Pulse NeedleFree Systems is developing needle-free injection products to serve the human mass immunization market, primarily large scale vaccination campaigns against endemic third world diseases, and to respond to health emergencies, such as bio-terrorism attacks or pandemic outbreaks. Pulse’s primary human injection system, the HSI-500, incorporates a proprietary protector cap designed to prevent the transmission of bloodborne pathogens between recipients. Pulse has achieved U.S. FDA clearance to market the HSI-500 system and is currently conducting additional product development activities and testing prior to commercialization.

Products similar to Pulse’s human injection systems were used for several decades in mass immunization and military settings all across the world. However, the prior generation of products were withdrawn from most markets when studies showed a risk of blood-borne pathogen transfer among injection recipients.  Thus, a key aspect of Pulse’s product development program is to confirm the safety profile of the devices against the risk of cross-contamination among injection recipients. Pulse’s single-use, auto-disable protector cap safety technology seeks to prevent blood-borne pathogens from being spread from one injection recipient to the next. In recent clinical tests (sponsored by the Program for Appropriate Technology in Health, through funding from the Bill and Melinda Gates Foundation), the company’s human injection system demonstrated that the current protector cap design greatly reduces the risk of cross-contamination among injection recipients, but does not altogether eliminate the risk of cross-contamination. The Company is pursuing design enhancements to improve system performance and eliminate the risk of cross-contamination among injection recipients.