Independent Research Shows Presence Of Protein Residue On Reusable Plastic Surgery Instruments Following Cleaning And Autoclaving

Main Category: Medical Devices / Diagnostics
Also Included In: Cosmetic Medicine / Plastic Surgery
Article Date: 30 May 2007 - 1:00 PDT

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Tulip BioMed(TM), Inc. (PINKSHEETS: TPBD), a developer of biodesign instruments for living tissue management, including instruments for plastic, cosmetic, and orthopedic surgeries, today released a summary of the results of a research investigation conducted at the University of California San Diego (UCSD) Medical Center that examined the interior surface of Tulip BioMed's disposable cannulas with the interior surfaces of non-Tulip reusable cannulas used in surgical settings. The study indicated that residue remains in reusable closed-end cannulas that have been previously used in plastic surgery procedures, despite cleaning. The research project was conducted by a team of medical doctors and researchers in the Division of Plastic Surgery at UCSD. The project was commissioned and paid for by Tulip BioMed.

Commenting on the study results, Richard P. Burgoon, Jr., Tulip BioMed's president and COO, noted, "While we can not state that any residue that may remain on the interior surface of reusable cannulas, despite cleaning and sterilization, are 'contaminants,' these results suggest that there may be the potential for the transfer of protein-residue material from one patient to another when reusable cannulas are utilized. Whether or not this could pose a safety or health risk to a patient is not known, and while no such risks may exist, this may be an issue for discussion between a physician and their patient. We believe that our one-time-use, disposable cannulas avoid these types of issues, and any concerns related to these issues. Our view is that even as our Tulip BioMed disposable products gain greater adoption in the areas of liposuction, fat transfer and other closed end cannula procedures, reusable cannulas will continue to be utilized, but with perhaps less frequency on a patient-to-patient basis, and with increased frequency of replacement."

A representative photograph (1000X magnification) comparing the interior surface of a Tulip BioMed disposable cannula with the surfaces of non-Tulip reusable cannulas that were used less than five times and others used greater than 10 times, is available at www.tulipbiomed.com/seethedifferenceweb.htm. The company noted that, typically, a reusable cannula may be used multiple times on multiple patients over several years before a physician replaces it with a new one.

About the Study

The research was conducted by principal investigators Mayer Tenenhaus, MD, an associate professor of plastic surgery, and Dhaval Bhavsar, MD, a senior clinical fellow, both at UCSD. A double-blind study was conducted comparing the inner surface of disposable Tulip BioMed 2.1mm cannulas with the inner surface of several non-Tulip reusable cannulas (3mm) that were provided to the principal investigators after use and ready for surgery (i.e., cleaned and autoclaved in the customary manner for such cannulas; "autoclaving" is a process that uses steam to sterilize objects). A scanning electron microscope (SEM) was used to examine the interior metal surfaces of the cannulas. The surfaces were scanned at multiple resolutions, ranging from 50 to 20,000 times magnification. In all cases, the interior surface of the disposable cannulas appears, in a relative context, cleaner and smoother compared with the reusable cannulas that were examined.

In addition, an assessment of the materials remaining on the interior metal surfaces of the reusable cannulas was conducted using a nuclear magnetic resonance imaging (NMR) scan. To assess this material, the cannulas were washed with 10cc phosphate buffered saline (pH 7.4) and passed through the interior portion of the cannulas using a 10cc plastic syringe in an effort to substantially mimic the force of a typical injector during surgery. The released fluids were then collected in sterile test tubes, centrifuged and the material at the bottom of the centrifuged tubes was evaluated. All samples showed the presence of nitrogen-hydrogen bonds, suggesting that the material released from the reusable cannulas included organic materials containing amino acids, e.g., a protein-residue. These results suggest that the organic material obtained from the tested reusable cannulas was most likely human tissue.

The company believes that it has designed a minimally invasive disposable cannula system that can eliminate any concerns regarding reuse of instruments in liposuction, fat transfer and other closed end cannula procedures. A lubricious coating, which covers both the inside and outside of the Tulip BioMed disposable cannulas, is intended to not only decrease the trauma to the cells inside the cannula, but is also intended to increase the ease of manipulation for extraction and re-injection procedures, minimize bruising and shorten recovery periods.

Doctors and industry professionals who would like to discuss the advantages of Tulip BioMed's products are encouraged to call the company at 800-978-8547.

About Tulip BioMed, Inc.

Tulip BioMed, Inc. (PINKSHEETS: TPBD), a Nevada corporation, has its operations based in San Diego, California. Founded in 2004, Tulip BioMed, Inc. is a medical devices company that manufactures and distributes patented technologies for the living tissue markets, including plastic and cosmetic surgery, biopsy, orthopedic surgery, and stem cell therapy. 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. For more information please visit our website at: www.tulipbiomed.com. Products are available for sale at www.tulipdisposable.com.

Safe Harbor: This press release contains certain forward-looking information about Tulip BioMed, Inc., 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.

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