$1.4M to help SFC Fluidics develop insulin patch pump
Fayetteville-based SFC Fluidics just received funding to help develop a dual hormone patch pump for those with Type 1 diabetes, right on the heels of a partnership with diabetes research organization JDRF aimed at bringing the company’s fully integrated insulin patch pump to market within two years.
On Thursday, SFC Fluidics said it obtained a $1.4 million grant from the National Institute of Diabetes and Digestive and Kidney Disease of the National Institutes of Health to develop a patch pump that can deliver both insulin and glucagon in a small system the size of existing insulin-only patch pumps. Glucagon is a hormone that helps the liver release glucose in order to raise blood-sugar levels.
The company said the system will have the required safety features so the pump can give automated doses of insulin and glucagon to “fine tune” the patient’s glycemic control. Typical insulin pumps don’t dispense glucagon.
In a statement, Greg Lamps, SFC’s vice president for product development said the system will be a vital part of a future state of the art artificial pancreas — a fully-automated system that will help those with Type 1 diabetes closely control their glycemic levels.
Type 1 diabetes is an autoimmune disease that effects about 1.25 million Americans, with 200,000 of
those under the age of 20. In those with Type 1 diabetes insulin-producing beta cells in the pancreas are mistakenly destroyed by the body’s immune system. By 2050, JDRF — formerly called the Juvenile Diabetes Research Foundation — estimates 5 million people in the U.S. will have Type 1 diabetes, with about 600,000 of those under the age of 20.
There is currently no cure and those with Type 1 diabetes depend on injected or pumped insulin to survive. Even when closely controlled, people with Type 1 diabetes can experience dangerously high or low blood-glucose levels that can threaten life.
The Industry Development and Discovery Partnership between SFC Fluidics and JDRF, the leading organization funding research into Type 1 diabetes, is a two-year commitment to further develop SFC Fluidics’ next generation automated insulin delivery device. A key element of the deal will be the device’s open protocol communication capabilities.
JDRF began its OpenProtocol Automated Insulin Delivery System Initiative in 2017. The goal is to encourage technology developers to create components for an automated insulin delivery device that can work in concert with each other regardless of the maker.
The upside for developers is a fast-tracked approval with the U.S. Food and Drug Administration to get their products to market. The benefit for those with Type 1 diabetes is open protocol devices become available faster and are more customizable. The open protocol system allows users to select, as well as mix and match the components they feel will best suit their needs and improve their quality of life.
“It has great, great potential,” Daniel Finan, research director of JDRF, said in a recent interview.
According to Medical Device Manufacturing in the U.S., a report from research firm IBIS World released in June, the segment has $39.5 billion in annual revenue with an average revenue growth prediction of 3 percent per year through 2023 to $45.8 billion. According to the report, 5.2 percent of the market in 2018 or about $2.05 billion, will come from diabetes devices including continuous glucose monitoring gear and insulin pumps.
Automated insulin delivery systems involve an insulin pump; a continuous glucose monitoring system, that keeps precise track of the user’s glucose levels; and an algorithm, typically run on a smartphone, that allows the devices to work in concert to automatically keep the users blood glucose level in the best possible parameters.
In January JDRF and SFC Fluidics entered into a similar partnership to further develop SFC Fluidic’s small, automated insulin delivery device. The tiny non-mechanical pump will deliver precise doses of insulin and contain an integrated continuous glucose monitor in a single pod that can be disposed of every three days.
The version to be used under the open protocol criteria will include SFC patch pump system but it will be able to communicate with other continuous glucose monitors and work with algorithms approved by the FDA.
Tony Cruz, CEO of SFC Fluidics, said current insulin pumps that require a lot of direct interaction with their user are effectively obsolete, but there are few other options in the U.S. market for those with Type 1 diabetes. In late 2016, Medtronic received FDA approval for its MiniMed 670G, a hybrid system that mimics a healthy pancreas with some automated functions, according to the company.
“There are limited choices now,” Cruz said.
He hopes to have the SFC Fluidics open protocol patch pump on the market in two years time at the most. “We see the light at the end of the tunnel,” Cruz said.
SFC Fluidics is a VIC Technology Venture Development portfolio company. Fayetteville-based VIC has 16 portfolio companies in fields that include nanotechnology, cancer diagnostics, pharmaceuticals and semiconductors.