Vixiar Medical’s Indicor™ is designed for point of care use in hospital and outpatient care. Heart failure decompensation is often caused by hemodynamic congestion, a high-pressure fluid state in the heart and blood vessels that goes unseen. The Indicor is a tool to provide data in that hidden stage to bring to light worsening heart failure. This may allow less extreme medical care to lower the probability of acute decompensation leading to hospitalization. The Indicor has been tested in over 600 patients in multiple studies. Market potential is estimated at $5 billion (US) annually.

The Problem: Seven million people in the US have heart failure leading to 1.2 million hospitalizations annually. Decompensation events are often caused by hemodynamic congestion, a high-pressure fluid state in the heart and blood vessels. It happens when high filling pressures build up inside the heart before signs like swelling or shortness of breath show up. Hemodynamic congestion has a hidden stage during which excess fluids accumulate in the body days or weeks before a patient feels ill or gains weight. By the time the patient does feel ill or exhibits symptoms like shortness of breath, they have probably already moved into the realm of dangerous decompensation. The heart simply cannot pump enough blood to keep them alive. Immediate medical intervention is needed.

The Solution: The Indicor is a simple, easy to use non-invasive device. It provides a meaningful physiological measurement, Pulse Amplitude Ratio (PAR), in the hidden stage of heart failure management. PAR is the ratio of the peripheral pulse amplitude at the end of the maneuver to the mean baseline amplitude, derived from a finger photoplethysmography (PPG) signal. It brings to light information that may result in less extreme medical intervention. This could lower the probability of acute decompensation and hospitalization. Some interventions, such as administration of diuretics, can be addressed in the clinic or home. Catching worsening hemodynamic congestion at this stage is important to healthcare providers, the patients and their family. It also has a positive financial impact on a condition that results in $32B annually in direct healthcare costs and $564M in Medicare penalties.

Market Opportunity: Initial focus is U S heart failure patients (7 million in the US and 26 million globally). There are over 1 million hospital admissions annually. The disease costs the US healthcare system $32 billion in direct cost alone, much related to hospitalization. We size the US heart failure market for our system at $5 billion annually, composed of three main segments – acute care, clinic/MD office care and home use. Additional Indicor markets include post cardiac surgical care, dialysis patients and liver failure; areas where assessment of congestion and fluid volume is critical. The device could also be impactful in primary care visits for routine screening.

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 fined by CMS annually.

Currently, by the time patients experience clinical symptoms they have decompensation, 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 hidden congestion, which can lead to readmissions. Today, there is a lack of reliable, non-invasive, easy to use tools to measure worsening hemodynamic congestion. 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.