enFuse, an on-body delivery system, provides subcutaneous abdominal bolus administration of drug or biologic products in accordance with the drug product requirements. The mechanical, wearable device can deliver large volumes of small molecule and biologic medications subcutaneously. Patients can receive their needed treatment in a single injection under the skin, rather than the intravenous route.
Enable Injections designed enFuse to streamline and improve in-clinic or patient self-administration. enFuse features hands-free, hidden needle drug delivery.
The approval allows the Cincinnati-based company to market the enFuse system throughout Europe. Enable Injections currently has work underway with a number of pharmaceutical partners to conduct clinical trials. It plans for joint commercial launches with therapies in combination with enFuse. The system first received FDA approval for the delivery of Empaveli in October 2023. The company also has partnerships with companies such as Roche and Serina Therapeutics.
“The CE Mark is a significant milestone in our regulatory journey, validating our novel technology and demonstrating our commitment to the highest standards of quality and safety for patients,” said Michael D. Hooven, Enable Injections chair and CEO. “This approval increases credibility and confidence in our product by regulatory authorities, empowering Enable to reach patients internationally. We look forward to working with our current and future partners to commercialize our platform throughout the European Union.”
