PharmaJet

PharmaJet operates in the medical device sector, specializing in needle-free injection technology designed to improve the delivery of vaccines and liquid medicines. The company was founded in 2005 by the mother-daughter team of Kathy Callender and Heather Callender-Potters. The inspiration came from Kathy Callender, a dental hygienist who, during volunteer work overseas, observed the significant risks associated with needle reuse and improper disposal. This firsthand experience of a critical global health issue, coupled with a call from the World Health Organization (WHO) for a needle-free alternative, became the company's founding mission. Heather Callender-Potters brought over two decades of private equity and international investment experience to the venture.

PharmaJet's business model centers on the sale of its proprietary needle-free injection systems and the single-use disposable cartridges required for their operation. The company serves a diverse client base that includes pharmaceutical companies, governments, and global health organizations like the WHO and PATH. Revenue is generated through device sales, with significant opportunities in mass vaccination campaigns and routine immunizations, as well as potential royalties and milestone payments from pharmaceutical partners who use PharmaJet's devices for their drug pipelines. The company's technology is also positioned for the animal vaccine market.

The company has developed two primary products: the Tropis® and Stratis® systems. Both devices operate using a spring-powered mechanism that creates a micro-stream of fluid, delivering a precise dose into the skin in a fraction of a second without a needle. The Tropis® system is designed for intradermal delivery (into the skin layer), a method that can enhance immune response and potentially allow for smaller vaccine doses, which is crucial during supply shortages. The Stratis® system is cleared for intramuscular or subcutaneous delivery. Both systems have achieved significant regulatory milestones; the Stratis system has U.S. FDA 510(k) marketing clearance, a CE Mark, and WHO Prequalification (PQS) certification, while the Tropis system holds a CE Mark and WHO PQS certification. The first FDA clearance for an injector was granted in 2008, with subsequent approvals for specific applications, such as the delivery of an influenza vaccine with the Stratis device in 2014.

Keywords: needle-free injection, vaccine delivery, jet injector, intradermal delivery, intramuscular delivery, medical device, global health, immunization technology, vaccine administration, public health, dose-sparing, bioCSL, World Health Organization (WHO), PATH, drug delivery systems, pharmaceutical partnerships, Tropis, Stratis, FDA 510(k), CE Mark