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BioSig Technologies, Inc. (Nasdaq: BSGM) is a Minneapolis-based medical technology company focused on the development and commercialization of advanced digital signal processing technology. The company aims to revolutionize the $3 billion electrophysiology (EP) market with its flagship product, the PURE EP™ Platform. This FDA-cleared, non-invasive class II device combines innovative hardware and software to provide unparalleled clarity and precision in visualizing intracardiac signals. The technology facilitates highly targeted cardiac ablation procedures, improving procedural efficiency and patient outcomes.
BioSig's commitment to addressing healthcare's critical priorities—saving time, reducing costs, and saving lives—is reflected in its collaborative efforts with leading medical centers, including the Cleveland Clinic, Mayo Clinic, and Texas Cardiac Arrhythmia Institute. The PURE EP™ Platform's Near-Field Tracking (NFT) algorithm, introduced in Q4 2023, has already demonstrated a significant reduction in ablation time by approximately 66%, highlighting its potential to enhance clinical procedures.
Despite recent challenges, including workforce reductions and strategic shifts, BioSig remains focused on expanding its product's adoption and exploring new market opportunities. The company recently appointed Bridge Associates International Pharmaceutical Consulting (BAIPC) to advise on business model strategies and continues to work on potential commercialization opportunities within the AI space.
Under the leadership of a new CEO and a reconstituted Board of Directors, BioSig is committed to restoring and creating lasting shareholder value. The company has also addressed compliance issues with the Nasdaq Hearings Panel, further solidifying its position in the marketplace.
For more information and the latest updates, visit the SEC's website.
BioSig Technologies (NASDAQ: BSGM) presented promising results from its PURE EP™ study at the Asia Pacific Heart Rhythm Society Conference in Singapore. The randomized study involving 29 patients showed that the PURE EP™ System reduced procedural times by an average of 11.3 minutes compared to traditional ECG systems, translating into potential cost savings of approximately $418.10 per procedure. This is significant given the annual performance of over 75,000 AF ablations in the US. Further studies are planned to validate these findings and explore the financial benefits for hospitals.
BioSig Technologies (NASDAQ: BSGM) announced the publication of a peer-reviewed case report on its proprietary PURE EP™ System in the Journal of Atrial Fibrillation & Electrophysiology. The report details the use of its High Frequency Algorithm (HFA) in a patient undergoing pulmonary vein isolation, demonstrating improved signal clarity and target identification for ablation therapy. Co-authored by experts from Cleveland Clinic, this study contributes to the growing clinical evidence supporting the technology. BioSig is expanding its applications through a master research agreement with Cleveland Clinic.
BioSig Technologies (NASDAQ: BSGM) has announced a partnership with the Cleveland Clinic to explore expanded clinical applications for its PURE EP™ System. This research agreement aims to enhance digital signal processing in electrophysiology, particularly in cardiac ablation procedures. Cleveland Clinic's expertise will help identify new workflows and improve arrhythmia treatment methods. The PURE EP™ System, recently rated superior to conventional systems in a blinded study, is gaining traction in major healthcare systems amid a growing electrophysiology market projected to reach $16 billion by 2028.
BioSig Technologies (NASDAQ: BSGM) will present its PURE EP™ System at the 17th Edition Venice Arrhythmias 2022 Congress from October 13-15, 2022. This event marks the first introduction of the advanced digital signal processing technology to the European electrophysiology market. The PURE EP™ System, designed to enhance intracardiac signal visualization, showcases features like signal processing automation and comprehensive procedural analysis via the ACCUVIZ™ Module. The global electrophysiology market is projected to reach $16 billion by 2028 with an 11.2% growth rate.
BioSig Technologies announces that the PURE EP™ System has been acquired by Methodist Hospital in San Antonio. This acquisition signals continued expansion for BioSig as it enhances cardiac care by integrating with current workflows and providing superior signal visualization, crucial for complex cardiac ablation procedures. The PURE EP™ System has been rated highly by electrophysiologists, with 93.6% of signal samples being equivalent or superior to conventional systems. The global electrophysiology market is projected to grow 11.2% annually, reaching $16B by 2028.
BioSig Technologies (BSGM) has announced the release of PURE EP™ Software Version 6 with ACCUVIZ™ Module, enhancing its signal processing technology.
This update features a High Frequency Algorithm for improved cardiac data visualization, along with Automatic Tachycardia Characterization and TRUSOURCE Analysis. The software aims to optimize workflows for electrophysiologists.
BioSig will present this innovation at the Cleveland Clinic Global EP Summit on September 23-24, 2022.
BioSig Technologies (NASDAQ: BSGM) recently announced significant enhancements to its commercial strategy, focusing on expanding its sales and marketing teams. The company has doubled its sales force and plans to triple it by Q4 2022, appointing new National Account Executives to drive the adoption of its innovative PURE EP™ System. Additionally, a newly strengthened marketing team will implement a comprehensive strategy to boost brand equity and market presence. Key clinical data demonstrating a 75% improvement in signal quality from the PURE EP™ System has been published, further validating its competitive edge.
BioSig Technologies, Inc. (NASDAQ: BSGM) announced the installation of a second PURE EP™ System at the Cleveland Clinic, enhancing access to its signal processing technology. The additional unit supports the clinical evaluation of PURE EP™ across both Main and Fairview campuses of the Heart, Vascular & Thoracic Institute. BioSig's strategy aims to expand physician engagement with its technology, which has gained traction among electrophysiology labs in the Midwest. The company also plans to participate in the Cleveland Clinic Global EP Summit 2022, showcasing advancements in electrophysiology care.
BioSig Technologies, Inc. (NASDAQ: BSGM) announced its participation in the Kansas City Heart Rhythm Symposium on August 20-21, 2022. The company's PURE EP™ System, aimed at enhancing cardiac electrophysiology procedures, will be highlighted in a presentation by Dr. Hicham El Masry. The event will also feature product demonstrations and updates on the clinical pipeline. Additionally, a physician-led research protocol studying the PURE EP™ System during RF ablation is underway at the Kansas City Heart Rhythm Institute, focusing on participants with paroxysmal atrial fibrillation.
BioSig Technologies, Inc. (NASDAQ: BSGM) reports a boost in its sales pipeline following the recent commercial launch of the PURE EP™ System. The company is seeing increased interest from medical centers, including new agreements with the Cleveland Clinic and Kansas City Heart Rhythm Institute. BioSig has streamlined evaluation agreements to 60 days and introduced a leasing program, aiming for faster adoption of its technology. CEO Kenneth Londoner anticipates continued growth in commercial activity driven by rising demand for minimally invasive procedures.
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