Non-invasive heart failure solution.
The only durable, smart, and miniature
heart assist device
Heart pump LVAD, RVAD, and Bi-VAD
CARDIONYX will 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 require open-heart surgery to be installed and has a treatment cost calculated to be 10X lower than current technologies.
Combining physicians who 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 damage and clot formation. The CARDIONYX-VAD has a unique, 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, both of them require heart or chest surgery.
1. Heart transplant: The preferred solution. In the USA alone there are only ≈ 2,200 donations per year, a highly insufficient amount to meet the demand (300.000).
2. Ventricular Assistance Device (VAD): Only 5,500 VAD implantation surgeries are performed annually in the US, a highly insufficient amount to meet the demand (300.000).
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 pump with an innovative design and proprietary technology, can be placed in numerous conformations and tailored to the patients' heart-support needs. Damage to the aortic or pulmonary valves is prevented and their functionality is preserved.
• Novel pump design, with minimal-shear impellers powered by a magnetic drive.
• Auto-regulation proprietary algorithm designed to match pump output and flow patterns to patient demands in real-time.
• Easy to deploy - The pump is inserted percutaneously using a one-of-a-kind endovascular procedure. Minimal peri-procedural recovery and complications.
Relevant information for investors
Total available market: $ 60 B
Serviceable available market: $ 25 B
Market general data - M&A history
- Abbot Laboratories ® bought St. Jude Medical, Inc. for $25 billion.
- St. Jude Medical, Inc. bought Thoratec Corporation for $3.4 billion.
- Abbot Laboratories ® 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.
Medtronic plc. bought HeartWare Inc. for $1.1 billion in 2016.