The developed world is in the midst of what can be described as a “great graying.” As the population ages, certain illnesses become more prominent, leading to an increased need for rapid, effective care. Above all, there is a pressing need to leverage the latest technologies to ensure the best outcomes for patients.
In this era of aging population, heart disease is becoming an increasingly prominent challenge. Although cardiac issues can strike young and old alike, they are a particular concern for the elderly, as the risk of heart disease increases with age. As a result, heart disease as a whole is on the rise, leading to an increased focus on improved ways of combatting this growing problem.
BioSig Technologies stands at the forefront of this endeavor, developing medical monitoring technologies that provide patients and healthcare providers the data needed to spot cardiac issues before they progress.
The PURE EP System
You can have the freshest and most complete data set in the world, but it will be useless if a required piece of data gets lost in pile. Traditional EKG systems do a wonderful job of collecting information, but in a pinch, they lack the ability to show the info doctors need without forcing them to wade through background noise.
That is where the PURE EP System comes into play.
The PURE EP system is a brand new heart monitoring tool that records and displays high fidelity cardiac signals with intuitive visualizations. These visualizations let doctors zero in on the most relevant info when needed, eliminating noise, digital artifacts, and baseline wander in real time. The end result is that healthcare providers can respond to cardiac emergencies more quickly than was previously possible.
Gaining FDA Approval
The FDA is always cautious about approving new medical devices. After all, its mandate is to ensure that only proven, effective, treatments and procedures are used in the United States. One of the greatest challenges facing the FDA is shortening the time it takes to collect and analyze data needed to deliver effective cardiac treatments.
The PURE EP system shows significant promise in this area. In clinical trials, it has been shown to display data in a way that helps doctors diagnose conditions in a fraction of the time old methods required. In turn it allows doctors to get to the root of a problem while minimizing the stress and trauma a patient may undergo during diagnosis. This has been recognized by the FDA, which granted 510(k) approval this past August.
Helping Save Lives While Generating Revenue
Heart disease is the #1 cause of death in the United States, ahead of stroke, cancer, and all types of accident. This makes improving heart disease response times a promising way to reduce mortality—and also, a very lucrative business.
The value of heart disease visualization technology can be illustrated by looking at catheter ablation, just one procedure among the many where it can be used.
The worldwide market for catheter ablation related technologies is expected to exceed four billion dollars next year, with double digit percentage growth projected for the foreseeable future. PURE EP technology, when used as an augmentation to existing procedures, can not only find a place in this rapidly growing field – it can save lives.
Assuming that the PURE EP is used in just a quarter of catheter ablation cases in the United States, that means there will be a total of at least seventy-one thousand patients (out of two hundred and eighty-five thousand total) using this product. The commercial potential is significant.
Strong commercial growth
And PURE EP is not just a “potential” commercial category. It and the company behind it are already witnessing rapid real-world progress.
In August of 2018, BioSig received 510(k) clearance from the FDA, meaning it has been recognized as “safe and effective.” Earlier in the year, the company listed on the NASDAQ (ticker: BSGM). In 2017, the company entered into a strategic partnership with The Mayo Clinic, establishing a relationship with the world’s #1 ranked medical center.
And currently, a major study is in the works at Austin’s Texas Cardiac Arrhythmia Institute at St. David’s Medical Center. The study will use PURE EP in real human research subjects, providing the conclusive evidence of efficacy the company needs on its path to full FDA approval.
Learn More About BioSig Technologies Today
There are few issues more pressing in the healthcare field today than heart disease. BioSig’s mission is to leverage the latest medical technology in the fight against this scourge – enabling doctors to catch conditions earlier and ensure better outcomes for patients regardless of age or medical state. With regulatory progress under its belt, the company is already well on its way to making the future of cardiac treatment a reality.