During its series of pre-submission meetings with the FDA, Ideal Medical Technologies proposed to the FDA a series of clinical studies that will be performed in order to demonstrate the ability of the FUSION system to bring safe and effective glucose control to the ICU patient population. At this time the FDA and Ideal Medical Technologies are in agreement as to the number of clinical studies needed, and Ideal Medical Technologies plans to complete this series of clinical studies, including the pivotal study required for FDA marketing approval, by the end of 2021.
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. By having this designation, we are able to get feedback from the FDA on issues involving our FUSION system within 30-45 days, versus the usual 75-90 day wait experienced by other companies trying to bring medical devices to market, that have not been designated as breakthrough devices. This quicker FDA feedback time may help to shorten the time it takes to bring the FUSION system to market.
The FDA has determined that Ideal Medical Technologies AI based glucose control software will be eligible to be brought to market as a class II medical device under the De Novo pathway. In addition, the other two components of the FUSION system, which are the EIRUS continuous glucose monitor and intravenous pumps, will be brought to market as class II medical devices. Both the Breakthrough Medical Device designation and class II medical device eligibility should help to expedite FDA market approval of the FUSION system.
Ideal Medical Technologies has completed a series of pre-submission meetings with the FDA, and at this time is preparing its investigational device exemption (IDE) application, with plans to submit this application to the FDA by the end of December, 2019. 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.
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.
The first few clinical studies will involve use of our prototype system, which has already been successfully tested in pre-clinical studies. However, once our contract manufacturer has completed work on our commercial grade system, which is pictured here in an artists rendering, we will begin to perform studies using the device that we will eventually bring to market.
Our final study will be a pivotal study on several hundred ICU patients (cardiac, medical, neuro, trauma) at several U.S. based academic and non-academic medical centers. Once our pivotal study is completed, we will submit a market application to the FDA, which when approved will allow for marketing and sales of the FUSION system to the over 5,000 acute care hospitals in the U.S. that care for ICU patients.