This morning, Bigfoot announced $18 million in incremental Series B funding, closing the round at $55 million following an initial $37 million tranche in December. The round brings Bigfoot’s aggregate financing to over $90 million, about halfway to the $200+ million that CEO Mr. Jeffrey Brewer says is needed to bring both the Loop automated insulin delivery and Inject MDI auto-titration systems to market. Capital raised to date will bring the company through final development and of both systems and at least one PMA submission.
In a huge win for Bigfoot, Abbott was included in the list of investors for the first time, upping their commitment since partnering to feature a next-gen, continuous FreeStyle Libre in both Loop and Inject last July. Since other new and existing investors also participated in this second Series B tranche ($18 million), we imagine that Abbott’s contribution was <$10 million, but whatever the magnitude, this is still a huge vote of confidence and de-risking for Bigfoot. The move is reminiscent of Dexcom’s $5 million investment in Tandem’s successful $69 million public stock offering in February.
As a sidebar, Mr. Brewer told us via email that a US pivotal trial of Loop is now expected to begin in early 2019 following an IDE by the end of 2018, the former being pushed back meaningfully from December guidance for a 2018 pivotal commencement. We’re not sure what caused the delay, since the company still ambitiously has no plans to conduct interim studies. Timing for Inject, however, remains the same: The system still had to undergo “at least one” feasibility trial before entering a pivotal as of December, leaving the “2018” pivotal timing shared at DiabetesMine’s D-Data Exchange theoretically within reach. Despite the Loop delay, a CNBC article notes that Bigfoot maintains hopes for “selling and marketing its systems in 2020.”
- Mr. Brewer specified that there will be no Bigfoot data shared at ADA and there is none planned yet for DTM. We might’ve expected to see a readout from the interim Inject study or more simulation data, but that may have to wait until at least ATTD 2019!
- Bigfoot has over 70 employees and is hiring “aggressively,” including a slew of engineers, a vice president of business development, and a clinical education manager, among other roles.
-- by Brian Levine, Adam Brown, and Kelly Close