Beta Bionics Announces the Nationwide Launch of the iLet Bionic Pancreas with Dexcom G7 CGM System

Beginning Dec. 18, iLet users will have the option of using a Dexcom G7 CGM System.

CONCORD, Mass., December 7, 2023: Beta Bionics, Inc., a pioneering leader in the development of advanced diabetes management solutions, announced today the nationwide launch of the iLet Bionic Pancreas automated insulin delivery system with the Dexcom G7 Continuous Glucose Monitoring (CGM) System planned for December 18, 2023. With a firmware update, users will be able to update their iLet to integrate with Dexcom G7 without any additional cost for new hardware.

Beta Bionics’ flagship product, the iLet Bionic Pancreas, is an autonomous insulin delivery system that streamlines diabetes management and reduces the burden on patients and physicians. The only input required to get started is the user’s weight — the iLet does the rest. Healthcare providers no longer need to determine complex settings including correction factors, insulin-to-carb ratios or pre-set basal rates. When iLet users “GO BIONIC” with their diabetes management, there’s no carb counting* or calculating insulin corrections throughout the day – the iLet determines 100% of the insulin doses.

With the Dexcom G7 integration, users can experience the freedom and benefits of the iLet Bionic Pancreas with the fastest‡ and most accurate CGM1,2 available. Dexcom G7 features an all-in-one sensor and transmitter, no fingersticks from day 1† and only a 30-minute warmup‡ time when starting a new sensor. Dexcom CGM also enables you to share your numbers with up to 10 people§ with the Dexcom Follow app, allowing users to stay connected with their loved ones and care teams. This iLet Bionic Pancreas firmware update will allow users to select Dexcom G7 or Dexcom G6 CGMs, or switch back and forth, depending on their supplies.

“Our goal is to give our patients choice with their CGM technology and to be able to update quickly and easily without new hardware or additional costs,” explained Sean Saint, CEO at Beta Bionics. “We truly appreciate our partnership with Dexcom and their speed and adaptability. Once we established our timeline, we were able to rapidly integrate, test and launch with Dexcom G7 in only four months. It’s a clear testament to our teams working in unison with a common goal of providing the latest technology to help users manage their diabetes with less work and less burden.”

“Dexcom G7 was designed with connectivity in mind and this latest integration with Beta Bionics is a testament to that,” said Jake Leach, executive vice president and chief operating officer at Dexcom. “We look forward to offering iLet Bionic Pancreas users even more choice in their diabetes management and the opportunity to experience the industry-leading accuracy and simplicity of Dexcom G7.”

To upgrade, existing iLet Bionic Pancreas users can download or update the iLet app from the Apple App store or Google Play store (available on December 18, 2023). Once they have updated their iLet app, they can easily update the firmware on their iLet Bionic Pancreas. During setup, users will be able to select whether they wear a Dexcom G6 or Dexcom G7 CGM when connecting a sensor and will also experience other features to help streamline the setup process.

 *User must be carb aware

‡Dexcom G7 can complete warmup within 30 minutes, whereas other CGM brands require up to an hour or longer.
1 U.S. Food and Drug Administration, 510(k) Substantial Equivalence Determination Decision Summary, K213919. Published December 7, 2022. https://www.accessdata.fda.gov/cdrh_docs/reviews/K213919.pdf.
2 U.S. Food and Drug Administration, 510(k) Substantial Equivalence Determination Decision Summary, K222447. Published March 3, 2023. https://www.accessdata.fda.gov/cdrh_docs/reviews/K222447.pdf.
†Fingersticks required for diabetes treatment decisions if symptoms or expectations do not match readings.
§Separate Follow app and internet connection required.

About Beta Bionics

Beta Bionics is a medical technology company focused on the design, development, and commercialization of its iLet Bionic Pancreas in both the single hormone and bi-hormonal 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, relieving some of the burden of living with diabetes. To learn more, visit www.betabionics.com.

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.

 

Investor Relations Contact:

ir@betabionics.com

Media and Public Relations Contact:

media@betabionics.com

 

 

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Beta Bionics Announces iLet Bionic Pancreas is Now Added to the Express Scripts National Commercial Formularies

CONCORD, Mass., November 14, 2023: Beta Bionics, Inc., a pioneering leader in the development of advanced diabetes management solutions, announced that effective November 10th, Express Scripts has added the iLet Bionic Pancreas and associated monthly supplies to their commercial national formulary offerings. For plans that cover the iLet Bionic Pancreas under their pharmacy benefit and use one of these formularies, this decision makes it faster and easier for eligible users to gain access to the iLet Bionic Pancreas.

Historically, insulin pumps have been covered through the durable medical equipment (DME) insurance benefit where there may be significant up-front hardware costs to initiate therapy. In many instances the patient and payer share in the financial burden, which locks the patient to the insulin pump for the length of the pump’s four-to-five-year warranty. Coverage under a pharmacy benefit can reduce the potentially large up-front cost of the pump for both the patient and the payer, allowing patients to upgrade their insulin pump when new technology becomes available.

Sean Saint, CEO of Beta Bionics, “On World Diabetes Day, we are thrilled to make this announcement.  This is a significant milestone in the growth and rapid commercial launch of the iLet Bionic Pancreas. Now that the iLet has been added to the Express Scripts National Commercial Formularies, members of plans that cover the iLet Bionic Pancreas under the pharmacy benefit and select one of these formularies will have a streamlined process as opposed to the traditional DME channel that is standard in the diabetes industry” explained Saint. “Beta Bionics wants to make it as easy as possible for users to access this transformational device and to open the door for many more people with insulin dependent type 1 diabetes across the US to gain access to the iLet.”

Beta Bionics’ flagship product, the iLet Bionic Pancreas, is an autonomous insulin delivery system that streamlines diabetes management and reduces the burden on patients and physicians. The only input required to get started is the user’s weight — the iLet does the rest. Healthcare providers no longer need to determine complex settings including correction factors, insulin-to-carb ratios or pre-set basal rates. When iLet users “GO BIONIC” with their diabetes management, there’s no carb counting* or calculating insulin corrections throughout the day – the iLet determines 100% of the insulin doses.

 

 *User must be carb aware

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Beta Bionics Secures $100 Million in Series D Funding to Advance Diabetes Technology and Expand Market Presence

CONCORD, Mass., August 30, 2023: Beta Bionics, Inc., a pioneering leader in the development of advanced diabetes management solutions, is thrilled to announce the successful closure of its Series D funding round securing $100 million in new equity capital.

The Series D funding was co-led by new investors Sands Capital and Omega Funds with an additional new investor, Marshall Wace, also participating. Previous investors Soleus Capital, Eventide Asset Management LLC, Farallon Capital, Perceptive Advisors, certain funds managed by RTW Investments, LP, ArrowMark Partners, and Pura Vida Investments also participated.

Sean Saint, CEO of Beta Bionics, “This significant investment represents a powerful vote of confidence in Beta Bionics’ mission to redefine diabetes management with user-centric technologies. We are deeply grateful to our investors for recognizing the immense potential of our products. We are eager to push the boundaries of what’s possible by expanding access to the iLet Bionic Pancreas nationwide and further develop and test the bi-hormonal bionic pancreas.”

“We’re excited to support the Beta Bionics team as they work to launch and develop breakthrough technologies that help reduce the burden of diabetes,” said Parker Cassidy, Partner, Sands Capital Ventures.

“Our ability to secure this capital is a testament to iLet’s competitive differentiation and our financial discipline,” said Stephen Feider, CFO of Beta Bionics. “Thank you to the investors for believing in our team and the mission.”

Beta Bionics’ flagship product, the iLet Bionic Pancreas, is an autonomous insulin delivery system that streamlines diabetes management and reduces the burden on patients and physicians. The only input required to get started is the user’s weight — the iLet does the rest. Healthcare providers no longer need to determine complex settings including correction factors, insulin-to-carb ratios or pre-set basal rates. When iLet users “GO BIONIC” with their diabetes management, there’s no carb counting* or calculating insulin corrections throughout the day – the iLet determines 100% of the insulin doses.

 

*User must be carb aware

About Beta Bionics

Beta Bionics is a medical technology company focused on the design, development, and commercialization of its iLet Bionic Pancreas in both the single hormone and bi-hormonal 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, relieving some of the burden of living with diabetes. To learn more, visit www.betabionics.com.

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.

 

 

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Beta Bionics Announces FDA Clearance for the use of a Prefilled Insulin Cartridge with the iLet Bionic Pancreas

  • Now the iLet Bionic Pancreas is cleared for three insulins
  • More insulin choices for users
  • Prefilled insulin cartridge saves time and provides convenience for users

CONCORD, Mass., June 22, 2023: Beta Bionics, Inc. — a medical technology company focused on diabetes — announces FDA 510(k) clearance for compatibility with the Fiasp® Pumpcart® (insulin aspart) prefilled insulin cartridge. The iLet is the first and only automated insulin-delivery system that does not require carb counting and fully automates 100% of all user insulin doses – and will provide users the choice of three insulins – Novolog®, Humalog® and Fiasp® Pumpcart®.

“Beta Bionics has been working tirelessly to create an insulin delivery system that offers less burden and more convenience for the type 1 community. Since launching last month in May 2023, the iLet Bionic Pancreas is now available and clinics and users are being trained on its simple design and easy management features,” said Sean Saint, President and CEO of Beta Bionics. “When Fiasp® Pumpcart® prefilled cartridges are available, users will save time not having to manually fill cartridges and will have more choice for their diabetes management.”

The iLet was designed to alleviate the work of diabetes management in everyday life and nearly eliminate the expertise that has been required to set up and manage a traditional insulin pump. The only input that is required to get started is the user’s weight. No carb counting*, bolusing, correction factors, insulin-to-carb ratios, or pre-set basal rates – the iLet manages a user’s glucose levels with just a meal announcement and it does the rest of the work. The iLet is paired with a Dexcom G6 Continuous Glucose Monitoring System for glucose readings.

If you’d like to GO BIONIC with the iLet Bionic Pancreas, visit our website to fill out our form to get started – www.betabionics.com.

 

*Carb awareness is required.

About Beta Bionics

Beta Bionics is a medical technology company focused on the design, development, and commercialization of its iLet Bionic Pancreas in both the insulin dosing (the iLet) and bihormonal 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 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.

Fiasp® Pumpcart®, and Novolog® are registered trademarks of Novo Nordisk A/S. Fiasp® Pumpcart not yet available for sale in the US.

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Beta Bionics Announces FDA Clearance and Commercialization of the iLet Bionic Pancreas

– First and only, automated insulin-delivery system that determines 100% of all insulin doses.
– No carb counting*, no corrections, no calculating boluses.
– Only needs your body weight to get started.

CONCORD, Mass., May 22, 2023: Beta Bionics, Inc. — a medical technology company focused on diabetes — announces FDA 510(k) clearance and the commercial launch of the iLet Bionic Pancreas. The iLet is the first and only automated insulin-delivery system that does not require carb counting and fully automates 100% of all user insulin doses – which means no calculations, less input, and less burden for the user. The iLet is paired with the Dexcom G6 Continuous Glucose Monitoring System.

“This company has worked tirelessly over the past seven years to bring the first Bionic Pancreas to market. And now the iLet is here, ready to be prescribed to the T1D community and will ship imminently,” said Sean Saint, President and CEO of Beta Bionics. “As the first fully-automated insulin dosing system, the iLet changes the paradigm of diabetes management. By eliminating traditional setup, carb counting, and manual correction boluses, the iLet has removed many of the traditional tasks for both the user and healthcare provider. We hope that, for many people, the iLet helps to make diabetes a little bit easier.”

The iLet was designed to alleviate the work of diabetes management in everyday life and nearly eliminate the expertise that has been required to set up and manage a traditional insulin pump. With the iLet, healthcare providers can spend less time with the technology and more time with their patient. The only input that is required to get started is the user’s weight — the iLet does the rest. There is no longer the need to figure out the complexities of carb counting, bolusing, correction factors, insulin-to-carb ratios, or pre-set basal rates. iLet users enter their weight and then “GO BIONIC” with their diabetes management.

“The iLet’s unique algorithms autonomously personalize insulin dosing for each person’s unique needs,” explained Dr. Steven Russell, MD, PhD, Chief Medical Officer at Beta Bionics. “This degree of automation relieves healthcare providers from the burden of reviewing blood glucose and CGM data in order to adjust pump settings, allowing them to spend more time discussing other needs. There are so many people with diabetes with stubbornly high A1c and low time in range, despite adjustments to their therapy. Data from the Pivotal Trial suggests the iLet could make a big difference for those people.”

“I am grateful to all of my colleagues at Beta Bionics, and to so many others far and wide, who together transformed the idea of a bionic pancreas into the reality it has now become,” said Dr. Ed Damiano, PhD, Founder and Executive Chairman at Beta Bionics. “The scope of this effort has spanned nearly the entirety of my son’s life, since he first developed diabetes just before his first birthday, over 23 years ago. From that day, I drew motivation from him and dreamt of automating our tireless care for him so that he could have a long, healthy, and less encumbered life. Today we celebrate the dream that the iLet now fulfills. As we begin our commercial efforts to bring the iLet to the T1D community, we will continue our ongoing work on the bihormonal bionic pancreas so that we may one day deliver upon the promise that our next technology holds.”

*User must be carb aware.

About Beta Bionics
Beta Bionics is a medical technology company focused on the design, development, and commercialization of its iLet Bionic Pancreas in both the insulin dosing (the iLet) and bihormonal 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 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.

Investor Relations Contact:
ir@betabionics.com 

Media and Public Relations Contact:
Media@betabionics.com

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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

Back

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

Back

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

Beta Bionics is a public benefit corporation.

We are committed to balancing purpose with profit and giving back to society as we fulfill our public benefit mission.

Safety Information – The iLet Bionic Pancreas System is indicated for use by people with type 1 diabetes 6 years of age and older. The iLet Bionic Pancreas requires prescription by a physician. Refer to the iLet Bionic Pancreas System User Guide at www.betabionics.com/resouces/user-guides, or for complete safety information including indications, contraindications, warnings, cautions, compatible devices, compatible drugs and instructions, refer to www.betabionics.com/resources/safety. DO NOT start to use the iLet Bionic Pancreas System without adequate training. Incorrect use may result in over-delivery or under-delivery of insulin, which could lead to hypoglycemia or hyperglycemia.

Medical Disclaimer – This website is for information only and is not a substitute for medical advice and/or services from a healthcare provider. All personal health care decisions and treatment should be discussed with a healthcare provider who is familiar with your individual needs.

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