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Bigfoot Biomedical

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Bigfoot Biomedical, Inc. is a medical technology startup headquartered in California.[1] The company was founded by parents of children with Type 1 Diabetes (T1D): Jeffrey Brewer, Bryan Mazlish, and Lane Desborough.[2]

Early History

The company’s start may be traced back to 2011, when quantitative trader Bryan Mazlish’s son received his diagnosis of T1D. He developed a control algorithm to drive the first[3] automated and cloud-connected, closed-loop, artificial pancreas device for his wife and son, who have been using the closed-loop automation of insulin delivery since 2013.[4] The existence of this “homebrew artificial pancreas” was kept from the press and the subject of rumor, earning Mazlish the nickname Bigfoot from author Dan Hurley in a piece for Wired Magazine in 2014.[5]

In late 2014, Mazlish joined with Brewer and Desborough to form Bigfoot Biomedical in order to scale and commercialize the technology, calling the company Bigfoot Biomedical.[4][6]

In January 2017, it was reported that, Bigfoot Biomedical received investment from the Juvenile Diabetes Research Foundation (JDRF).[7]

In June 2017, the team from Patients Pending LTD, makers of the Timesulin smart insulin pen, including CEO John Sjölund joined Bigfoot Biomedical to lead the development of a smart pen solution for people utilizing multiple daily injections to manage their diabetes.[8]

Acquisitions and Collaborations

In May 2015, Bigfoot acquired all the assets of Asante Solutions, former manufacturer of the Snap insulin pump. Later that month, Bigfoot announced a development agreement with Dexcom in June 2015, securing the technology needed for the continuous glucose monitoring component of the system.[9]

In June 2017, Bigfoot announced the acquisition of London-based startup Patients Pending, LTD, maker of the Timesulin smart insulin pen tracker,[10] and the company's Bluetooth-enabled insulin pen dose capture technology, with the goal being to use Patients Pending's Bluetooth-enabled dose capture technology to provide people on injection therapy with dose titration decision support,[11] giving smart dosing guidance based on previous glucose trends and insulin doses captured from the cap with a commercial launch possible in 2019.[12]

July 2017 saw Bigfoot announce a collaboration with Abbott Laboratories to integrate Abbott’s FreeStyle® Libre glucose sensing technology with Bigfoot’s insulin delivery solutions in the United States.[13] The agreement allows for Bigfoot's use of a "next generation" version of the Libre sensor system that allows for continuous glucose transmission.[14] The Abbott FreeStyle® Libre does not require users to prick their finger to retrieve glucose values or calibrate the sensor. For Bigfoot, the deal offers an opportunity to disrupt the automated insulin delivery field with the first integration of a sensor technology designed to eliminate the need for fingerstick calibrations and aids Bigfoot in its goal of creating patient-friendly technologies.[15]

System Components

The Bigfoot automated insulin delivery system will combine an insulin pump programmed with a proprietary control algorithm, a continuous glucose monitoring sensor and transmitter, and a commercial off-the-shelf smartphone. It will also integrate data generated from a Bluetooth connected blood glucose meter.[16]

Development Timeline

Bigfoot Biomedical’s first clinical trial[17] enrolled its first patients in 2016.[18][19] A pivotal trial for the automated insulin delivery system is planned for late 2018[15] at as many as a dozen clinical research sites and including both doctors and patients who are new to pump therapy.[20] A separate trial for the company's MDI (multiple daily injection) auto-titration system is also planned.[15]

References

  1. ^ Smith, Peter Andrey (22 February 2016). "A Do-It-Yourself Revolution in Diabetes Care". The New York Times. Retrieved 6 April 2016.
  2. ^ Knutson, Ryan (8 June 2015). "Computer Experts Deliver Insulin to Diabetic Kids". The Wall Street Journal. Retrieved 6 April 2016.
  3. ^ "No More Sleepless Nights: The Relationship Between Innovative Therapies for Parents of Children with Type 1 Diabetes". Welkin Health. Retrieved 11 August 2017.
  4. ^ a b Hurley, Dan. "Artificial Pancreas Makers Race to Market". Discover Magazine. No. May 2016. Retrieved 6 April 2016.
  5. ^ Hurley, Dan (24 December 2014). "Diabetes Patients are Hacking Their Way Toward a Bionic Pancreas". Wired Magazine. Retrieved 6 April 2016.
  6. ^ Evans, Rogene. "Ones to Watch, ten companies we're keeping an eye on". Medical Design and Outsourcing. Retrieved 28 September 2016.
  7. ^ "Bigfoot Biomedical gets investment from JDRF's new venture fund for smart automated insulin delivery system". MobiHealthNews. 2017-01-30. Retrieved 2017-10-16.
  8. ^ "Bigfoot Biomedical acquires Timesulin". 2017-06-08.
  9. ^ "Bigfoot Biomedical Ups its Game Through Recent Acquisition and Partnership". Medical Product Outsourcing. 8 June 2015. Retrieved 6 April 2016.
  10. ^ Hoskins, Mike. "NEWS: Bigfoot Closed Loop to Use Next-Gen Abbott FreeStyle Libre". DiabetesMine. Healthline. Retrieved 9 August 2017.
  11. ^ K, Sarah. "Bigfoot Biomedical Aims to Take Multiple Daily Injections to the Next Level with Timesulin Acquisition". Diabetes Daily. Retrieved 9 August 2017.
  12. ^ Levine, Brian. "What's Making a Splash in Diabetes Technology This Summer?". diaTribe.org. diaTribe. Retrieved 9 August 2017.
  13. ^ Parmar, Arundhati. "New Abbott diabetes deal is a "missed opportunity" for DexCom". MedCity News. Breaking Media, Inc. Retrieved 9 August 2017.
  14. ^ Kennedy, Lynn. "Bigfoot & Abbott to Automate Insulin Delivery Without Fingersticks". diaTribe.org. diaTribe. Retrieved 9 August 2017.
  15. ^ a b c Thompson, Mary. "Bigfoot and Abbott: A Match Made in Heaven? An Interview with Bigfoot Biomedical CEO Jeffrey Brewer" (PDF). The MedTech Strategist. Innovation In Medtech, llc. Retrieved 9 August 2017.
  16. ^ Brown, Adam (25 January 2016). "Bigfoot Biomedical Reveals Its Automated Insulin Delivery System!". diaTribe. Retrieved 6 April 2016.
  17. ^ Hoskins, Mike. "NEWSFLASH: Bigfoot to Kick Off Closed Loop Clinical Trial!". Healthline.
  18. ^ Crotti, Nancy. "Artificial Pancreas Race Includes a Motivated Underdog". QMed. Retrieved 28 September 2016.
  19. ^ Falconer, Sara. "I Was Hooked Up to Bigfoot's Artificial Pancreas". Insulin Nation. Retrieved 28 September 2016.
  20. ^ Zimberoff, Larissa. "Bigfoot Biomedical Chooses Abbott's Libre Over Dexcom's CGM". A Sweet Life. Diabetes Media Foundation. Retrieved 9 August 2017.
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