Enable Injections’ enFuse Syringe Transfer System has secured CE mark approval under the European Union Medical Device Regulation (EU MDR).
This approval allows the company to distribute drug delivery solutions throughout the EU.
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Comprising an on-body delivery system, enFuse is designed for abdominal bolus administration of either biologic or drug products subcutaneously, conforming to the specific product requirements.
Aimed at enhancing the process of in-clinic or patient self-administration, the wearable technology claims to facilitate hands-free, “hidden” needle drug delivery through an under-skin injection.
According to the company, enFuse can be used with patient-filled and pre-filled syringes, providing dose volume flexibility. This is especially beneficial for dose-finding clinical trials in which the optimal drug volume is to be established.
Enable Injections’ syringe and vial transfer systems are engineered to leverage the original container closure, which means that the packaging and storage of drug products do not require any changes from the present syringe and vial formats.
This approach removes the custom container solution requirement, leverages current manufacturing offerings and fill technology.
It also prevents the necessity for long-term stability related to custom containers, minimises the partner count in the supply chain, and may reduce the clinic and market time.
For conducting clinical trials and preparing for a joint commercial launch of their therapies in conjunction with the enFuse technology, the company is collaborating with several pharmaceutical partners.
Enable Injections CEO and chairman Michael Hooven said: “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.
“This approval increases credibility and confidence in our product by regulatory authorities, empowering Enable to reach patients internationally.”
Based in the US, Enable is focused on enhancing the patient treatment experience through the development and manufacturing of its enFuse wearable drug delivery platform.
In February 2024, the company revealed plans to expand to a manufacturing centre spanning 90,000ft² to increase the capacity of its headquarters in Cincinnati, US.
