Over the last three decades, significant progress has been made in gaining a better understanding of atrial fibrillation (AF, AFib), a complex cardiac arrhythmia once considered essentially benign that is now directly linked to morbidity and death, mostly due to stroke. As researchers have been able to better define the pathophysiology of AF, treatment options have advanced as well, including catheter ablation procedures becoming routine. Technology is playing a key role, albeit for spotting AF, as the Apple Watch is trumpeted to do (and Stanford is looking to evaluate), or giving cardiologists better tools to improve outcomes for ablation procedures, such as the PURE EP™ System of BioSig Technologies (NASDAQ: BSGM).
AF is the most common arrhythmia today, affecting over 33 million people globally, including up to 6 million people in the U.S. Estimates are that the number of Americans affected will rise to over 12 million by 2030. How many people actually could be diagnosed with AF is a little bit of a guessing game. While prevalence increases with aging (9% of people over 65 have AF), it is indiscriminate and can present at any age and in people with varying lifestyles. Just ask Ed Dentel, a 46 year old man that works out regularly and hadn’t even heard of the condition before his Apple Watch pegged his AFib in December.
With AFib, the steady contractions of muscle fibers in the atria (upper chambers of heart) aren’t coordinated with those of the heart’s lower chambers (the ventricles) because disordered electrical signals cause rapid and chaotic contractions in the atria. Consequently, the blood isn’t emptied from the upper chambers to the lower chambers as it should, meaning that blood may pool in the atria. This can lead to serious complications, including stroke (risk increased 4-5x), blood clots and heart failure, in addition to short-term issues with shortness of breath, dizziness and weakness.
During a catheter ablation to try and remedy the discombobulated electrical signals, a cardiologist uses extreme heat or cold to scar heart tissue in a bid to mute the stray electrical signals causing the arrhythmia. Simply, the scarred tissue doesn’t have the ability to transmit the abnormal electrical impulses, which can eliminate the problem.
It is not a perfect world, though, and often times multiple ablation procedures are required and sometimes the AFib never completely goes away.
The cardiologist doesn’t simply look to destroy heart tissue without using all available efforts to isolate the source of rapidly discharging electrical triggers (called “hot spots”). A mapping catheter and other technology help point to the spots within the atria to ablate. However, there are limitations to today’s electrophysiology technology to precisely locate hot spots, limitations that could potentially be overcome with BioSig’s PURE EP™ System.
In its efforts, BioSig has brought together leading physicians, executives and engineering experts from top medical centers, healthcare programs, Fortune 500 companies and elite educational systems, including Mayo Clinic, Mount Sinai Medical Center, UCLA, Johnson & Johnson, Nasdaq and Prudential Securities.
The BioSig system is a combination of advanced hardware and software that offers a broader dynamic range and real-time processing to provide the cardiologist a raw cardiac signal with sharper clarity and less “noise” than anything on the market today. Utilizing superior data is believed to improve outcomes from ablations for treating not only AFib, but also Ventricular Tachycardia (VT), a condition rarer than AFib, but responsible for about 300,000 sudden cardiac deaths in the U.S. annually. Similar to AF, VT is characterized by electrical signals firing incorrectly. Because the ventricles are contracting too quickly, the atria doesn’t have time to refill, so blood is not getting pumped properly through the body.
In July, BioSig was recognized by The Silicon Review as one of the Top 50 Innovative Companies to Watch in 2018 as it progressed with its technology serving an unmet need in the $4.6 billion electrophysiology marketplace.
The following month, the U.S. Food and Drug Administration gave BioSig the green light to proceed with human testing as it aligns to meet its goal of a commercial launch of the PURE EP™ System later this year. In November, BioSig inked an agreement with Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center in Austin, Texas to conduct First-in-Human studies using the system. Only days after signing that agreement, a separate one was penned with Mayo Clinic to also conduct First-in-Human studies.
Mayo Clinic has extensive knowledge of the potential of the PURE EP™ System, having previously conducted 12 pre-clinical studies, results which have been published in a number of industry journals. In March 2017, BioSig and Mayo Clinic signed a 10-year collaboration agreement for the purpose of developing new, advanced features for the system, looking to build upon what is already a significant improvement for the good of patients and doctors.
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