Enable Injections announced significant regulatory milestones for its enFuse on-body drug delivery system, securing approval from Brazil's health regulatory agency and registration in the United Kingdom. The Brazilian Health Regulatory Agency (ANVISA) approved the enFuse system for subcutaneous administration of medications, confirming that the technology meets Brazilian safety and quality standards and enabling distribution throughout the country.
Partnership with Sobi Advances
The Brazilian approval represents a key milestone in Enable's partnership with Sobi, announced in September 2024, with plans to develop and distribute the enFuse system for the administration of Empaveli/Aspaveli in Sobi territories. This collaboration demonstrates the growing commercial potential of the wearable drug delivery technology.
"Obtaining approval for the enFuse system in Brazil is an important regulatory milestone that underscores our commitment to bring our innovative technology to as many patients as possible, globally, who could benefit from a more comfortable administration experience," said Michael D. Hooven, Chairman and CEO of Enable Injections.
Expanding Global Regulatory Footprint
Beyond Brazil, Enable Injections has secured additional regulatory approvals across key markets. The enFuse technology received registration with the United Kingdom's Medicines and Healthcare products Regulatory Agency (UK MHRA) as of June 6, 2025, and obtained European Union Medical Device Regulation (EU MDR) CE Mark in March 2025.
Technology Advantages
The enFuse on-body injector features hands-free, hidden needle drug delivery through subcutaneous injection, offering an alternative to intravenous administration that is typically time-consuming and resource intensive. The system is designed to enhance the patient treatment experience by streamlining and improving at-home self-administration or in-clinic subcutaneous delivery of large volumes of pharmaceutical and biologic therapeutics.
Hooven emphasized the company's mission: "By continuing to collaborate closely with our pharmaceutical partners, we remain steadfast in our mission to improve the lives of patients and caregivers through our wearable enFuse technology, minimizing disruption to their daily lives."
Commercial Development
Enable Injections is currently working with multiple pharmaceutical partners to conduct clinical trials and plan for joint commercial launches of their therapies in combination with the enFuse technology. The company's enFuse technology received its first combination product U.S. FDA approval in 2023, establishing a foundation for broader commercial deployment.
The Cincinnati-based healthcare innovation company focuses on developing and manufacturing the enFuse system with the aim of improving convenience, supporting superior outcomes, and advancing healthcare system economics through enhanced drug delivery capabilities.
