Enable Injections

About Enable Injections

Enable Injections, established in Cincinnati, Ohio, in 2010, is a healthcare company focused on advancing drug delivery systems. The company was founded by Mike Hooven, a seasoned medical device entrepreneur with over 30 years of industry experience. Hooven's background includes founding AtriCure, Inc. (Nasdaq: ATRC), a successful medical device company specializing in atrial fibrillation treatment, and Enable Medical, which was later acquired by AtriCure. His extensive experience in founding and leading medical technology ventures has shaped Enable Injections' trajectory.

The company's core business revolves around its proprietary enFuse® on-body delivery system, a purely mechanical wearable injector designed for the subcutaneous administration of large-volume biologic drugs (up to 25 mL). This technology allows patients to self-administer treatments that would traditionally require intravenous (IV) infusion in a clinical setting, offering greater convenience and mobility. The enFuse device features a hands-free, hidden needle that retracts automatically after the dose is delivered, aiming to simplify the patient experience. The system is designed to be compatible with standard drug container closures, such as vials and syringes.

Enable Injections operates on a business-to-business model, partnering with pharmaceutical and biotechnology companies. Its revenue is generated through development agreements that include milestone payments, followed by licensing, manufacturing, and supply agreements for the enFuse system to be used in combination with a partner's specific therapeutic. The company has established strategic collaborations with major pharmaceutical firms, including Sanofi, Roche, and Apellis Pharmaceuticals. A significant milestone was achieved in September 2023, when the U.S. Food and Drug Administration (FDA) approved the enFuse, branded as the EMPAVELI Injector, for use with Apellis' drug for paroxysmal nocturnal hemoglobinuria (PNH). The enFuse system has also received a CE Mark in Europe, allowing for its marketing throughout the European Union.

Since its inception, Enable Injections has secured substantial funding, totaling over $300 million. A notable funding round was a Series C financing of $215 million in January 2022, led by Magnetar Capital. This financial backing supports the expansion of its manufacturing capabilities and the advancement of its commercialization programs with pharmaceutical partners.