MedTech Company BioSig Technologies Deploys Disruptive Technology To Improve Arrhythmia Care

This article was previously published to Benzinga.

Arrhythmia is a heart condition that causes it to beat either too fast, or irregularly. It’s triggered by abnormal electrical activity and affects the heart’s rhythm, leading it to beat out of sync with the rest of the body. 

Not every patient experiences arrhythmia in the same way, so it’s sometimes necessary for doctors to provide each patient with a personalized approach to treatment and recovery. 

Lifestyle choices and comorbidities, medication, stress and environmental factors can cause the heart to beat out of sync. The world is experiencing an uptick in arrhythmia cases linked to the after effects of COVID-19.

Atrial fibrillation (AFib) is the most common type of arrhythmia, affecting over 33 million people globally. It leads to more than 750,000 annual hospitalizations and over 158,000 deaths per year in the U.S. alone. 

If left undiagnosed or ignored, AFib can lead to serious health consequences, including blood clots, stroke or sudden cardiac arrest. One-fourth of all strokes are caused by atrial fibrillation in victims ages 40 or older. It has also been linked to a 50% increased risk of dementia and a 30% increased chance of Alzheimer’s patients who receive little to no treatment. 

AFib represents a $37 billion healthcare problem in the U.S and is expected to top $55 billion by 2030.

What Is Catheter Ablation?

According to the National Institute of Health’s (NIH) National Heart, Lung and Blood Institute (NHLB), catheter ablation is a minimally invasive procedure that uses various types of energy, such as radio frequencies, lasers and frigid temperatures, to create tiny scars in heart tissue that prevent abnormal electrical signals from continuing to move throughout.  

Despite the therapeutic advancements and proven benefits of modern catheter ablation procedures, long-term remission rates remain suboptimal. Between 20-50% of patients must undergo a second procedure.

Advancements To Catheter Ablation And The Future of Arrhythmia

BioSig Technologies Inc. (NASDAQ: BSGM) is a medical technology company aiming to disrupt the $8 billion dollar electrophysiology market with their novel signal acquisition and processing platform: The PURE EP™ System.   

Through a powerful combination of hardware and software, the PURE EP™ System provides advanced diagnostic signals that deliver high clinical value in all types of ablation procedures. PURE EP™ aims to improve clinical decision-making and enhance procedural workflow by delivering high fidelity intracardiac signal intelligence for real-time analysis during an ablation procedure.

BioSig states that PURE EP™ represents a novel technological advancement for a field that has not witnessed innovation in nearly two decades. The Company has received close to 50 patents protecting its technology in the past few years – and now represents one of the largest patent holdings in the industry.

In April 2021, the company announced the results of a PURE EP 2.0, a multicenter, blind and randomized clinical trial conducted across three of the nation’s top medical centers.

Results showed a 93% consensus rating, including a 75% improvement in signal quality and an 83% increase in confidence in signal interpretation, and were published in the Journal of Cardiac Electrophysiology in a report titled: “Evaluation of a novel cardiac signal processing system for electrophysiology procedures: the PURE EP 2.0 study.”

To learn more about BioSig and The PURE EP™ System, visit https://www.biosig.com.

New Leadership Driving Commercial Activity

This past month, BioSig announced the appointment of John Sieckhaus as Chief Operating Officer. Mr. Sieckhaus brings over 30 years of experience in the healthcare industry, including 21 years at St. Jude Medical and Abbott Laboratories (NASDAQ: ABT). During his tenure with St. Jude Medical, Mr. Sieckhaus held commercial leadership positions of rising responsibility, including U.S. National Sales Leader, Senior Vice President & General Manager when he led sales and customer relationship management activities in the United States across all cardiovascular product lines. 

Additionally, at the end of last year, BioSig appointed seasoned electrophysiology sales executive, Gray Fleming as Chief Commercial Officer. Mr. Fleming brings over 20 years of experience in the healthcare industry—also including 17 years at Abbott Laboratories and St. Jude Medical. Fleming’s experience in delivering high-performing sales management initiatives led to substantial revenue growth with several key accomplishments, including the successful contracting of multiple leading IDN and GPO organizations. These initiatives resulted in some of the largest market share gains in St. Jude Medical’s history.

BioSig noted that they are excited to have attracted two of their industry’s top commercial executives, stating that Mr. Sieckhaus and Mr. Fleming bring the experience and relationships needed to move the needle and drive the next phase of their commercial growth. 

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