BioSig Technologies Inc Stock Price, News & Analysis

BioSig Technologies has commenced operations with its PURE EP™ System at Deborah Heart and Lung Center in New Jersey, marking a significant advancement in its clinical trials. This initiative aims to evaluate the effectiveness of the system in capturing intracardiac signals, crucial for electrophysiology procedures. Led by Dr. Raffaele Corbisiero, the trials are particularly timely due to the COVID-19 pandemic's impact on cardiovascular health. BioSig also expands its clinical study sites, now including prestigious institutions like Massachusetts General Hospital and UPenn.

BioSig Technologies, Inc. (NASDAQ: BSGM) announced notable advancements in its PURE EP™ System, demonstrating growing acceptance with new installations at leading medical centers. With a record cash balance of $36.9 million, the Company is well-positioned for future growth. Recent highlights include new installations at Massachusetts General Hospital and the Hospital of the University of Pennsylvania, along with the acceptance of substantial clinical data abstracts. Despite halting its ViralClear subsidiary's COVID-19 trials, BioSig remains optimistic about expanding its business and product pipeline into 2021.

BioSig Technologies, Inc. (Nasdaq: BSGM) and its subsidiary, ViralClear Pharmaceuticals, have halted their Phase 2 trial studying the efficacy of oral merimepodib combined with remdesivir in severely ill COVID-19 patients. The decision follows an unblinding by the Safety Monitoring Committee, which revealed concerning differences in survival rates between treatment and placebo groups among NIAID Grade 3 patients. With no plans to continue developing merimepodib, the company will explore potential partnerships for its licensing or acquisition.

ViralClear Pharmaceuticals (Nasdaq: BSGM) and Sorrento Therapeutics are collaborating to explore synergistic effects of their antiviral agents against COVID-19. Sorrento will test its STI-1400 antibody alongside ViralClear's oral antiviral, merimepodib. The preclinical study aims to evaluate the combined efficacy in a Golden Syrian hamster model. If successful, results may support future human clinical trials with the drug combination. Merimepodib has shown promise in prior clinical studies, indicating potential for treating COVID-19.

BioSig Technologies, Inc. (Nasdaq: BSGM) has announced an increase in the ongoing Phase 2 trial of its drug merimepodib, now enrolling 80 subjects, focusing on hospitalized COVID-19 patients requiring non-invasive ventilation. The company added two Principal Investigators, expanding the trial to ten locations. A US-based CMO will manufacture Phase 3 supplies of merimepodib oral solution. Additionally, a monotherapy trial will commence post the current trial's completion. These steps reflect significant developments in the drug's clinical evaluation and potential market introduction.

BioSig Technologies (Nasdaq: BSGM) announced a Phase 2 clinical trial of merimepodib in combination with remdesivir for hospitalized patients with COVID-19 requiring supplemental oxygen. The randomized, double-blind, placebo-controlled trial aims to evaluate efficacy and safety at 10 sites across the US, led by Dr. Andrew Badley from the Mayo Clinic. A conference call is scheduled for September 22, 2020, to discuss trial details. Merimepodib has shown antiviral activity against SARS-CoV-2 and was previously investigated for chronic hepatitis C and psoriasis.

BioSig Technologies has announced positive results from the PURE EP study, showcasing its advanced signal processing capabilities compared to conventional systems. An independent analysis rated 85.3% of PURE EP signals as equivalent or superior to standard sources. The study involved data from 15 atrial fibrillation ablation procedures and highlighted that 35.5% of reviewers found more components visible in PURE EP data. Results were presented at ESC Congress 2020, further solidifying BioSig's position in the electrophysiology market.

BioSig Technologies (NASDAQ: BSGM) announced the acceptance of its abstract titled 'Computational Reconstruction of Electrocardiogram Lead Placement' for presentation at the 2020 Computing in Cardiology Conference (CinC). The research introduces a novel algorithm that reconstructs ECG lead placements using signal correlations, enhancing the classification of cardiac conditions. Co-authored by experts from Reified LLC and Mayo Clinic, the method may unlock new clinical applications. The presentation will occur virtually on September 15, 2020.

BioSig Technologies, Inc. (Nasdaq: BSGM) announced a conference call and webcast on September 15, 2020, to discuss the randomized, blinded data from the PURE EP 2.0 Clinical Study during atrial fibrillation ablation procedures at St. David’s Medical Center, Austin, Texas. The presentation will include key findings and a commercial market update. A replay of the call will be available for two weeks post-event. BioSig specializes in biomedical signal processing technology aimed at improving signal fidelity in electrocardiograms.