Cincinnati-based Enable Injections announced today it has received European Union Medical Device Regulation (EU MDR) CE Mark approval for its enFuse Syringe Transfer System, a significant regulatory milestone that opens the European market to the company's wearable drug delivery platform.
The approval validates the safety and efficacy of the enFuse technology, which is designed to deliver large volumes of pharmaceutical and biologic therapeutics via subcutaneous administration. This wearable platform aims to transform medication delivery by providing an alternative to traditional intravenous administration.
"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."
How the enFuse Technology Works
The enFuse on-body delivery system facilitates subcutaneous abdominal bolus administration of drugs or biologics in accordance with specific product requirements. Its design focuses on patient-centric features, including:
- Hands-free operation
- Hidden needle mechanism
- Simple under-the-skin injection process
- Alternative to intravenous administration
This technology represents a potential paradigm shift in how patients receive certain medications, particularly biologics that traditionally require intravenous administration in clinical settings.
Clinical and Commercial Progress
Enable Injections is not developing this platform in isolation. The company has established partnerships with several pharmaceutical companies to conduct clinical trials and plan commercial launches of combination therapies using the enFuse technology.
The company reached a significant milestone in 2023 when the first enFuse combination product received U.S. FDA approval. This European approval builds on that success, expanding the potential market reach for the technology.
Patient and Healthcare System Benefits
The enFuse platform addresses several challenges in current drug delivery methods. For patients, it offers the potential for self-administration of medications that would otherwise require clinic visits. The subcutaneous route may also improve patient comfort compared to intravenous administration.
From a healthcare system perspective, shifting appropriate therapies from intravenous to subcutaneous administration could reduce the burden on clinical resources and potentially lower overall treatment costs.
Market Expansion Strategy
With CE Mark approval secured, Enable Injections is positioned to commercialize its platform throughout the European Union. The company plans to leverage existing and future pharmaceutical partnerships to bring enFuse-enabled therapies to European patients.
"We look forward to working with our current and future partners to commercialize our platform throughout the European Union," Hooven added.
The approval comes at a time when healthcare systems globally are seeking innovations that can improve patient experience while potentially reducing healthcare delivery costs, particularly for chronic conditions requiring regular medication administration.
