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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 that CEO Ken Londoner will present at the Oppenheimer MedTech, Tools & Diagnostics Summit on May 26, 2021, from 8am to 5pm EST. The company's PURE EP™ System, a groundbreaking signal processing platform for cardiac care, has been used in over 850 patient cases by 48 physicians across 9 clinical sites. BioSig is focused on enhancing ECG and intra-cardiac signal fidelity, crucial for electrophysiology procedures.
BioSig Technologies (NASDAQ: BSGM) has increased its patient case goal for the PURE EP™ System from 1000 to at least 1500 by the end of 2021. So far, 44 physicians have completed over 800 arrhythmia patient cases across nine medical centers, including the Mayo Clinic and University of Pennsylvania. The Texas Cardiac Arrhythmia Institute leads with over 300 cases. The Company anticipates steady procedural growth and aims to establish 20 installation sites by year-end. Atrial fibrillation affects millions, highlighting the demand for BioSig's innovative technology.
BioSig Technologies, Inc. (Nasdaq: BSGM) announced that CEO Ken Londoner will deliver a keynote update at the Wall Street Conference on May 5, 2021, at 12:05 pm ET in West Palm Beach, Florida. The event will feature twelve companies from the MedTech and biotech sectors. BioSig’s PURE EP™ System, aimed at enhancing electrophysiology procedures, has received FDA 510(k) clearance and has been utilized in over 800 patient cases across nine clinical sites. With cardiac arrhythmias affecting millions, this technology could significantly impact patient care.
BioSig Technologies (BSGM) announced that the PURE EP System is now being utilized by Mayo Clinic in Phoenix, Arizona for cardiac arrhythmia treatments. This marks the second installation of the technology, following its use in Florida since January 2020. The PURE EP System enhances signal fidelity and is part of a 30-day clinical evaluation led by experienced electrophysiologists. Over 660 cases have been documented using this technology across nine clinical sites, supporting BioSig's growth in the medical technology sector.
BioSig Technologies announces the addition of two experienced sales executives to enhance the commercialization of its PURE EP System, an electrophysiology system designed for arrhythmia procedures. Mr. Robert Sandler will oversee sales in Texas, while Mr. Timothy Jones will manage Florida sales. Their combined expertise, in regions with over 350 electrophysiology labs, aims to accelerate growth. With expectations to triple its customer base by 2021, BioSig's innovative technology addresses significant market needs, as approximately 33 million people suffer from atrial fibrillation worldwide.
BioSig Technologies (NASDAQ: BSGM) has launched the PURE EP™ Software Version 4, enhancing their signal processing technology for irregular heartbeats. This upgrade improves user experience and introduces features like faster real-time signal analysis and a more efficient case setup process. The software rollout will benefit both new and existing customers. Over 660 patient cases have already utilized the PURE EP™ System across eight clinical sites. The company aims to drive innovation and boost commercial sales as part of their growth strategy.
BioSig Technologies, Inc. (BSGM) has completed enrollment for its PURE EP 2.0 clinical trial, involving 51 patients across multiple prestigious hospitals, including Mayo Clinic and Massachusetts General Hospital. The trial aims to validate the effectiveness of the PURE EP System against traditional cardiac signal sources. BioSig anticipates announcing results in Q3 2021, with further insights expected at the Heart Rhythm 2021 convention in late July. The PURE EP System, already FDA cleared, is designed to enhance signal fidelity, potentially leading to improved procedure efficacy and reduced healthcare costs.
BioSig Technologies (NASDAQ: BSGM) has joined the Alliance for Artificial Intelligence in Healthcare (AAIH), enhancing its commitment to AI solutions in healthcare following recent patent awards. The AAIH includes major players like Amazon and Bayer, focusing on improving care quality and reducing costs. BioSig has also launched an AI collaboration with the Mayo Foundation to enhance its PURE EP™ System, which aids in treating arrhythmias. The AI healthcare market is projected to grow from $4.9 billion in 2020 to $45.2 billion by 2026, indicating significant opportunities for BioSig.
BioSig Technologies (BSGM) announced the PURE EP™ System's significance in cardiac ablations, highlighted in EP Lab Digest's April issue. The system is regarded as vital for capturing intracardiac signals, influencing treatment decisions during procedures. Dr. Deepak Gaba noted its superior signal quality, with over 680 cases conducted. The technology supports various arrhythmias and is gaining acceptance among physicians, as it addresses unmet clinical needs. The company plans to leverage accumulated data to develop AI and machine learning applications for electrophysiology.
BioSig Technologies, Inc. (NASDAQ: BSGM) announced the adoption of its PURE EP™ systems by a leading healthcare institution across multiple states. This expansion follows the resumption of elective procedures, contributing to anticipated sales growth. With over 680 cases performed using the PURE EP™ System, which addresses various arrhythmias, the company accumulates vital data for its AI platform. CEO Kenneth L. Londoner expressed optimism about future sales and the acceptance of their technology among leading electrophysiologists.
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