March 18, 2019 -From the outside, diabetes may look like a simple condition to manage but it's actually a constant math test where the right answer is nebulous and the stakes range as high as death. But a new technology about to get broader commercial release could make insulin management the self-driving car of endocrinology.
January 22, 2019 - Bigfoot Biomedical, developer of insulin-delivery devices targeted for launch next year, is poised to become a major competitor to established companies such as Medtronic, Dexcom and Insulet, Jefferies analyst Raj Denhoy predicts in a recent research note.
The analyst estimates Bigfoot's total addressable market at $21 billion in the United States alone, an opportunity that rivals even the largest of big pharma opportunities, he said.
July 28, 2018 - In their quest to make care better for people with diabetes, medical device companies are doing lots of innovating — in prices.
Medtronic is rolling out an offer to pay up to $25,000 if patients using its most advanced insulin pump end up in the hospital. Abbott Laboratories debuted its latest continuous glucose monitor at prices designed to be low enough to foster quick worldwide adoption. Most radically, Bigfoot Biomedical plans to offer its upcoming insulin devices for a monthly subscription price instead of an upfront fee of thousands of dollars.
March 29, 2018 - This week, Bigfoot Biomedical announced a $55 million Series B to advance their push to integrate glucose monitoring, insulin delivery and smart software. The financing will support a pivotal trial and other efforts to gain premarket approval (PMA) from the FDA.
Beyond tying together monitoring and delivery, Bigfoot wants to simplify the whole process of diabetes management. Under one prescription, users could receive the infusion system (unless they choose to give their own shots), glucose monitor, the app that talks to both and various disposables – though not insulin.
December 19, 2017 - The series B gives Bigfoot the financial muscle to move its automated insulin infusion device into a pivotal clinical trial in the U.S. next year.
Milpitas, CA-based Bigfoot is working on two products: an insulin infusion device that mimics the function of the pancreas and a smart injection pen. Bigfoot is putting a network of sensors and algorithms around the delivery devices to automate and optimize diabetes management.
December 18, 2017 - Bigfoot Biomedical Inc., a developer of a system to manage Type 1 diabetes, has raised a $37 million venture round as it prepares to seek regulatory approval for the product next year.
July 31, 2017 - But perhaps the most interesting (and somewhat surprising) new deal in the AP space comes from Bigfoot Biomedical, which continues to demonstrate its willingness to break new ground in pursuit of the most patient-friendly solutions for people with diabetes.
August 1, 2017 - After two and a half years of development, during which the company has raised over $40M in funding, the company has rejected one of the most respected names in diabetes tools––Dexcom––to partner with Abbott Laboratories for its initial launch. It’s not easy to make technology changes but Brewer, the CEO of Bigfoot, felt the switch was crucial. The difference in the two products came down to calibration and accuracy.
July 17, 2017 - “In the first generation of automated systems, we think sensors that require calibration have been the crippling aspect of the user experience. We’ve learned from our own personal experiences and from what we’ve seen in data modeling, that calibration is the biggest risk to a closed loop. People don’t do it well, or consistently or even at all. And that turns out to be a big problem. Our concern is that systems that require calibration aren’t going to be as easy to use or as safe as those that don’t require it.”
July 13, 2017 - When Jeffrey Brewer's son was 15, the boy nearly lost his life because he took too much insulin. The diabetic teen took insulin to eat a large bag of chips late at night. But about 20 minutes later, he forgot about that first dose and took another. He spent two days in the hospital, his father said. "It was only by a miracle that my wife woke up at 4 a.m. and checked on him," said Brewer, president and CEO of Bigfoot Biomedical. "He would have been dead by 7 a.m." Now, Bigfoot Biomedical and north suburban-based Abbott Laboratories hope to help prevent such problems — and make life easier for millions of people with diabetes — with a new partnership announced Thursday.
June 24, 2017 - “Artificial pancreas, or automated insulin delivery, is a solved problem from a technology perspective. What’s really NOT solved is how to build a solution that everybody can use and that is going to get reimbursed and prescribed by doctors. This is the challenge that Bigfoot has undertaken.”
April 6, 2017 - In 2002, Bigfoot Biomedical CEO Jeffrey Brewer’s technology career was flourishing, having founded two successful startup dot-coms that later became publicly traded companies. He had just moved his family from Silicon Valley to New York City, and was ready for new challenges. But when his young son received a devastating diagnosis just weeks after the family settled into their new home, Brewer found himself unable to focus on anything else. Stunned by the lack of information, high risk of error and antiquated devices available to help manage his son’s type 1 diabetes, Brewer began laying the groundwork for his most important technology project to date: automated insulin delivery (AID).
November 17, 2016 - Bigfoot Biomedical's founder and CEO Jeffrey Brewer was among the first to back the artificial pancreas with a donation to JDRF, a diabetes research organization. But when things weren't moving fast enough, he — along with Bryan Mazlish, the company's chief technology officer — decided to take matters into their own hands and build their own artificial pancreas.
October 24, 2016 - Bigfoot has been generating a great deal of interest within the diabetes community of late - and not just because of its unusual name. The company brings together leading players in the "Do-It-Yourself AP System" and "we are not waiting" movements - diabetes community-led efforts that helped jump-start the current trend toward more connected, technology-enabled diabetes care. Its aim is to offer a best-in-class AP that is secure, highly connected, highly automated, and truly patient-, physician-, and payor-friendly.
August 19, 2016 - I was diagnosed with Type 1 diabetes in 1974, and heard about the possibility of an artificial pancreas two decades later. Recently, I got to wear one from Bigfoot Biomedical.
I heard the term “artificial pancreas” for the first time in 1995 from Dr. Jay Skyler, the noted diabetes researcher who is now a Professor of Medicine, Pediatrics and Psychology at the University of Miami Miller School of Medicine. Dr. Skyler waxed poetic about a mythical system used to keep blood sugars steady...
August 10, 2016 - Bigfoot Biomedical has obtained the FDA’s blessing to conduct a clinically-supervised test of an algorithm designed to translate readings from a Dexcom CGM into insulin-delivery instructions for a pump. On June 29th, the FDA granted Bigfoot an investigational device exemption (IDE), a form of relaxation of certain FDA requirements for premarket clinical trialing, to test the company’s pump-controlling software. Bigfoot will be proceeding with a feasibility study limited to 50 participants and five clinical facilities.
August 1, 2016 - Bigfoot Biomedical is a company working on introducing an “artificial pancreas” for Type 1 diabetics who are on insulin therapy. The company has developed its own algorithms that control the delivery of insulin by a pump based on readings from a continuous glucose monitor (CGM). Now these algorithms are about to be tested in a clinical trial thanks to an FDA Investigational Device Exemption and enrollment of initial patients.
July 22, 2016 - The founders and leaders of tiny Bigfoot Biomedical each have at least one family member living with type 1 diabetes. So their motivation in creating the first artificial pancreas may have more of a personal motivation versus say, Medtronic, which recently confirmed it has applied for FDA approval for its version.
The Milpitas, CA, company, founded in 2014, has received FDA approval of an investigational device exemption (IDE) for the first clinical trial of its “smartloop” automated insulin delivery system.
July 21, 2016 - On June 29, the FDA gave Bigfoot the green light to move forward on its Investigational Device Exemption (IDE) submission, allowing the first clinical study for its "smartloop" system to begin. This three-month clinical study will take place at three sites across the U.S., gathering data that will move the needle on getting this ready for FDA submission in 2017 and hopefully commercialization in 2018!
July 21, 2016 - Startup Bigfoot Biomedical has started a clinical trial for its artificial pancreas device in Type 1 diabetes patients. The move comes after Medtronic ($MDT) recently submitted to the FDA for an approval of its own artificial pancreas product.
The devices giant, though, has a reputation for being technologically challenged when it comes to diabetes--so the startup may have room to best it on that front. If the technology becomes accurate enough, it could eliminate both finger-stick testing for blood glucose and insulin injections and replace that with a patch-based device.
June 23, 2016 - It’s tough to pick just 10 medtech startups to profile out of the hundreds or thousands dotting the U.S. landscape, but we tried anyway.
It helped that we kept our criteria simple: A relatively new company, with only one or two (or no) financing rounds under their belts. Some are so deeply in stealth mode that they never responded to our enquiries.
More important in our selection process was that the technology being developed sparked our interest. That made it even tougher to winnow the field, as the array of unmet needs being met by ingenious medical devices is truly inspiring.
April 20, 2016 - We all want to get our hands on the latest and greatest technology in type 1 diabetes, and it appears a closed-loop system is on the horizon. With several players in the race to bring artificial pancreas technology to market, one company to watch is Bigfoot Biomedical.
April 6, 2016 - There are several companies and groups of researchers racing to bring an artificial pancreas to market, be it one that automates insulin delivery or one that does this and provides glucagon, as well. One of the more intriguing entrants into this race is Bigfoot Biomedical...
April 1, 2016 - The technology, a potential life-saver for those with Type 1 diabetes, is almost here. Which team will be the first to bring it to patients?
February 2, 2016 - Jeffrey Brewer is no stranger to the diabetes community. Known by many in the diabetes space as the enterprising CEO of JDRF who launched JDRF’s Artificial Pancreas Project in 2005 at the same time that JDRF also created programming to bring adult type 1s back into the fold, Brewer has been a pivotal figure in bringing a sense of modernity and urgency to type 1 diabetes.
January 25, 2016 - Bigfoot reveals its automated insulin delivery system: smartphone interface, no pump screen or buttons, potential 2018 launch + subscription model.
January 13, 2016 - In this presentation, "Meeting in the Middle: The Convergence of Life Sciences and Health Tech," Jeffrey Brewer and other presenters discuss how the fields of life science and health technology mutually benefit one other and how they, as innovators, are making health care more accurate, accessible, and affordable. In this clip, Mr. Brewer demos the first prototype of Bigfoot's smartloop™ automated insulin delivery system.
October 13, 2015 - What’s a parent to do when he learns that his child has a chronic disease such as type 1 diabetes? If you are like Lane Desborough, you don’t wait passively for progress, you connect with others who are likeminded—and then you start a company.
October 10, 2015 - Bigfoot Biomedical has developed a fully functioning, automated insulin delivery solution for the treatment of Type 1 Diabetes (T1D). By integrating its FDA-approved insulin pump and the leading continuous glucose monitor (CGM) with a smartphone app and a comprehensive, cloud-based data platform, Bigfoot enables a safer and less costly way to treat the millions of people living with T1D. Founded by proven entrepreneurs with track records of innovation and value creation, Bigfoot is creating a durable business of scale, and meeting an important unmet health need...
June 8, 2015 - Parents developed algorithms to monitor children’s blood sugar, provide insulin.
In the world of diabetes, the Holy Grail is a device that can monitor a person’s blood sugar and deliver insulin as needed—effectively an artificial pancreas.
June 5, 2015 - Bigfoot Biomedical just announced that it has signed a development agreement with Dexcom to integrate CGM data into its future automated insulin delivery system. This rapid news comes just one week after Bigfoot acquired Asante’s technology . While there aren’t many specifics on what Bigfoot has planned, we believe its automated insulin delivery system may include a Dexcom Gen 5 transmitter sending CGM data (via Bluetooth) to a custom-built controller that fits over the Asante disposable insulin pump body.
May 14, 2015 - Bigfoot Biomedical, which is developing a "bionic pancreas," said it raised $3 million from 8 unnamed investors.
Although it’s in stealth mode, Bigfoot executives have said they’d like to complete product development by 2016. The company’s executives include Bryan Mazlish, Juvenile Diabetes Research Foundation CEO Jeffrey Brewer and Jon Brilliant, the former CFO of Welldoc, according to a regulatory filing.
May 13, 2015 - Bigfoot Biomedical, known best for its grassroots approach to building an artificial pancreas for Type 1 diabetes, is emerging from hacker mode and raising some capital. The startup just brought in a $3.5 million bridge convertible note, and is looking to raise between $10 million and $15 million in a Series A this summer.
March 4, 2015 - Yes, Bigfoot does exist in the diabetes community and as you may have heard, he lives with his family in New York.
Our friends at diaTribe recently published a comprehensive interview with the mysterious man who'd long been rumored to have secretly created a homemade artificial pancreas system: D-Dad and husband Bryan Mazlish.
February 18, 2015 - Three leaders in diabetes have come together to form a new type 1 diabetes technology startup called Bigfoot Biomedical and have soft-launched a teaser webpage at bigfootbiomedical.com: “Many didn't believe Bigfoot could be real. It is. And it's coming.”
December 24, 2014 - I continue to obsess with tracking down Bigfoot. Please, I tell an official who claims to know the guy, tell him I will guarantee his confidentiality. Meetings in an underground parking garage are an option. But still the Bigfoot character who had supposedly hacked a fully automated bionic pancreas remains in hiding, refusing to talk to anyone. Others have heard about him, too. “I have heard whispered rumors that such a person exists,” says Amy Tenderich, who runs the prominent Diabetes Mine site. “But nobody will tell us who he is.”
Then, an email appears in my inbox. It contains a phone number to call.
