Enable Injections Announces CE Certification of the enFuse® On-Body Delivery System for Use with Aspaveli® Distributed by Sobi

Regulatory milestone expands access to wearable, patient-centric drug delivery for rare disease treatment across Europe

CINCINNATI, May 22, 2026 (GLOBE NEWSWIRE) — Enable Injections, Inc. (“Enable”), a healthcare innovation company developing and manufacturing the enFuse^® On-Body Delivery System (OBDS), today announced CE Certification of its enFuse on-body injector and syringe transfer system for use in combination with Aspaveli^® (pegcetacoplan). The enFuse OBDS will be commercialized as ASPAVELI^® enFuse^® and distributed by Swedish Orphan Biovitrum AB (“Sobi”) across the European Union.

Aspaveli was first approved for paroxysmal nocturnal hemoglobinuria (PNH) in December 2021 by the European Commission. In January 2026, Aspaveli became the first treatment of primary IC-MPGN and the first treatment for C3G and primary IC-MPGN for patients 12 years and older.

Enable received European Union Medical Device Regulation (EU MDR) CE Mark approval of the enFuse Syringe Transfer System in March 2025. The latest amendment to the CE Certification supports the subcutaneous administration of Aspaveli via the enFuse platform and allows for the ASPAVELI enFuse to be used by caregivers and patients who are 12 years of age and older.

Designed to streamline and improve in-clinic or patient self-administration, the wearable enFuse OBDS delivers subcutaneous drug formulations through a simple injection under the skin, instead of intravenously, via a discreet, hands-free device utilizing a small, hidden needle.

“With this expanded CE Certification, European patients with PNH, C3G and primary IC-MPGN are now able to experience a novel way of receiving their critical medication with a delivery method that prioritizes safety, comfort and convenience,” said Michael D. Hooven, Chairman and CEO of Enable Injections. “We are proud that our partnership with Sobi has resulted in the expanded availability of our wearable, patient-centric technology and look forward to bringing enFuse technology to additional international markets and ultimately to more patients.”

“The availability of ASPAVELI enFuse offers patients an administration option that greatly enhances convenience. We are empowering patients from 12 years with increased flexibility and control, strengthening their autonomy,” said Lydia Abad-Franch, Chief Medical Officer and Head of Research & Development at Sobi. “This regulatory decision marks a pivotal milestone in our collaboration with Enable and underscores our shared commitment to innovation, reflecting our dedication to improving the lives of people living with rare diseases.”

This extended certification in the EU follows recent regulatory clearance for the enFuse system in combination with EMPAVELI in Saudi Arabia, device clearance in Brazil, marketing approval in South Korea, and Medical Device License in Canada, which are all part of the broader strategic partnership with Sobi announced in September 2024. The enFuse technology received its first combination product U.S. FDA approval in 2023 for the EMPAVELI Injector, commercialized by Apellis Pharmaceuticals.

View the full release here.