Enable Injections, Inc., a healthcare innovation company developing the enFuse on-body drug delivery system, announced that the Brazilian Health Regulatory Agency (ANVISA) has approved the enFuse system for subcutaneous administration. This confirms that the enFuse on-body injector and its syringe and vial transfer systems meet Brazilian safety and quality standards, enabling distribution across the country. The approval marks a milestone in Enable’s partnership with Sobi to develop and distribute the system for 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,” said Michael D. Hooven, Chairman and CEO of Enable Injections. “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 was also registered in the UK with the Medicines and Healthcare products Regulatory Agency (MHRA) on June 6, 2025, and received EU MDR CE Mark in March 2025. The device delivers large volumes of drugs via a simple, hidden-needle injection under the skin, offering an alternative to time-consuming intravenous administration. It is designed to improve patient experience by enabling at-home self-administration or in-clinic subcutaneous delivery of pharmaceuticals and biologics.

Enable Injections, based in Cincinnati, develops and manufactures the enFuse system to improve convenience, support better outcomes, and enhance healthcare efficiency.