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January 24, 2006
By: Chris Trembath
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SAN DIEGO, CA — (MARKET WIRE) — 01/23/2006 — Cell Bio-Systems, Inc. (OTC: CBSI), a developer of certain medical devices and patented technologies for the plastic, cosmetic, orthopedic, and living tissue markets, reports significant progress on several fronts in its year-end review of its business. In 2005, the company achieved certain key corporate and product milestones, including putting into place a core management team with valuable industry experience, the internal management infrastructure to support its products, and name-brand partners. In addition, its disposable instrument products continue in the process to gain FDA approval, having recently passed several required biocompatibility tests. Mark Pilkington, CEO, asserts the time is right for the company’s vision. “Having identified the medical and regulatory issues, trends, and processes that will impact the future of living tissue management, we believe we are right on track with our disposable surgical instruments. The interest we have generated in the marketplace is exciting.” Over the past year, CBSI has achieved the following highlights. FDA clearance process advanced: — 510-K submission completed and submitted for 30-90 day approval processing — In December 2005, the multi-port harvester instrument passed the first three in a series of biocompatibility tests required for FDA clearance. Strengthened management team: — Darin Andersen joined the company as president and chief operating officer. Andersen brings more than 15 years of successful business and technology consulting and leadership experience to CBSI. His experience with partner programs, acquisitions and the day-to-day implementation and management of start-up technology firms is especially useful to the company. — Bill Hales was added to the company as vice president, investor relations. Hales has more than 17 years of international and domestic experience in the investment banking business. — Ratan Bajaj was hired as vice president of global operations to handle overseas and U.S. manufacturing operations and is instrumental in vendor negotiations, tooling designs, manufacturing, engineering, automation and full scale production and development of new products. Product development advancement: — CBSI introduced its first accessory product, the patented “SuperLuer Transfer” ahead of schedule. CBSI holds the exclusive license to the SuperLuer. The SuperLuer is a key complementary accessory that allows the safe transfer of tissue between luer syringes. — CBSI unveiled a new line of four products to over 2,000 surgeons at the ASPS Plastic Surgery Show 2005 in September. Partner and business support established: — CBSI has developed a strategic branding and distribution relationship with Tulip Medical to market the disposable cannulas and accessories under the industry-leading Tulip brand name. — CBSI put into place consulting relationships with capital advisory services, technical and regulatory services, a branding and marketing consulting firm, and a public relations agency to support its financial, business and marketing goals. Darin Andersen, president and chief operating officer, said, “With our 510-K now in process of final approval, we anticipate being able to sell product at general production levels by Q2, 2006 and think the market will be anxious for them by then as well.”
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