SOURCE: Cell Bio-Systems

February 21, 2006 11:30 ET

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

Instruments Pass Another Hurdle in Process of Gaining FDA Clearance

SAN DIEGO, CA -- (MARKET WIRE) -- February 21, 2006 -- 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.

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