December 2019 - Beta Bionics

The iLet is a pocket-sized, wearable investigational medical device that autonomnously controls blood sugar in people with diabetes and other conditions — it is the world’s first bionic pancreas system
FDA’s Breakthrough Device Designation Program provides Beta Bionics with priority review among other benefits related to FDA interaction
The iLet Bionic Pancreas System was granted breakthrough designation in all configurations (insulin-only, glucagon-only, and bihormonal), including use with Zealand Pharma’s dasiglucagon, a glucagon analog with a unique stability profile in a ready-to-use aqueous solution

Boston, MA – December 10, 2019 – Beta Bionics, Inc. — a medical technology company developing and aiming to commercialize the world’s first fully automated bionic pancreas — today announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its investigational iLet Bionic Pancreas System.

The iLet Bionic Pancreas System is a pocket-sized, wearable investigational medical device that is designed to autonomously control blood-sugar levels. The on-body wear is similar to that of an insulin pump. Unlike insulin pump therapy, however, the investigational system is designed such that users enter only their body weight for the iLet to initialize therpay. Immediately thereafter, the iLet begins controlling blood-sugar levels automatically, without requiring the user to count carbohydrates, set insulin delivery rates, or deliver bolus insulin for meals or corrections.

The iLet is designed to function as three medical devices in one. It can be configured as an insulin- only bionic pancreas, a glucagon-only bionic pancreas, or a bihormonal bionic pancreas using insulin and glucagon. The insulin-only and bihormonal configurations may be helpful in diabetes. The glucagon-only configuration may be helpful in rare conditions that often lead to chronic, low blood-sugar conditions, such as congenital hyperinsulinism (CHI). Beta Bionics is committed to obtaining regulatory approval and commercializing all three iLet configurations.

The Breakthrough Designation for the iLet Bionic Pancreas System contemplates configurations with most insulin analogs approved for pumping as well as dasiglucagon, Zealand Pharma’s stable pumpable glucagon analog, which has a unique stability profile in a ready-to-use aqueous solution.

We believe the iLet Bionics Pancreas System represents a true breakthrough therapy for the management of glycemia, particularly in type 1 diabetes,

said Ed Damiano, President and CEO of Beta Bionics.

We are partuclarly excited by the possibility that the iLet may be able to provide safer and more effective therapy in far more people than current therapies due to its simplicity of use.

About Beta Bionics

Beta Bionics is a for-profit Massachusetts public benefit corporation founded in 2015 to commercialize the iLet, a revolutionary bionic pancreas that is driven by mathematical dosing algorithms, which incorporate lifelong autonomous learning to automatically control glycemia. These mathematical dosing algorithms were developed in the Damiano Lab at Boston University and refined based on results from home-use clinical trials in adults and children with T1D. Beta Bionics is a Certified B Corporation™ whose founders — in addition to Ed Damiano — include other parents of children with type 1 diabetes and people with type 1 diabetes. Beta Bionics is committed to acting in the best interests of the diabetes community and to profoundly disrupting the diabetes medical device industry by bringing the iLet to market as expeditiously and responsibly as possible. Beta Bionics is pursuing regulatory approval of its insulin-only bionic pancreas, followed by its dual-hormone system, which will also administer a glucagon analog in order to raise blood-sugar levels without the need to consume carbohydrates.

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

Beta Bionics

Ed Damiano
edamiano@betabionics.com

Ed Raskin
eraskin@betabionics.com

Investor Relations Contact

Jeremy Feffer
jeremy@lifesciadvisors.com

A pilot study performed by researchers at the Massachusetts General Hospital tested autonomous glycemic control using the bionic pancreas system in both insulin-only and bihormonal configurations
While using the bionic pancreas, the study subjects experienced improved glycemic control and decreased diabetes-management burden
The study suggests that autonomous glycemic control using the bionic pancreas is worthy of further investigation on a wider scale in patients with cystic fibrosis-related diabetes (CFRD)

Boston, MA – December 3, 2019 – Beta Bionics, Inc. — a medical technology company developing and aiming to commercialize the world’s first fully automated bionic pancreas today announced that its bionic pancreas glucose control algorithms that use lifelong autonomous learning were deployed in a pilot study comparing usual care with automated insulin-only and bihormonal (insulin and glucagon) delivery in three patients with cystic fibrosis related diabetes (CFRD). Results of the study were published in the Journal of Cystic Fibrosis (J.S. Sherwood, R.Z. Jafri, C.A. Balliro, et al., Automated glycemic control with the bionic pancreas in cystic fibrosis-related diabetes: A pilot study, Journal of Cystic Fibrosis, https://doi.org/10.1016/j.jcf.2019.08.002).

Researchers at the Massachusetts General Hospital performed a three-arm, random-order, cross-over, pilot study comparing the bihormonal bionic pancreas versus the insulin-only bionic pancreas versus usual care for CFRD. The bionic pancreas dosing algorithms utilized in this pilot study were identical to those used in other studies in subjects with type 1 diabetes. There were no restrictions on activity and subjects continued their normal diet, exercise, and work throughout the study. The bionic pancreas was initialized only with subject body weight, without any information regarding their usual insulin regimen.

Given the sample size of the study, only descriptive statistics were reported for the group. The group mean blood-glucose level, as measured by continuous glucose monitoring (CGM), was nominally lower in both the bihormonal (139 ± 15 mg/dl) and insulin-only (149 ± 10 mg/dl) bionic pancreas study arms relative to the usual care study arm (159 ± 35 mg/dl). During bionic pancreas arms, subjects used the meal announcement feature on average less than once per day, and survey data suggested that subjects had a decreased diabetes-management burden. Subjects reported they spent less time thinking about diabetes, felt more freedom with food choices, and had overall greater peace of mind.

We are encouraged by the results of this pilot study suggesting that our bionic pancreas technology can potentially be deployed in multiple conditions of glycemic disregluation, including CFRD

said Ed Damiano, President and Chief Executive Officer of Beta Bionics.

We look forward to continuing our commitment to innovation through clinical research as we plan to test multiple applications of our technology in further clinical studies in an effort to maximize the potential good our technology and company can bring to the diabetes community.

This pilot study was supported by the National Institutes of Health under award number R01DK119699-01.