Healthcare Industry News: RT Technology
News Release - April 6, 2009
Bioject Announces FDA Market Clearance for the Zetajet Needle-Free Injection Therapy SystemPORTLAND, Ore.--(HSMN NewsFeed)--Bioject Medical Technologies Inc. (OTCBB:BJCT ), a leading developer of needle-free injection therapy systems, today announced that the U.S. Food and Drug Administration (FDA) has granted market clearance for the Zetajet(TM) Needle-Free Injection Therapy System. Bioject’s new ZetajetTM system is the latest advance in needle-free delivery systems, offering a significant array of unique product features and patient benefits that can provide highly competitive differentiation to a wide variety of injectables market segments.
The Zetajet(TM) Needle-free Injection Therapy System is a compact, spring-powered, needle-free injection device. It is intended to deliver vaccines and injectable medications either subcutaneously or intramuscularly. The Zetajet(TM) uses jet force to propel a finely dispersed stream of injectable medication into the subcutaneous or intramuscular tissue without the use of a needle.
The syringe assembly has a unique ”auto-disable” feature that prevents re-use of the syringe. The plunger is pre-assembled into the syringe and can be used for reconstitution and other pre-injection tasks.
A custom molded exterior, providing a multitude of ergonomic options, can be added to achieve specific attributes needed for different clinical applications. The exterior molding of the device can be customized in shape, texture and color for a wide spectrum of therapeutic and patient segments, offering the ultimate in selective branding. For instance, devices designed for geriatric or arthritic users can have features added to the exterior of the device that make the device easier to handle, reduce winding effort, and require less activation force without actually changing the core device.
The self-powered spring device uses an auto-disable syringe, and it is ideal for use in mass immunization programs world-wide. The auto-disable feature dramatically reduces the risks of both the spread of disease from accidental needle-stick injuries and the re-use of a syringe or needle, and prevents possible contamination of syringes and vials. With these unique advances in delivery technology, the Zetajet(TM) is anticipated to provide the optimal injection therapy system for both developed and developing countries to provide a safer and more effective method for delivering their parenteral injectables.
“This new state-of-the-aRT Technology offers features that make this the perfect injection system for many areas of medicine where injectables are given. Such areas may include self injected pediatric vaccines, therapeutic medications and fertility injections, as well as injectables used for chronic conditions, such as Hepatitis C, and many other professional and self-administered injectables,” said Dr. Richard Stout, Executive Vice President and Chief Medical Officer of Bioject. “We are very excited to introduce this new and exciting technology to our current customers and patients as well as new collaborators, especially in areas such as developing world immunization programs where this will have distinct safety advantages and improve patient care.”
“We believe the introduction of the Zetajet(TM) will establish Bioject’s needle-free technology offering as the new standard of care in the marketplace and could significantly drive global demand for this delivery option. With the FDA 510(k) clearance achieved, we are now determined to find the best strategic partners with whom to introduce the Zetajet(TM), in combination with the right therapeutics, in order to create highly differentiated products that maximally enhance the patient experience,” said Ralph Makar, President and CEO of Bioject.
Bioject Medical Technologies Inc., based in Portland, Oregon, is an innovative developer and manufacturer of needle-free injection therapy systems (NFITS). NFITS provide an empowering technology and works by forcing medication at high speed through a tiny orifice held against the skin. This creates a fine stream of high-pressure fluid penetrating the skin and depositing medication in the tissue beneath. The Company is focused on developing mutually beneficial agreements with leading pharmaceutical, biotechnology, and veterinary companies.
For more information about Bioject, visit www.bioject.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding Bioject’s expectations with respect to the demand for its products. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the Company, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such risks, uncertainties and other factors include, without limitation, the risk that the Company’s products, including the Zetajet(TM), will not be accepted by the market, the risk that the Company will be unable to successfully develop and negotiate new strategic relationships, uncertainties related to the time required for the Company to complete research and development, obtain necessary clinical data and government clearances, the risk that additional capital may not be available on acceptable terms, if at all, and the risk that the Company may be unable to comply with the extensive government regulations applicable to Bioject’s business. Readers of this press release are referred to the Company’s filings with the Securities and Exchange Commission, including the Company’s reports on Form 10-K and Forms 10-Q for further discussions of factors that could affect the Company’s business and its future results. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. The Company assumes no obligation to update forward-looking statements if conditions or management’s estimates or opinions should change.
Source: Bioject Medical Technologies
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