No. As it turns out, it is actually more important for ICU patients who do not have diabetes. The presence of diabetes and a chronic state of hyperglycemia provides some element of protection to diabetic patients against the extreme glucose fluctuations seen in the ICU setting. However, both the ICU patients who do not have diabetes (70%), and those who do (30%) will benefit from safe and effective glucose control.
Poor glucose control causes impaired function of the infection fighting white blood cells and sets off some of the bodies’ inflammatory cascades, both of which can impair organ function including the bone marrow, kidneys, lungs and heart. These deleterious end organ effects explain why ICU patients have worse outcomes with ineffective glucose control.
No. There are currently no approved closed loop glucose control systems (artificial pancreas) approved by the FDA for use in either the ICU or non-ICU settings of U.S. hospitals.
No. We have designed the FUSION system to work with multiple different types of continuous glucose monitors (CGM), including those requiring a direct connection (e.g., EIRUS), and those that are connected via Bluetooth technology (e.g., Dexcom G6). This will give the FUSION system the flexibility to work well in both the ICU and non-ICU settings.
In the ICU, we will be able to work with continuous glucose monitors such as the CE marked EIRUS system, which is a CGM that works off of a microdialysis technique and that can maintain its accuracy in patients experiencing shock and who are on vasopressor support. The EIRUS CGM system creates an ultrafiltrate of the blood via a specially designed central venous catheter that has a dialysis membrane attached to it. This ultrafiltrate is carried back outside the body to a glucose sensor, where the glucose level is measured and reported to the FUSION system every 1 minute via a direct connection to our Medical Computer. This glucose measurement method is more reliable than other methods that rely on aspiration of whole blood across a sensor positioned outside the body. The EIRUS continuous glucose monitor has already been shown to be reliable and accurate in clinical studies, and has achieved a CE mark, meaning it is available for use in the European Union. We have already demonstrated the ability of the FUSION system to work with the EIRUS system, in one of our published animal studies.
We will also be able to work with the Dexcom G6 CGM system, which the FDA is currently allowing to be used in the ICU setting for purposes of monitoring the glucose level of COVID-19 patients. Multiple studies have already demonstrated that the Dexcom G6 system is very accurate in critically ill COVID-19 patients (see the blog on this website). The Dexcom G6 CGM system has been approved by the FDA as an integrated continuous glucose monitor (iCGM), meaning it can be used by automated insulin dosing (AID) software for purposes of creating an artificial pancreas system. The FDA considers the FUSION systems AI based glucose control software an AID system. We have already demonstrated the ability of the FUSION system to work with the Dexcom CGM system, in one of our published animal studies.
The ability to work with interstitial (e.g., under the skin) based CGM systems such as the Dexcom G6 will given us the flexibility to use our FUSION system to control the blood glucose levels of diabetic patients in the non-ICU setting, once we receive FDA approval for this indication.
By designing the FUSION system to work with multiple different CGM types, we will have the flexibility to incorporate more accurate and reliable CGM systems, if they come to market in the future.
The CGM system we are using (e.g., EIRUS or Dexcom G6) will provide a stream of glucose data to the artificial intelligence (AI) based glucose control software being run on the FUSION systems Medical Computer. The AI software takes in this glucose data and makes adjustments to the infusion rates of insulin and/or glucose under its control, in order to bring safe and effective glucose control to the ICU patient. By making adjustments to these infusion rates every 5/10 minutes, the AI software is able to keep up with the very dynamic glucose state of ICU patients, thus avoiding both hypoglycemia and hyperglycemia, while at the same time minimizing glucose variability. Our AI based glucose control software was based on a comprehensive review of man's natural glucose control system - Pancreas (insulin release) and Liver (glucose release) - and thus exhibits biomimicry.
These three glucose measurements have been shown to have direct correlation to ICU patient outcomes. In a large study on hypoglycemia performed on almost five thousand ICU patients, it was shown that patients who experienced even one hypoglycemic measurement (< 81 mg/dL) had a 46% higher mortality rate (Egi, Mayo Clinic Proceedings, 2010). In a large study on hyperglycemia on 259K VA patients, it was shown that having an average ICU glucose level > 200 mg/dL increased the odds ratio of death by more than 100% (Falciglia, Critical Care Med, 2009). In a large study on glucose variability on over two thousand ICU patients, it was shown that patients with glucose variability in the highest 25th percentile had 400% higher mortality rates.
Yes. In our simulation study, we modeled 126,000 ICU "patients" and ran five day simulations on each "patient", which resulted in 107 million glucose values for analysis. In this simulation study we had an overall hypoglycemia (<70 mg/dL) rate of 0.09%. When we asked our FUSION systems AI based glucose control software to control the simulated patients to a range of 100-140 mg/dL, we had a zero rate of hypoglycemia. The FDA accepts simulations as a valid means to test glucose control software, and in fact used the results from this simulation study to determine that the FUSION system is a Breakthrough Medical Device. In this same study our overall rate of hyperglycemia (>140 mg/dL) was 2.1%, and our glucose variability rate, as measured by coefficient of variation, was 11.1%. Clinical studies have shown that variability rates this low can lower ICU mortality rates two fold (e.g., lowered from 20% to 10%).
Yes. However, Ideal Medical Technologies current plan for the FUSION system is to first seek an indication for use from the FDA for treatment of hyperglycemia as a therapy for COVID-19 patients. Once the FUSION system has been proven to be safe and effective in the treatment of COVID-19 patients, and the FDA approves an interstitial based CGM for use in the hospital setting, our plan is to expand the FUSION systems indication for use to diabetic patients admitted to a non-ICU setting. This will require additional studies to determine that the FUSION system is safe and effective in this patient population, and of course FDA approval of this indication for use. The ICU version of the FUSION system will have built in hardware capabilities to use an interstitial CGM (e.g., Dexcom G6) as a glucose measurement source, thus the FUSION system will only require a software update prior to being deployed into the non-ICU setting.
Yes. Studies have shown that safe and effective glucose control in diabetic patients in a non-ICU hospital setting lowers their rates of post-operative wound infections, pneumonia, length of stay, mortality rates, and significantly decreases their total cost of care.
Yes. However, it will be limited to use in major surgical cases where the patient requires placement of a central venous catheter as part of their surgical procedure, and when the patient will be treated in an ICU setting at the end of the surgical procedure.
Yes. The current methods of glucose control in the ICU setting take up to 2 hours per day per patient. Ideal Medical Technologies estimates that the FUSION system will only take 5 minutes of nursing time per patient per day to use. On start up the only required inputs are the patients weight and physician prescribed glucose range. After start up the only ongoing nursing input will be daily changes of the intravenous bags of insulin and glucose used by the system to maintain glucose control. This means that the nurse will be able to spend more time monitoring their patient, which should help to improve patient outcomes and patient satisfaction.
Yes. Hospitals in the U.S. receive fixed reimbursement rates from the government/insurance companies based on the diagnostic related groups (DRG's) of the patient. This means that the various conditions the patient has, such as congestive heart failure, diabetes, pneumonia, etc determine how much the hospital receives to care for the patient. Hospitals increase their net revenue when they can improve the quality of patient care and shorten the patients length of stay. Multiple studies have shown that glucose control in the ICU setting can save from $1,500 - $4,000 per patient and shorten the length of stay by 1-2 days, which would be realized by the hospital as an increased profit margin. Given that each FUSION system could be used up to 90 times per year, hospitals may see their net revenue increase by at least $135,000/year for each FUSION system they use.
Yes. Once we have successfully launched our FUSION system into the U.S. market, we will expand into the European Union. After that, we will then consider expansion into the rest of the world, depending on the demand.
Yes. Ideal Medical Technologies has been issued patents in both the U.S. and European Union for its complete glucose control system. The U.S. patent rights run through 2031, and the European Union patent rights run through 2028. We feel this length of patent protection should be long enough for our FUSION system to become the market leader in glucose control in the hospital setting for the two largest medical device markets in the worlds - the U.S. and European Union.
No. Ideal Medical Technologies is working with a contract manufacturer that has a proven record of engineering complex medical devices such as the FUSION system. This manufacturer is ISO 13485 certified, meaning they adhere to international standards for a quality management system for medical devices. In addition, they are FDA certified to manufacture medical devices such as the FUSION system. This manufacturer will assist IMT with testing of its 1st generation FUSION system (pictured here), and with development of our 2nd generation FUSION system.
No. Ideal Medical Technologies will be working with a Business Process Integration (BPI) company that is ISO 13485 certified. This company will assemble the various components of the FUSION system (e.g., Medical Computer, Medical Cart, CGM system, IV pump system) into the final device, and will be responsible for maintaining inventory, performing quality control, and processing all orders and returns via their FDA certified warehouse. They have the capability to distribute the fully assembled FUSION system to hospitals throughout the U.S. and European Union. By working with a BPI partner with distribution capabilities, Ideal Medical Technologies should be able to shorten the time it takes to bring the FUSION system to market, and improve COVID-19 outcomes.
Ideal Medical Technologies plans on using a direct sales force for the U.S. market. For the European Union and rest of the world we will explore the possibility of partnering with a larger corporation that already sells medical devices to hospitals throughout the world.
No. We anticipate that hospitals will realize net savings of at least $1,500 each time they use the FUSION system, even when accounting for the cost to use the system.
We will make money through sales of the consumable goods needed to run the FUSION system (central venous catheter, glucose sensor, and intravenous tubing). In addition, we will make money by either selling or leasing the FUSION medical device to hospitals.
Yes. The ICU market will increase as the majority of patients admitted to adult ICU's are older than 65 years of age, and the worldwide population of individuals older than 65 years of age will increase as a percent of the population in the coming decades. Currently around 9 percent of the worlds population is older than 65, however this percent will increase to 17 percent by 2050. This will lead to more than a doubling of ICU admissions by 2050, when accounting for the projected 25 percent increase in the worlds population by 2050.
Around 9% of U.S. adults have diabetes at this time (95% type 2), however this percent is expected to more than double to 20% by 2050. This increase, combined with a projected 20% increase in the U.S. population by 2050 will lead to a 240% increase in hospitalized patients with diabetes.
Both ICU patients and diabetic patients admitted to a non-ICU setting will benefit from the safe and effective glucose control provided by the FUSION system. This safe and effective glucose control will lead to decreased morbidity/mortality rates, shorter lengths of stay, and overall reduced cost of care.