XCellCure has a disruptive technology better equipped to Rule Out an impending heart attack for patients presenting to the ER with indeterminate chest pain. Portability allows detection and monitoring cardiovascular disease (CVD) and in the field delivering data to an assigned clinician. AMiAwareTM delivers value to ER triage by differentiating uncertain chest pain or suspect acute coronary syndrome (ACS) from indigestion. In 15 minutes, using 30 µl of blood, this pioneering technology detects high sensitive cardiac troponin (hs cTnI), patented prognostic markers (reported in over 5 human studies) to flag those headed for a heart attack, plus 9 additional markers to measure the degree of heart tissue damage and kidney function. This rapid test provides information that otherwise takes days to identify. Providing the earliest recognition of an impending CV event or having the highest power to Rule Out a CV event brings valuable information to the clinician to make more informed treatment or monitoring decisions, versus one slightly elevated hs cTnI.
XCellCure is extending the portability of the device to allow rapid testing for home use allowing those experiencing uncertain symptoms to seek emergent help, or monitor healing post a CV event. hs cTnI alone is not conclusive to Rule Out or In a heart attack. Adding markers indicative of an impending cardiac event 12.5 times likely to occur within 6 months of symptom recognition gives improved clinical information.
Medications, stress, and disease pose a risk of sudden heart attack. With AMiAware physicians and patients can better monitor heart tissue healing using less than 30 µl of human blood. Over 85.6 million people in the U.S. could benefit from cardiac marker monitoring; projecting revenue in excess of $1 billion 3 years post product launch with 1% market share. Our detection device may be adapted to detect any multiple marker combination to identify disease, illicit drug use, or environmental contaminants. This cost effective solution is expected to turn down the U.S. annual cost of management of heart failure exceeding $39.2 billion and over $315.4 billion to treat heart disease and stroke.
XCellCure, LLC aims to reduce heart attack death, the number 1 killer in the USA and worldwide responsible for over 17.3 million deaths annually. By identifying a heart attack in process - but not yet signaling cardiac tissue death- this new technology’s early detection reduces the incidence of heart failure. This novel wireless handheld, point of care diagnostic/prognostic device, using a drop of blood can diagnose if a patient is currently having a heart attack or is headed down that path. This is the best device available today to Rule Out an MI in progress or a pending MI over the following 90 to 240 days. Results are transmitted using wireless communication as needed. The portable device reads 15 bio-markers (all have prior clinical studies and patent protection) with laboratory precision and is expected to move efficiently through the FDA for clearance of a 510(K) Class II (two) device.
Now selling XCellCure’s laboratory (ISO13485 certified) microarray using novel methods to report completed results on 50 patients in 6 hours reporting in quadruplicate the 13 key markers, thus enhancing time to study completion and publication.
XCellCure is seeking funding to launch sales, complete the portable/home devices, and ramp up production. The company is self-funded; this is a fresh investment. XCellCure has 2 patents issued and 3 under review in Europe, U.S. and China. The U.S. market is in excess of 85.6 million for monitoring and another 8.2 million for ER triage. With the patent in China we have access to the World Health Organization’s estimate of 230M people with heart disease and that number is expected to increase by 50% in the next few years, making it a must to have this device. This device saves lives, time and money. We look forward to a meeting.
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