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Cell Bio-Systems Inc. Successfully Concludes Full Series of Biocompatibility Tests on Its Disposable Surgical Instruments

Posted on: Tuesday, 21 February 2006, 12:01 CST

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 has passed the final of four tests for biocompatibility in its process of gaining FDA clearance for distribution of its disposable surgical instruments.

Independent testing was conducted by NAMSA (North American Science Associates, Inc.) on the multi-port harvester. The month-long testing series included two different ISO maximization sensitization studies that identify the potential for dermal sensitization and allergies. Under the conditions of this study, the SC and SO test article extracts showed no evidence of causing delayed dermal contact sensitization. Previous biocompatibility tests, already approved, included a cytotoxicity study, an ISO intracutaneous study, and a USP and ISO systemic toxicity study. The instrument components performed well in all tests.

Marc Pilkington, chief executive officer of CBSI, said, "It's exciting to have completed another milestone in our FDA 510K clearance process. The only remaining test is completion of sterilization validation testing and we are confident we will pass that one equally well. With these positive results we anticipate FDA clearance soon so that we can start to get products into the hands of doctors who are awaiting them to improve processes for fat transfer and living tissue management."

The study was conducted under controlled conditions based on the requirements of the International Organization for Standardization 10993: Biological Evaluation of Medical Devices, part 10, Tests for Irritation and Sensitization, and was also conducted in accordance with the requirements of the FDA Good Laboratory Practice Regulations, 21 CFR 58. A Certificate of Quality Assurance Inspections was issued with the test results.

For over 35 years, NAMSA has been one of the world's leading companies specializing in the safety evaluation of medical devices. NAMSA offers testing services and products to medical device manufacturers, raw material suppliers, pharmaceutical companies, sterilizers and other related industries.

About Cell Bio-Systems, Inc.

Cell Bio-Systems, Inc. (OTC: CBSI) is a Nevada corporation with operations 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-System 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.

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: Beth Walsh Clearpoint Agency, Inc. Contact via http://www.marketwire.com/mw/emailprcntct?id=1D50762DE6FBC3D5 858-724-2500  

SOURCE: Cell Bio-Systems

Source: MARKET WIRE

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