FDAnews Device Daily Bulletin


Dec. 1, 2005

Bioject Medical Technologies has signed a long-term collaboration agreement with the nonprofit health organization PATH for developing a single-use, needle-free, disposable cartridge jet injection system for global immunizations, the medical device manufacturer said.

Under agreement, Bioject will develop a needle-free, auto-disable, single-dose cartridge injection system for use in immunization programs in the developing world. The agreement covers activities from technical feasibility, country-level market assessments, fundraising, international public health clinical trials and scale-up for high-volume manufacturing, to full market implementation, said Bioject.

More than one billion vaccine doses are delivered worldwide by hypodermic injection every year, the firm said. This number is expected to grow considerably in the next 10 years due to an increase in immunization coverage of target populations and the addition of new vaccines to the World Health Organization's immunization program. "The incidence of needlestick injuries, particularly in developing countries, is also anticipated to increase significantly if a safer injection alternative is not implemented," Bioject said.

Bioject said its new product will meet the immunization challenges as it uses injection cartridges that are easy to fill, needle-free, single-use, autodisabled, fully disposable and low-cost. The system consists of a durable, small, handheld injector with disposable cartridges that administer safe and reproducible injections, which requires no external power supply.