CAMBRIDGE, Mass., Sept. 28, 2021 /PRNewswire/ -- Portal Instruments, developer of the Prime needle-free drug delivery platform, announced that a new clinical study demonstrating patient preference for Prime needle-free injections was published this month in the journal Drug Delivery.
Portal's PRECISE II clinical study had subjects self-inject themselves with saline in either the abdomen or thigh, and showed that 76 percent of patients preferred to do so with the Prime needle-free system over a standard 27-gauge pre-filled needle and syringe. The full study is available here:https://www.tandfonline.com/doi/full/10.1080/10717544.2021.1976309.
Portal Instruments is developing Prime to transform the delivery of high viscosity biologic drugs by delivering a high pressure, narrow stream of medication, about the size of a strand of hair, through the skin in less than half a second. The platform consists of a reusable injector and disposable drug cartridge, which will be completed and made available through pharmaceutical partners.
"The hesitancy surrounding needles has been a recurring headline in the news for quite some time and more so in these COVID pandemic times. The CDC noted in the 2021 Epidemiology and Prevention of Vaccine-Preventable Diseases that injection and needle stick pain are among the top reasons why children and adults tend to refuse vaccines.1 In the U.S., an estimated 25% of adults have a fear of needles.1 Beyond the fear and pain of injecting, the process of dealing with disposal, travel and storage of needle-based injectors can be burdensome for many patients. With 76% of patients preferring the Prime needle-free injection, we believe that offering a needle-free injector could be a significant benefit for patients and a differentiator for our pharmaceutical partners," said Patrick Anquetil, CEO of Portal Instruments
Patrick will be presenting the study at the virtual Partnerships in Drug Delivery (PODD) conference on October 28th.
The PRECISE II study assessed the tolerability and preference during self-injections of sterile saline using the Prime needle-free injector and a prefilled needle and syringe. All subjects received three injections. For the first two injections, participants were randomized for injection site, in either the abdomen or thigh, and for order of injection methods. For the third and final injection, subjects were able to choose between the Prime needle-free device or the prefilled needle and syringe.
On multiple different measurements, subjects in the PRECISE II study showed a preference for the Prime needle-free injector. Immediately following the injection, the average subject-reported pain scores for the Prime injector were significantly lower than the scores with the prefilled syringe. When asked about injection method preference, 76% of subjects preferred Prime over the prefilled syringe. When given the choice of the third self-injection technique, 79% of subjects selected the Prime injection method. Hypothetical medication adherence was also higher with Prime, with 76% of subjects reporting a higher likelihood of taking their medication with the Prime injector over a prefilled syringe.
"We are very pleased with the results of this study" said Mary Jacoski, Senior Medical Director at Portal. "Our objective is to simultaneously create a modern drug delivery system for biologics while improving the patient experience and ultimately adherence and outcomes. This is an important step towards realizing that goal."
Portal Instruments is developing and commercializing a needle-free jet injection platform, licensed from MIT, to transform the drug delivery experience for patients suffering from chronic disease. Our aim is to replace all needles and syringes with a safe, fast, and connected device and to become the standard for modern drug delivery. The Prime jet injector is an investigational device and has not been evaluated for safety and is not yet approved or available for commercial use. Portal Instruments' Quality Management System is ISO 13485 certified. For more information, please visit www.portalinstruments.com or follow @portalcambridge on Twitter.
1 Wolicki, JoEllen, and Elaine Miller. "Vaccine Administration." Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 18 Aug. 2021, www.cdc.gov/vaccines/pubs/pinkbook/vac-admin.html.
SOURCE Portal Instruments