Enable Injections Announces Regulatory Approval in Saudi Arabia for the EMPAVELI® Injector based on enFuse® Technology
CINCINNATI, Dec. 18, 2025 (GLOBE NEWSWIRE) — Enable Injections, Inc. (“Enable”), a healthcare innovation company developing and manufacturing the enFuse® On-Body Delivery System, today announced that the EMPAVELI® Injector, based on enFuse technology, has received marketing authorization from the Saudi Food and Drug Authority (SFDA). The authorization for the injector and syringe transfer system is granted under the SFDA’s Medical Device Marketing Authorization (MDMA) framework, the regulatory clearance required for legal sale and distribution of medical devices in the Kingdom of Saudi Arabia.
“Gaining SFDA authorization is a meaningful step for Enable,” said Michael D. Hooven, Chairman and CEO of Enable Injections. “Every new market opens the door for more patients to experience therapies in a way that fits their lives. We’re excited to bring our technology to Saudi Arabia and to continue expanding access to simple, comfortable, and truly patient-centered drug delivery.”
This regulatory clearance in Saudi Arabia complements the Company’s broader global strategy, which includes a strategic partnership with Swedish Orphan Biovitrum AB (“Sobi”) announced in September 2024. Under the agreement, Enable will supply the enFuse system for the subcutaneous delivery of EMPAVELI®/Aspaveli® (pegcetacoplan), with Sobi responsible for distribution in Sobi territories.
Enable’s collaboration with Sobi was designed to streamline and improve patients’ self-administration experience by leveraging the wearable, hidden-needle enFuse technology to enable simple injections under the skin instead of more burdensome delivery methods.
The enFuse technology received its first combination product U.S. FDA approval in 2023 and has since received device marketing authorizations from several ex-U.S. regulatory authorities, including European Union Medical Device Regulation (EU MDR) CE Mark, registration in the UK with the United Kingdom’s Medicines and Healthcare products Regulatory Agency (UK MHRA), and Brazilian Health Regulatory Agency (Agencia Nacional de Vigilancia Sanitaria or ANVISA) approval.
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