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Cell Bio-Systems Inc. Passes Sterilization Validation Testing on Its Disposable Surgical Cannulas

Posted on: Monday, 27 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 testing required for its process of gaining FDA clearance for distribution of its disposable surgical instruments.

Independent testing was conducted by SteriPro Labs on CBSI's Tulip-branded disposable cannulas. The sterilization validation testing, initiated January 4 and successfully completed Feb. 14, 2006, included Bioburden, Bioburden Recovery, and Verification Dose Sterility tests. These studies were conducted to validate the effectiveness of gamma radiation at 25kGy for sterilization of the disposable cannulas. Test results were acceptable in accordance with AAMI TIR 27; zero positive cultures were observed.

Marc Pilkington, chief executive officer of CBSI, said, "Our products have passed all required tests upon first tries, which is great, and validates what we knew would happen. With these positive results we expect FDA clearance any day now and so we are prepping our sales and marketing programs to quickly get product into the marketplace."

Previous biocompatibility tests, already passed, included two ISO maximization dermal sensitization studies, a cytotoxicity study, an ISO intracutaneous study, and a USP and ISO systemic toxicity study. The instrument components performed well in all tests.

SteriPro Labs is a division of Sterigenics International, the largest contract sterilizer in the world and a technical leader in medical sterilization. SteriPro Labs is focused primarily on the pre-sterilization phase of the supply chain, enabling medical device, tissue, pharmaceutical and biologic manufacturers to develop and maintain the most cost-effective sterilization processes for their products.

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=EB6CE0B7EE068C5D 858-724-2500  

SOURCE: Cell Bio-Systems

Source: MARKET WIRE

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