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BioSig Technologies completes enrollment in PURE EP 2.0 clinical trial

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BioSig Technologies Inc (NASDAQ:BSGM) said it has completed enrollment in the PURE EP 2.0 clinical trial.

The multi-center, prospective clinical trial was conducted at the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, Texas, Mayo Clinic Florida Campus in Jacksonville, Florida, and Massachusetts General Hospital in Boston. 

During the trial, BioSig said the PURE EP System was used in all types of arrhythmia cases, including atrial fibrillation, ventricular tachycardia, and atrial flutter. Atrial fibrillation, the most common arrhythmia type affecting over 6 million people in the US, accounted for more than 40% of enrollments.

READ: BioSig Technologies sees its PURE EP System highlighted in new feature article in EP Lab Digest

The PURE EP System has been awarded 510(k) clearance by the US Food and Drug Administration (FDA) and the company commenced commercialization in 2020. It recently announced commercial sales to St. David’s HealthCare in Austin, an HCA Healthcare-owned hospital, and the Mayo Foundation for Medical Education and Research. 

The company said clinical data, collected under the terms of the PURE EP 2.0 study, will support the national rollout to medical centers across the US. 

The study aimed to establish the safe and effective use of the PURE EP System and assess the quality of the PURE EP intracardiac signals when compared to existing recording and mapping systems. Collected clinical data underwent randomized, blinded, and controlled evaluation by a panel of independent electrophysiologists to determine the clinical value of the PURE EP signals. 

BioSig said it has submitted a scientific abstract for consideration by the Heart Rhythm Society and expects to announce the study results at the Heart Rhythm 2021 convention, due to take place on July 28-31. 

Full clinical study results

BioSig said that it expects to publish the full clinical study results in leading industry publications in the second half of 2021.

Last year the company announced the data results recorded during 15 atrial fibrillation ablation procedures from the PURE EP System, the signal recording system, and the 3D mapping system. The review concluded that the PURE EP signals were preferred to conventional sources of intracardiac signals.

In addition to the enrolled patient data, the company said it maintains a registry of over 600 ablation procedures performed with the PURE EP System at eight hospitals in the US. This dataset is being used to support new product development to complement the PURE EP System.

“We are pleased to complete the enrollment in our flagship clinical study,” said BioSig CEO Kenneth Londoner. “The objective of our clinical strategy is to determine the clinical and economic benefits of the PURE EP System which could include improved procedure efficacy, reduced procedure times, and a decrease in repeat procedures.”

He added: “Strong clinical evidence is the foundation of our commercial strategy. We look forward to revealing the clinical findings from our trial in the coming months and engaging the healthcare community in our new, targeted studies to demonstrate the additional clinical value of our technology.”

Contact the author: [email protected]

Follow him on Twitter @PatrickMGraham

Story by ProactiveInvestors


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