Research

Clinical Research & Test Performance

Needle-free injections have been successfully used on individuals in different clinical research & test performance Needle-free injections have been successfully used on individuals in different age groups (infants, adolescents, adults, and the elderly). No adverse side effects were observed, and all subjects preferred the relatively painless needle-free procedure to injections with traditional needles and syringes. A record number of clinical tests demonstrating the efficiency of our NFIT devices have been conducted by numerous biomedical research groups and healthcare agencies such as the US Food and Drug Administration (FDA), the World Health Organization (WHO) and the Center for Disease Control (CDC), and reported in over 100 world-renowned medical journals such as Vaccine, Proceedings of the National Academy of Sciences USA, and the New England Journal of Medicine. It has led to these devices receiving both the US FDA clearance and the CE certification from the European Union and being utilized by organizations such as WHO and the Gates Foundation. Collaborative Research Agreements* Our principal, Bioject, is active in clinical investigations using needle-free technology.

Through a network of leading public and private research institutions, pharmaceutical and biotechnology companies, Bioject devices are being used in a broad range of research studies for both development-stage and approved drugs. By enhancing injectable products with proprietary, customized needle-free injection systems, Bioject helps partners improve the utility and utilization of their medicines. * No adverse side effects were observed, and all subjects preferred the relatively painless needle-free procedure to injections with traditional needles and syringes. A record number of clinical tests demonstrating the efficiency of our NFIT devices have been conducted by numerous biomedical research groups and healthcare agencies such as the US Food and Drug Administration (FDA), the World Health Organization (WHO) and the Center for Disease Control (CDC), and reported in over 100 world-renowned medical journals such as Vaccine, Proceedings of the National Academy of Sciences USA, and the New England Journal of Medicine. It has led to these devices receiving both the US FDA clearance and the CE certification from the European Union and being utilized by organizations such as WHO and the Gates Foundation.

Collaborative Research Agreements*

Our principal, Bioject, is active in clinical investigations using needle-free technology. Through a network of leading public and private research institutions, pharmaceutical and biotechnology companies, Bioject devices are being used in a broad range of research studies for both development-stage and approved drugs. By enhancing injectable products with proprietary, customized needle-free injection systems, Bioject helps partners improve the utility and utilization of their medicines.  

*source: http://www.bioject.com/customer/collaborative


Preanesthetic medication of children with midazolam using the Biojector jet injector.

Anesthesiology. 1995 Aug;83(2):264-9. Greenberg RS1, Maxwell LG, Zahurak M, Yaster M.

Background

A rapid, dependable, and economical technique to atraumatically sedate children before anesthesia that does not prolong postanesthesia care unit time remains elusive. The Biojector jet injection system uses carbon dioxide rather than a needle to deliver an intramuscular injection. The dose-response relationship when midazolam is administered was studied using this jet injector.

Methods

Forty children (2.3 +/- 1.3 yr old) undergoing elective myringotomy and tube placement were randomly assigned to receive 0.05, 0.1, 0.15, 0.2, or 0.3 mg.kg-1 midazolam injected intramuscularly using the Biojector disposable syringe (0.006-inch orifice). Assessment of each child before, during, and 10 min after injection, on application of the anesthesia face mask, and every 15 min for 1 h after arrival to the postanesthesia care unit was made by an observer blinded to drug dosage.

Results

Face mask tolerance using doses > or = 0.1 mg.kg-1 midazolam was acceptable and statistically different from 0.05 mg/kg. Crying on injection tended to increase with increasing dose. All children were awake and arousable, meeting discharge criteria, after 30 min from arrival in the post anesthesia care unit.

Conclusion

Midazolam (0.1-0.15 mg.kg-1) administered using jet injection effectively and rapidly produces sedation, in a manner acceptable to parents, without delaying post anesthesia care unit discharge.