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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, Inc. (NASDAQ: BSGM) announced its signal processing technology will be featured during the 16th Annual International Symposium on Ventricular Arrhythmias on October 15-16, 2021. The company’s PURE EP™ System, designed to enhance ECG signal clarity, has been instrumental in over 1500 patient cases across 13 clinical sites. Preliminary clinical data reveal a 75% overall improvement in intra-cardiac signal quality. The event is co-hosted by the University of Pennsylvania and The Mount Sinai Hospital, targeting professionals involved in ventricular arrhythmia management.
BioSig Technologies, Inc. (NASDAQ: BSGM) announced significant findings from the PURE EP 2.0 study, validating their PURE EP™ System as superior in intracardiac signal quality compared to conventional methods. Conducted across three major U.S. hospitals, the study involved 51 cardiac ablation procedures and achieved a 93% consensus among blinded reviewers. Results indicated a 75% improvement in signal quality, and an 83% enhanced confidence in interpreting complex signals. With over 60 physicians engaged in 1400 cases, BioSig aims to leverage these results for growth in electrophysiology and bioelectronic medicine.
BioSig Technologies (NASDAQ: BSGM) has partnered with Plexus Corp. to enhance the manufacturing and professional services for its innovative PURE EP™ System. This partnership aims to accelerate the commercialization of BioSig’s advanced biomedical signal processing platform designed for arrhythmia care. Plexus, which serves the healthcare sector significantly, will assist in developing a new product pipeline for BioSig’s subsidiary, NeuroClear Technologies. The PURE EP™ is already FDA cleared and has shown promising results with over 1300 patient cases conducted.
BioSig Technologies has appointed James J. Barry, Ph.D. as an Independent Director. With over 30 years in the medical device sector, Dr. Barry brings valuable experience, having previously served as CEO at InspireMD and leading roles at Boston Scientific. His expertise is expected to enhance the strategic expansion of the PURE EP(tm) system, which aims to improve electrophysiology procedures. The system is already in use at over 12 clinical sites and has had over 1300 patient cases completed. The company is focused on launching this technology in key regions, including the Northeast and Texas.
BioSig Technologies expands its presence by installing the PURE EP(tm) System at St. Elizabeth’s Medical Center in Boston, aimed at enhancing physiologic pacing procedures. This system, which has been used by over 60 physicians in more than 1300 cases across 12 clinical sites, aims to improve cardiac signal fidelity and procedural outcomes. The company is targeting market expansion in the Northeast, Texas, and Florida, achieving its goal of 13 hospital partners. Atrial fibrillation, affecting millions, underscores the importance of advanced cardiac technologies.
BioSig Technologies (Nasdaq: BSGM) has been invited to participate in the Mark E. Josephson Twenty-Eighth Annual State-of-the-Art Arrhythmia Symposium, scheduled for September 11, 2021. This event honors Dr. Josephson, a renowned pioneer in cardiac electrophysiology. BioSig's flagship product, the PURE EP™ System, has achieved FDA 510(k) clearance and is designed to enhance electrophysiology procedures. With over 1,200 patient cases handled by more than 60 physicians, the PURE EP™ aims to improve diagnostic outcomes in patients suffering from cardiac arrhythmias.
BioSig Technologies announced its participation in the Kansas City Heart Rhythm Symposium on August 21-22, 2021, showcasing its PURE EP(tm) System. At the event, Dr. Amin Al-Ahmad will present findings from the PURE EP 2.0 trial to address challenges in electrophysiology labs. The PURE EP(tm) System has achieved FDA 510(k) clearance and has been utilized in over 1,260 patient cases across eleven clinical sites. The company aims to leverage its recent success to enhance procedural efficiency in heart rhythm management.
BioSig Technologies, Inc. (NASDAQ: BSGM) will host presentations at the Heart Rhythm 2021 convention, featuring its PURE EP(tm) System. The first presentation on July 28 will showcase the system's signal processing capabilities, with esteemed speakers from prominent institutions. The second presentation on July 29 will focus on clinical applications, led by leading doctors from Mayo Clinic and Texas Cardiac Arrhythmia Institute.
TCAI is the largest user, with over 330 cases. The conference runs from July 28-31, 2021, at the Boston Convention Center, and BioSig will exhibit at booth 849.
BioSig Technologies (NASDAQ: BSGM) has signed an agreement with Medical City North Hills in Texas for the clinical evaluation of its PURE EP technology aimed at enhancing arrhythmia care. This partnership adds to BioSig's installations in Texas, alongside facilities like Houston Methodist Hospital. With over 400 EP labs, Texas represents a key market for BioSig’s growth strategy. The FDA-cleared PURE EP device has already facilitated over 1,000 patient cases across multiple sites, highlighting its potential to address the growing prevalence of cardiac arrhythmias.
BioSig Technologies, Inc. (BSGM) has announced a conference call on July 26, 2021, to discuss findings from its PURE EP 2.0 clinical trial, which involved 51 patients across three leading medical centers. The PURE EP™ System aims to enhance procedural efficiency in electrophysiology by improving signal fidelity for cardiac ablation procedures. More than 50 physicians have utilized the system in over 1000 patient cases. The trial's enrollments were completed in April 2021, and further presentations will take place at upcoming medical conventions.
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