Cincinnati’s top-funded startup has made another key change to its C-suite as it continues to land new partnerships with industry players both big and small.
Evendale-based Enable Injections, known for its wearable drug-delivery device called the EnFuse, appointed Matt Huddleston, its current executive vice president and chief technology officer, to the role of chief commercial officer, effective immediately. In the role, Huddleston, who has been with Enable since 2012, will lead marketing and business development efforts and work to expand the company's commercial operations as it works with a growing list of pharmaceutical partners.
EnFuse, a palm-sized wearable drug delivery device that serves as an alternative to traditional IV infusion, must be used in combination with a drug therapy, and the first EnFuse combination product received U.S. Food and Drug Administration approval in October 2023.
The move signals a new phase of growth for the company amid its first formal launch.
“The (new) role is really an acknowledgement that we are now a commercial manufacturing company. I've always said that's the last box we need to check,” Huddleston told me. “For these pharma companies, these launch activities start three years before the actual product hits the market, so we have to be prepared and able to support them early on. There's a lot of coordinated activities, communications, development that has to happen, which is why it's really important we build this function out."
Huddleston, a professional engineer and licensed patent agent, has more than 30 years of experience in the medical device space. He said he first met Mike Hooven, founder, chairman and CEO of Enable Injections, shortly after Hooven launched the company in 2010.
Huddleston joined shortly after and has held many different positions over the years.
“It's the true ‘napkin to commercial product’ story that not very many people get an opportunity to do,” he said. "And I'm loving it."
The chief technology officer role won’t be refilled, per se, but in February David Kroekel, the company’s former senior vice president of product development and operations, was promoted to chief operating officer. Kroekel handles early product development, engineering, manufacturing and supply efforts for the EnFuse.
Enable expands Roche partnership, adds Serina Therapeutics
The EnFuse is a first-of-its-kind, hands-free, palm-sized wearable drug delivery device that’s designed to deliver large volumes of medications subcutaneously (through the skin). It delivers a drug more quickly, and a patient can complete treatment at home versus at a clinic.
Since its first FDA approval last year, in which Apellis Pharmaceuticals will use the EnFuse to deliver its drug Empaveli, for use in adults with paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disease, Enable has followed with several big announcements in 2024.
In February, it finalized plans to move into a new multimillion-dollar, 90,000-square-foot manufacturing facility in the Springdale Commerce Park. Huddleston told me Enable will transition into that building as it brings on new partnerships.
In early May, it announced an expanded partnership with Swiss-based Roche, the world’s largest biotech company. Roche, in the deal, obtains a worldwide, exclusive license to develop and commercialize combinations of the EnFuse technology with its specific molecules, while Enable will be responsible for clinical and commercial manufacturing and supply of the enFuse system.
Most recently, May 15, Enable also announced a new partnership with Serina Therapeutics (NYSE American: SER), a Huntsville, Ala.-based clinical-stage biotech firm developing a medication, SER-252, for the treatment of Parkinson’s disease.
Huddleston said Enable has been very successful – both publicly and privately – in its efforts to add new partners post-FDA approval.
“Those partnerships (in particular) speak to our ability to not only serve one of the biggest pharmaceutical companies in the world (in Roche), but smaller startups, too, that are developing something exciting,” Huddleston said. “We have almost an index fund of different partnerships. We can work with anybody.”
There are more projects in the pipeline. Hooven noted Huddleston will continue to be an “influential leader in his new role” as the company prepares to launch more commercial products.
“Since joining the company in 2012, Matt has been an invaluable asset to the Enable team and to our success,” Hooven said in a news release. “His knowledge of the medical device industry and expertise in engineering led him to be a significant contributor to the core elements of our wearable enFuse technology, while simultaneously playing an instrumental role in our business development efforts, including brokering our six ongoing pharmaceutical partnerships.”
To date, Enable Injections has raised more than $311 million in venture funding, including a $215 million Series C in January 2022 – a record raise for a Greater Cincinnati startup, ranking it as the region’s best-funded startup.
Its backers include multibillion-dollar drugmaker Sanofi; Magnetar Capital, an Illinois-based hedge fund; Squarepoint Capital; Woody Creek Capital Partners; Cincinnati Children’s Hospital; CincyTech; Cintrifuse; Cleveland Clinic; and Ohio Innovation Fund, among others.
The company employs more than 200 in the region.
