Where Are They Now? Enable Injections

Enable Injections flagship EnSure device. via enableinjections.com

The Cincinnati medical technology startup is poised to revolutionize therapeutic delivery

When you’re working in the field of cancer treatments, progress is understandably slow. Development can take years, approval processes can be rigorous and technology and manufacturing needs to be precise and robust. When TechOhio first profiled Cincinnati startup Enable Injections in 2015, the young company was at the beginning of that process. Enable Injections is developing a medical device called the enFuse. Once approved, the device will allow administration of therapeutics through the skin. Because the patient won’t be tethered to an IV, the enfuse will allow flexible delivery in a healthcare facility or at home at the push of a button.

“The enFuse is really exciting because it is designed to help patients and healthcare providers,” said Jennifer Estep, associate director of marketing. “The patient never sees a needle. So if you’re a patient with, for instance, Crohn’s disease, ulcerative colitis, rheumatoid arthritis or even cancer, the enFuse would potentially allow patients to give themselves their infusion at home with a small and friendly device. The enFuse looks a lot less like a medical device and more like a yo-yo. It’s small, discrete and can be worn underneath your shirt. I could be infusing right now, and you wouldn’t know it, and then I’m able to go about my life instead of taking time out to go in for my infusions in a health care clinic.”

Since 2015, the company has been in the thick of that long process — building partnerships, developing their technology, garnering funding and more. Along the way, they’ve won awards, earned $30 million and $40 million funding rounds and inking development deals with pharmaceutical firms. All that progress has brought the enFuse closer to reality for patients. And while it will still take time to get the product on the market, the light at the end of the tunnel is getting clearer.

“The future is exciting, even as we navigate the challenges and risks of COVID,” said Estep. “For patients who are immunocompromised, the enFuse would allow a patient to continue their infusions without having the unnecessary health risk of going to a clinic. The enFuse also helps to alleviate some of the health care burden by freeing up more resources in those clinics. We’re working with the FDA and our partners to get our product on the market as soon as possible.”

Enable Injections’ development process is due to a number of factors. Not only is the industry a slow-moving one, but when introducing an entirely new technology to a process that’s been around for years, every step along the way must be perfect. Fortunately for Enable Injections, they have a product that’s worth the wait.

“The challenge with the way therapeutics are currently advancing is that they are more personalized,” said Estep. “They have larger molecules and are difficult to manufacture, but are also more difficult to administer and give to patients. A biologic can’t be put into a capsule or a pill. They need to be cold stored, mixed at time of infusion and usually require an injection. They are expensive, difficult to administer and require patients who are required to receive them to be exposed to needles. So the enFuse was developed, from the beginning, with the idea of getting a patient to be more comfortable if they have a fear of needles. It certainly took a lot of different steps to evolve into the form that you see today, a friendly device that never exposes a needle to the user. The needle is inserted when the button is pressed, and that’s when it’s already on the patient. It’s a very fine-gauge needle that gives a much more comfortable infusion.”

To create the enFuse, Enable Injections has even revolutionized their own manufacturing process. Amid the COVID-19 pandemic, Estep said the company has been excited to keep their manufacturing right here in Ohio. And to keep their manufacturers even safer, the process has become more autonomous.

“With our partners in the region, our team has developed high-tech, state-of-the-art manufacturing for the very difficult process of assembling the very, very tiny components of the enFuse,” said Estep. “It’s now produced through modular manufacturing, which enables robots to do those demanding tasks that are taxing on operators performing them manually. Our manufacturing process has evolved greatly and we will have the capability to assemble and produce thousands to millions of devices in the near future. And as it goes through the manufacturing process, each device has about a thousand data points taken to make sure that everything is perfect and when the device finishes in the manufacturing line, it is verified, validated, and ready for the patient when they receive it.”

Creating pioneering medical technology, there’s no better place for Enable Injections to launch than Cincinnati. The company has access to Ohio’s many world-class healthcare organizations, top-ranked universities to partner with and a startup community in southwest Ohio that grows stronger with every passing day.

“Cincinnati has been a great home,” said Estep. “Mike Hooven, our CEO, is very grounded in the area, and AtriCure, one of his former companies, is also here. We have a great investment base in the Midwest and locally in Cincinnati. We have important connections with the University of Cincinnati, CincyTech, Cincinnati Children’s Hospital and Innovate Cincinnati as well. We have many groups to thank and investors who are involved with the success that we’ve had so far, and they’re all definitely invested in where we’re going with our future. We have investors outside of Ohio as well, but we appreciate the local influence and being able to provide jobs in the region that are high-tech and future-focused, especially in the health care and med-tech market.”

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