FDA Grants PharmaJet 510(k) Clearance on Intradermal Needle-Free Injection Device

First FDA-cleared needle-free injection alternative to needle-based “Mantoux” method.

GOLDEN, Colo. – March 22, 2011 – The U.S. Food and Drug Administration (FDA) has awarded PharmaJet 510(k) clearance to market a 0.1mL Intradermal (ID) Needle-Free Injection System. Delivery to the intradermal tissue layer is the approach used for many vaccines, such as tuberculosis and rabies, for which ID delivery has proven efficacious. In addition, ID delivery is being explored for vaccines such as polio, influenza and many others in development. PharmaJet will now market the first FDA-cleared intradermal, needle-free alternative to the current needle-based “Mantoux” technique, which is time consuming, difficult for the healthcare provider to administer and painful for the patient to receive.

The intradermal layer is rich with cells that help stimulate the body’s immune response. With PharmaJet’s needle-free ID delivery into the same location as traditional needle/syringe injection, evidence suggests that the volume of some vaccines may be reduced by as much as 80 percent and still provide the appropriate immune protection. Intradermal delivery may allow for vaccine dosages to be stretched, providing significant savings in delivery costs and expanded coverage for vaccines in limited supply. This delivery system will enable routine use of lower-cost dose and volume-sparing strategies for mass vaccination and pandemic vaccine stockpile management.

“This is important technology and we are pleased to have the 1st FDA-cleared needle-free ID injection system”, stated James A. Bowman, president of PharmaJet Inc. “PharmaJet is proud to be the leader in needle-free injection technology, revolutionizing the way vaccines are delivered.”

In addition to this newly cleared ID device, PharmaJet currently markets an FDA-cleared, needle-free system for intramuscular (IM) and subcutaneous (SC) injection that delivers vaccines and liquid medications in a volume of 0.5mL. The PharmaJet single-use, auto-disabling, needle-free system delivers a narrow, high-velocity fluid injection.