New Data at Heart Rhythm 2023 Suggests that Unipolar Signals May be Used for a More Precise, Accurate Approach to Treating Arrhythmias

• Data from three abstracts highlight the potential of an optimized radiofrequency ablation technique for pulmonary vein isolation (PVI)

• Preservation of raw unipolar signal using BioSig’s PURE EP platform guidance enabled real-time tissue-specific feedback when conducting ablation

Cleveland, OH and Westport, CT, May 19, 2023 (GLOBE NEWSWIRE) -- Researchers from Cleveland Clinic will be presenting data from three abstracts at Heart Rhythm 2023 that evaluated an optimized radiofrequency ablation technique for pulmonary vein isolation (PVI)—a type of ablation procedure used to treat atrial fibrillation (AF)—compared to the existing standard, the Ablation Index. Researchers used BioSig Technologies, Inc. (NASDAQ: BSGM) proprietary PURE EP Platform for real-time tissue-specific feedback to achieve equal lesion quality and dimension in a third of the time as conventional methods that rely on surrogate metrics.

Across all three studies, researchers compared the efficacy of using unipolar signals to guide procedures to the current standard of using an Ablation Index. While there is a well-established body of pre-clinical evidence validating the use of unipolar signals to assess the efficacy of ablationⁱ, capturing the unipolar signal has been a challenge with existing processing platforms due to room and radiofrequency noise saturation, wandering baseline, and improper filtering.

“Despite past evidence suggesting validation and efficacy, unipolar signals have not been used to help guide lesion and ablation because of their susceptibility to interference from an inherently noisy lab environment,” said Oussama Wazni, MD, MBA, section head, cardiac electrophysiology and pacing at Cleveland Clinic and lead researcher. "These studies suggest that the preservation of raw cardiac signal enables the use of unipolar signals to help guide ablations, while improving lesion precision and reducing procedure time."

Zachary Koch, Principal Advisor of Product Development at BioSig Technologies added, "We are thrilled to collaborate with the Cleveland Clinic on these important studies that showcase the potential of our PURE EP Platform to deliver unprecedented clarity of the raw electrical signal. The PURE EP engineering enables physicians to access the value of unipolar radiofrequency guidance, established by previous studies. These new studies not only validate previous findings, but also identify optimal duration and placement of radiofrequency therapy at the tissue level, unlocking potential time savings and improved efficacy.”