When John Wilcox was a sixth grader, he attended a fundraising event organized by JDRF, the global nonprofit that funds Type 1 diabetes research. He had been diagnosed with Type 1 diabetes on his ninth birthday. Wilcox was a kid who liked science, and the research presented at the event both intrigued and inspired him.
How great would it be, he thought, if he could one day showcase his own diabetes research at a major gathering?
In June 2022, Wilcox — now 26 — did just that, when he co-authored research on the emotional impacts of insulin pump infusion set failures, then co-presented it at the American Diabetes Association’s 82nd Scientific Sessions in New Orleans.
“It’s always been a dream,” he said. “It was just surreal to be like, ‘Wow, this is something I remember thinking about back when I was a kid.’”
The presentation, however, did more than just fulfill a childhood dream. It also brought further exposure to Wilcox’s startup, which is swiftly gaining momentum.
SmartFusion
Wilcox is the co-founder and CEO of Diatech Diabetes, a Memphis-based medical device business that’s developing a software platform called SmartFusion, to help people with diabetes obtain proper amounts of insulin.
In the U.S., there’s about 600,000 diabetes patients who use insulin pumps — generally those with Type 1 diabetes. Those pumps are about the size of a cell phone, and connected to the body via disposable pieces called infusion sets. They regularly inject insulin into the body, ideally ensuring the patients receive the correct amount of insulin.
But the margin for error is high, and malfunctions happen frequently. For example, if the infusion site on the skin becomes loose, a leakage can cause an under-delivery of insulin. And if the cannula — a thin medical tube — is injected into damaged skin tissue, it can cause blockage, potentially leading to an insulin buildup and overdose.
Most insulin pumps, however, won’t alert patients about these issues. They’ll tell patients about failures that prevented them from delivering insulin — but not if the insulin was delivered, and not properly received. The hope is that Diatech’s SmartFusion platform changes this, by studying data in an insulin pump’s system to make analyses and predictions, while also providing alarms that say when a pump is malfunctioning and insulin dosages aren’t right.
Gaining funds
Diatech came to Memphis in in 2019 for Epicenter’s ZeroTo510 Medical Device Accelerator, and got a major boost when it scored a $300,000 SBIR Phase One grant from the National Institutes of Health (NIH) in September 2021. Recently, that grant was matched with $100,000 from the entrepreneurial support organization LaunchTN, which is set to give Diatech an additional $150,000 matching investment once it raises $300,000 in private capital.
The company is also looking to apply for a Phase Two SBIR grant, and it’s under consideration for a $1.4 million grant from the JDRF, which could help it fund upcoming clinical studies.
But don’t expect Diatech to be doing these studies on its own.
Major partnerships
The startup has partnered with both a European insulin pump manufacturer and a U.S. insulin pump manufacturer — Wilcox said he couldn’t provide their names — and it’s set to complete preclinical studies with the European partner this fall, with plans to begin clinical studies in April. Data from that study could be used for a regulatory filing with the European Medicines Agency (EMA), the European Union’s FDA-equivalent; and this same data could then potentially be used for a filing with the FDA.
“We see the possibility to be able to gain FDA clearance from that data that we would get from this study in Europe,” Wilcox said.
Diatech does, however, also want to do a U.S.-based preclinical and clinical study with its domestic partner as well, and the American and European studies could go on concurrently.
Here’s how they would work.
The manufacturing partner would provide its insulin pump, which Diatech could then pair with its SmartFusion software, and demonstrate how it can detect infusion site failures more effectively than the pump’s current failure detection system.
“We'll basically be doing a one-versus-one, pump-with-SmartFusion, pump-without-SmartFusion [study] and showcasing clinical outcomes with the use of our system,” Wilcox explained. “We would not be pitting the separate manufacturers pumps against each other; we would just be pitting their own pump versus their own pump with SmartFusion.”
The partnerships, however, could lead to more than just these clinical studies. They could also lead to licensing agreements, or the acquisition of Diatech — if the startup shows a manufacturer that its software would provide it with a competitive edge over rivals.
According to Wilcox, some discussions about an acquisition have already been held, and this is intriguing. But the company isn’t relying solely on that possibility.
Diatech, he noted, is very busy, and will keep pushing forward.
“We’re trying to continue making a lot of progress … and we’re still very confident in our go-to-market plan,” he said. “So, we’re continuing to chug, and it’s a continued effort."
