Beta Bionics develops the iLet Bionic Pancreas, an autonomous insulin delivery system that streamlines diabetes management and reduces the burden on patients, caregivers and physicians. The company focuses on advanced diabetes management solutions and related product development. It plans to use new funding to support expanded commercialization of the iLet Bionic Pancreas and to develop its product pipeline. Financially, Beta Bionics closed a $60M Series E financing to advance those plans. The company is based in Irvine, California. No operating metrics were disclosed in the article. Beta Bionics designs, develops, and commercializes the iLet Bionic Pancreas, an autonomous insulin delivery platform that can operate in single-hormone and bi-hormonal configurations. The iLet uses adaptive, self-learning control algorithms together with continuous glucose monitoring and pump technology to autonomously compute and administer insulin and/or glucagon. The system is intended to mimic the body’s natural glycemic control and reduce the burden of diabetes management for patients and physicians. Led by CEO Sean Saint, the company is organized as a for-profit public benefit corporation and is a Certified B Corporation. Beta Bionics says it will use newly raised capital to expand operations and further its development efforts. The company is based in Concord, MA. Beta Bionics is a clinical-stage medical technology company based in Concord, MA, led by CEO Dr. Ed Damiano. The company designs, develops, and plans to commercialize the iLet® Bionic Pancreas System, which uses adaptive, self-learning control algorithms with continuous glucose monitoring and pump technology to autonomously compute and administer insulin and/or glucagon. Beta Bionics is preparing for regulatory submissions and commercialization pending FDA clearance. The company intends to use the new financing for product development, regulatory submissions, and commercialization preparations for the iLet following FDA clearance. Prior financings include Series B and B-2 rounds in 2018 and 2019 that raised approximately $126 million. Beta Bionics is developing and commercializing the iLet Bionic Pancreas System, a dual-chamber, autonomous, pocket-sized wearable that automatically controls blood-sugar levels. The iLet embeds clinically tested mathematical dosing algorithms driven by lifelong autonomous learning to calculate and dose insulin and/or glucagon using continuous glucose monitor data; users initialize it by entering only their body weight. The device can be configured as an insulin-only, glucagon-only, or dual-hormone system, and the company is pursuing regulatory approval first for the insulin-only device followed by the dual-hormone configuration. Previous home-use studies in adults and children with type 1 diabetes showed dramatic improvements in glycemic control, including reductions in blood-glucose levels, hypoglycemia, and glycemic variability. Financially, Beta Bionics has raised just over $126 million across its Series B and B2 equity financings, with the most recent $63 million Series B2 closing in July 2019. The company will use proceeds to complete final product development, conduct phase 3 clinical trials, submit regulatory filings, and prepare for commercial launch. Beta Bionics develops the iLet, a pocket-sized autonomous dual-chamber bionic pancreas that calculates and doses insulin and/or glucagon using data from a continuous glucose monitor. The iLet uses dosing algorithms developed in the Damiano Lab and incorporates machine-learning AI to autonomously regulate glucose. Beta Bionics plans to begin a pivotal Phase 3 development program in the second half of 2019 and is collaborating with Zealand Pharma to use dasiglucagon as the glucagon component. Prior clinical studies showed the dual-hormone system increases time in the normal glucose range, reduces hypoglycemic events, and lowers the need for corrective carbohydrate intake. Founded in 2015 as a for-profit Massachusetts public benefit corporation and a Certified B Corporation, Beta Bionics is based in Boston with certain operations in Irvine, California. Zealand Pharma’s strategic equity investment supports the company’s continued development and Phase 3 plans.

Total raised

$338M

Funding rounds

7

Latest round

Series E

Latest activity

Nov 2024