The COVID market for the FUSION system will consist of all hospitalized COVID-19 patients who experience hyperglycemia, which early studies have shown will consist of at least 60% of COVID patients. In early 2021, there were over 100,000 COVID-19 patients hospitalized on a daily basis in the U.S. Although COVID vaccinations have decreased this number to around 20,000 as of July 2021, the rapid increase in the Delta variant (see image to left) has put those who remain unvaccinated at significant risk of hospitalization, including young adult patients. Once the COVID-19 pandemic has passed, the market for the FUSION system will consist of the ICU and non-ICU markets noted below.
In the U.S. there are currently 80,000 adult ICU beds, and 6 million ICU patients admitted per year into these beds. These numbers are similar in the European Union (EU). Nearly 100% of ICU patients have a blood glucose greater than 110 mg/dL, and 80% of cardiac surgery patients will experience hyperglycemia in the post-operative phase. If one uses a conservative estimate of 75% of all ICU patients as the potential treatment group, there are 9 million ICU patients eligible for glucose control by intravenous insulin therapy in the U.S. and EU on an annual basis. Given the average length of stay of ICU patients of 4 days, there would be 36 million ICU patient days annually in the U.S. and EU that would require glucose control through an artificial pancreas system, which is an average of approximately 100,000 patients per day. Ideal Medical Technologies will generate revenue through sales of the disposable equipment required for use of the IV pump system, and through sale or lease of the FUSION artificial pancreas system.
In the U.S. there are approximately 800,000 non-ICU beds and 7 million diabetic patients (95% are type 2) admitted to these beds on an annual basis. This number of admissions would be approximately doubled if the EU is included. If one uses a conservative estimate of 50% of these patients being candidates for an artificial pancreas system, the potential treatment group between the U.S. and EU would be 7 million patients. Given an average length of stay of 8 days for these diabetic patients, there would be 56 million non-ICU diabetic patient days annually in the U.S. and EU that would require glucose control through an artificial pancreas system, which is an average of approximately 150,000 patients per day. For treatment of diabetic patients in a non-ICU setting, the FUSION system would use a continuous glucose monitor (CGM) similar to what diabetic patients currently use for their daily treatment (e.g., Dexcom G6 CGM). Although Ideal Medical Technologies plans to initially bring its FUSION system to market for use in the ICU setting, it will seek to add the diabetic patients in the non-ICU setting as an indication for use of the FUSION system, once the FDA has approved an interstitial fluid based CGM (e.g., Dexcom G6) for use in the hospital setting. The FDA is currently allowing use of the Dexcom G6 CGM system in the hospital setting, as a means to safely monitor the glucose level of COVID patients.