Enable Injections Gains CE Mark for enFuse Wearable Drug Delivery Tech

Enable Injections has earned CE mark approval for its enFuse syringe transfer system, allowing it to deliver its solutions in the EU.

The company’s enFuse on-body delivery system provides subcutaneous abdominal bolus administration of drug or biologic products. It features hands-free, hidden needle drug delivery through an injection under the skin, instead of intravenously. It also has no wiring or tubing.

The system was engineered to streamline and improve in-clinic or patient self-administration. It can deliver 5-25 mL with a single device, and four devices can be worn simultaneously. It’s compatible with common drug product viscosities of 1-100cP.

Enable is presently working with pharmaceutical partners to conduct clinical trials and plan for joint commercial launch of their therapies with the enFuse technology. The first enFuse combination products earned U.S. Food and Drug Administration (FDA) approval in 2023.

“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’ chairman 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.”