Brazilian Regulators Approve Enable Injections’ enFuse System

Enable Injections Inc. (Enable) has secured approval from the Brazilian Health Regulatory Agency (Agencia Nacional de Vigilancia Sanitaria, or ANVISA) for the subcutaneous administration of medication using its enFuse on-body drug delivery system.

ANVISA’s approval of the company’s enFuse technology demonstrates that the enFuse on-body injector, enFuse syringe, and vial transfer systems adhere to applicable Brazilian safety and quality standards and requirements, allowing distribution throughout the country.

The approval in Brazil marks a milestone in Enable’s partnership with Sobi, announced in September 2024, with plans to develop and distribute the enFuse system for administering Empaveli/Aspaveli in Sobi territories.

“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,” Enable Injections Chairman/CEO Michael D. Hooven said. “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.”

The enFuse technology is registered in the United Kingdom with the Medicines and Healthcare products Regulatory Agency (UK MHRA) as of June 6, and received European Union Medical Device Regulation (EU MDR) CE Mark in March.

The enFuse on-body injector features hands-free, hidden needle drug delivery through a simple injection under the skin rather than intravenously, which is time-consuming and resource intensive. The enFuse 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.

Cincinnati-based Enable Injections is a global healthcare company that developed and manufactures the enFuse on-body drug delivery system. A wearable technology, the enFuse system delivers large volumes of pharmaceutical and biologic therapeutics by subcutaneous administration, thereby improving convenience, supporting superior outcomes, and advancing healthcare system economics. Enable is currently working with various pharmaceutical partners to conduct clinical trials and jointly launch their therapies in combination with the enFuse technology. Enable’s enFuse technology received its first combination product U.S. Food and Drug Administration approval in 2023.