Bioject Medical Technologies Inc. (BJCT.OB), developer of needle-free injection therapy systems (NFITS), today announced the U.S. Food and Drug Administration (FDA) has granted market clearance for its Zetajetâ„¢ NFITS. The company said the next step is to pursue partnerships to maximize the systemâ€™s market introduction.
The Zetajet uses jet force to deliver vaccines into subcutaneous or intramuscular tissue, sans needles; the syringe also has a self-powered spring device equipped with an â€œauto-disableâ€ feature that eliminates reuse of the syringe, making it an attractive option for situations or programs requiring mass immunization.
â€œThis 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,â€ Dr. Richard Stout, executive vice president and chief medical officer of Bioject stated in the press release. â€œWe 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.â€
The auto-disable feature significantly reduces the risk of accidental needle-stick injuries or re-use of the syringe, both of which can be extremely dangerous and increase the risk of spreading disease. For this reason, Bioject believes Zetajet to be an ideal product for both developing and developed countries.
Ralph Makar, president and CEO of Bioject, said the company hopes the use of its product will become widespread in the broad global healthcare industry.
â€œWe believe the introduction of the Zetajetâ„¢ will establish Biojectâ€™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 Zetajetâ„¢, in combination with the right therapeutics, in order to create highly differentiated products that maximally enhance the patient experience,â€ Makar stated.