Bioject gains US clearance for Zetajet needle-free injection
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
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
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.
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