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

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

  •  The trial achieved key primary and secondary endpoints, demonstrating improved outcomes over standard of care for people living with type 1 diabetes.
  •  The study population — 440 adults and children 6 years and older with type 1 diabetes — was more diverse and representative of the U.S. type 1 diabetes population than any previous pivotal trial of automated insulin delivery systems.
  • 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.
  •  Dr. Steven J. Russell, principal investigator, presented the results from the multi-center randomized Insulin-Only Bionic Pancreas Pivotal Trial at Advanced Technologies & Treatments for Diabetes (ATTD) on Saturday, April 30, 2022.
  •  The study results have been included in a comprehensive submission package to the FDA for regulatory review

CONCORD, Mass., April 30, 2022 (GLOBE NEWSWIRE) — Beta Bionics, Inc. — The results of the multi-center randomized Insulin-Only Bionic Pancreas Pivotal Trial (IO BPPT) were presented today by Dr. Steven J. Russell, Associate Professor of Medicine, Harvard Medical School, at the International Conference on Advanced Technologies & Treatments for Diabetes (ATTD).

Insulin-Only Bionic Pancreas Pivotal Trial Results & Background

The pivotal trial was designed to test the safety and efficacy of the iLet Bionic Pancreas relative to a standard of care control group over a 13-week study period. The standard of care group was comprised approximately one-third each on automated insulin delivery (AID) systems, insulin-pump therapy with continuous glucose monitoring (CGM), and multiple daily injection therapy with CGM. The trial was conducted in a home-use setting and enrolled 440 adults and children aged 6 years and older with type 1 diabetes. The primary analysis of the trial compared the iLet, using Humalog® or Novolog®, versus standard of care in 326 adults and children; the remaining 114 adult participants used the iLet with Fiasp®.

The iLet Bionic Pancreas met all key endpoints in the IO BPPT. The primary analysis demonstrated improved outcomes over standard of care in the following domains:

  • Significant reduction in HbA1c: After 13 weeks, the average HbA1c in the people who used the iLet Bionic Pancreas was reduced by 0.5% compared to those using standard of care. In an analysis of participants who had a baseline HbA1C greater than 7%, there was a 0.7% reduction of HbA1c in the iLet Bionic Pancreas arm vs standard of care.
  • No increased risk of hypoglycemia: People with diabetes who used the iLet Bionic Pancreas did not experience any significant increase in the average time they spent with their CGM values less than 54 mg/dL over 13 weeks compared to those using standard of care.
  • Increased time in range: People who used the iLet Bionic Pancreas had an average of 2.6 hours more time in range per day over the 13 weeks than those using standard of care.

Beta Bionics is committed to making its type 1 diabetes management technology accessible to the many, not just the few, by reducing the cognitive burden of living 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 people with type 1 diabetes in the United States than any previous pivotal trial of an AID system.1 The racial and ethnic composition in the primary analysis included 74% White non-Hispanic, 10% Black non-Hispanic, 10% Hispanic or Latino and 6% other or more than one race.

The results of this trial confirm that the iLet Bionic Pancreas may serve a population of people who are otherwise unable to reach glycemic goals with currently available diabetes technology,

said Jeanne Jacoby, FNP, CDCES, Director of Medical Affairs, Beta Bionics.

As a medical professional and a person with diabetes, I look forward to us being able to offer a solution that may change the lives of this underserved population.

The IO BPPT was a 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 IDE sponsor and study coordinator, the Jaeb Center for Health Research, and 16 clinical research centers across the U.S.

Addressing the Cognitive Burden of Type 1 Diabetes

The cognitive and emotional impact of diabetes can lead to data and decision-making overload. Adults with type 1 diabetes in the U.S. ranked simpler management as the greatest unmet need and reduced mental effort as the fourth greatest unmet need in current diabetes technology.2 Despite advances in medications and technology, approximately 80%3 of people with type 1 diabetes are not meeting the American Diabetes Association (ADA) therapy goal of an HbA1c below 7%.

Recent advances in type 1 diabetes technology lack the flexibility to support the diverse needs, experiences, and resources of those living with diabetes. If cleared by the U.S. Food and Drug Administration (FDA), Beta Bionics hopes the iLet Bionic Pancreas will improve the lives of people living with diabetes by improving glycemic control relative to the standard of care and by helping reduce data and decision-making overload. The iLet Bionic Pancreas received breakthrough device designation in 2019 from the FDA and its regulatory submission is currently under review.

We are committed to improving the lives of people living with diabetes by helping to reduce the data and decision-making overload,

said Martha Goldberg Aronson, Interim CEO and Board Director, Beta Bionics.

The IO BPPT results show significantly reduced HbA1c without increasing the risk of hypoglycemia utilizing technology requiring only the user’s weight to initialize.

Even with the technology that is currently available, the management of type 1 diabetes requires a significant number of mathematical inputs. The iLet Bionic Pancreas is designed to serve those beyond the current market — those who do not reach their ADA goal, are overloaded by data or are tired of math and numbers. The iLet Bionic Pancreas requires only one numerical input to get started—the user’s weight.1

Ever since my son developed type 1 diabetes as an infant almost 22 years ago, I had hoped that technological advancements would bring even better glycemic control to people with diabetes, and without the relentless demand that insulin-dosing decisions fall to them or their health care providers,

said Dr. Ed Damiano, Founder and Executive Chair, Beta Bionics.

I see the results of this pivotal trial as being truly pivotal for the type 1 diabetes community, as the culmination of two decades of technological evolution that brings me great joy and a wonderful sense of accomplishment and pride in our team at Beta Bionics, the clinical collaborators who conducted the study, our strategic partners and investors who supported us over the years, and the industriousness of human innovation.

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.

1. Data on File. 2. Pettus et al. Diabetes Technol Ther., 2019;21(6):336–343. 3. Pettus et al., Diabetes Care, 2019;42:2220–2227.

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

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

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

  • 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 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.
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

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

Back

Beta Bionics Announces Executive Leadership and Board Transitions in Preparation for Commercialization of the iLet® Bionic Pancreas System

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

·       Dr. Ed Damiano, President & CEO of Beta Bionics, is now assuming the role of Founder and Executive Chair

·       Martha Goldberg Aronson, Board Chair, is now serving as interim CEO and Board Director

·       Christy Jones, Board Member, is now serving as Lead Independent Director

·       Mike Rosinko, Chief Technology Officer of Beta Bionics, retires after leading R&D teams in diabetes MedTech for over 15 years

CONCORD, Mass., March 2, 2022 (GLOBE NEWSWIRE) — Beta Bionics, Inc. — a clinical-stage medical technology company committed to the design, development, and commercialization of the iLet® Bionic Pancreas System — today announced that Dr. Ed Damiano, President & CEO and co-founder of Beta Bionics, is assuming a new role with the title of Founder and Executive Chair. Martha Goldberg Aronson, Chair of the Board, is now serving as interim CEO while Beta Bionics conducts an external search for a new CEO. Goldberg Aronson remains on the Board and Christy Jones is now serving as the Lead Independent Director of the Board.

Beta Bionics recently announced locking of the database for the Insulin-Only Bionic Pancreas Pivotal Trial in December of 2021, as well as the closing of its Series C equity financing in February of 2022. These achievements, and the evolution of the leadership team in 2022, position the organization well for successful commercialization of the insulin dosing iLet® Bionic Pancreas System following FDA clearance.

In his role as Founder and Executive Chair, Damiano will focus on product pipeline and new-technology development, advancing clinical research programs, including the Bihormonal Bionic Pancreas Pivotal Trial, regulatory submissions and interactions with regulatory authorities, and preparation of scientific manuscripts for the primary literature. He will also remain a champion for the Beta Bionics public benefit mission and will continue to communicate that mission to the principal Beta Bionics stakeholders, including the diabetes community and the Beta Bionics employees and shareholders.

The locking of the database for the Insulin-Only Bionic Pancreas Pivotal Trial and the additional financing that we recently received were watershed moments for us at Beta Bionics,”

said Damiano.

These milestones are transformational for the organization as a whole, and have important implications for me personally, as I focus my expertise and skill sets on those tasks that best support the company going forward. The last year saw enormous growth for Beta Bionics and strong additions to our senior leadership team in Marcie Cain, our Chief People Officer, and Michael Pereira, our Chief Operating Officer. I look forward to working with Martha and the rest of the Board as we transition from the R&D and clinical-stage company we are today to the commercial-stage organization we aspire to be.

As interim CEO and Board Director, Goldberg Aronson will be working with Damiano and the Board of Directors through the ongoing CEO search. Goldberg Aronson has spent her career in the medical device industry and has led global healthcare businesses ranging in size from incubation to $1 billion in revenue.

I am excited to work with Ed in his role as Founder and Executive Chair,”

said Goldberg Aronson.

This team of passionate, dedicated employees is well-positioned to take this company to the next phase of growth. As we prepare for commercialization, we remain committed to fulfilling the Beta Bionics public benefit mission.

In addition to these changes in executive leadership, Chief Technology Officer, Mike Rosinko, who led the R&D team in the development of the iLet Bionic Pancreas System, has retired after five years with Beta Bionics. Rosinko has had a distinguished career that has spanned more than 30 years in MedTech, including 15 years leading R&D teams in diabetes MedTech. Rosinko will continue as a consultant to Beta Bionics, sharing his expertise in refining and extending the company’s technology portfolio and product pipeline.

I am proud of the progress made on developing the iLet for testing in the recently completed Insulin-Only Bionic Pancreas Pivotal Trial,”

said Rosinko.

I am pleased to have had the opportunity to work with Ed and the Beta Bionics team to develop technology designed to improve the lives of people living with diabetes. I am looking forward to continuing my work with Ed and the Beta Bionics team as we further advance and develop this technology.

About the iLet® Bionic Pancreas

The iLet is a pocket-sized, wearable investigational medical device designed to autonomously dose insulin and/or glucagon. 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 and/or glucagon doses 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; not just people with type 1 diabetes on the iLet, but also their family members, caregivers, and healthcare providers who have time and resource limitations and potentially no access to subspecialists.

The intent of the technology is to achieve near-normal glycemia and lift the cognitive daily burden of diabetes management in as many people with diabetes as possible. The cognitive and emotional impact of diabetes can lead to data and decision-making overload for people living with diabetes. Despite advances in medications and technology, approximately 80%1 of people who live with type 1 diabetes are not meeting the ADA therapy goal of an HbA1c below 7%.

Recent advances in type 1 diabetes technology lack the flexibility to support the different needs, experiences, and resources of those living with diabetes. If cleared by the FDA, Beta Bionics hopes the iLet Bionic Pancreas will improve the lives of people living with diabetes by improving glycemic control relative to the standard of care and by helping reduce data and decision-making overload.

About Beta Bionics
Beta Bionics® is a clinical stage medical technology company focused on the design, development, and commercialization of its iLet® Bionic Pancreas System. The iLet Bionic Pancreas 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.

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. Pettus et al., Diabetes Care. 2019;42:2220–2227

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

Back

Beta Bionics Announces Closing of $57 Million Series C Financing

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

  • The financing round was co-led by existing Series B and B-2 investors Soleus Capital, Perceptive Advisors, Farallon Capital Management, L.L.C., RTW Investments, LP, and Eventide Asset Management
  • New investor Pura Vida Investments participated in the round
  • Other participants included existing Series B and B-2 investors ArrowMark Partners, LifeSci Venture Partners, and strategic partner Novo Nordisk
  • Funds will support product development, regulatory submissions, and preparations for the commercialization of the insulin dosing iLet® Bionic Pancreas System following FDA clearance

CONCORD, Mass., Feb. 17, 2022 (GLOBE NEWSWIRE) — Beta Bionics, Inc. — a clinical stage medical technology company committed to the design, development, and commercialization of the iLet® Bionic Pancreas System — today announced the completion of a $57 million Series C equity financing. Proceeds from the financing will support product development, regulatory submissions, and preparations for the commercialization of the insulin dosing iLet® Bionic Pancreas System following FDA clearance.

The Series C financing round was co-led by existing Series B and B-2 investors Soleus Capital, Perceptive Advisors, Farallon Capital Management, L.L.C., RTW Investments, LP, and Eventide Asset Management. In addition, new investor Pura Vida Investments participated in the round, as did previous Series B and B-2 investors ArrowMark Partners, LifeSci Venture Partners, and strategic partner Novo Nordisk. This financing adds to the Series B and B-2 financings in 2018 and 2019 that raised approximately $126 million.

We are very pleased to have completed our third round of institutional financing and are excited to welcome Pura Vida into our strong syndicate of investors,

said Dr. Ed Damiano, President and CEO, Beta Bionics.

This financing will support the growth of our organization and further development of the iLet, as we continue to work toward our mission to bring autonomous insulin-delivery solutions to those living with type 1 diabetes. We are grateful for the continued support and vision of our investor syndicate and are delighted to be adding another well-respected investor to this esteemed group.

We are excited to play a role in helping Beta Bionics deliver patient-centric innovation to the type 1 diabetes community and reduce the cognitive and emotional impacts that type 1 diabetes has on this population,

said Efrem Kamen, managing member of Pura Vida Investments.

We look forward to supporting the team and company through the next phase of its growth.

About the iLet® Bionic Pancreas

The iLet is a pocket-sized, wearable investigational medical device designed to autonomously dose insulin and/or glucagon. 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 infuse insulin and/or glucagon without requiring the user to count carbohydrates, set insulin-to-carbohydrate ratios, set insulin basal rates, set correction factors, or deliver 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; not just people with type 1 diabetes on the iLet, but also their healthcare providers who have time and resource limitations and potentially no access to subspecialists.

The intent of the technology is to achieve near-normal glycemia and lift the cognitive daily burden of diabetes management in as many people with diabetes as possible.

The cognitive and emotional impact of diabetes can lead to data and decision-making overload for people living with diabetes. Despite advances in medications and technology, approximately 80%1 of people who live with type 1 diabetes are not meeting the ADA therapy goal of an HbA1c below 7%.

Recent advances in type 1 diabetes technology lack the flexibility to support the different needs, experiences, and resources of those living with diabetes. If cleared by the FDA, Beta Bionics hopes the iLet Bionic Pancreas will improve the lives of people living with diabetes by improving glycemic control relative to the standard of care and by helping reduce data and decision-making overload.

About Beta Bionics

Beta Bionics® is a clinical stage medical technology company focused on the design, development, and commercialization of its iLet® Bionic Pancreas System. The iLet Bionic Pancreas 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.

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. Pettus et al., Diabetes Care. 2019;42:2220–2227

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

Back

Beta Bionics Announces Data Lock of the Insulin-Only Bionic Pancreas Pivotal Trial and Enrollment into the Screening Protocol of the Bihormonal Bionic Pancreas Pivotal Trial

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

  • The iLet® Bionic Pancreas is a pocket-sized, wearable investigational medical device that is designed to autonomously determine and deliver insulin and/or glucagon doses to control blood-glucose levels in people with diabetes and other conditions of glycemic dysregulation
  • Data lock has been completed for the randomized controlled trial period of the Insulin-Only Bionic Pancreas Pivotal Trial, which tested the insulin-only configuration of the iLet Bionic Pancreas in approximately 440 adults and children 6 years and older with type 1 diabetes
  • Enrollment has begun into the screening protocol of the Bihormonal Bionic Pancreas Pivotal Trial at Massachusetts General Hospital. This pivotal trial will test the bihormonal configuration of the iLet Bionic Pancreas in approximately 700 adults and children 6 years and older with type 1 diabetes

CONCORD, Mass., Dec. 22, 2021 (GLOBE NEWSWIRE) — Beta Bionics, Inc. — a clinical stage medical technology company committed to the design, development, and commercialization of the iLet® Bionic Pancreas System — today announced the completion of the randomized controlled trial for the Insulin-Only Bionic Pancreas Pivotal Trial and enrollment into the screening protocol of the Bihormonal Bionic Pancreas Pivotal Trial at Massachusetts General Hospital. The iLet Bionic Pancreas is designed to mimic the biological pancreas by autonomously calculating and dosing insulin and/or glucagon as needed based on an input signal from a continuous glucose monitor worn by a person with type 1 diabetes. Insulin dosing decisions (basal, bolus, and correction) are made autonomously by the proprietary algorithm embedded on the iLet. The intent of the technology is to achieve near-normal glycemia and lift the cognitive daily burden of diabetes management in as many people with diabetes as possible.

The cognitive and emotional impact of diabetes can lead to data and decision-making overload for people living with diabetes. Despite advances in medications and technology, approximately 80%1 of people who live with type 1 diabetes are not meeting the ADA therapy goal of an HbA1c below 7%.

Recent advances in type 1 diabetes technology lack the flexibility to support the different needs, experiences, and resources of those living with diabetes. If cleared by the FDA, Beta Bionics hopes the iLet Bionic Pancreas will improve the lives of people living with diabetes by improving glycemic control relative to the standard of care and by helping reduce data and decision-making overload.

Data Lock of the Insulin-Only Bionic Pancreas Pivotal Trial

The Insulin-Only Bionic Pancreas Pivotal Trial 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 17 clinical research centers across the U.S. It was designed to test the safety and efficacy of the insulin-only configuration of the iLet Bionic Pancreas System relative to a standard-of-care control group over a 13-week study period. The trial was conducted in the home-use setting and enrolled approximately 440 adults and children 6 years and older with type 1 diabetes. It was the largest sample size to date for a randomized controlled trial of an automated insulin delivery system.

Beta Bionics is committed to making its type 1 diabetes management technology accessible to the many, not just the few. Consequently, the trial was designed to reach a broad demographic with respect to race, ethnicity, age, therapy type, and baseline glycemic control. A large cross-section of trial participants was recruited in an attempt to represent, as closely as possible, the type 1 diabetes population in the U.S.

Data lock for the randomized controlled trial occurred last week. Data lock is the process of locking a clinical trial database to prevent further changes to the database. This is also the time when the data are “unblinded” or released to the statisticians who will analyze the data. Public presentation of the clinical data is expected in the first half of 2022.

Data lock of the Insulin-Only Bionic Pancreas Pivotal Trial represents a major milestone for our organization as we work to bring autonomous insulin-delivery solutions to those living with type 1 diabetes,

said Dr. Ed Damiano, President and CEO of Beta Bionics.

We are grateful to the study participants, sponsors, and clinical collaborators for their commitment and dedication to testing the iLet in this well-designed, real-world, hypothesis-driven clinical trial. The time and effort they have brought to their work will be instrumental in helping us at Beta Bionics fulfill our mission of providing safe and effective glycemic control to people living with type 1 diabetes while helping reduce the emotional and cognitive burden of diabetes management.

Enrollment into the Screening Protocol of the Bihormonal Bionic Pancreas Pivotal Trial

Enrollment into the screening protocol of the Bihormonal Bionic Pancreas Pivotal Trial began last week at Massachusetts General Hospital. The screening protocol identifies potential participants for the pivotal trial. This trial is being coordinated by the Jaeb Center for Health Research and will test the bihormonal configuration of the iLet Bionic Pancreas System using Zealand Pharma’s dasiglucagon in adults and children 6 years and older with type 1 diabetes. The trial includes three sub-trials, which are anticipated to provide the clinical data necessary to support the market application for the bihormonal configuration of the iLet Bionic Pancreas and the new-drug application (NDA) for the use of dasiglucagon in bihormonal artificial pancreas systems.

The first of these three sub-trials will be an initial three-month single-arm, bihormonal-only safety and test-run period that will enroll two participants at each of the approximately 30 clinical sites. A six-month, three-arm, randomized controlled trial will follow the test-run period and will enroll approximately 700 participants. A six-month extension study will immediately follow the randomized controlled trial for all of the approximately 700 participants.

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

About the iLet® Bionic Pancreas

The iLet is a pocket-sized, wearable investigational medical device designed to autonomously dose insulin and/or glucagon. 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 infuse insulin and/or glucagon without requiring the user to count carbohydrates, set insulin-to-carbohydrate ratios, set insulin basal rates, set correction factors, or deliver 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; not just people with type 1 diabetes on the iLet, but also their healthcare providers who have time and resource limitations and potentially no access to subspecialists.

About Beta Bionics

Beta Bionics® is a clinical stage medical technology company focused on the design, development, and commercialization of its iLet® Bionic Pancreas System. The iLet Bionic Pancreas 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. The iLet® Bionic Pancreas system is an investigational device, limited by federal (or United States) law to investigational use only.

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.

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.

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

  1. Pettus et al., Diabetes Care. 2019;42:2220–2227

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

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Beta Bionics Announces Appointment of Christy Jones to Board of Directors

Irvine, CA – May 6, 2021 – Beta Bionics, Inc., a medical technology company focused on the design, development, and commercialization of the iLet® bionic pancreas system, today announced the appointment of Christy Jones to its Board of Directors.

We are delighted to welcome Christy to our Board of Directors,

commented Ed Damiano, President and Chief Executive Officer.

Christy is a highly respected entrepreneur with a successful track record of bringing new technologies to market. Her unique experience as a founder and CEO of both public and private companies in the health sciences and tech sectors, will be invaluable in guiding our mission to bring the iLet to as many people with diabetes as possible.

I am excited for the opportunity to work alongside such a passionate and mission-driven organization. I look forward to helping the team drive the company’s public benefit mission forward as we work to create a solution that will improve the quality of life for people with diabetes.

said Ms. Jones.

Ms. Jones is Managing Director of Richmond Capital Partners and serves on the board of Extend Fertility, which she founded in 2004. She previously served on the board of Optiva, Inc. She is also the co-founder of Trilogy Software and served as the President and Founder of pcOrder, which she successfully led from start-up to a NASDAQ-listed public corporation. Ms. Jones has been honored as Ernst and Young’s “National Young Entrepreneur of the Year”, a “Top 100 Young Innovator” by MIT’s Technology Review, and “Top 20 Leaders Under 30” by Working Woman.

Ms. Jones is an Aspen Institute Henry Crown Fellow and received her Master of Business Administration from Harvard Business School and a Bachelor of Arts in Economics from Stanford University.

About Beta Bionics

Beta Bionics® is a medical device company focused on the design, development, and commercialization of its iLet bionic pancreas system, which has the potential to be a revolutionary solution for people with diabetes on intensive insulin therapy. The iLet bionic pancreas is designed to use adaptive control algorithms, together with continuous glucose monitoring and pump technology, to autonomously compute and administer all doses of either insulin or glucagon or both and mimic the body’s natural ability to maintain tight glycemic control.

The iLet bionic pancreas features an intuitive user interface, which only requires the input of a patient’s body weight to initiate dosing. The iLet’s simple user interface, together with its automated, adaptive control algorithms, is designed to eliminate many of the cumbersome tasks of diabetes management in order to decrease the cognitive and emotional burden of living with diabetes.

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 all children and adults living with diabetes and other conditions of glycemic dysregulation.

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.

Investor Relations Contact

Hattie Bailey hbailey@betabionics.com

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Beta Bionics announces the appointment of Martha Goldberg Aronson as Chair of its Board of Directors

Concord, MA – February 9, 2021 – Beta Bionics, Inc., a medical technology company focused on the design, development, and commercialization of the iLet® bionic pancreas system, today announced the appointment of Martha Goldberg Aronson as Chair of its Board of Directors, effective immediately.

Ms. Aronson, who joined the Beta Bionics Board as a Director in February of 2020, succeeds Ed Damiano, President and Chief Executive Officer of Beta Bionics, who has served as Chair since inception of the company in 2015. Dr. Damiano will remain a member of the Board while continuing to serve in his roles as President and Chief Executive Officer of Beta Bionics.

On behalf of the Board, I am pleased to welcome Martha into the role of Chair,

commented Ed Damiano, President and Chief Executive Officer.

We look forward to continuing to benefit from Martha’s leadership, knowledge, and healthcare expertise as we seek to fulfill our mission to bring the iLet to as many people living with diabetes as possible. It has been a great honor to have served as Chair of the Beta Bionics Board of Directors over the past five years, and I’m looking forward to continuing to work closely with Martha and the Board.

I am honored to take on the role of Chair of the Beta Bionics Board of Directors as we continue to grow the organization and deliver on the Company’s mission. Working alongside Ed and our fellow directors, we will not only strive toward this mission, but also serve our varied stakeholders as a public benefit corporation and Certified B Corp.

said Ms. Aronson.

Ms. Aronson brings more than two decades of leadership experience in publicly traded companies in the med-tech industry. She currently serves as Lead Independent Director on the board of Conmed Corporation (NYSE: CNMD) and on the board of Cardiovascular Systems Inc. (NASDAQ: CSII). Her previous board roles included serving as a director at Hutchinson Technology, Inc. (NASDAQ: HTCH) and Methode Electronics (NYSE: MEI). She was the executive vice president and president of Global Healthcare at Ecolab, Inc., where she was responsible for the global healthcare business with a specific focus on products and programs for infection prevention. Prior to that, Ms. Aronson served as senior vice president and president, North America, at Hill-Rom Holdings, where she was responsible for a $1-billion hospital equipment business. Ms. Aronson also spent 18 years in various general management and executive roles at Medtronic, Inc., both in the U.S. and internationally.

Ms. Aronson received her Master of Business Administration from Harvard Business School and a Bachelor of Arts in Economics from Wellesley College, graduating magna cum laude and Phi Beta Kappa.

About Beta Bionics

Beta Bionics® is a medical device company focused on the design, development, and commercialization of its iLet bionic pancreas system, which has the potential to be a revolutionary solution for people with diabetes on intensive insulin therapy. The iLet bionic pancreas is designed to use adaptive control algorithms, together with continuous glucose monitoring and pump technology, to autonomously compute and administer all doses of either insulin or glucagon or both and mimic the body’s natural ability to maintain tight glycemic control.

The iLet bionic pancreas features an intuitive user interface, which only requires the input of a patient’s body weight to initiate dosing. The iLet’s simple user interface, together with its automated, adaptive control algorithms, is designed to eliminate many of the cumbersome tasks of diabetes management in order to decrease the cognitive and emotional burden of living with diabetes.

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 all children and adults living with diabetes and other conditions of glycemic dysregulation.

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

Investor Relations Contact

Hattie Bailey
hbailey@betabionics.com

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Beta Bionics appoints Beth Brooke to its Board as Independent Director

Concord, MA – December 30, 2020 – Beta Bionics, Inc. — a medical technology company developing the iLet™ the world’s first fully automated bionic pancreas system — today announced that Beth Brooke has been appointed to the Company’s Board of Directors.

We are so pleased to have Beth join our Board of Directors at Beta Bionics. Her fierce commitment to egalitarianism, opportunity, diversity, and innovation is perfectly aligned with the core principles and values of our benefit mission at Beta Bionics,

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

Throughout her career, Beth has helped shape public health policy through her strategic leadership in both the public and private sectors. This unique experience, combined with her advocacy for diversity and inclusiveness, will be vitally important in guiding our purpose and mission at Beta Bionics, acting in the best possible interest of all people living with type 1 diabetes.

Ms. Brooke serves on the Boards of eHealth, Inc (NASDAQ:EHTH) and other private companies, in addition to the United States Olympic and Paralympic Committee. She is the former Global Vice Chair of Public Policy at Ernst & Young, where she served on its Global Board and as the global sponsor for Diversity and Inclusiveness. In the Clinton Administration, she worked in the U.S. Department of the Treasury and was responsible for tax-policy matters related to healthcare reform, insurance, and managed care.

Additionally, Ms. Brooke has been named by Forbes to its list of 100 Most Powerful Women eleven times, is in the OutStanding LGBT Hall of Fame, and chairs the steering committee of The Partnership for Global LGBTI Equality, in conjunction with the World Economic Forum.

Ms. Brooke received a Bachelor’s of Science degree from Purdue University, graduating with highest distinction while studying Industrial Management and Computer Science and playing women’s intercollegiate basketball. She has received honorary doctorates from Purdue University, Indiana University and Babson College and is in the Indiana Basketball Hall of Fame.

I’m honored to have the opportunity to work with the terrific management team at Beta Bionics to revolutionize the quality of life for so many people dealing with type 1 diabetes and their families. I am also excited to do this as a Certified B corporation, and have the opportunity to govern in accordance with the company’s incredible mission,

said Ms. Brooke.

Ms. Brooke will be serving as Director alongside Ms. Martha Aronson, Mr. Sean Carney, Dr. Finny Kuruvilla from Eventide Asset Management Funds, Mr. Jeff Hitchcock from Children With Diabetes, and Dr. Ed Damiano, President and CEO of Beta Bionics.

About Beta Bionics

Beta Bionics® is a for-profit Massachusetts public benefit corporation founded in 2015 to commercialize the iLet bionic pancreas system. The iLet controls glycemia using integrated mathematical dosing algorithms, which incorporate lifelong autonomous learning to determine and automatically deliver microdoses of insulin and glucagon. 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 T1D and people with T1D. Beta Bionics is committed to acting in the best interests of the diabetes community and to bringing the iLet to market as expeditiously and responsibly as possible. Beta Bionics is pursuing regulatory clearance 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, PhD
edamiano@betabionics.com

Gibb Clarke, MBA
gclarke@betabionics.com

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Beta Bionics appoints Martha Aronson and Sean Carney to its Board as Independent Directors

West Concord, MA – February 20, 2020 – Beta Bionics, Inc. — a medical technology company developing and aiming to commercialize the world’s first fully automated bionic pancreas system called the iLet® today announced that Martha G. Aronson and Sean D. Carney have been appointed to the Company’s Board of Directors effective immediately.

We are all very excited and feel extremely fortunate, at Beta Bionics, to have Martha and Sean join our Board of Directors. Their experience and expertise in the commercial and financial aspects of our business are substantial, and will be invaluable assets to our Board and management team going forward,

said Ed Damiano, President and CEO of Beta Bionics.

The enthusiasm that Martha and Sean express for our mission, and the value they place in our differentiated technology, and the clinical data it has generated, has made a stong impression on the Beta Bionics team. I am eagerly looking forward to having them join as independent board members on our journey to bringing the iLet to as many people with diabetes as possible.

Ms. Aronson brings more than two decades of leadership experience in publically traded companies in the med tech industry. She currently serves as a director on the boards of Conmed Corporation (NYSE: CNMD) and Cardiovascular Systems Inc. (NASDAQ: CSII). She served as a director of Hutchinson Technology, Inc. (NASDAQ: HTCH) from 2010 to 2016 and Methode Electronics (NYSE: MEI) from 2016-2019. From 2012 to 2016, Ms. Aronson served as the executive vice president and president of Global Healthcare at Ecolab, Inc., where she was responsible for the global healthcare business with a specific focus on products and programs for infection prevention. Prior to that, Ms. Aronson was senior vice president and president, North America, at Hill-Rom Holdings, where she was responsible for a $1 billion hospital equipment business. Ms. Aronson also worked at Medtronic, Inc. in various general management and executive roles, both in the US and internationally, for 18 years. She received an MBA from Harvard Business School and a BA in Economics from Wellesley College, graduating magna cum laude and Phi Beta Kappa.

I’m excited about the opportunity to contribute to improving the quality of life for so many people with type 1 diabetes and their families. It is also rewarding to be part of a public benefit corporation board and a certified B corporation board,

said Ms. Aronson.

Mr. Carney was previously an investment professional for approximately 20 years with Warburg Pincus, a leading global private equity firm with over $40 billion in assets under management. Mr. Carney was active across a range of industries, with a particular focus on medical devices. He has been a board member for over 15 privately held companies and 5 publically traded companies including, Dexcom (NASDAQ: DXCM), Tornier (NASDAQ: TRNX), and Wright Medical (NASDAQ: WMGI). Mr. Carney received an MBA from Harvard Business School and an AB in Economics from Harvard College, graduating magna cum laude and Phi Beta Kappa.

I look forward to working alongside the Beta Bionics Board members and dedicated management team to contribute to help bring the Company’s exciting technology to market for the benefit of type 1 diabetes patients, as well as their families and physicians,

said Mr. Carney.

The arrival of Ms. Aronson and Mr. Carney brings the number of board members for the Company to seven. The new members will be serving alongside Dr. Adam Steensberg from Zealand Pharma, A/S, Dr. Finny Kurivilla from Eventide Asset Management Funds, Mr. Jeff Hitchcock from Children With Diabetes, Mr. Ed Raskin from Beta Bionics, and Dr. Ed Damiano from Beta Bionics and Boston University.

About Beta Bionics

Beta Bionics® is a for-profit Massachusetts public benefit corporation founded in 2015 to commercialize the iLet bionic pancreas system. The iLet is 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 T1D and people with T1D. 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

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Beta Bionics receives FDA breakthrough device designation for the iLet™ Bionic Pancreas System

  • 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

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