HeartSounds, Inc.

The cardiac pump system consists of two parallel circuits:  The right side accepts oxygen-depleted blood returning from the body and pumps it out to the lungs via the pulmonary arteries to become oxygenated.  The left side accepts the oxygen-rich blood from the lungs and pumps it out to the body for use. The blood pumped from the heart to the body and back is known as the systemic circulatory system.  Common blood pressure monitoring is useful for gauging systemic blood circulation but will not provide information about events in the pulmonary system.  Unfortunately, it is not as simple to access the pulmonary system for analysis.  One important gauge of pulmonary function is Pulmonary Arterial Pressure (PAP), which is useful in diagnosing and guiding management of cardiac dysfunctions (i.e., shock, CHF), specifically providing information about left heart preload.  The most common methods for acquisition are Pulmonary Arterial Catheterization (PAC), the process of threading a catheter through the heart and out into the pulmonary circulation; and echocardiography, a sonographic snapshot of heart function.  Both procedures are expensive and labor intensive, and, to make matters worse, PAC insertion is a dangerous procedure shown to have high mortality rates.  This leaves a gap in the market for a device that can measure PAP non-invasively in a cost- and labor-efficient fashion.

Enter HeartSounds’ icuPATCH, which can provide PAP non-invasively without the need for a highly paid specialist to administer (both echocardiography and PAC require a skilled physician to perform the procedure and analyze the information obtained).  Studies demonstrate a correlation between the timing of heart valve closures and PAP.  When there is an increase in PAP, the closure of the pulmonic valve (P₂) is delayed with respect to the closure arterial valve (A₂).  By calculating the time gap between these valve closures, one can evaluate PAP.  Unfortunately, access to valve closure time gap information has proven difficult to achieve.  However, HeartSounds’ PATCH™ platform can easily access these data simply using the natural sounds of the cardiac cycle. 

A simple cardiac cycle is comprised of two basic sounds.  The first heart sound (S₁) consists of two overlapping signals, the closure of the mitral valve and the closure of the tricuspid valve-which act as regulators preventing backflow of blood from the ventricles.  The second heart sound (S₂) consists of the closure of the aortic valve (A₂) and closure of the pulmonic valve (P₂)- which act as regulators preventing backflow of blood into the heart once pumped out.  The icuPATCH™ can isolate these independent valve closure sounds, even though they are nearly identical and simultaneous, and calculate the time gap between the two sounds.

Shock is a broad group of serious medical conditions resulting in insufficient blood flow to support normal bodily function.  In fact, septic shock alone is responsible for 215,000 deaths a year, more than breast cancer, prostate cancer, or AIDS.  Treatment of shock can be difficult to manage given that shock can be caused by numerous diverse conditions and is further complicated by the fact that treatment for one diagnosis can be deleterious or even lethal for a patient with a different causal diagnosis.  Shock can be grouped into three primary categories:

• Cardiogenic Shock (or pump failure) can be the result of numerous cardiac issues, including myocardial infarction, heart failure, arrhythmias, cardiomyopathy, etc.
• Distributive Shock (or after-load problems) are frequently caused by Sepsis, but can also be attributed to anaphylactic or neurogenic shock.
• Pre-load problems can be the result of hypovolemic shock, a severe blood and fluid loss, as well as hemorrhagic and mechanical shock.

While it is difficult to determine total cases of shock in the US, a look at the incidence and prevalence of the various causes are emblematic of the frequency that shock is encountered.

Shock is frequently encountered in the ICU, and there are more than 60,000 beds in ICUs across America filled by 4.4 million, primarily elderly patients annually.  This is a rapidly growing market as the first of the baby boomer generation begin reaching 65 in 2011 and projections for 1 in 5 people to be over 65 by 2030.

Ease of Use:  Currently, only 10-20% of ICUs in the U.S. are staffed with specialized intensivists.  Pulmonary arterial catheterization (PAC) requires administration by a skilled cardiologist or intensivist and takes approximately 45 minutes of active involvement.  The intensivist is typically reimbursed more than $1,000 for the procedure.  Echocardiography also requires expert application and reading.  With the icuPATCH™, a trained nurse or generalist can administer the device in just seconds.

Continuous Monitoring:  Echocardiography provides a snapshot of cardiac function, meaning multiple imaging sessions need to occur to gauge treatment effectiveness.  PACs can remain in for up to 3 days but expose patients to infectious, arrhythmogenic and mechanical risk and contribute to elevated morbidity and mortality.  The continuous and non-invasive nature of the icuPATCH™ makes permanent monitoring throughout the treatment simple and inexpensive.

Currently, the highly-invasive PA catheterization process is the “gold standard” of shock management.  Because of the market opportunity and the invasiveness of catheterization, many cardiovascular techniques, strategies and methods have been introduced.  These technologies include echocardiography, esophageal Doppler and arterial pulse contour analysis.  None of these solutions have developed significant traction in the market and they all have their drawbacks.  Echocardiography is very expensive and too large to administer “on demand”.  In any given ICU, only a few of these machines exist.  Continuous echocardiography is exceedingly impractical.  The esophageal Doppler has relatively poor signal-to-noise and cannot accurately reconstruct or calculate changes in PA pressure.  Other analysis techniques in development have not published or demonstrated enough data that proves their efficacy.  Pulmonary Arterial Catheterization (PAC) is the primary competitor in this space.  It is administered on 75,000 patients per year and has many drawbacks.  Insertion and continuous monitoring are labor intensive and require specially trained personnel to ensure proper positioning and analysis of data acquired.  Use of PA catheters is associated with high mortality rates (2-3%) just from complications of the catheter (infection, perforation, arrhythmia, etc).