Beta Bionics Appoints Dr. Steven Russell as Chief Medical Officer in Preparation for the Commercial Launch of the iLet Bionic Pancreas System

Caution: The iLet Bionic Pancreas is an investigational device limited by Federal law to investigational use. Not available for sale.

CONCORD, Mass., January 4, 2023: Beta Bionics, Inc. — a clinical-stage medical technology company —announced the appointment of Steven Russell, MD, PhD, to the role of Chief Medical Officer as the company prepares for commercial launch of the iLet Bionic Pancreas System.

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“As we move closer to commercial launch of the iLet Bionic Pancreas, we have strategically added a wealth of knowledge and experience to our executive team,” explained Sean Saint, President and CEO of Beta Bionics.  “Dr. Russell is one of the foremost thought leaders in the field of diabetes technology and I have turned to him often over the years for his expertise and perspective. His experience with the bionic pancreas in a clinical setting is second to none. There is no better person we could have for our Chief Medical Officer as we complete the regulatory review process and prepare for the US launch of the iLet.”

Dr. Russell is an endocrinologist and diabetologist with 20 years of experience managing diabetes. He is an Associate Professor of Medicine at Harvard Medical School and an attending physician at Massachusetts General Hospital (MGH) Diabetes Associates in Boston where he has maintained a clinical practice managing diabetes in the outpatient and inpatient settings. Dr. Russell’s research at MGH has been focused on the application of new technologies to improve the care of people with diabetes, including the collaboration with Dr. Ed Damiano’s research group at Boston University to develop and test a wearable bionic pancreas for automated blood glucose control in diabetes. Dr. Russell has directed nearly all of the bionic pancreas clinical trials, including 20 studies in type 1 diabetes, type 2 diabetes, and cystic fibrosis related diabetes. He received a Bachelor of Science degree in biochemistry from Trinity University in San Antonio, and both a PhD in biological chemistry and an MD from the University of Texas Southwestern Medical Center in Dallas. He completed his residency training in internal medicine and his fellowship in endocrinology, diabetes, & metabolism at MGH, and a postdoctoral fellowship studying insulin and aging at the Joslin Diabetes Center in Boston.

“The bionic pancreas project has been the focus of my professional life for many years. Until the completion of the pivotal trial, I felt I was able to bring the most value to the project as an academic physician, providing advice and executing clinical trials,” said Dr. Russell.  “Now that the pivotal trial is complete, I think my contributions will be most impactful by providing medical leadership within Beta Bionics as we work to obtain FDA clearance and prepare for the launch of the iLet. I am excited to be part of an all-star team and look forward to supporting people with diabetes and healthcare providers as the iLet emerges from the research setting into clinical use.”

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, but iLet users enter only their body weight to initialize therapy and do 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.

“I am thrilled to welcome Steven to Beta Bionics as our new Chief Medical Officer,” said Ed Damiano, PhD, Founder and Executive Chair of Beta Bionics. “I began collaborating with Steven on the bionic pancreas project over 15 years ago. Our partnership has spanned inpatient clinical trials, pre-pivotal home-use clinical trials, and most recently, a pivotal trial of the iLet in adults and children with type 1 diabetes. Simply put, the bionic pancreas would not be as far along as it is today without Steven Russell. As a parent of a son with T1D, I am grateful for all that he has done to advance this technology and advocate for all people with T1D.”

Dr. Russell will retain his Harvard Medical School faculty appointment and will maintain his medical practice on a part-time basis at MGH Diabetes Associates.

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 determine all of the insulin and/or glucagon delivered by the device 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 adults and children living with diabetes and other conditions of glycemic dysregulation.

Caution: The iLet Bionic Pancreas is an investigational device, pending 510(k) clearance. Not available for sale.

Investor Relations Contact:
Stephen Feider
Chief Financial Officer & Corporate Secretary
ir@betabionics.com 

Media and Public Relations Contact:
Karen Hynes
Vice President, Marketing
Media@betabionics.com

 

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Beta Bionics Appoints Sean Saint as CEO and Board Member

Caution: The iLet® Bionic Pancreas and iLet Duo™ are investigational devices limited by Federal (or United States) law to investigational use. Not available for sale. 

CONCORD, Mass., August 15, 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 appointment of Sean Saint to the role of Chief Executive Officer. Mr. Saint will also serve on the Beta Bionics Board of Directors. Martha Goldberg Aronson, who has served as interim CEO since February, will work with Mr. Saint through a transition period and will remain on the Beta Bionics Board of Directors.

Mr. Saint — an engineer, entrepreneur, diabetes technologist and innovator, and person with type 1 diabetes — was selected after an exhaustive search by the Beta Bionics Board of Directors in partnership with a third-party executive search firm.  Mr. Saint brings extensive experience to the role of CEO and has a proven track record of marrying innovative product development with commercial expertise.  He began his career in medical technology as an engineer at Medtronic/AVE.  In 2003, he began working in the diabetes device industry in technical and management roles of increasing responsibility at companies including Dexcom and Tandem Diabetes Care. After many years of working in the diabetes device industry, Mr. Saint developed type 1 diabetes.  From the personal experience that came with living with type 1 diabetes, Mr. Saint added new perspective to his career and in 2013 founded Companion Medical, maker of the InPen.  As CEO of Companion, Mr. Saint led the team through the development and launch of the InPen, and ultimately the acquisition of the company by Medtronic in 2020. Mr. Saint graduated from California Polytechnic State University, San Luis Obispo, with a mechanical engineering degree and is an inventor on more than 175 issued patents and pending patent applications.

I am very pleased to welcome Sean Saint to Beta Bionics as our new CEO,

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

Sean has a fierce commitment to improving the lives of people with diabetes and deep roots — both personal and professional — in type 1 diabetes and the diabetes medical technology industry.  He also has a long history with the bionic pancreas, as he took the lead at Tandem Diabetes over 10 years ago to collaborate with me and my team at Boston University to build the very first wearable version of the bionic pancreas on a mobile device platform.  Sean blends a remarkably rare set of talents, experiences, leadership, and passion for positively impacting the lives of people with diabetes.  He is uniquely qualified, and the best possible person in my mind, to lead Beta Bionics as we cross the bridge from a purely R&D and clinical-stage company to the commercial-stage organization we plan to soon become.  I would also like to take this opportunity to express my appreciation to Martha for her willingness to step into the role of interim CEO over these past six months and for her dedication and commitment to Beta Bionics.

I met Ed Damiano in 2011 and was extremely impressed by what he and his team were doing,

said Mr. Saint.

I am pleased to say I was able to support Ed on some of his early work on the bionic pancreas at Boston University. I never could have envisioned that I would later be given the opportunity to join Beta Bionics as CEO.  I am thrilled that I can now join the team to help bring Ed’s vision to fruition.  As a person with type 1 diabetes myself, I am excited to lead the Beta Bionics team in bringing the truly novel iLet system to market.  In addition, I am as excited as ever to continue advancing our bihormonal iLet program.

The results of the Insulin-Only Bionic Pancreas Pivotal Trial were announced in April of 2022 and Beta Bionics has filed a submission with the FDA for clearance of the iLet Bionic Pancreas System, which carries a Breakthrough Device Designation. These milestones position the organization well for successful commercialization of the iLet Bionic Pancreas System following FDA clearance.

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 and iLet Duo™ are investigational devices limited by Federal (or United States) law to investigational use. Not available for sale.

View source version on GlobeNewswire

Investor Relations Contact: 

ir@betabionics.com

Media and Public Relations Contact: 

Katy O’Neill

Beehive Strategic Communication

media@betabionics.com

 

 

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The Insulin-Only Bionic Pancreas Pivotal Trial Showed Consistent Mean HbA1c Reductions Across a Variety of Subgroups at ADA’s 82nd Scientific Sessions

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

  • The randomized Insulin-Only Bionic Pancreas Pivotal Trial (IO BPPT) included a more diverse population of participants with type 1 diabetes (T1D) than previous pivotal studies of other AID systems with respect to minority representation, existing method of insulin delivery, and baseline HbA1c levels.1
  • In addition to meeting other key endpoints, pre-specified exploratory subgroup analyses in the trial consistently show reduced mean HbA1c across populations regardless of race, education, or income level for those in the bionic pancreas group relative to those in the standard of care group with continuous glucose monitoring (CGM).
  • Adult users in the bionic pancreas group experienced reductions in diabetes distress and fear of hypoglycemia with statistically significant differences favoring the bionic pancreas group relative to the standard of care group.
  • Parents of children in the bionic pancreas group reported a significant increase in diabetes treatment satisfaction compared to the standard of care group.
  • The iLet Bionic Pancreas is a pocket-sized, wearable, investigational medical device designed to autonomously determine and deliver all insulin doses needed to control blood glucose levels in people with diabetes.

CONCORD, Mass., June 9, 2022 (GLOBE NEWSWIRE) — Beta Bionics, Inc. — The results of the multi-center randomized Insulin-Only Bionic Pancreas Pivotal Trial (IO BPPT) were presented during a session hosted by Dr. Roy W. Beck and clinical investigators at the American Diabetes Association (ADA) 82nd Scientific Sessions. The trial met key endpoints, including consistently showing reduced mean HbA1c across populations regardless of race, education, or income level in exploratory analyses of subpopulations. Dr. Gregory Forlenza explained the study design, remarking that the iLet Bionic Pancreas helped to “remove numeracy” from the management of type 1 diabetes.

The randomized trial included a more diverse population of participants with T1D than pivotal studies of other AID systems with respect to minority representation, method of insulin delivery, and HbA1c levels. The results from pre-specified subgroup analyses of the iLet in adults, youth, and the iLet with Fiasp® in adults from the IO BPPT as presented at ADA are summarized below.

  • Relative to the standard of care group with continuous glucose monitoring (CGM), a mean reduction in HbA1c of 0.5% was seen on the iLet in each of three cohorts: the iLet in adults, youth, and the iLet with Fiasp in adults.
  • 43% of adult participants on the iLet with Humalog®/NovoLog® saw a reduction of 0.5% or greater in HbA1c compared to only 17% of those in the standard of care group.
  • In exploratory analyses of different subgroups of adults (race/ethnicity, education, income, and baseline insulin therapies), the 13-week HbA1c results were consistently 7.0-7.3% on the iLet Bionic Pancreas with a greater improvement seen in those populations with higher baseline HbA1c.
  • In an exploratory subgroup analysis of youth (ages 6-17 years) with initial HbA1c >9%, those in the bionic pancreas group saw an increase in time in range of 31% compared to the standard of care group — this increase in time in range is equal to an additional 7.4 hours/day.
  • 51% of youth (ages 6-17 years) on the iLet with Humalog/NovoLog saw a reduction of 0.5% or greater in HbA1c compared to only 8% in the standard of care group.
  • 29% of youth (ages 6-17 years) saw an HbA1c reduction of 1% or more on the iLet with Humalog/NovoLog compared to 6% of those in the standard of care group. Said presenter and investigator Laurel Messer, Ph.D., RN, CDCES,

In children who are going to have a lifetime of diabetes, this [1% HbA1c reduction] is significant in reducing morbidity and mortality.

  • Adult users in the bionic pancreas group experienced a reduction in diabetes distress and fear of hypoglycemia with statistically significant differences favoring the bionic pancreas group relative to the standard of care group.
  • Parents of children in the bionic pancreas group reported a significant increase in diabetes treatment satisfaction compared to the standard of care group.

We know that health inequities exist in almost every aspect of healthcare delivery: Type 1 diabetes is no exception,

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

Beta Bionics is thrilled to see that exploratory analyses consistently indicate glycemic improvements across race, education, and income from the IO BPPT. This supports our public benefit commitment to making type 1 diabetes management technology accessible to the many.

The session provided details on the iLet in adults, youth, and the iLet with Fiasp in adults in the IO BPPT. The following investigators participated in the session moderated by Dr. Roy Beck:

  • Gregory P. Forlenza, MD: iLet Bionic Pancreas and IO BPPT Study Design
  • Davida Kruger, MSN APN-BC: Adult Cohort Humalog/NovoLog versus Standard of Care
  • Laurel H. Messer, Ph.D., RN, CDCES: Pediatric Cohort Humalog/Novolog versus Standard of Care
  • Steven J. Russell, MD, Ph.D.: RCT Results for Fast Acting Insulin Aspart (Fiasp)
  • Jill Weissberg-Benchell, Ph.D., CDCES: Patient-Reported Outcomes
  • Steven J. Russell, MD, Ph.D.: Ancillary Studies and Discussion of the Results

As a nurse practitioner and diabetes care and education specialist, I have always said a diagnosis of diabetes does not come with a math degree,

said Jeanne Jacoby, FNP, CDCES, Director of Medical Affairs, Beta Bionics, and a person living with diabetes.

I was excited to see that the exploratory sub-group analysis shows consistently reduced mean HbA1c regardless of education level for those in the bionic pancreas group.

Insulin-Only Bionic Pancreas Pivotal Trial (IO BPPT) 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 trial was designed to reach a broad demographic with respect to race, ethnicity, age, therapy type, and 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. 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 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.

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.

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. Beck, R., Forlenza, G., Kruger, D., Messer, L.,& Russell, S. (2022, June 3). The Insulin-Only Bionic Pancreas Pivotal Trial—Randomized Clinical Trial Results [Mini Symposium]. ADA’s 82nd Scientific Sessions, New Orleans, LA, United States.

View source version on GlobeNewswire

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 the ADA’s 82nd Scientific Sessions

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 1, 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 Bionics.

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.

View source version on GlobeNewswire

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 Appoints Gilad Glick to the Board of Directors and Veena Rao, Ph.D. as Chief Commercial Officer

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

  • Gilad Glick, former Chief Executive Officer, Itamar Medical, appointed to Beta Bionics’ Board of Directors
  • Veena Rao, Ph.D., Vice President of Business Development and interim Chief Commercial Officer, appointed Chief Commercial Officer

CONCORD, Mass., May 10, 2022 (GLOBE NEWSWIRE) — Beta Bionics, Inc. — a clinical-stage medical technology company committed to the design, development, and commercialization of the iLet® Bionic Pancreas — today announced the appointments of Gilad Glick, former Chief Executive Officer, Itamar Medical, to the Board of Directors and Veena Rao, Ph.D., to the role of Chief Commercial Officer. Rao was previously Beta Bionics’ Vice President of Business Development and interim Chief Commercial Officer. The strategic evolution of the leadership team and Board of Directors positions Beta Bionics for success ahead of commercialization of the iLet® Bionic Pancreas. The iLet® is currently pending FDA clearance.

Gilad Glick Appointed to Board of Directors

Beta Bionics has appointed Gilad Glick, former Chief Executive Officer of Itamar Medical, to its Board of Directors. Glick has over 25 years of medical device experience across Europe and the U.S., within a variety of functional areas focused on commercialization, strategy, sales, marketing, and research and development. Prior to joining Itamar Medical as Chief Executive Officer, Glick served as Vice President of Worldwide Sales and Marketing at Biosense Webster, a Johnson & Johnson company, overseeing all strategic and commercial activities.

We are delighted to welcome Gilad to our Board of Directors, and look forward to working with him as we prepare for the commercialization phase of the iLet® Bionic Pancreas,

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

His expertise within the healthcare and medical device industry, and his strong strategic, commercial, and international experience will be instrumental to the growth and maturation of our organization and business over the coming years.

I look forward to working with a dedicated and passionate management team committed to improving the lives of people with diabetes,

said Glick.

It is rewarding to have the opportunity to contribute to Beta Bionics’ public benefit mission, as the team seeks to improve the lives of people unable to reach glycemic goals with currently available diabetes technology and help reduce the cognitive burden experienced by people with type 1 diabetes, as well as their families and physicians.

Glick is a member of Israel’s 8400 Heath Network, a founder of the MedTech Commercialization Institute and a member of Almeda Venture MedTech Fund’s Board of Directors. He earned a Master of Business Administration from the Maastricht School of Management in the Netherlands, majoring in General and Strategic Management. He is also a graduate of the Strategic Marketing Management Executive Program at the Stanford Graduate School of Business.

Veena Rao Assumes Chief Commercial Officer Position

Rao initially served as Beta Bionics’ Vice President of Business Development, beginning in late 2020; in early 2021, she also assumed the role of interim Chief Commercial Officer. As Chief Commercial Officer, Rao will continue her responsibilities for the strategic direction and leadership of all sales, marketing, market access, and customer care activities related to the launch and commercialization of the iLet®, following FDA clearance. She will also contribute to the senior leadership team’s ongoing commitment to Beta Bionics’ public benefit mission and the continued pursuit of an innovative culture, focused on the customer and the community.

Veena brings a unique blend of commercial and scientific expertise, as well as key external relationships in automated insulin delivery, connected pens, glucose monitoring, and areas of digital health, all of which are instrumental as we move from being a clinical-stage company to a commercial-stage company,

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

Her leadership is critically important as we continue to build out a top-tier commercial team, focused on improving the lives of the type 1 diabetes community with our innovative technology.

Rao has more than 20 years of experience in medical devices, life sciences, pharmaceuticals, and diabetes. Throughout her career, she has led multiple cross-functional teams in developing device and drug delivery strategic plans and customer care initiatives, played a critical role in strategic deals related to connected care and delivery, developed promotional messaging strategies and branding efforts, and created and scaled innovation teams for device, delivery, and digital health functions.

Rao earned a Master of Business Administration from the University of Virginia, a Ph.D. in Chemical Engineering from Stanford University, and a Bachelor of Science in Chemical Engineering from the University of Minnesota.

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.

View source version on GlobeNewswire

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

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.

View source version on GlobeNewswire

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

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

View source version on GlobeNewswire

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

View source version on GlobeNewswire

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

View source version on GlobeNewswire

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
View source version on GlobeNewswire

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

© 2023 Beta Bionics, Inc. Beta Bionics and iLet Bionic Pancreas are registered trademarks of Beta Bionics, Inc. All rights reserved. All other trademarks are the property of their respective owners. The use of third-party trademarks does not constitute an endorsement or imply a relationship or other affiliation.