Pivotal Trial Results of the iLet® Bionic Pancreas to Be Presented at the ADA’s 82nd Scientific Sessions

Concord, Massachusetts, UNITED STATES


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

  • Dr. Roy W. Beck will moderate a session: The Insulin-Only Bionic Pancreas Pivotal Trial—Randomized Clinical Trial Results at 12:45 p.m. CDT on Friday, June 3, in Ernest N. Morial Convention Center Great Hall A at the ADA Scientific Sessions. The session will feature results from the following populations within the Insulin-Only Bionic Pancreas Pivotal Trial (IO BPPT): Adults, pediatrics, and adults using the iLet® Bionic Pancreas with Fiasp®. Additionally, information on the results of the patient-reported outcomes will be shared.
  • There are also four poster sessions on Sunday, June 5 from 12:00-1:00 p.m. CDT in the Poster Hall to present results from the Insulin-Only Bionic Pancreas Pivotal Trial.
  • The iLet® Bionic Pancreas is a pocket-sized, wearable, investigational medical device designed to autonomously determine and deliver insulin doses to control blood glucose levels in people with diabetes.

CONCORD, Mass., June 01, 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 Dr. Roy W. Beck and investigators will host a session: The Insulin-Only Bionic Pancreas Pivotal Trial—Randomized Clinical Trial Results at 12:45 p.m. CDT on Friday, June 3, in Ernest N. Morial Convention Center Great Hall A in New Orleans during the American Diabetes Association (ADA) 82nd Scientific Sessions.

The session will feature results from the following populations within the Insulin-Only Bionic Pancreas Pivotal Trial (IO BPPT): Adults and pediatrics using the iLet with Humalog® or Novolog®, and adults using the iLet with Fiasp®. Information on the results of the patient-reported outcomes will also be shared. The following investigators will also be participating in the session:

  • Roy W. Beck, MD, Ph.D. Jaeb Center for Health Research: Session Chair
  • Greg Forlenza, MD: The iLet Bionic Pancreas and Study Design
  • Davida Kruger, MSN, APN-BC: Main Adult RCT Results     
  • Laurel H. Messer, Ph.D.: Main Pediatric RCT Results         
  • Bruce Buckingham, MD: RCT Results Using Fast-Acting Aspart (Fiasp®) in the Bionic Pancreas   
  • Jill Weissberg-Benchell, Ph.D., CDCES: Patient-reported Outcomes
  • Steven A. Russell, MD, Ph.D.: Ancillary Studies and Discussion of Results

“This data release builds on the IO BPPT momentum that started at ATTD, and it continues to advance our understanding of what the iLet® may offer,” said Martha Goldberg Aronson, Interim CEO and Board Director, Beta Bionic. “We are excited and honored to celebrate significant milestones — such as another data release — with the diabetes community at the American Diabetes Association Meeting.”

On Sunday, June 5, from 12:00-1:00 p.m. CDT in the Poster Hall the following poster sessions will occur to present results from the IO BPPT:

  • Courtney Balliro, BS, RN, CDE: Safety of Glucose Regulation by the Bionic Pancreas without Continuous Glucose Monitoring Input
  • Jill Weissberg-Benchell, Ph.D., CDCES: Adult’s Lived Experience Using the Insulin-Only Bionic Pancreas/ Youth and Parent’s Experiences Using the Insulin-Only Bionic Pancreas
  • Jane Lynch, MD: Outcomes from the Insulin-Only Bionic Pancreas Pivotal Extension Study
  • Nelly Mauras, MD: Utility and Safety of Backup Insulin Regimens Generated by the Bionic Pancreas – A Randomized Study

For more information on the IO BPPT results, read the previous data release: The iLet® Bionic Pancreas Significantly Reduced HbA1c and Improved Time in Range vs Standard of Care for a Diverse Range of People with Type 1 Diabetes.

To learn more about the ADA Meeting, visit: 82nd Scientific Sessions | American Diabetes Association

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 Duo™) 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 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.

Investor Relations Contact:
Hattie Bailey
Senior Investor Relations Manager & Assistant Corporate Secretary
ir@betabionics.com

Media and Public Relations Contact:
Katy O’Neill
Beehive Strategic Communication
media@betabionics.com