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Bigfoot Biomedical Inc. is a medical technology start-up headquartered in Milpitas, California, [1] founded by a team of people with personal connections to type 1 and type 2 diabetes. [2] [3]
On September 22, 2023, Abbott Laboratories announced that it had completed the purchase of the company. [4]
The foundation of Bigfoot Biomedical was started when co-founder Bryan Mazlish's son was diagnosed with type 1 diabetes. Mazlish developed a control algorithm to drive the first automated artificial pancreas device for his wife and son. [5] [6]
In 2014, Mazlish joined with Jeffrey Brewer, CEO of JDRF, and Lane Desborough, chief engineer at Medtronic, to form SmartLoop Labs in order to scale and commercialize the technology. [6] [7]
In February 2015, the company was renamed Bigfoot Biomedical Inc. following an article published in Wired Magazine about the work of Bryan Mazlish as someone who'd successfully hacked their own automated system and dubbing him “Bigfoot.” [8]
In May 2015, Bigfoot acquired the assets of Asante Solutions, former manufacturer of the Snap insulin pump. [9]
In June 2017, Bigfoot acquired London-based start-up Patients Pending, LTD makers of the Timesulin smart insulin pen, to lead the development of a smart pen solution for people utilizing multiple daily injections to manage their diabetes. [10] [11]
In July 2017, Bigfoot entered an agreement with Abbott Laboratories to develop and commercialize diabetes management systems integrating Abbott's FreeStyle Libre glucose sensing technology with Bigfoot's insulin delivery solutions in the United States. [12]
In July 2020 the FDA accepted for review the Bigfoot Unity Diabetes Management Program, a dose-decision support system utilizing proprietary smart pen caps and integrating Abbott's FreeStyle Libre 2 continuous glucose monitoring platform. [13]
In September 2023, it was announced Bigfoot had been acquired by the Illinois-headquartered Abbott, for an undisclosed sum. [14]
Bigfoot's portfolio also includes the Bigfoot Autonomy Diabetes Management Program with a closed-loop, automated insulin delivery system, [15] sometimes referred to as an “artificial pancreas.” [15] [16] It received the FDA Breakthrough Device designation. [17] [18]
An insulin pump is a medical device used for the administration of insulin in the treatment of diabetes mellitus, also known as continuous subcutaneous insulin therapy. The device configuration may vary depending on design. A traditional pump includes:
Abbott Laboratories is an American multinational medical devices and health care company with headquarters in Green Oaks, Illinois, United States. The company was founded by Chicago physician Wallace Calvin Abbott in 1888 to formulate known drugs; today, it sells medical devices, diagnostics, branded generic medicines and nutritional products. It split off its research-based pharmaceuticals business into AbbVie in 2013.
Medtronic plc is an Irish medical device company. The company's operational and executive headquarters are in Minneapolis, Minnesota, and its legal headquarters are in Ireland due to its acquisition of Irish-based Covidien in 2015. While it primarily operates in the United States, it operates in more than 150 countries and employs over 90,000 people. It develops and manufactures healthcare technologies and therapies.
JDRF is a nonprofit 501(c)(3) organization that funds type 1 diabetes (T1D) research, provides a broad array of community and activist services to the T1D population and actively advocates for regulation favorable to medical research and approval of new and improved treatment modalities. It was initially founded as the JDF, the Juvenile Diabetes Foundation. It later changed its name to the Juvenile Diabetes Research Foundation and is now known as JDRF.
Alfred E. Mann, also known as Al Mann, was an American physicist, inventor, entrepreneur, and philanthropist.
Automated insulin delivery systems are automated systems designed to assist people with insulin-requiring diabetes, by automatically adjusting insulin delivery in response to blood glucose levels. Currently available systems can only deliver a single hormone—insulin. Other systems currently in development aim to improve on current systems by adding one or more additional hormones that can be delivered as needed, providing something closer to the endocrine functionality of the pancreas.
Abiomed, Inc. is a medical device technology company that operates as a stand-alone business within Johnson & Johnson's MedTech Segment. Abiomed develops and manufactures temporary external and implantable mechanical circulatory support devices. The company is headquartered in Danvers, Massachusetts with additional offices in Woburn, Baltimore, Berlin, Aachen, and Tokyo.
MiniMed Paradigm is a series of insulin pumps manufactured by Medtronic for patients with diabetes mellitus. The pump operates with a single AAA battery and uses a piston-plunger pump to infuse a programmed amount of insulin into the patient through a length of tubing. The Paradigm uses a one-way wireless radio frequency link to receive blood sugar measurements from select glucose meters. The Paradigm RT series adds the ability to receive data from a mated continuous blood-glucose monitor. Although the pump can use these measurements to assist in calculating a dose of insulin, no actual change in insulin delivery occurs without manual user-intervention.
TCA Venture Group is the leading source of funding to early-stage companies in Southern California. In 2023, TCA had about 400 members. In August 2014, an analysis by CB Insights ranked TCA No.1 out of 370 angel groups on “Network Centrality” and No. 5 overall in “Investor Mosaic.”
DexCom, Inc. is a company that develops, manufactures, produces, and distributes continuous glucose monitoring (CGM) systems for diabetes management. It operates internationally with headquarters in San Diego, California, and has manufacturing facilities in Mesa, Arizona and Batu Kawan, Malaysia.
International Diabetes Center at Park Nicollet (IDC) is a center for diabetes care, research and education located in Minneapolis, Minnesota, United States. The center provides clinical, motivational and educational services for people with diabetes. It is part of HealthPartners Institute.
The Journal of Diabetes Science and Technology(JDST) is a bimonthly peer-reviewed medical journal covering all aspects of diabetes. JDST covers all aspects of diabetes technology including glucose monitoring; insulin and metabolic peptide delivery; the artificial and bioartificial pancreas, telemedicine; software for modeling; physiologic monitoring; technology for managing obesity; diagnostic tests of glycation; and the use of bioengineered tools such as MEMS, new biomaterials, and nanotechnology to develop new sensors and actuators to be applied to diabetes. Articles in JDST cover both basic research and clinical applications of technologies being developed to help people with diabetes. It is published by SAGE Publishing on behalf of the Diabetes Technology Society. The journal was established in 2007 and the editor-in-chief is David C. Klonoff.
Insulin degludec/liraglutide, sold under the brand name Xultophy, is a fixed-dose combination medication for the treatment of adults with type 2 diabetes to improve glycemic control in combination with diet and exercise. It contains insulin degludec and liraglutide. It is administered by subcutaneous injection.
Insulin glargine/lixisenatide, sold under the brand name Soliqua among others, is a fixed-dose combination medication that combines insulin glargine and lixisenatide and is used to treat diabetes.
Nightscout is a free and open-source project, and associated social movement, that enables accessing and working with continuous glucose monitor (CGM) data. Nightscout software aims to give users access to their real time blood sugar data by putting this data in the cloud. In addition to browser-based data visualization, Nightscout can also be used to review data from a phone or smartwatch, or to remotely monitor CGM data for individuals with type 1 diabetes. Associated with Nightscout software is a broader "CGM in the Cloud" social movement, supporting individuals seeking to access and use realtime CGM data through commercial and DIY approaches.
The Open Artificial Pancreas System (OpenAPS) project is a free and open-source project that aims to make basic artificial pancreas system (APS) technology available to everyone. The OpenAPS project was designed with the idea of quickly getting the APS technology to more people using a direct approach, rather than waiting for clinical trials to be completed and regulatory approval to be granted.
A continuous glucose monitor (CGM) is a device used for monitoring blood glucose on a continual basis instead of monitoring glucose levels periodically by drawing a drop of blood from a finger. This is known as continuous glucose monitoring. CGMs are used by people who treat their diabetes with insulin, for example people with type 1 diabetes, type 2 diabetes, or other types of diabetes, such as gestational diabetes.
Tidepool is a nonprofit company founded in 2013 which makes open-source tools to help people better manage diabetes. The company works together with Medtronic to create an interoperable automated insulin pump system.
Robin Koops is a Dutch mechanical engineer, designer and inventor. He is known for developing an artificial pancreas.