Non-invasive heart failure solution.
The only durable, smart and miniature cardiovascular assist device (Heart Pump – LVAD, RVA and Bi-VAD)
CARDIONYX aims to change the lives of more than 5 million people globally, providing improved quality of life and increased life expectancy to patients suffering from moderate to severe Heart Failure.
CARDIONYX brings an easy solution for most of the unmet market needs by offering an unprecedented attractive alternative to the only two existing solutions.
CARDIONYX aims to increase the quality of life and chance of survival of patients who suffer from Heart Failure, through the use of cutting edge technologies. CARDIONYX Ventricular Assist Device does not demand open heart surgery to be installed and has a treatment cost calculated to be 10X lower than current technologies.
Combining physicians that deal with the everyday realities of cardiac patients with a capable technical and business team, fundamental problems are creatively tackled to create ground-breaking solutions.
Established in 2018, CARDIONYX highlights its innovative Ventricular Assist Device and promises to release the medical ecosystem from open-heart surgery. Applying over one million US dollars of academic research results, CARDIONYX presents for the first time its smart, catheter-based, cost-effective and durable solution, which reduces significantly the risk of blood clotting and destruction. The CARDIONYX-VAD has a proprietary algorithm, which provides real-time feedback to its software by continuous analysis of in-heart parameters; This unique feature allows live and automatic auto-regulation between the CARDIONYX system and body requirements.
Heart failure is globally on the rise.
According to the World Health Organization, 17.9 million people die due to cardiovascular diseases worldwide, each year. This represents 31% of global deaths. Additionally, 85% of these deaths are due to heart attacks and/or stroke. An aging and growing population, with poor diet and lifestyle choices, are drivers to this tendency.
According to the New York Heart Association (NYHA), Heart Failure is classified into four classes (Class I to IV).
Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnoea.
There are 4.5 million patients in the world (1 million in the U.S.) per year in this category.
Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.
There are 1 million patients in the world (0.3 million in the U.S.) per year in this category.
The medical eco-system does not have today any durable solution to offer to 96% of class IV patients. Why?
There are two major explanations:
Either related to Medical facts or related to the cost of treatment.
Currently, there are only two possible solutions, and unfortunately, all of them require heart or chest surgery.
1. Heart transplant: The preferred solution. In the USA alone there are ≈ 2,200 donations per year, an insufficient amount to meet the demand.
2. Ventricular Assistance Device (VAD): Only 5,500 VAD implantation surgeries are performed annually in the US.
Patients who suffer from advanced Heart Failure often have other diseases, and are weak, or frail; For these reasons, overcoming an open chest or heart surgery (with or without general anesthesia or cardiopulmonary bypass) becomes a very high risk and extreme challenge when considering the markedly increased risk for perioperative complications such as infection, bleeding, thrombosis and increased hospitalization time.
Cost of treatment:
Medical health insurance company's effectiveness index: American health insurance companies have an Index that measures treatment cost-effectiveness.
If the treatment cost of an advanced stage illness is below 20K dollars per year, it is considered very profitable. If the treatment cost is above 100K per year, it is considered unprofitable.
Cardionyx’s next-generation miniature smart heart pump
Dramatically reduces risks and costs of destination therapies.
Quality of life as well as life expectancy is taken to the next level.
Implantable through catheterization.
No surgery - 20 minutes procedure.
Very little damage (if any) to blood cells.
Ambulatory procedure / Short hospitalization required (0-2 days).
Highly profitable for health insurance companies.
Applicable to most Class IV patients.
New hope for Class III patients.
A multistage pump, placed inside either the ascending aorta or the pulmonary trunk, for either Left Ventricular Support, Right Ventricular Support, or Bi-Ventricular support. Damage to the aortic or pulmonary valves is prevented, and heart functionality is preserved.
Novel pump design, with fully suspended impellers powered by a magnetic drive; capable of delivering a high volume of blood with low blood damage.
Multistage design that allows the use of different impeller sets, thus adapting the device to accommodate each patient's specific needs.
Auto-regulation proprietary algorithm designed to match specific patient requirements.
Easy to deploy procedure - The VAD is inserted percutaneously and fixed to its final position using nitinol whiskers.
Total available market: $ 60 B
Serviceable available market: $ 25 B
Market general data - M&A history
- Abbot bought St. Jude Medical for $25 billion.
- St. Jude Medical bought Thoratec for $3.4 billion.
- Abbot controls 80% of the total market of durable pumps.
They describe their current product as:
Indicated for providing short- and long-term mechanical circulatory support.
Abbott has seen growth in its heart failure unit last year. During Abbott’s 4Q19 earnings call incoming CEO Robert Ford said the company was in a strong position.
Medtronic bought HeartWare for $1.1 billion in 2016.