Health - Purple Foxy Ladies originally published at Health - Purple Foxy LadiesCaution: The iLet Bionic Pancreas is an investigational device limited by Federal law to investigational use. Not available for sale.
Beta Bionics, Inc. — a clinical-stage medical technology company — announced the appointment of Steven Russell, MD, Ph.D., to the role of Chief Medical Officer as the company prepares for the commercial launch of the iLet Bionic Pancreas System.
"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 U.S. 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 Ph.D. 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, Ph.D., 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.
Caution: The iLet Bionic Pancreas is an investigational device, pending 510(k) clearance. Not available for sale.
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Original Source: Beta Bionics Appoints Dr. Steven Russell as Chief Medical Officer in Preparation for the Commercial Launch of the iLet Bionic Pancreas System
Health - Purple Foxy Ladies originally published at Health - Purple Foxy Ladies