Medical device and MedTech insights, news, tips and more

Enable Injections Receives First U.S. Food and Drug Administration (FDA) Approval

October 2, 2023


Enable Injections, Inc. (“Enable”) today announced that the U.S. Food and Drug Administration (FDA) has approved the EMPAVELI Injector (enFuse®) for the subcutaneous delivery of EMPAVELI® (pegcetacoplan), which is commercialized in the United States by Apellis Pharmaceuticals, Inc. for adults with paroxysmal nocturnal hemoglobinuria (PNH). The EMPAVELI Injector is a compact, wearable injector designed to streamline the self-administration experience with minimal disruption to patients’ daily lives.

“The approval of the EMPAVELI Injector will enhance the patient experience of administering a large volume (20 mL) of subcutaneous therapy,” said Michael D. Hooven, Enable Injections’ Chairman and CEO. “Enable’s purpose is to redefine drug delivery for the benefit of patients. We are excited about achieving this milestone and are looking forward to growing enFuse® partnerships to improve the patient experience around the world.”

“The EMPAVELI Injector is the first purely mechanical, large-volume, on-body subcutaneous drug delivery device,” said Matthew Huddleston, Enable Injections’ Chief Technology Officer and Executive Vice President of Business Development. “The technology was designed while always keeping the patient at the forefront. Its simplicity empowers patients to confidently self-administer their therapy at home with greater mobility.”

The enFuse® technology allows hands-free, hidden needle drug delivery of up to 25 mL, and is designed for simplicity and to enable flexibility for at-home self-administration or in-clinic use.

About Enable Injections
Cincinnati-based Enable Injections is a global healthcare innovation company developing and manufacturing drug delivery systems designed to improve the patient experience. Enable’s body-worn enFuse® delivers high-volume pharmaceutical and biologic therapeutics via subcutaneous administration, with the aim of improving convenience, supporting superior outcomes, and advancing healthcare system economics. For more information, please visit

See Full Press Release at the Source: Enable Injections Receives First U.S. Food and Drug Administration (FDA) Approval

Press Release by: Enable Injections

Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry. We pride ourselves on our professionalism and ability to communicate quickly and honestly with all parties in the hiring process. Our clients include both blue-chip companies and innovative startups within the MedTech space. Over the past 17 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs.

We offer a variety of different solutions for hiring managers depending on the scope and scale of each individual search. We craft a personalized solution for each client and position with a focus on attracting the best possible talent in the shortest possible time frame.

Are you hiring?
Contact us to discuss partnering with Legacy MedSearch on your position.

More insights

October 12, 2023
Brainomix and Nanoflex Robotics to Collaborate on an AI-Assisted Robotic System for Remote Stroke Intervention
Learn More
October 10, 2023
FDA clears Intelivation Technologies new Hammerdesis™ Interphalangeal Fusion System
Learn More
October 9, 2023
FDA Awards HistoSonics Clearance of its First-of-a-Kind Edison® Histotripsy System
Learn More

Begin your legacy now. We are your medtech and medical device talent advisory firm.