Five months after signing a deal with Abbott to integrate the medical device giant’s FreeStyle Libre glucose sensing technology to optimize insulin delivery, Bigfoot Biomedical has closed a Series B round to support product development and clinical trials for two of its Class III devices for diabetes management, according to the company statement.
Funds managed by new investor Janus Henderson Investors co-led the $37 million Series B round with existing investor Quadrant Capital Advisors. Other participants in the Series B included Cormorant Asset Management, Senvest Capital, Senvest Management, Visionnaire Ventures, JDRF T1D Fund and T1D Exchange. This marks the first tranche of the funding round.
Bigfoot is developing Bigfoot Loop to optimize insulin delivery specific to the user’s needs. A second product, Bigfoot Inject, is a connected insulin pen-based system for people on injection therapy. The insulin pen product is tied to the company’s June acquisition of London-based biotech company Patients Pending, which developed an insulin pen timer cap and a Bluetooth-enabled insulin pen dose capture technology.
Asked about the clinical trial, Bigfoot Biomedical CEO Jeffrey Brewer said in an email that the company expects to begin pivotal trials in the second half of 2018 at clinical research sites across the U.S. Although the Bigfoot Loop study is still in the planning stages, it is expected to enroll approximately 300 people.
“The primary endpoint will be tied to safety of the system, with secondary endpoints including HbA1c time in range of a safe glucose value and quality of life measures. Additional details for this and the Bigfoot Inject system studies have not yet been disclosed, but we will post the trials on clinicaltrials.gov when appropriate,” Brewer noted.
The developments signal just how far the medtech startup has come since its origins as a group formed by parents of children with 
Type 1 diabetes who developed a prototype artificial pancreas to better manage their condition.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
