Bigfoot Biomedical Inc. has picked up some ammunition as it moves closer to commercializing its insulin-management solution, an up-and-coming competitor in a space dominated so far by giants like Dexcom and Medtronic.

Bigfoot, based in Milpitas, California, announced this week it has snagged $45 million in Series C funding to help cover the final stages of development for the startup’s first product.

That product, dubbed Bigfoot Unity, is a connected insulin pen that integrates Abbott’s FreeStyle Libre glucose sensing technology. The goal is to help people who inject insulin gauge when and how much to inject based on a doctor’s recommendations.

The product, which will need FDA clearance, is expected to hit the market by the end of 2020, the company’s chief marketing officer, Red Maxwell, said in a phone interview.

While insulin pumps are gaining traction, most people with type 2 diabetes still inject insulin, Maxwell said. Type 2 diabetes is the more common form among U.S. patients.

The $45 million initial tranche of the Series C funding was led by pharma company Abbott.

“Our industry partnership with Abbott uniquely positions us to reduce the heavy burden of dosing decisions for people with insulin-requiring diabetes,” Bigfoot CEO Jeffrey Brewer said in a statement.

A number of companies are scrambling to develop tools and services designed to help patients manage the ins and outs of injecting insulin. In general, products aim to ease the process through a marriage of insulin pumps, smart pens, continuous glucose monitors and AI technology that can detect when insulin is needed and how much. The result often is known as a closed-loop system or artificial pancreas that can deliver insulin independently of human intervention.

Among the first to develop such a system was Medtronic, whose initial product was for patients with type 1 diabetes, which mostly affects younger patients. But Medtronic’s diabetes division is suffering from low sales of the company’s CGM sensor. By contrast, Dexcom is the market leader. Both Medtronic and Dexcom are hoping to bring more type 2 diabetes patients into the world of continuous glucose monitors and insulin pumps.

Although pumps can spare patients from multiple daily insulin injections, some may prefer to continue with the injections, Maxwell said. They may not want to wear a pump 24/7.

Bigfoot Unity offers something of a hybrid approach. The product stitches together the different systems involved in the injection process – such as CGMs and insulin pen caps – so they can talk to each other and calculate a recommended dose of insulin, Maxwell said.

The company is planning to package the product as a monthly subscription, he said. The package would include the Abbott CGM, as well as a range of Bigfoot products, including insulin pen caps, a backup blood glucose meter, pen needles and glucose test strips. The system also includes a mobile phone app. Clinicians, meanwhile, would be able to view patient data via a secure web portal.

“Right now, people with diabetes have to manage multiple prescriptions, and our vision is to deliver this as a service, a bundled offering,” Maxwell said. Because the product is still pending FDA clearance, he declined to comment on expected costs.

Down the road, Bigfoot plans to introduce a version for insulin pumps, called Bigfoot Autonomy, as well as a next generation of Bigfoot Unity, Maxwell said. The second Unity product will incorporate AI and machine learning to adjust recommended insulin dosing scales based on patient data. The current version depends on input from a physician.

Bigfoot is in talk with insurers over how the initial Bigfoot Unity might be reimbursed, Maxwell said. The company has something of a head start in its partnership with Pittsburgh-based Allegheny Health Network, a subsidiary of insurer Highmark Health. Endocrinologists and primary care doctors at Allegheny have been helping to fine-tune Bigfoot Unity’s provider-facing aspects.

Other participants in the most recent investment tranche for Bigfoot include Quadrant Capital Advisors, Senvest Capital, Janus Henderson and Cormorant Asset Management. Bigfoot raised $55 million in a Series B round in 2018. An earlier round in 2017 brought in $37 million.

The money will cover costs of product development and work on FDA clearance, as well as clinical trials for future iterations of the Bigfoot Unity product.

Photo: freedigitalphotos user Salvatore Vuono