Heart Failure is a major public health problem, responsible for 1 of every 10 deaths in the U.S., being one of the primary causes of death in the developed world. There are approximately 7M million people in America living with HF, while every year 550,000 new cases of HF are diagnosed. It is the leading cause of hospitalization in people over the age of 65 [1]. There is a myriad of causes [2] for HF, but the condition is generally described as the heart not being able to contract as well as it should (HFrEF) or to relax as it is supposed to (HFpEF, Fig. 1). This occurs because the Left Ventricle’s (LV) muscles dilate (former) or grow hypertrophic and stiffer (latter), rendering it unable from pumping enough oxygen-rich blood to the rest of the body while accumulating an excess of blood in the lungs. The diminished cardiac output results in a cascade of health events that eventually lead to the patient’s death. Preserved or reduced Ejection Fraction (EF), which refers to the amount of blood being pumped per beat, is a counterintuitive way of describing this condition. However the logic is simple: it’s a denominator problem. Less blood being pumped out creates two major problems: 1) A traffic jam of blood in the patient’s lungs; and 2) the patient’s organs receiving less blood than they should.

• EF = (stroke volume)/(end-diastolic volume)

The Left Atrium Unloading Device (LAUD, Fig. 2) is intended for patients suffering from late-stage HF. In other words, patients with HF Class III-IV according to NYHA functional classification system; or Stage D, according to the AHA’s [3], which can be measured and diagnosed using standard clinical procedures [4]. HF has four different stages (Class I-IV or A, B, C, and D depending on the classification system used), referring to the progression of the condition. The goal of existing treatments is to keep the patient from progressing through the stages or slow it down. The LAUD is intended for Class III-IV treatment [5]. The optimal treatment for an HF patient would both reduce left atrium (LA) pressure and increase cardiac output (CO). Durable mechanical circulatory support (MCS) devices like Abbott’s HeartMate 3 improve the survival and quality of life of end stage heart failure patients, both as bridges to transplantation or as destination therapy. However, few of the 60K patients per year that would benefit from MCS receive such treatment (about 3000-3500/year). Limitations of more widespread use include the invasiveness of the procedure (i.e., sternotomy), the mandatory presence of a transcutaneous driveline, the ongoing burden of complications related to current technology, and a lack of FDA-approved MCS device-based treatment for HFpEF patients. The only other available option is heart transplant, of which demand far outstrips supply. The LAUD is intended as – either Bridge-to-Transplant therapy (BTT) or as Destination Therapy (DT) [6]. Estimates place the population in the U.S. that may benefit from a fully implantable, long-term MCS device at 60,000 patients/year.

Our value proposition rests on the premise of a patient-centric approach to the treatment. Its cornerstones rest on five basic principles:

1. Cardiost’s technology is intended primarily to improve HF patients’ quality of life – from dependent to self-sufficing.

2. Cardiost’s approach requires a less-invasive procedure - thoracoscopy vs. open-heart surgery.

3. Cardiost’s solution slows the progression of the disease by alleviating the heart’s workload WITHOUT touching the LV.

4. Cardiost’s proposal reduces reduces the afterload [7], decreasing pulmonary congestion.

5. Cardiost’s goal is to reduce hospitalizations and, therefore, costs.

By increasing the amount of oxygen-rich blood flow using the concept of “unloading the Left Atrium” Cardiost’s technology will be able to mitigate a myriad of symptoms [8] as well as health problems associated with this condition. Furthermore, by increasing the availability of oxygen-rich blood flow (i.e., supplementing CO) the patient’s quality of life will improve dramatically – according to some preliminary simulation tests, the increase could reach as much as 33% of patient’s CO [9].

The current standard of care for HF is primarily focused on improving clinical status and patient quality of life (i.e., symptom management) using pharmacological therapies (i.e., ACE inhibitors, beta blockers) for late-stage patients8. Pharmacological approaches have proven difficult to implement owing to cost, complexity, and patient tolerance, leaving many patients that cannot be stabilized. Mechanical circulatory support (MCS) devices can assist the functioning of the circulatory system either as a short-term option (i.e., bridge-to-transplant treatment) or as a long-term treatment (destination therapy)11. However, only 6-8% of patients are eligible to receive MCS therapies (namely, left ventricular assist devices [LVAD]; Moreover, current device options have proven insufficient and burdensome, with a rehospitalization rate of 29% within 60 to 90 days of discharge. Current MCS devices that are LV-centered solutions share a design flaw that limits their clinical efficacy – they rely upon trying to replace LV function altogether, one of the most important muscles of the human body.

Cardiost’s novel approach of delivering much-needed, oxygen-rich blood into the patient’s systemic circulation partially bypassing a compromised left ventricle will translate into better quality of life (QoL), improved quality-adjusted life years (QALY), fewer hospital visits, decreased rehospitalization rates, and a better standard of care.