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BioSig Technologies, Inc. (BSGM)

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4.3900+0.0400 (+0.92%)
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Previous Close4.3500
Open4.4500
Bid4.4400 x 1100
Ask4.4900 x 800
Day's Range4.3000 - 4.5400
52 Week Range2.7900 - 12.4300
Volume215,650
Avg. Volume315,078
Market Cap139.557M
Beta (5Y Monthly)1.79
PE Ratio (TTM)N/A
EPS (TTM)-1.8720
Earnings DateNov 18, 2020
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est13.00
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  • BioSig Completes Enrollment in the PURE EP 2.0 Clinical Study
    GlobeNewswire

    BioSig Completes Enrollment in the PURE EP 2.0 Clinical Study

    Westport, CT, April 13, 2021 (GLOBE NEWSWIRE) -- 51 patients undergoing elective cardiac ablation treatments were enrolled in the trial at Mayo Clinic, Massachusetts General Hospital, and St. David’s Medical CenterThe trial is designed to demonstrate the quality and clinical value of the PURE EPTM signals when compared to conventional sources of cardiac signals. The Company expects to announce the study results in Q3 2021 BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company commercializing an innovative signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced it completed enrollment in the PURE EP 2.0 clinical trial. The multi-center, prospective clinical trial was conducted at the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, TX, Mayo Clinic Florida Campus in Jacksonville, FL, and Massachusetts General Hospital in Boston, MA. During the trial, the PURE EPTM System was used in all types of arrhythmia cases, including atrial fibrillation, ventricular tachycardia, and atrial flutter. Atrial fibrillation, the most common arrhythmia type affecting over 6 million people in the U.S.1, accounted for over 40% of enrollments. The PURE EPTM System has been awarded FDA 510(k) clearance. The Company commenced commercialization in 2020, having recently announced commercial sales to St. David’s HealthCare of Austin, Texas, an HCA Healthcare-owned hospital, and Mayo Foundation for Medical Education and Research. Clinical data, collected under the terms of the PURE EP 2.0 study, will support the national rollout to medical centers across the U.S. The study aimed to establish the safe and effective use of the PURE EPTM System and assess the quality of the PURE EPTM intracardiac signals when compared to existing recording and mapping systems. Collected clinical data underwent randomized, blinded, controlled evaluation by a panel of independent electrophysiologists to determine the clinical value of the PURE EPTM signals. The Company has submitted a scientific abstract for consideration by the Heart Rhythm Society. It expects to announce the study results at the Heart Rhythm 2021 convention, which is due to take place on July 28-31, 2021. The Company expects to publish the full clinical study results in leading industry publications in the second half of 2021. In Q3 2020, the Company announced the data results recorded during 15 atrial fibrillation ablation procedures from the PURE EPTM System, the signal recording system, and the 3D mapping system. The review concluded that the PURE EPTM signals were preferred to conventional sources of intracardiac signals. In addition to the enrolled patient data, the Company maintains a registry of over 600 ablation procedures performed with the PURE EPTM System at eight hospitals in the United States. This dataset is being used to support new product development to complement the PURE EPTM System. "We are pleased to complete the enrollment in our flagship clinical study. The objective of our clinical strategy is to determine the clinical and economic benefits of the PURE EPTM System which could include improved procedure efficacy, reduced procedure times, and a decrease in repeat procedures,” commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc. “Strong clinical evidence is the foundation of our commercial strategy. We look forward to revealing the clinical findings from our trial in the coming months and engaging the healthcare community in our new, targeted studies to demonstrate the additional clinical value of our technology.” About BioSig Technologies BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com). The Company’s first product, PURE EPTM System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording, and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory. Forward-looking Statements This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. 1 Top 10 Things You should Know About Heart Rhythm; Scripps Health. CONTACT: Andrew Ballou BioSig Technologies, Inc. Vice President, Investor Relations 54 Wilton Road, 2nd floor Westport, CT 06880 aballou@biosigtech.com 203-409-5444, x133

  • BioSig Invited to Join Alliance for Artificial Intelligence in Healthcare (AAIH)
    GlobeNewswire

    BioSig Invited to Join Alliance for Artificial Intelligence in Healthcare (AAIH)

    Westport, CT, April 09, 2021 (GLOBE NEWSWIRE) -- Global leaders, including Amazon, Bayer, and GE Healthcare, joined the AAIH to date to collaborate on developing novel solutions to improve the quality of care and reduce failure ratesThe Company recently launched a new AI program with the Mayo Foundation for Medical Education BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company commercializing an innovative signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced that it had been invited by, and accepted, an invitation to join the Alliance for Artificial Intelligence in Healthcare (AAIH), following BioSig’s major patent awards for its AI-based platform that the Company recently won from the U.S. Patent Office. The AAIH is the global advocacy organization for the advancement and use of artificial intelligence in healthcare to improve patients’ lives and create more efficient, sustainable, and accessible healthcare systems. The AAIH and its member companies and organizations are dedicated to developing novel interventions and product solutions to reduce failure rates and costs while improving quality across the entire healthcare spectrum from biomedical discovery, clinical research, medical diagnostics and devices, and precision medicine. The initiative, which spans out of the Alliance for Regenerative Medicine, was formally launched in 2019 with 22 founders, including Amazon WS (NASDAQ: AMZN), Bayer (XETR: BAYN), GE Healthcare (NYSE: GE), GlaxoSmithKline (NYSE: GSK), and the University of Pittsburg. “Artificial intelligence excels at analyzing and uncovering patterns in vast volumes of clinical data – a fundamental building block in improving patient care. BioSig is a company that is committed to providing superior technological solutions based on precise signal information. We believe that a joint effort between various healthcare community representatives is a much-needed step towards solving common challenges and accelerating the adoption of AI-powered solutions. We are excited to join the Alliance and collaborate with its members on our shared goals for improving the standards of patient care,’ commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc. BioSig recently launched a strategic collaboration with the Mayo Foundation for Medical Education and Research to develop a next-generation AI- and machine learning-powered software for the PURE EP™ System. The Company’s platform technology provides signal information during the cardiac ablations for the treatments of arrhythmias or irregular heartbeats, a condition that affects over 33 million people worldwide[1]. Under the terms of the newly launched AI initiative, the Company aims to develop novel technological solutions to improve existing therapies by combining the PURE EP™'s electrophysiological signals and other data sources. The Company has also announced major strategic collaborations with other subject-matter experts to further the AI and machine learning applications of the PURE EP™ System in their collaboration for AI technical advisory services with Harvard- and MIT-trained computer scientist and physicist, Dr. Wissner-Gross, of Reified. In 2020, the Company co-authored an abstract with Reified, titled ‘Computational Reconstruction of Electrocardiogram Lead Placement,’ that presented a new method for analyzing electrocardiograms that may ultimately help to improve the automated classification of patient conditions. “This is an exciting time for artificial intelligence and machine learning applications in healthcare, and we look forward to contributing to next-generation technological solutions in the space,” responded Dr. Wissner-Gross. The global market for AI in healthcare is expected to grow from $4.9 billion in 2020 to $45.2 billion by 2026 at an estimated compound annual growth rate (CAGR) of 44.9%. According to Accenture, key clinical health AI applications, when combined, can potentially create $150 billion in annual savings for the United States healthcare economy by 2026. About AAIHThe AAIH is a coalition of technology developers, pharmaceutical companies, and research organizations who have expressed the common goal of realizing the potential for AI and machine learning in healthcare to significantly improve quality of care, but who also recognize the need to address substantial industry challenges. By convening stakeholders to present a unified voice, we are working to establish responsible, ethical, and reasonable standards for the development and implementation of AI in healthcare. As an organization, the AAIH brings together industry, academia, research institutions, government NGOs, key opinion leaders, and other international stakeholders to develop appropriate regulatory principles. By engaging with a wide array of participants across the healthcare spectrum, the AAIH works to actualize the promise of artificial intelligence in medicine thereby improving patients’ lives and creating more efficient, sustainable, and accessible healthcare systems. Learn more on www.theaaih.org. About BioSig TechnologiesBioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).The Company’s first product, PURE EP™ System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory. Forward-looking Statements This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. 1 Top 10 Things You should Know About Heart Rhythm; Scripps Health CONTACT: Andrew Ballou BioSig Technologies, Inc. Vice President, Investor Relations 54 Wilton Road, 2nd floor Westport, CT 06880 aballou@biosigtech.com 203-409-5444, x133

  • EP Lab Digest Features Physician Experience with BioSig’s Cardiac Signal Acquisition Technology
    GlobeNewswire

    EP Lab Digest Features Physician Experience with BioSig’s Cardiac Signal Acquisition Technology

    Westport, CT, April 08, 2021 (GLOBE NEWSWIRE) -- Leading industry publication highlights the rising importance of intracardiac signals in complex cardiac ablations that treat irregular heart rhythm disordersHigh-quality intracardiac signals are deemed essential to determine ablation endpointsPURE EP™’s signals are described as ‘indispensable’ by the physician user BioSig Technologies, Inc. (Nasdaq: BSGM) ("BioSig" or the "Company"), a medical technology company commercializing an innovative signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced the PURE EP™ System was highlighted in a feature interview for the April issue of EP Lab Digest, a leading industry publication for electrophysiology professionals. EP Lab Digest interviewed Deepak Gaba, MD, clinical electrophysiologist, and Shari Slyder, BS, RT, Managing Director of Cardiovascular Services, who currently use the PURE EP™ System at Memorial Hospital in South Bend, Indiana. The feature interview titled ‘Improved Intracardiac Signal Visualization During RF and Cryo Procedures’ highlighted the rising importance of intracardiac signals in complex ablations and the process of incorporating the PURE EP™ System into the practice at Memorial Hospital that conducts 480 EP cases annually. According to Dr. Gaba and Mrs. Slyder, the ability to accurately discern local and far-field electrograms is essential for identifying arrhythmia substrate and guiding ablation endpoints. As the new high-density catheters and advanced electrode designs enter the market, there is a renewed focus on acquiring and displaying high-fidelity intracardiac signals. Dr. Gaba, who, along with his colleagues, has performed more than twenty-five procedures using PURE EP™ to date, describes the superior quality of PURE EP™ signals in different clinical scenarios using both Cryo and radiofrequency energy. Dr. Gaba further highlights that the signals acquired with the PURE EP™ System affect his decisions about arrhythmia's origination and optimal site of energy delivery. Additionally, Shari Slyder, a certified radiologic technician (AART), elaborates on the advantages of PURE EP™’s advanced noise shielding capabilities—a unique feature of its proprietary architecture. Read the full article here. "As we continue expanding our clinical footprint, we are rapidly learning how the cardiac information provided by PURE EP™ complements other technologies and elevates the experience in the electrophysiology lab. The growing physician acceptance of our technology is a result of our dedication to addressing unmet clinical needs. We are pleased to see the increased industry’s focus on the importance of high-fidelity intracardiac signals across all types of cardiac arrhythmias," commented Olivier Chaudoir, Senior Director of Marketing at BioSig Technologies, Inc. The PURE EP™ System is being used in all types of arrhythmia cases, including atrial fibrillation, ventricular tachycardia, and atrial flutter. More than 680 patient cases have been conducted with the technology to date. The Company continues to accumulate significant amounts of data to be utilized in the new product development to complement the PURE EP™ System, including AI- and machine learning-powered applications and modules for electrophysiology. The article is the latest interview in a series of publications featuring BioSig’s PURE EP™ System in industry-leading media outlets. Previous publications include a January 2021 editorial by EP Lab Digest’s Editor-in-Chief, Bradley P. Knight, M.D., FACC, FHRS, a December 2020 feature interview with Rafaelle Corbisiero, M.D. and Pedram Kazemian, M.D. of Deborah Heart and Lung Center, and an April 2020 interview with Andrea Natale, M.D. of Texas Cardiac Arrhythmia Institute at St. David’s Medical Center. About BioSig Technologies BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com). The Company’s first product, PURE EP™ System, is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory. Forward-looking Statements This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. CONTACT: Andrew Ballou BioSig Technologies, Inc. Vice President, Investor Relations 54 Wilton Road, 2nd floor Westport, CT 06880 aballou@biosigtech.com 203-409-5444, x133