ASHEVILLE — Ideal Medical Technologies (IMT), an Asheville-based startup that is using artificial intelligence (AI) to control glucose in the critical care space, has raised $200,000 in debt, according to a recent securities funding.
One investor contributed to the round. The filing did not indicate how the company intends to use funds.
IDT is developing an AI-based Artificial Pancreas system called FUSION. It uses software that adjusts the doses of intravenous insulin/glucose infusing into the patients on a 5-10 minute basis.
“The FUSION systems glucose control software attempts to mimic the native pancreas/liver in all respects, from the timing of insulin/glucose release to how quickly it can raise or lower its doses of insulin/glucose flowing into the patient, based on the glucose dynamics of each patient,” the company noted on its website.
In March of 2019, the Food and Drug Administration (FDA) classified Ideal Medical Technologies FUSION system as a Breakthrough Medical Device. The FDA’s Breakthrough Medical Device program is designed to expedite patient access to breakthrough technologies that have the potential to offer more effective treatment for life-threatening conditions, such as poor glucose control in the ICU setting.
IMT said it has completed a series of pre-submission meetings with the FDA, and at this time is preparing its investigational device exemption (IDE) application.
“Our IDE application is being reviewed by a regulatory specialist who has decades of experience working with new medical devices and interacting with the FDA,” the company said. “Once the FDA has approved our IDE application, we will begin a series of clinical studies with our FUSION system at a major U.S. academic medical center. These studies will be overseen by one of the worlds foremost experts in glucose control in the hospital setting.”
