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BioSig Technologies Achieves First Commercial Sale Of Its PURE EP System

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BioSig Technologies Achieves First Commercial Sale Of Its PURE EP System

BioSig Technologies, Inc. was one of the sponsors for the Benzinga Global Small Cap Conference that took place on December 8-9, 2020.

According to recent information published on WHO's 2019 Global Health Estimates, heart disease remains the leading cause of death globally.

While there are many cardiovascular technologies to help professionals with diagnoses and procedures, they haven't changed much in 20 years. Current technologies still rely on hardware filtering, which leads to manipulated signals preventing professionals from seeing the raw data. Therefore, increasing the risk of not providing an accurate diagnosis on time. 

BioSig Technologies, Inc. (NASDAQ: BSGM), a medical technology company founded in 2009,  is unlocking the future of bioelectronic medicine with its PURE EP System™, making data more accurate and procedure time shorter. The company's goal is to render cleaner information to increase cardiac ablation procedure accuracy and timeliness.

The company recently achieved its first commercial sale, which goes in line with its expected revenue for Q4 2020. Here is everything you need to know.

First Commercial Sale

Last week, St. David’s HealthCare of Austin, Texas, purchased three PURE EP™ Systems, marking the company’s first commercial sale and a critical milestone to expand its clinical footprint nationwide. 
“This installation cements our valued relationship with St. David’s and adds to the traction we are gaining in the electrophysiology (EP) market,” said Kenneth L. Londoner, Chairman & CEO of BioSig Technologies, Inc. 

BioSig installed the first PURE EP System at St. David’s Medical Center in November 2019. Shortly after that, Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center conducted the first patient cases under the company’s clinical study, Novel Cardiac Signal Processing System for Electrophysiology Procedures (PURE EP 2.0 Study). 
The company has now done more than 400 successful procedures, and 6 EP centers have installed its Pure EP system. These 6 EP centers include the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Mayo Clinic’s Florida campus, Massachusetts General Hospital, the University of Pennsylvania, and Deborah Heart and Lung Center.

BioSig’s PURE EP System

PURE EP System received FDA 510(k) clearance in August 2018. A computerized system intended to acquire, digitize, amplify, filter, measure, record, and store electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory. 

The PURE EP System is designed to reveal the full range of cardiac signals and provide signal clarity during procedures to address cardiac arrhythmias and related conditions. This ultimately reduces the probability that a procedure will be repeated and increases the safety and efficacy profile.

“The proprietary hardware and software were developed to reveal important components of the signals which are very hard for the eye to see, exposing very high-frequency micro components of the signals in the midst of noise,” said Londoner. “Our tools are very intuitive with multiple software capabilities and algorithms to help doctors understand the patients’ cardiac signals.”

A blinded, independent analysis confirmed that the PURE EP System's signals are preferred to conventional sources. In 35.5% of samples, the reviewers selected PURE EP data because "more signal components were visible,” and it produces reliable and high-quality signals compared to the standard of care systems.

The Future Of Bioelectronic Medicine

Bioelectronic medicine, a diverse $20 billion market, explores how targeted electrical signals can harness the body’s natural mechanisms to diagnose and treat a range of diseases that currently have a high unmet need.

In fact, it is expected to help diagnose and treat diseases within neurology, auto-immune diseases, diabetes, arthritis, hypertension, pain management, cancer, and others. Including familiar devices, such as pacemakers, and emerging technologies, such as vagus nerve stimulators and implantable neurostimulators. 

The field is making rapid strides attracting interest and investment from major players in technology and healthcare, such as Abbott Laboratories (NYSE: ABT), Medtronic, Inc. (NYSE: MDT), and Johnson & Johnson (NYSE: JNJ). 

We are still in the early stages of Bioelectronic medicine; however, the developing technologies might play a critical enabling role in the future. 

Photo by jesse orrico on Unsplash

 

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