Tulip begins to pave the way for global distribution plan
June 27, 2006 — /MARKET WIRE/ — SAN DIEGO, Calif. — Tulip BioMed(tm), Inc. (PINKSHEETS: TPBD), formerly known as Cell Bio-Systems, a developer of medical devices and patented technologies for the living tissue markets, including plastic, cosmetic, and orthopedic surgeries, today announced it has retained Quality System Consulting Specialists of Poway, Calif., to support its international certification strategies.
Tulip BioMed, with patented technology and disposable surgical instruments in production after having received U.S. FDA clearance in May, is beginning its pursuit of certification marks in Europe and Canada. These international certifications prove that the company and products meet standards required for specific usages of its instruments. Quality System Consulting will help the company to custom design programs that meet the regulatory requirements of each certifying body in the various countries, using a minimalist approach that keeps costs under control.
Darin Andersen, president and chief operating officer of Tulip BioMed, said, “The certification process we are undertaking with Quality System Consulting is a key part of our effort to get our products registered to sell in Europe and Canada, with other countries to follow. We are confident that working with an experienced company like this will streamline our efforts to ensure fast product clearance and easy market acceptance.”
The company is seeking certification and product registration in several countries outside of the United States as part of its overall global distribution plan. Some of the world’s largest potential markets are in Europe and Latin America. Asia is also developing rapidly a large potential market for plastic surgery products. Tulip BioMed will go through the appropriate in-country agencies, such as Health Canada and the European Medicines Agency, for formal approval once the strategy is defined and processes set. Europe requires a CE marking, which is a declaration by the manufacturer that the products meet all appropriate provisions of the relevant legislation implementing certain European Directives regarding medical devices. Additional testing and proof of testing to specific standards validate the conformity assessment procedure. Canada has a separate set of requirements as specified by its medical device regulatory agency, Health Canada, but not a specific marking. Once these regulations are passed, Tulip BioMed will also pursue marks for Latin America, Australia and Asia.
“We believe Tulip BioMed’s patented technology has a distinct safety advantage over the traditional instruments now used in cosmetic and plastic surgeries in Europe and Canada,” said Delton West, president of Quality System Consulting. “With our experience, the processes Tulip has already undertaken in order to receive FDA clearance, and their consistently high standards, we believe we will complete the process for Europe and Canada by the start of Q1, 2007.”
About Tulip BioMed, Inc.
Tulip BioMed, Inc. (PINKSHEETS: TPBD), formerly known as Cell Bio-Systems, Inc., is a Nevada corporation with operations based in San Diego, California. Founded in 2004, Tulip BioMed, Inc. 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. Tulip BioMed, Inc. is the exclusive licensee of patented syringe connection devices that use the worldwide-recognized Tulip brand name. Tulip BioMed, Inc. 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 go to: www.tulipbiomed.com. Products are available for sale at www.tulipdisposable.com.
About Quality System Consulting Specialists
Quality System Consulting Specialists has served medical device manufacturers for over five years. The company’s focus is in developing, implementing and monitoring quality systems to meet regulatory requirements in the medical device industry.
Safe Harbor: This press release contains certain forward-looking information about Tulip BioMed, Inc., formerly 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 Tulip BioMed, 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. Tulip BioMed, 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.
Email: [email protected]
SOURCE: Tulip BioMed, Inc.