Pivotal Trial Results of the iLet® Bionic Pancreas To Be Presented at ATTD

• Dr. Steven J. Russell will present the results from the multi-center randomized Insulin-Only Bionic Pancreas Pivotal Trial at the International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) on Saturday, April 30, 2022, at 9:00-9:20 am CEST (Central European Summer Time).
• The iLet Bionic Pancreas is a pocket-sized, wearable device that is designed to autonomously determine and deliver insulin doses to control blood glucose levels in people with diabetes.
• The Insulin-Only Bionic Pancreas Pivotal Trial population was more diverse and representative of the United States type 1 diabetes community than any previous pivotal trial of an automated insulin delivery system.
  

CONCORD, Mass., April 25, 2022 (GLOBE NEWSWIRE) -- Beta Bionics, Inc. ? a clinical stage medical technology company committed to the design, development, and commercialization of the iLet^® Bionic Pancreas ? announces that Dr. Steven J. Russell, Associate Professor of Medicine, Harvard Medical School, will present the results from the multi-center randomized Insulin-Only Bionic Pancreas Pivotal Trial (IO BPPT) at the International Conference on Advanced Technologies & Treatments for Diabetes (ATTD). The plenary session (4) will be on Saturday, April 30, 2022, from 9:00-9:20 am CEST in Hall 112.

"Along with striving to improve HbA1c and time in range, we are committed to addressing the cognitive burden of managing T1D," said Martha Goldberg Aronson, Interim CEO and Board Director, Beta Bionics. "The IO BPPT results demonstrate that commitment and signal the momentum we feel as a company. We are excited for the data to be shared publicly and for our continued progress towards the next phase of the organization."

The IO BPPT was an investigator-initiated, multi-center, randomized controlled trial funded, in part, by a grant from the National Institutes of Health to Boston University, and conducted in collaboration with the study coordinator, the Jaeb Center for Health Research, and 16 clinical research centers across the U.S. The trial was designed to test the safety and efficacy of the insulin dosing configuration of the iLet Bionic Pancreas relative to a standard-of-care control group over a 13-week study period. Standard of care included both pump therapy and multiple daily injections. The trial was conducted in the home-use setting and enrolled 440 adults and children 6 years and older with type 1 diabetes.

The trial was designed to reach a broad demographic with respect to not only race, ethnicity, age, and therapy type but also baseline glycemic control. The IO BPPT population was more diverse and representative of the United States type 1 diabetes community than any previous pivotal trial of an automated insulin delivery system.¹  

The cognitive and emotional impact of diabetes can lead to data and decision-making overload. American adults with type 1 diabetes ranked simple and predictable diabetes management as the greatest unmet need and ranked reduced mental effort as the fourth greatest unmet need in type 1 diabetes therapy.² Despite advances in medications and technology, approximately 80% of people who live with type 1 diabetes are not meeting the ADA therapy goal of an HbA1c below 7%.³  

For more information on Plenary 4 or the ATTD 2022 schedule, visit: https://cslide.ctimeetingtech.com/attd2022/attendee/confcal/session/calendar/2022-04-30

About the iLet^® Bionic Pancreas
The iLet^® is a pocket-sized, wearable investigational medical device designed to autonomously dose insulin. It is designed to be worn like an insulin pump; however, iLet^® users would enter only their body weight to initialize therapy and would not set any insulin regimen parameters. The iLet^® is designed to then automatically titrate and infuse insulin without requiring the user to count carbohydrates, set insulin-to-carbohydrate ratios, set insulin basal rates, set correction factors, or determine bolus insulin for meals or corrections. The technology is designed to help a broad base of people who wish to use technology to manage diabetes.

About Beta Bionics
Beta Bionics^® is a clinical stage medical technology company focused on the design, development, and commercialization of its iLet^® Bionic Pancreas in both the insulin dosing (the iLet^®) and bihormonal (iLet Duotm) 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 Corporationtm. Since its founding in 2015, its mission is to help improve health outcomes and the quality of life of children and adults living with diabetes and other conditions of glycemic dysregulation.

Beta Bionics operates in Massachusetts and California. For further information, visit www.betabionics.com or follow Beta Bionics on Facebook, YouTube, Instagram, LinkedIn, and Twitter @BetaBionics.

Caution: The iLet^® Bionic Pancreas is an investigational device limited by Federal (or United States) law to investigational use. Not available for sale.

1. Data on File. 2 Pettus et al. Diabetes Technol Ther. 2019; 21(6): 336?43 3. Pettus et al., Diabetes Care. 2019;42:2220?2227

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