Bigfoot Biomedical, Inc announces that they have raised a Series A investment of $35.5 million in support of their efforts to complete development of their highly anticipated Smartloop automated insulin delivery system.
Due to the Series A Financing, Bigfoot’s Board of Directors will now include Thomas Brener, Managing Director of Quadrant Capital Advisors, Bigfoot’s largest shareholder and lead investor in the Series A and Bob Kavner, who has served as a director or board chairman for for companies like Pandora Media, Earthlink Networks, Overture Services, and Ticketmaster-Citysearch.
The investment is led by entities advised by Quadrant Capital Advisors, with participation from Cormorant Asset Management, Senvest Capital, and Visionnaire Ventures.
Company spokesperson, Melissa Lee wrote in an email that this extra capital will help Bigfoot get through the process of continued development for the system and services needed to get through the final trial.
About Bigfoot’s Smartloop System
The system also constantly learns about it’s user and personalizes therapy and gives automated decision support to patients and providers.
As we previously shared on Diabetes Daily, Bigfoot Biomedical’s smartloop system hopes to realize the following:
- View and operate your system via your smartphone
- Simple insulin infusion pump tightly integrated with your continuous glucose monitor
- Secure wireless on-body network of wearable devices
- Proprietary algorithms for closed loop automation
- Cloud-based therapy personalization and remote monitoring
- Accessed with single prescription and reimbursed as a service for a monthly fee
About Bigfoot Biomedical
A Bigfoot Biomedical press release states that the company first started with co-founders Jefferey Brewer and Brian “Bigfoot” Mazlish, the chief technology officer who initially built an automated delivery system for his type 1 wife and son in 2014.
In under two years, the company acquired the assets of Asante Solutions which included the Snap insulin pump and the headquarters in Silicon Valley and partnerships with top glucose monitoring companies. By July of 2016, they began the enrollment of participants in their first clinical trial for the smartloop system.
Jeffrey Brewer explains how “From a standing start it took Bigfoot a year and a half to reach this milestone; to design, develop, manufacture, and begin human trials with a fully integrated automated insulin delivery system, ” and they hope to swiftly and safely complete the process.
Melissa Lee also stated in an email that, “As you have likely seen from more recent photos of our investigational system, the look and feel continues to evolve as we move closer to realizing our potential commercial version.”
Right now the company is nearing the end of their 3 month clinical human trial for the Smartloop system. Bigfoot is planning their pivotal trial for mid-2017 which is the next step as part of the guidance set forth by FDA on automated insulin delivery systems.
The pivotal trial is longer and involves more participants in a real-world setting to test in a most accurate setting. When that trial is done the next step would be to submit for Pre-Market Approval (PMA) to the FDA.
Bigfoot aims for that final step to take place in early 2018.
Below is an infographic from Bigfoot Biomedical on why they seek the public’s support:
Photo Credit: Bigfoot Biomedical, Inc.