Shots:
- Enable Injections recently shared survey findings indicating that many oncology assets with strong commercial potential are often prematurely abandoned or deprioritized due to challenges in formulating small volumes (<3 mL) for subcutaneous delivery.
- To address this need, Enable Injections developed enFuse, an innovative, hands-free, wearable drug delivery platform with a discreet, hidden needle that allows patients to self-administer IV medications easily.
- PharmaShots is pleased to welcome Mehul Desai, VP of Medical Affairs at Enable Injections, who shares insights on the Empaveli (pegcetacoplan) Injector powered by enFuse technology.
Saurabh: Could you introduce us to enFuse, the world’s first purely mechanical, hands-free, wearable drug delivery platform, and explain what sets it apart in today’s healthcare landscape?
Mehul: The enFuse technology is a drug delivery system designed to deliver large volumes of medications subcutaneously, in which patients receive their needed treatment in a simple injection under the skin, instead of intravenously – which can be time-consuming and painful.
The enFuse on-body injector is the first-ever purely mechanical system, meaning it doesn’t require wiring, tubing, batteries, or any electronics, to deliver large volumes.
Saurabh: What unique features does the enFuse platform offer, and how does the system function in practice?
Mehul: The enFuse injector adheres to a patient’s skin on the abdomen using an adhesive. The patient pushes a button located at the center of the device, to insert a small, hidden needle into the skin from which medication is comfortably and silently delivered. When the medication has been fully delivered, the button pops back out as the needle automatically retracts and is locked in place, so the patient never sees the needle. Patients can then remove the injector and dispose of it appropriately.
Furthermore, our method of drug delivery is unique in that it utilizes elastomeric technology and pressure-sensitive delivery. This means that the enFuse injector adapts to one’s body composition and tissue density so that the skin can absorb medication comfortably at its own pace, rather than forcing medication at a constant flow rate.
Saurabh: What important patient needs or benefits are addressed by using the enFuse delivery system?
Mehul: For patients in need of large volumes of medication, their only options to receive needed treatment were intravenously or subcutaneously through syringe and needle or syringe pump. Each of these delivery methods requires additional set-up time, manual effort to deliver drug, and larger, visible needles with often painful entry.
With patient comfort and safety top of mind, enFuse technology was designed to work with one’s unique body composition to deliver needed medication through the skin as comfortably as possible, while remaining silent and discreet.
The small, hidden needle is never seen by the patient, automatically retracted and locked in place after administration.
Additionally, with its hand-free design alleviating the need for tubes or a power source, patients can remain mobile during their injection, performing light activities like cooking or walking, while receiving their medication.
Saurabh: What were the patient and healthcare provider feedback during the enFuse clinical trials, and did it lead to any modifications in the device?
Mehul: Patient input was at the forefront of design for the enFuse drug delivery system to ensure the injector and transfer systems offered simplicity and safety, and importantly, improved patients’ overall treatment experience.
Since becoming available to patients, feedback has included: *
“I can have a streamlined experience. It’s been psychologically liberating. The injector has allowed me to pursue my passions and continue work on my life project.”
“The injector allowed me to not worry constantly. I can enjoy life.”
“Freedom and endless possibilities. I can have it on me and generally go do what I need to do. That is the most awesome feeling. Having the injector is psychologically freeing.”
When compared to a subcutaneous syringe pump, 100% of surveyed patients preferred the enFuse injector and system primarily due to ease of use, more mobility during infusion, less setup time and less pain at the injection site.
Saurabh: You presented survey results about enFuse at AACR 2025. Can you share more about those findings and their significance?
Mehul: In April, Enable presented findings from a survey of drug development experts exploring the systemic underutilization of promising large-volume subcutaneous oncology therapies and misconceptions hindering their development.
Survey results revealed that the widespread, and misguided, belief that subcutaneous delivery volumes must be limited to around 3 mL or less without a permeation enhancer (an enzyme co-formulated with the drug that interacts with the subcutaneous space and increases its permeability) has negatively impacted oncology drug development. The survey findings suggest that this perception has led to the premature abandonment or deprioritization of numerous oncology assets with commercial potential.
These insights reinforce the potential of technologies such as the enFuse injector to offer a viable path forward for valuable oncology therapeutics once deemed unviable.
Furthermore, data from two clinical studies presented at ASCO by Sanofi, a current partner of Enable Injections, demonstrated that the cancer therapy isatuximab administered subcutaneously via an investigational enFuse on-body injector shortened treatment time to mere minutes with similar efficacy and safety but improved preference compared to intravenous infusion. This data will form the basis of global regulatory submissions across all currently approved lines of treatment.
Saurabh: How do you ensure the safety and reliability of enFuse for home use, especially for patients new to self-administration?
Mehul: Whether enFuse technology is approved for use at home or in the clinic is dependent on the type of medication that is jointly approved with the device.
Currently, the Empaveli (pegcetacoplan) Injector, based on enFuse technology, is approved for at-home self-administration with Empaveli, a therapeutic marketed by Apellis for adults with paroxysmal nocturnal hemoglobinuria (PNH) or patients over the age of 12 with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN).
Complete instructions for how to use the Empaveli Injector are provided to all patients and providers by Apellis with clear written and visual context, as well as a patient support program that includes self-administration training from an Apellis Care Educator (ACE).
Saurabh: enFuse has recently received CE Mark approval in Europe after gaining US approval in 2023. What are your next regulatory steps or plans for other regions?
Mehul: Earlier this month, Enable announced that the Brazilian Health Regulatory Agency (Agencia Nacional de Vigilancia Sanitaria) approved the enFuse system for administration of medication subcutaneously. This approval marks a milestone in Enable’s partnership with Sobi, announced in September 2024, with plans to develop and distribute the enFuse system for the administration of Empaveli/Aspaveli in Sobi territories.
In addition, the enFuse technology is registered in the UK with the United Kingdom’s Medicines and Healthcare products Regulatory Agency (UK MHRA) as of June 6, 2025.
We are continuing to work with a number of pharmaceutical partners to conduct clinical trials and plan for joint commercial launch of their therapies in combination with the enFuse technology.
Saurabh: In addition to PNH and Parkinson’s disease, what other therapeutic areas or medications do you visualize enFuse being used with in the future?
Mehul: The enFuse technology is well-suited for patients who require regular administration of treatments. While broadly compatible with a wide range of drugs, current collaborations are most concentrated in rare diseases, neuromuscular, and oncology.
With a design that allows compatibility with small molecule and biologic drug formulations across a wide range of viscosities and volumes (5-25mL for a single device, with up to four devices worn simultaneously), the applications for enFuse technology are limitless.
Several ongoing studies are evaluating Enable’s wearable technology in a wide range of conditions.
About the Author:
Mehul Desai
Mehul Desai, PharmD, MBA, has vast experience in medical and clinical affairs across the pharmaceutical space. At Enable Injections, he leads medical and clinical programming to support publication, new partnerships, and regulatory approvals. Prior to Enable Injections, Dr. Desai served as Associate Medical Director for argenx, driving the strategic direction, supporting clinical trial execution, and contributing to business development activities across various therapeutic areas.
Disclaimer: *Quotations Courtesy of Apellis Pharmaceuticals. Patient quotes may not necessarily reflect the views and opinions of all patients. Individual patient experience may vary.
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