Wednesday, June 6, 2018

iLet - A Bionic Pancreas

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The 411: Successfully Funded and Received IDE Approval from the FDA - iLet -  Building a bionic pancreas to improve the lives of people with type 1 diabetes

Found on: - https://wefunder.com/beta.bionics (and) https://www.betabionics.org (and) article - https://globenewswire.com/news-release/2018/05/21/1509314/0/en/Beta-Bionics-Receives-IDE-Approval-from-the-FDA-to-Begin-a-Home-Use-Clinical-Trial-Testing-the-New-iLet-Bionic-Pancreas-System.html

BETA BIONICS
Building a bionic pancreas to improve the lives of people with type 1 diabetes

“At Beta Bionics, Inc., we have developed a bionic pancreas called the iLet™, a pocket-sized, wearable medical device that autonomously manages blood sugar levels in people with diabetes. Our iLet technology has demonstrated dramatic improvements in clinical outcomes. Through its ability to continuously adapt to the ever-changing insulin needs of people with diabetes, the iLet is the quintessential embodiment of personalized medicine – a sturdy and irrevocable bridge to the ever-elusive cure.

Edward Damiano
CEO, BETA BIONICS

OUR AMBITION

We are driven to build a technology that will automatically manage our children's diabetes, day and night, and keep them safe from the far-reaching harms, the immediate dangers, the emotional burden, and the fear that type 1 diabetes carries with it every day of their lives. That technology will provide a bridge that spans the divide between where we are today and the biological cure of tomorrow – a cure that has been ever present in our dreams, and ever elusive from our lives.

See the Reality

"Sometimes it's hard and not fair. I just don't like diabetes." — Elise Cunha, type 1 diabetes since age one

Elise had just celebrated her first birthday when she was diagnosed with type 1 diabetes. In 2014, Elise participated in a clinical trial testing the bionic pancreas. It automatically gave her insulin to prevent her blood sugar from going too high and glucagon to prevent it from going too low, so Elise didn't have to worry about it. Instead, she could do what six-year-olds do best: have fun.

Problem: Current Tools Aren't Good Enough

People with type 1 diabetes are responsible for making dozens of decisions every day matching insulin dosing to carbohydrate consumption, exercise, activity, stress, etc.

Type 1 diabetes management is a relentless 24/7 tightrope act of trying to keep blood sugar levels low, but not too low.

Over $3 billion every year can be attributed to hospitalizations for acute complications of type 1 diabetes.

Long-term complications are even more costly.

Solution: The Bionic Pancreas

Automatically reduces mean blood sugar levels in everyone to levels that would likely eradicate long-term complications of type 1 diabetes.

Automatically curtails low blood sugar levels in everyone to levels that would likely eliminate severe hypoglycemia in people with type 1 diabetes.

Automates blood sugar control for everyone, thus unburdening people with type 1 diabetes of the relentless need to comply with therapy. 

Unburdens people with type 1 diabetes and their families of the constant fear of hypoglycemia, and of the worry and dread of long-term complications.

WF: What are you guys building? 

BB: At Beta Bionics, Inc., we are developing a bionic pancreas system called the
iLet™, a revolutionary fully integrated and wearable bionic pancreas medical
device platform that automatically and autonomously manages blood sugar levels in people with insulin-dependent type 1 diabetes (T1D) 24/7, and thus reduces the burden and cost of diabetes care.

WF: What is driving you toward innovating in this industry? 

BB: Our children were diagnosed with type 1 diabetes at very young ages. David Damiano, Max Raskin, and Marissa Hitchcock, the children of three of the board members of Beta Bionics, were diagnosed at the ages of 11 months, 7 years, and 2 years, respectively. Quite independently, but inevitably, we all realized that diabetes management is relentless, exhausting, and unforgiving. As parents of kids with T1D, this project has become entirely a labor of love. Our small team at Beta Bionics is deeply motivated to bring the iLet to fruition for the entire T1D community – a community to which we all belong.





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