While most of us would prefer to take our medications orally, many kinds of drugs, such as biologics, must be injected. Biologics themselves, however, are often difficult to inject, as the effective dose is often large and the biologic is often viscous, requiring significant force and injection time to administer, meaning more discomfort. Patients needing these complex molecules typically must visit a clinic to have these biologics administered intravenously by a clinician.
While enFuse may accomplish what seems to be a simple task, the design of the device is quite brilliant. We could tell during our meeting with CEO Mike Hooven and his team that a lot of thought went into the development of the device, both the patients and the drug manufacturers whose biologics will be used.
Using enFuse starts with filling the device’s balloon-like reservoir with the drug, and Enable Injections has developed versions of enFuse that are compatible both with industry-standard pre-filled syringes or vial closure devices. The patient simply pushes a vial into the transfer unit, which empties the contents using a tiny canister of pressurized CO2, or he/she can attach a syringe and fill the enFuse with the syringe’s plunger. In either case, there’s a fill gauge on the enFuse to show how much drug is inside it, and by nature of the filling system, the drug is also passively warmed to room temperature and mixed as it travels from the vial or syringe to the enFuse’s reservoir, making it ready to inject once transferred. The patient then removes enFuse from the transfer housing, adheres it to their abdomen, removes the safety tab, and pushes the button. A small needle is automatically inserted and starts administering the drug at a controlled flow rate.
The device is low-profile and can be easily worn under clothing, and the injection is less painful than a mosquito bite, so patients can go about their normal activities while wearing it. If at any time the flow of the drug becomes too painful, the patient can press and hold the button to pause the injection. Once the reservoir is empty, the button will pop back up with an audible click and retract the needle, letting the patient know that all of the drug has been injected and the device can be removed.
The enFuse has already gone through dozens of human factors studies to perfect its design, and in June, it will be used for the first time in a clinical study with drug manufacturer CSL Behring.
More info: Enable Injections…
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