SOURCE: Cell Bio-Systems

November 08, 2005 20:39 ET

CBSI Re-Engages TECSA Technical Services to Support Push for FDA Clearance of Disposable Surgical Instruments

SAN DIEGO, CA -- (MARKET WIRE) -- November 8, 2005 -- Cell Bio-Systems, Inc. (OTC: CBSI), a developer of medical devices and patented technologies for the plastic, cosmetic, orthopedic, and living tissue markets, today announced it will retain TECSA Technical Services to provide consulting services for all of CBSI's regulatory issues.

After reaching an agreement in principle in May 2004, the relationship was put on hold while CBSI raised money and developed production standards. Now, with patented technology and disposable surgical instruments in production, the company has re-engaged TECSA to provide a range of services, including ISO/CE compliance, FDA regulatory submissions, GMP guidance and training, and development of protocols from biocompatibility to sterilization.

Darin Andersen, president and chief operating officer of CBSI, said, "TECSA will be advising CBSI in all FDA matters from 510k claims to quality control processes. We are confident that working with a top notch company such as TECSA for this vitally important area helps to assure fast product clearance and easy market acceptance."

TECSA has worked with companies such as Mentor Corp. (MTR) and others. TECSA has over ten years experience in providing regulatory and quality assurance guidance and training to medical device companies.

"We believe Cell Bio-Systems' patented technology has a distinct safety advantage over the traditional instruments now used in living tissue procedures. We look forward to assisting the company in bringing this advance to market," said Christine Emanuel, president of TECSA Technical Services.

About Cell Bio-Systems, Inc.

Cell Bio-Systems, Inc. (OTC: CBSI) is a Nevada corporation whose operations are based in San Diego, California. Founded in 2004, Cell Bio-Systems is a medical device, biotechnology company that manufactures and distributes patented technologies for the plastic and cosmetic surgery, biopsy, orthopedic surgery, stem cell therapy and other living tissue markets. Cell Bio-Systems is the exclusive licensee of patented syringe connection devices that use the worldwide recognized Tulip brand name. Cell Bio-Systems manufactures, markets, and distributes medical devices, adapted with these and other patented technologies, to physicians, clinics, military, health organizations, hospitals and other distribution outlets. On the Web: http://www.cbsi-web.com/home

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 ASQ-certified quality auditor; FDA 510 (k), PMA, and IDE submissions; and assistance with regulatory compliance, design control, ISO 9000/ISO 13485, and training.

Safe Harbor: This press release contains certain forward-looking information about Cell Bio-Systems, Inc. ("Cell Bio-Systems") which is intended to be covered by the safe harbor for "forward-looking statements" provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. Words such as "expect(s)," "feel(s)," "believe(s)," "will," "may," "anticipate(s)," and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, financial projections and estimates and their underlying assumptions; statements regarding plans, objectives and expectations with respect to future operations, products and services; and statements regarding future performance. Such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of Cell Bio-Systems, Inc. that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include: our lack of operating revenue and earnings history, our need for additional capital to pursue our business strategy. We are a non-reporting company and as such do not make periodic filings with the Securities and Exchange Commission. We trade on the Pink Sheets and there can be no assurances that a liquid market will develop in our securities. Readers are cautioned not to place undue reliance on these forward-looking statements. Cell Bio-Systems, Inc. does not undertake any obligation to republish revised forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

Contact Information

  • Contact:
    Mr. Bill Hales
    Vice President Investor Relations
    Cell Bio-Systems, Inc.
    Tel: 858-244-4800
    Email: Email Contact

    Media Contact:
    Beth Walsh
    Clearpoint Agency
    Tel. 858-724-2500
    Email: Email Contact