Cincinnati-based Enable Injections, which develops and manufactures painless injectors, raised a $40M Series B round led by Paris-based pharmaceutical company Sanofi in October. Its disposable injectors or devices, which are slightly larger than a cookie, will allow patients to self-administer drugs with the touch of a button.

The innovation can eliminate the need for long intravenous treatments at the doctor’s office and allow patients to self-administer treatment comfortably and in their own time.

Enabling Painless Injections

The company was founded by Mike Hooven, a medical device industry veteran, who first launched Enable Medical Corp. in 1994 (later acquired by the atrial fibrillation company AtriCure Inc). In 2008, Hooven was consulting at CincyTech when he got acquainted with a technology for the painless vaccination of children. The idea came from an invention by Dr. Eric Wall, a surgeon at Cincinnati Children’s Hospital Medical Center.

Two years later, Hooven decided to expand the idea to where the market was. His current company has tremendous market potential as the current injectable market is growing around 11.8% CAGR and might soon eclipse oral delivery as the most valuable route of administration of pharmaceuticals. Valued at $328M in 2015, the market is expected to reach $640M by 2021.

The immense market potential means that there are some big problems waiting to be solved. Many patients, for instance, have to visit clinics for weekly infusions where drugs are delivered in large quantities. “Genen-tech Inc.’s breast cancer drug Herceptin (trastu-zumab)” for example, Medtech review reports, “is administered weekly (for life) via 30-90 minute intravenous infusion sessions.” Other biologic drugs for, say, rheumatoid arthritis require weekly injections that can be painful. The alternative is an Enable injector which can be placed on the body, is easy, comfortable, and might enable weekly injections to become monthly injections due to the device’s ability to deliver large volumes of drugs. A large volume drug, companies that develop wearable injectors argue, helps reduce the number of times a patient has to take an injection, and therefore, limits the feeling of being burdened by the disease.

There’s another unmet medical need: Current self-administration methods such as syringe pumps or auto-injectors can have complex setups and are, more often than not, cumbersome to use with their needles, tubing sets and pumps.

So how Is Enable Injections Different?

The startup claims to have developed a device keeping a specific goal in mind: “to provide a product that users prefer and can use safely and effectively to administer their injectable therapies.”

To use it, patients need to transfer the drug from the original container to Enable’s injector. The website of Enable Injections explains that there are three kinds of transfer system: by syringe, by vial, or by a ‘reconstitution’ system for drugs that require mixing. In the first two, the patient can empty the content of the syringe into the injector or place the vial into the injector. In the case of the third transfer, “the user simply inserts the two vials into the receptacle and fully automated mixing and transfer of the drug occurs”. In each of these, the biggest incentive of the Enable injectors is that the patients don’t have to be skilled to use it.

The device, with a capacity of 5-50 ml, itself works easily. “The Enable enFuse”, the company’s website elaborates, “incorporates a unique ‘pause function’ that allows the user to pause the injection at any time”. The device, which has an adhesive backing to it, can be attached to a preferable place on the skin such as thigh or abdomen. The patient then presses a button which allows the device to subcutaneously infuse the drug. A controlled flow of drug follows where the gauge in the window shows the infusion progress. When all of the drug has been delivered, a button on the device pops out and the patient can remove and discard the device. The startup claims that the button automatically retracts the needle and locks out.

This is probably the company’s biggest competitive advantage: “The needle is never exposed.” Many have long feared the injection while undergoing the treatment and therefore, the compact device where the needle is never exposed keeps anxiety at bay. It is also reported that the device uses the smallest possible needle, controls pressure and the flow rate, thereby enabling its biggest competitive advantage: reducing the pain associated with the procedure.

Selling Wearable Injectors   

Enable Injections business model relies on partnerships with pharmaceutical companies where the company will “design injectors according to the specifications for a partner’s particular application”. The startup has revealed that it currently has partnerships with five companies with recent agreements announced with Apellis Pharmaceuticals and UCB. But to be successful, the company will have to compellingly answer the most important question: At a time when it’s delivery, and not the drug, that defines a patient’s experience. Will it safely and appropriately deliver the right amount of medicine? The Co-Founder and CEO of Apellis Pharmaceuticals has said, “We are conducting human clinical trials using the enFuse technology to deliver our novel complement immunotherapies subcutaneously.” Hooven is optimistic. “More and more drug companies,” he has said, “are beginning to understand how devices can add value to their business.”

But Enable Injections isn’t alone in trying to improve injectors. Numerous companies are in the race to improve the delivery of the multibillion-dollar category of highly viscous drugs called biologics. According to Persistence Market Research, North America is projected to be the dominant regional market for wearable injectors with key players like Medtronic Plc, West Pharmaceutical Services, Becton, and Dickinson and Company, among others. In fact, the same report predicts that sales of wearable injectors is anticipated to surpass$10Bn by 2026, up from an estimated $3.8Bn by the end of 2018.

On one hand, safe and effective self-administered injectors can help reduce the cost of healthcare because you no longer have to pay someone to administer the drugs. But on the other, the device itself might not be free. The mechanical injector might cost $25-50 but Enable Injections’ agreements with pharmaceutical companies, at a time when drugs themselves cost hundreds of dollars, might mean that they do not pass on that cost to consumer.