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Vixiar Medical has developed a non-invasive hand-held device for assessing cardiac filling pressure to detect worsening heart failure. The company’s Indicor™ device is for point-of-care use in hospitals, physician’s offices, nursing facilities, and patient homes and is an alternative to more labor intensive, expensive, or more invasive approaches. Indicor has been tested in over 300 patients in multiple studies. Market potential is over $800m including over 8 million target patients annually in the US alone.
The Problem: Almost 25% of heart failure patients are readmitted to the hospital within 30 days of discharge, costing providers and insurers billions in unreimbursed costs and increasing patient mortality and morbidity. Hospitals whose readmissions exceed national averages are being fined over $400m annually. Currently, by the time patients experience clinical symptoms, it is usually too late, and they end up back in the ER. In the hospital, patients are discharged when their physical symptoms improve, but they are often released with building filling pressures, the earliest indicator of pending congestion and worsening heart failure. Unfortunately, filling pressure is difficult to measure with precision except via invasive measurement through catheterization. Clinicians agree what is needed is an accurate, rapid, non-invasive tool to detect this pre-symptomatic indicator, to guide treatment interventions and inform admissions and discharge decisions.
The Solution: Indicor™ estimates cardiac filling pressure rapidly and non-invasively at the point of care. In studies at Johns Hopkins, it has shown strong correlation to the gold standard, invasively measured pressure. The test takes under five minutes and is simple to administer. The device connects to a computer tablet via Bluetooth® to guide the patient through the procedure and collects and transmits patient test data to clinicians. IRB studies at Johns Hopkins published in the American Journal of Cardiology and other prestigious academic journals have demonstrated that the device has high specificity and sensitivity for identifying elevated pressures.
Market Opportunity: Initial focus is heart failure patients, of which there are 6 million in the US and 36 million globally. There are over 1 million hospital admissions annually. The syndrome costs the healthcare system nearly $40 billion, 60% of which is related to hospitalization. We size the heart failure market for our system at $800 million at saturation, composed of three main segments – acute care, office-based care and home use. Additional markets for the technology include post cardiac surgical care and dialysis patients, two areas where assessment of filling pressures and fluid volume is critical.