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FDA Grants PharmaJet Clearance on Intradermal Needle-free Injection Device

Golden, CO, – 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% 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.

“The potential significance of our technology is highlighted by this week’s World Tuberculosis Day 2011, commemorated on March 24, 2011,” stated James A. Bowman, President of PharmaJet Inc. “The World TB Day campaign is focused on recognizing innovations in TB research and new approaches to diagnose and treat TB. The diagnostic and vaccine approaches to prevention of TB will continue to rely on intradermal injections and the PharmaJet needle‐free ID injection system can provide direct benefits for these patients, helping to limit the global impact of TB.”

PharmaJet also 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, which penetrates the skin in less than 1/3 of a second.

About PharmaJet Inc. and Needle‐free Injection Technology

PharmaJet’s needle‐free injection technology delivers drugs and vaccines to intramuscular, subcutaneous and intradermal tissue depths. PharmaJet injectors use pressure to create a fine stream of liquid that penetrates the skin, delivering doses to the desired depth, while eliminating needle‐stick risk and the burden of sharps waste management. Further benefits of PharmaJet injectors include the potential for dose‐sparing of vaccines, reducing the overall cost of vaccine delivery. The PharmaJet system has been well received in the developed world, and is also extremely advantageous in the developing world due to its usability, affordability and inherent safety features.