BOSTON, July 12, 2018 (GLOBE NEWSWIRE) -- Beta Bionics, Inc., a medical technology company leveraging life-long, machine-learning, artificial intelligence to develop and commercialize the iLet Bionic Pancreas System — the world’s first fully autonomous bionic pancreas —announced today that the FDA has approved a supplement filed by Beta Bionics to its previously approved investigational device exemption (IDE) expanding ongoing home-use clinical trials testing its new integrated technology, which combines the iLet bionic pancreas and the Senseonics Eversense CGM.
The FDA previously granted IDE approval for clinical testing of the iLet integrated with the Dexcom CGM. The FDA’s recent approval to begin clinical testing of an Eversense-compatible iLet comes less than three weeks after Senseonics received FDA approval to begin commercial marketing of Eversense in adults with diabetes. Eversense is the only CGM system to feature an implantable glucose sensor, designed for long-term continuous use for up to three months, a removable and rechargeable transmitter, and on-body vibratory alerts for high and low glucose levels.
“The Senseonics Eversense CGM represents a categorically differentiated CGM choice for people with diabetes, in addition to transcutaneous CGM, and offers new patient preferences that have not previously been possible,” said Ed Damiano, President and CEO of Beta Bionics.
“We’re excited that the Eversense CGM System is now part of this important clinical study and by the work Beta Bionics has done to ensure the compatibility of Eversense with the iLet Bionic Pancreas System,” said Tim Goodnow, President and CEO of Senseonics. “It’s especially important to include another accurate CGM system in this trial to give patients an option. Giving patients a choice is critical, especially when they’re considering the CGM component of their artificial pancreas and whether an implantable, long-term sensor might be a good fit for their needs.”
Beta Bionics has set itself apart as a market leader committed to unprecedented interoperability and patient choice. The Company has developed its iLet Bionic Pancreas System to be interoperable with multiple insulins (including Humalog®, Novolog®, and Fiasp®), multiple hormones (including dasiglucagon by Zealand Pharma), and now two very different CGM options. Beta Bionics has again demonstrated its commitment to interoperability and patient choice, in contrast to those companies that have locked their technologies into exclusive arrangements that limit choices for people with type 1 diabetes.
“Patient choice of two highly accurate and differentiated CGM technologies is good for our kids, good for the T1D community and essential to building an innovative and sustainable business. With this milestone, Beta Bionics continues its commitment to remaining at the bleeding edge of product innovation for people with diabetes,” said Dr. Damiano.
Just weeks after Beta Bionics received the go-ahead from the FDA, home-use clinical trials began in adults with T1D at the Massachusetts General Hospital (MGH) using the Dexcom-integrated iLet in the insulin-only configuration with Humalog and Novolog and then again, several weeks later, at Stanford University Medical Center using the Dexcom-integrated iLet in the insulin-only configuration with Humalog, Novolog, and Fiasp. Under the Beta Bionics IDE and newly approved IDE supplement, an additional cohort of adults with T1D will begin using the Eversense-integrated iLet in the insulin-only configuration next month at MGH.
Beta Bionics plans to enter pivotal trials with its final iLet design in 2019 and expects to launch its first product in 2020.
About the IDE and PMA Process
Investigational use of the iLet was approved by the FDA under an investigational device exemption (IDE). An IDE allows testing of an investigational device in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application to the FDA. An IDE application and any IDE supplement is approved only after extensive review by the FDA of the device and clinical trial design.
About the iLet
The iLet bionic pancreas system is a pocket-sized, wearable medical device that autonomously controls blood-sugar levels in people with diabetes. The machine-learning, mathematical dosing algorithms integrated into the iLet were licensed by Beta Bionics from Boston University. 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, reductions in hypoglycemia, and reductions 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 initialized by entering body weight only and does not require the patient to count carbohydrates, set insulin delivery rates or deliver bolus insulin for meals or corrections. 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. 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 machine-learning artificial intelligence to autonomously 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. 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, which will be followed by its dual-hormone system that will also administer a glucagon analog in order to raise blood-sugar levels without the need to consume carbohydrates.
Beta Bionics is headquartered in Boston, Massachusetts with certain operations in Irvine, California. For further information, please visit www.betabionics.com or follow Beta Bionics Facebook, YouTube, Instagram, LinkedIn and Twitter @BetaBionics.
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