Beta Bionics Announces FDA Clearance for the use of a Prefilled Insulin Cartridge with the iLet Bionic Pancreas

Now the iLet Bionic Pancreas is cleared for three insulins
More insulin choices for users
Prefilled insulin cartridge saves time and provides convenience for users

CONCORD, Mass., June 22, 2023: Beta Bionics, Inc. — a medical technology company focused on diabetes — announces FDA 510(k) clearance for compatibility with the Fiasp^® Pumpcart^® (insulin aspart) prefilled insulin cartridge. The iLet is the first and only automated insulin-delivery system that does not require carb counting and fully automates 100% of all user insulin doses – and will provide users the choice of three insulins – Novolog^®, Humalog^® and Fiasp^® Pumpcart^®.

“Beta Bionics has been working tirelessly to create an insulin delivery system that offers less burden and more convenience for the type 1 community. Since launching last month in May 2023, the iLet Bionic Pancreas is now available and clinics and users are being trained on its simple design and easy management features,” said Sean Saint, President and CEO of Beta Bionics. “When Fiasp^® Pumpcart^® prefilled cartridges are available, users will save time not having to manually fill cartridges and will have more choice for their diabetes management.”

The iLet was designed to alleviate the work of diabetes management in everyday life and nearly eliminate the expertise that has been required to set up and manage a traditional insulin pump. The only input that is required to get started is the user’s weight. No carb counting^*, bolusing, correction factors, insulin-to-carb ratios, or pre-set basal rates – the iLet manages a user’s glucose levels with just a meal announcement and it does the rest of the work. The iLet is paired with a Dexcom G6 Continuous Glucose Monitoring System for glucose readings.

If you’d like to GO BIONIC with the iLet Bionic Pancreas, visit our website to fill out our form to get started – www.betabionics.com.

*Carb awareness is required.

About Beta Bionics

Beta Bionics is a medical technology company focused on the design, development, and commercialization of its iLet Bionic Pancreas in both the insulin dosing (the iLet) and bihormonal configurations. The iLet Bionic Pancreas platform is designed to use adaptive, self-learning, control algorithms, together with continuous glucose monitoring and pump technology, to autonomously compute and administer doses of insulin and/or glucagon and mimic the body’s natural ability to maintain tight glycemic control.

Beta Bionics is a for-profit, public benefit corporation and Certified B Corporation. Since its founding in 2015, its mission has been to help improve health outcomes and the quality of life of children and adults living with diabetes and other conditions of glycemic dysregulation.

Fiasp^® Pumpcart^®, and Novolog^® are registered trademarks of Novo Nordisk A/S. Fiasp^® Pumpcart not yet available for sale in the US.

Beta Bionics is a public benefit corporation.

We are committed to balancing purpose with profit and giving back to society as we fulfill our public benefit mission.

Safety Information – The iLet Bionic Pancreas System is indicated for use by people with type 1 diabetes 6 years of age and older. The iLet Bionic Pancreas requires prescription by a physician. Refer to the iLet Bionic Pancreas System User Guide at www.betabionics.com/resouces/user-guides, or for complete safety information including indications, contraindications, warnings, cautions, compatible devices, compatible drugs and instructions, refer to www.betabionics.com/resources/safety. DO NOT start to use the iLet Bionic Pancreas System without adequate training. Incorrect use may result in over-delivery or under-delivery of insulin, which could lead to hypoglycemia or hyperglycemia.

Medical Disclaimer – This website is for information only and is not a substitute for medical advice and/or services from a healthcare provider. All personal health care decisions and treatment should be discussed with a healthcare provider who is familiar with your individual needs.