business strategies.