BioSig’s PURE EP System Captures Clear Cardiac Signals in First Clinical Cases

UPDATE (April 19, 2019): More clinical cases have been completed at Greenville Memorial Hospital earlier this week, led by Dr. Andrew Brenyo. In a statement, Dr. Brenyo said the PURE EP system enabled him to “visualize waveform signals that [he] could not on [his] usual recording system”. This positive feedback indicates a strong start for the novel cardiac signals acquisition and recording system.

Originally posted April 15, 2019: 

Researchers from the Texas Cardiac Arrhythmia Institute in Austin touted early, promising results from their first clinical use of PURE EP, a novel cardiac signal acquisition system designed by BioSig Technologies.

People with an irregular heartbeat or atrial fibrillation might go to the hospital to get an electrogram so that clinicians can decide where they can intervene to restore regular heart rhythm. However, the electrograms used today can be riddled with noise and artifacts coming from other equipment found in the operating room. Such a procedure can take up to six hours, potentially yielding what is referred to in the industry as a ‘dirty signal’ that’s indiscernible to interpret by many electrophysiologists.

“We have engineered the PURE EP system,” said Ken Londoner, Chairman and CEO of BioSig Technologies in an interview with Xtalks. “It is a computer information system that helps with the recording, measuring, calculating and displaying of electrocardiograms during cardiac ablation procedures.”

The system reduces noise and artifacts, potentially improving the quality of the signal.

“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 microcomponents of the signals in the midst of noise,” explained Londoner. “Our tools are very intuitive with multiple software capabilities and algorithms to help doctors understand the patients’ cardiac signals.”

The system is intended to acquire, digitize, amplify, filter, measure and calculate, display, record and store electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory under the supervision of licensed healthcare practitioners who are responsible for interpreting the data. The goal of PURE EP is to provide cleaner information and potentially increase the accuracy and timeliness of cardiac ablation procedures.

Last summer, the company received US Food and Drug Administration (FDA) clearance for the PURE EP system, enabling the research team to perform clinical procedures.

In February, the system was used in seven procedures at the Texas Cardiac Arrhythmia Institute, led by Dr. Andrea Natale, Executive Medical Director of the institute. The quality of the cardiac signals was compared between the PURE EP and other devices commonly used cardiac mapping systems.

“With the use of the PURE EP system, I was able to identify cardiac signals which were previously undetectable to me,” commented Dr. Natale in a press release. “I believe that the PURE EP system could possibly change diagnostic and treatment strategies of arrhythmias, leading to more successful outcomes.”

The team plans to release the data from the initial clinical use at an upcoming conference. In the meantime, the team at BioSig has big plans for the future.

“We’re going to be doing more cases at other hospitals in the first half of 2019, then we’re going to be placing our systems into the market for purchase in the second half of the year,” said Londoner. “We’re also planning on doing some market clinical trials in the US to provide additional information to the medical community so they understand the benefits of our system.”

Given that about six million people have atrial fibrillation in the US and many experts agree that there is a real technical deficiency in the EP space, Londoner says he’s confident that the PURE EP system will satisfy the market need.

BioSig signed a ten-year collaboration agreement with Minnesota-based academic medical center, Mayo Clinic, to explore bioelectronic medicine. This emerging field is based on the belief that improved understanding of the body’s electrical network – via neuronal signaling – can lead to more effective therapies for diseases like cancer, diabetes, epilepsy, schizophrenia, hypertension and chronic pain.

“There’s a big belief that electricity will be of value going forward,” said Londoner. “That market is going to grow quite rapidly over the next 10-20 years.”