Bioject gains US clearance for Zetajet needle-free injection system
23 April 2009
Bioject Medical Technologies Inc. (OTCBB:BJCT), has announced FDA approval for its Zetajet Needle-Free Injection Therapy System.
Bioject’s new Zetajet system offers an array of unique product features and patient benefits that can provide highly competitive differentiation to a wide variety of injectable market segments.
The Zetajet 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™ 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 moulded exterior, providing a multitude of ergonomic options, can be added to achieve specific attributes needed for different clinical applications. The exterior moulding of the device can be customized in shape, texture and colour 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. 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 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 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, 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.
Bookmark this paget>