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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) announced a new research study led by Dr. Dhanunjaya DJ Lakkireddy at the Kansas City Heart Rhythm Institute. This study will examine the efficacy of the PURE EP™ System during Radiofrequency ablation in patients with paroxysmal atrial fibrillation, involving 30 participants. Positive outcomes could reduce procedural costs and duration. Additionally, Overland Park Regional Medical Center signed a national purchasing agreement to acquire the PURE EP™ System, marking a significant commercial milestone for BioSig.
BioSig Technologies (NASDAQ: BSGM) announces a pivotal agreement with Kansas City Heart Institute at Overland Park Regional Medical Center, marking its first leasing agreement under a new program. The purchase agreement for the PURE EP™ System signifies the technology's commercial adoption and establishes a national master agreement with a major U.S. healthcare system. Executives believe this agreement is crucial for enhancing heart rhythm procedures and improving patient outcomes, highlighting the importance of physician feedback in product evolution.
BioSig Technologies, Inc. (NASDAQ: BSGM) has announced the successful closing of its underwritten public offering, selling 4,341,667 shares at $0.75 per share, totaling approximately $3.26 million in gross proceeds. The funds will support commercialization efforts for the PURE EP™ System, enhance organizational development, and cover working capital and general corporate expenses. Laidlaw & Company served as the sole book-running manager for this offering. Detailed prospectus documents are available through the SEC and Laidlaw.
BioSig Technologies (NASDAQ: BSGM) has announced the pricing of a public offering of up to 4,666,667 shares of common stock at $0.75 per share, expected to raise approximately $3.5 million in gross proceeds. The offering is scheduled to close on June 28, 2022, subject to customary conditions. BioSig plans to utilize the net proceeds for commercialization of the PURE EP™ System, organizational development, and general corporate purposes. The company operates under SEC regulations following the effective shelf registration statement filed earlier.
BioSig Technologies, Inc. (Nasdaq: BSGM) announced its intention to conduct an underwritten public offering of common stock. The company aims to use the proceeds for commercialization of the PURE EP™ System, organizational development, working capital, and general corporate purposes. Laidlaw & Company (UK) Ltd. is the sole book-running manager for this offering. The offering remains subject to market conditions, and no completion assurances are provided. A shelf registration statement was previously filed and declared effective in January 2021.
BioSig Technologies, Inc. (NASDAQ: BSGM) announced a 60-day evaluation agreement with Cleveland Clinic for its PURE EP(TM) System, enhancing electrophysiology by improving intracardiac signal fidelity. The evaluation follows the induction of a new commercialization team and aligns with the company's national rollout strategy. Over 75 physicians have utilized this technology in over 2500 patient cases, indicating significant clinical interest. The PURE EP(TM) System demonstrated a 75% improvement in signal quality according to a recently published multi-center study.
BioSig Technologies (NASDAQ: BSGM) announced its national commercial launch of the PURE EP™ System, set for July 1, 2022. The company has over 30 advanced leads at Medical Centers of Excellence and has streamlined product evaluations from 180-360 days to just 60 days. The PURE EP™ System, a non-invasive class II device, enhances cardiac electrophysiology with significant clinical backing: over 2,200 patient cases and a 75% improvement in signal quality. BioSig's efforts are led by Chief Commercial Officer Gray Fleming, with a partnership established to facilitate financing options for prospective buyers.
BioSig Technologies will showcase its flagship PURE EP System at the upcoming EPLive conference in Austin, Texas, on June 2-3, 2022. This event attracts leading electrophysiologists and offers insights into treating complex cardiac arrhythmias. The Company’s enhanced NOVA-5 Software promises greater signal processing capabilities. To date, over 2,200 patient cases have been recorded using the PURE EP System, showcasing a 75% improvement in signal quality over conventional methods according to recent clinical studies.
BioSig Technologies (BSGM) has made significant advancements in its PURE EP(TM) system, achieving over 2,200 patient cases and engaging 75 physicians across 17 hospitals. The company has strengthened its management with the addition of industry veteran Gray Fleming as CCO to enhance commercialization strategies. Noteworthy updates include the rollout of a new software, NOVA-5, and a two-phase purchasing approach for the PURE EP system. BioSig is positioned in a promising $12.2 billion global electrophysiology market, with no debt reported, showcasing a solid foundation for growth.
BioSig Technologies (NASDAQ: BSGM) will exhibit at Heart Rhythm 2022 from April 29 to May 1, 2022 in San Francisco. The company will showcase its PURE EP(TM) Nova-5 Software, enhancing electrophysiology with better signal fidelity. A poster presentation will highlight clinical data on Dynamic Algorithmic Notch Filtering, co-authored by noted physicians. BioSig's system, with FDA 510(k) clearance, has seen 75 physicians complete over 2,200 patient cases, demonstrating a 75% improvement in signal quality according to study results.
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