Beta Bionics and Convatec announce partnership to bring Unomedical infusion set portfolio to the iLet™ Bionic Pancreas System

17 July 2019

• Convatec is a leading global manufacturer of widely popular infusion sets offering a variety of patient choice
• Beta Bionics is developer of the iLet Bionic Pancreas System and is committed to device interoperability and patient choice
• Convatec will manufacture infusions sets for delivery of both insulin and glucagon via the iLet Bionic Pancreas System   

Boston, MA and Reading, United Kingdom – July 17, 2019 – Beta Bionics, Inc. — a medical technology company leveraging lifelong autonomous learning to develop and commercialize the world’s first fully automated bionic pancreas — and Convatec Group Plc (LSE: CTEC) — a leading global medical products and technologies company — today announced that Convatec’s Unomedical subsidiary and Beta Bionics have entered into a collaboration and development agreement that will make portions of Unomedical’s world class infusion sets available for use with the iLet Bionic Pancreas System.

The arrangement between Beta Bionics and Convatec creates a deep and meaningful partnership between the two companies for the benefit of the diabetes community.  The arrangement is non-exclusive, consistent with other Beta Bionics partnerships designed to protect patient choice. The Unomedical sets will be deployed in two pivotal trials testing the iLet in its insulin-only and bihormonal (insulin and glucagon) configurations in 2020. Convatec’s Unomedical subsidiary develops, produces, and supplies a range of disposable infusion sets used in insulin infusion therapy, including their highly popular flexible-cannula sets currently used with insulin pumps today.

“Under the Beta Bionics public benefit structure, we are committed to acting in the best interests of the type 1 diabetes community with every decision that we make” said Ed Damiano, co-founder and CEO of Beta Bionics.  “We are very impressed with Unomedical’s products and world class manufacturing capabilities, and have great confidence in their steel and flexible-cannula infusion sets, having used them in all of our iLet clinical studies. Making the world’s most popular infusion sets compatible with the iLet is very exciting for us, and underscores our deep commitment to patient choice.”

“We at Unomedical are proud to be selected by Beta Bionics as infusion set partner for the iLet Bionic Pancreas system. Being the world’s largest manufacturer of infusion sets within diabetes technology, and committed to highest standards in patient safety, product efficacy and patient-centered design, we will do our utmost to support this exciting programme. Published clinical data has clearly surpassed our expectations to the potential of bihormonal infusion therapy and we are excited to be part of this development”, John M. Lindskog, President of Unomedical, adds.

About the iLet Bionic Pancreas System

The iLet consists of a dual-chamber, pocket-sized, wearable medical device that autonomously controls blood-sugar levels in people with diabetes.  Embedded in the system are clinically tested mathematical dosing algorithms driven by lifelong autonomous learning to automatically calculate and dose insulin and/or glucagon as needed, based on data from a continuous glucose monitor. To initialize the iLet, users enter only their body weight.  Immediately thereafter, the iLet begins controlling blood-sugar levels automatically, without requiring the user to count carbohydrates, set insulin delivery rates, or deliver bolus insulin for meals or corrections.

In previous home-use studies in adults and children with T1D, these algorithms demonstrated dramatic improvements in glycemic control relative to the standard of care. These improvements included significant reductions in blood-glucose levels, in hypoglycemia, and in intersubject and intrasubject glycemic variability (New England Journal of Medicine. 2014, 371:313-25; Lancet Diabetes and Endocrinology. 2016, 4:233-43; Lancet. 2016, 389:369-80). 

The iLet is effectively three medical devices in one.  It can be configured as an insulin-only bionic pancreas, a glucagon-only bionic pancreas, or a dual-hormone bionic pancreas (insulin and glucagon). The glucagon-only configuration may be helpful in rare, chronic, low blood-sugar conditions, such as congenital hyperinsulinism (CHI) and insulinoma syndrome.  Beta Bionics is committed to obtaining regulatory approval and commercializing all three iLet configurations.

About Beta Bionics

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

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

About Convatec

Convatec is a global medical products and technologies company focused on therapies for the management of chronic conditions. The Company is listed on the London Stock Exchange (stock symbol: CTEC) and has leading market positions in advanced wound care, ostomy care, continence and critical care, and infusion devices. Convatec's products provide a range of clinical and economic benefits, including infection prevention, protection of at-risk skin, improved patient outcomes and reduced total cost of care. www.convatecgroup.com.

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