Cardiac applications

The Problem

Cardiovascular disease is the number one killer worldwide, with one death every 30 seconds in the US.

There are 6 million heart failure patients in the US, and 1+ million new cases every year.

Almost 50% of patients with severe heart failure will die within 2 years.

Chagas disease, which can cause congestive heart failure, is an epidemic in South America with multimillion cases, and 300,000 cases in the US.

Many cancer patients suffer and die from chemotherapy-induced cardiac problems.

~1 million patients in the US suffer from hypertrophic cardiomyopathy, which can cause sudden death.

Open heart surgery and stenting are only temporary solutions, even treated patients move inexorably towards heart failure status. Unfortunately, conventional technologies are powerless at this stage.

The Solution

The Viper™Catheter – not only treats but cures

The Viper™Catheter offers a novel cure for this insidious problem. It will help surgeons and cardiologists perform a simple 20-minute procedure:

Emerging injectable agents (stem cells, genes, mitochondria, etc.) and their unique properties have proved their revolutionary potential to fight chronic coronary diseases, acute or chronic myocardial infarcts, heart failures, cardiomyopathies, arrhythmias and others.

A simple hydrogel/polymer injection into the weakened cardiac wall can instantly upgrade the cardiac pumping ability, as well as seal the leakage of heart valves.

Viper™ is not only a delivery device but also an independent therapeutic tool for a novel cure of Hypertrophic Cardiomyopathy, as it can execute alcohol septal ablation. No surgery or complicated intervention will be required anymore. All patients will be eligible for this fast, easy, and efficient procedure.

Regenerative Medicine – The Delivery Agent

Regenerative medicine is now widely used in many countries, although in the US it is still mostly at the clinical trial stage. However, progress has been made in recent years:

The State of Texas allowed the use of investigational adult stem cell treatments for patients who have been diagnosed with a terminal illness or severe chronic disease. It was signed into law by Governor Greg Abbott in 2017.

In 2017 the Regenerative Medicine Advanced Therapy (RMAT) program was created by the FDA to accelerate approval of technologies related to regenerative medicine

In 2018, the US Congress passed The Right to Try Law, giving patients with terminal and life-threatening diseases the right to try experimental drugs that have made it through an FDA Phase 1 safety trial without compassionate use approval from the FDA.

Worldwide, companies engaged in gene and cell therapy and other regenerative medicine raised over $13.3 billion in 2018, which is 73% more than in 2017.

1,028 clinical trials in this field were underway worldwide in 2018.

Transparency Market Research: The global stem cell market is expected to reach $ 270.5 Billion by 2025 (annual growth rate 13.8%, 2017-2025). The stem cells market in North America is projected to be worth $167.33 Billion by 2025.

The National Institute of Health estimates that the worldwide market for regenerative medicine will top $500 billion by 2030.

Catheters are leaders among medical devices used worldwide each year

Catheters
> 1 billion
Heart valves
300 000
Stents (cardiovascular)
> 1 million
Breast implants
~ 600 000
Dental implants
3 million
Pacemakers
600 000
Renal dialyzers
~ 1.2 million
Left ventricular assist devices
> 20 000
Intraocular lenses
~ 14 million
Contact lenses
125 million
Vascular grafts
~ 400 000
Hip and knee prostheses
2 million

The Viper™Catheter and trailblazing advances patients suffering from previously incurable diseases, and eliminate the need for traumatic or complicated interventions. Patients will benefit from this revolutionary new therapy and its ideal delivery device, the Viper™Catheter.

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The Viper™Catheter is currently limited by United States law to investigational use and is not approved for sale or commercial use at this time.