After executing a significant IP sale, Bigfoot Biomedical looks to double down on its diabetes management platform.
Less than two years ago, Bigfoot Biomedical launched its Bigfoot Unity platform in some U.S. states. CEO Jeffrey Brewer last year called it a “transformational attempt” to simplify CGMs and the data they produce. It features a smart insulin pen cap, which takes data from a CGM and informs the patient exactly how much insulin they need.
Just last month, the company made a major play to further bolster this platform. It sold pump-based automated insulin delivery technology patents to pump maker Insulet for $25 million. This asset sale generated significant funds to expand the Bigfoot Unity diabetes management system.
Further positives followed within weeks, as Bigfoot soon after received FDA clearance for the Android mobile app for Bigfoot Unity. The mobile app allows users to input and review therapy recommendations from healthcare professionals. Users can also access a glanceable display of their current glucose range and receive real-time alerts. Bigfoot said 41% of U.S. smartphone users choose Android devices, further expanding the platform’s reach.
Brewer recently spoke to Drug Delivery Business News to discuss the asset sale and what the future looks like for Bigfoot Unity.
The benefits of Bigfoot selling pump IP to Insulet
Brewer explained that a “substantial amount” of Bigfoot Biomedical’s early work came on a closed-loop automated insulin delivery (AID) system. The system featured a CGM driving a pump to deliver insulin with algorithms, much like many on the market. Insulet’s Omnipod 5 — one of the latest major developments in the AID space — received FDA clearance in January 2022. It’s the first tubeless, wearable automated insulin delivery system cleared for marketing in the U.S.
However, Bigfoot concluded that it couldn’t carry on with both the AID technology and the Bigfoot Unity platform.
“We can only focus on one of them for the time being,” Brewer told DDBN. “We’re focused on shots. It’s the bigger opportunty — we believe — to help more people. It’s more relevant to type 2 diabetes. So we’re putting all our focus and all our resources into proceeding in that area.”
Eric Benjamin, Insulet EVP of innovation, strategy, and digital products, said in the acquisition announcement that the company was “thrilled” to buy the assets. He noted that Bigfoot made “valuable contributions to the industry” through years of R&D in the AID space.
Brewer said he has confidence in Insulet to utilize Bigfoot’s “great asset” in its focus on simplicity and ease of use for pump users.
“We’re glad to see the technologies we’ve developed be able to see some utility and in that space,” Brewer said. “We’re going to use the money to focus on our connected injection systems and, specifically, a broader rollout of those in the marketplace later this year, using the pharmacy as a way to adjudicate pricing and to reach a broader population of people.”
What’s next for Bigfoot Biomedical?
Brewer said the next steps for Bigfoot are to take the limited commercial launch to a larger population of people.
He said the limited rollout generated “great data” to support Bigfoot Unity in the type 2 population. That includes ease of use, especially for people who might not be tech-savvy.
“They need something that’s going to really fit into their lives, and we think we have developed something built around CGM that really enables us to deliver on the opportunity of all this data,” Brewer explained. “But, we don’t give people data. We take the data and tell them what to do. [We tell them] how much insulin to inject and when and that’s what the population needs.”
Currently, the Bigfoot Unity works with the Abbott FreeStyle Libre 2 CGM. With the next-generation FreeStyle Libre 3 receiving FDA clearance last year, Brewer said Bigfoot plans to extend compatibility with future versions when ready. The company also plans to expand compatibility with other sensors. That includes ongoing discussions with Dexcom, which just launched its next-generation G7.
The big focus for Bigfoot Biomedical, Brewer explained, remains the pharmacy channel. He said the company is currently in discussions with Express Scripts, Optum and CVS to utilize their wide reach. Brewer said that getting an agreement with one or more of those companies will enable a more broad launch this year.
“We’re excited by the early success we’ve had in a limited rollout and the data that we’re generating,” Brewer said. “And we’re looking forward to bringing that to a much larger population of people. There are millions of them out there who need it.”
Innovation in the diabetes space
Diabetes goes beyond business for Brewer, who got involved with the Juvenile Diabetes Research Foundation (JDRF) and the Artificial Pancreas Project for developing a closed-loop insulin delivery system after his son was diagnosed with type 1 diabetes. For around 20 years, his focus centered around finding ways to support insulin delivery and manage diabetes.
When asked about the state of innovation in the market, he said there’s been plenty. However, Brewer believes it falls in an overserved part of the market: type 1 diabetes.
“I feel like my son’s well served, but the millions of people out there with type 2 diabetes who need a different kind of solution — and are treated by a different kind of doctor that’s not going to prescribe and support insulin pumps or doesn’t have the time to teach people how to interpret data — those folks need something different,” Brewer said.
With Bigfoot Unity, Brewer said more people can utilize the potential of data. They can access it in a “more friendly, scalable and safe way.”
By wrapping the insulin delivery around CGM, Bigfoot Biomedical believes it can address the type 2 market in a new way.
“We developed a system around a CGM,” Brewer said. “You’ve got that [Abbott FreeStyle] Libre, and, basically, it talks to the pen cap and tells you what to do. That’s the kind of simplicity I think people need. That’s what we’re focused on.”