When the U.S. Food and Drug Administration warned healthcare practitioners last fall that no flu vaccines had been approved to be administered via jet injection, the companies that spent years developing needleless syringes with this technology suddenly faced a major hurdle.
But needleless syringe maker PharmaJet Inc. appears to be plugging on, gaining traction in other areas of the world and raising some fresh capital.
PharmaJet is the maker of the Stratis system, a needle-free device used to deliver drugs, including vaccines, through the skin. It can deliver 0.5 mL of a drug — the dose for vaccines including hepatitis A and B, poliovirus, seasonal flu, HPV, and measles, mumps and rubella — either into the muscle or into the subcutaneous layer (under the skin) using jet injection technology.
Comprising a reusable injector, a needle-free syringe and a filling adapter, the drug-delivery system can be used in clinics or at home and takes about one-third of a second to administer an injection. The reusable portion of the device uses springs to create pressure that propels a liquid through an extremely small orifice, creating a “liquid needle” that can penetrate the skin.
The company says its needle-free injectors are an affordable way to make injections less unpleasant for people who don’t like needles as well as reduce needle stick injuries and better control blood-borne infections from needle reuse, especially in developing countries. According to the World Health Organization, up to 40 percent of injections are given with improperly sterilized syringes and needles, which adds millions of dollars to global medical costs and has led to more than a million deaths. Intradermal delivery can also reduce the amount of vaccine needed by as much as 80 percent in some cases, according to the Centers for Disease Control and Prevention.
According to the Denver Business Journal, the device itself costs about $200 each and can deliver 30,000 injections.
Flu clinics in New Jersey, Colorado and Oregon, and Kroger Pharmacy began using Stratis after it was cleared by the FDA in 2009. Co-founder Kathy Callender told the Journal earlier this year that the FDA warning issued last year has not only halted use of the device by clinics but also caused doubt among public health agencies, and the company is working out the issue with the FDA.
PharmaJet has also been raising some cash. It’s collected $2.8 million since April and could continue raising up to $4 million, according to a recent U.S Securities and Exchange Commission filing. So far, 16 investors have participated in the equity round. The company did not respond to a request for interview, but according to its website, a second-generation device for intradermal delivery (into the upper layer of skin) is being developed.
As it awaits resolution with the FDA on the flu vaccine, PharmaJet is getting traction in other areas. In 2010, the company paired up with Inviragen and received a $15.5 million NIAID contract to develop a needle-free dengue vaccine. It also ran a pilot in 6,000 children in Cambodia last year and reportedly has devices in use in 20 countries.
It’s not the only one making needle-free vaccine delivery devices. Competitors Bioject Medical Technologies, National Medical Products, Injex Pharmaceuticals and Zogenix make similar devices. The market for these products is poised to grow steadily over the next 10 years.
Callender, a former dental hygienist, experienced needle reuse in the developing world and teamed up with her daughter, Heather Callender-Potters, to form PharmaJet in 2005. The business is based in Golden, Colorado.
[Photo from PharmaJet]