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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 the formation of a Scientific Advisory Board (SAB) for its subsidiary, ViralClear Pharmaceuticals, which is in Phase II trials for its lead asset, merimepodib, targeting COVID-19. The SAB includes notable experts like Robin Robinson, Ph.D., and J. Paul Waymack, M.D., who will guide ViralClear in drug discovery and regulatory development. Merimepodib has shown broad-spectrum antiviral activity against SARS-CoV-2. The company anticipates adding more experts to the SAB in the coming months.
BioSig Technologies (BSGM) announced Jerry Zeldis, CMO of its subsidiary ViralClear Pharmaceuticals, will speak at the B Riley FBR Infectious Disease Summit on July 21, 2020. The summit focuses on therapeutics for infectious diseases, including COVID-19, and Zeldis will participate in the "Arresting the Viral Replication Cycle" panel at 1:15 PM ET.
ViralClear is developing merimepodib, a novel treatment for COVID-19, which has shown strong antiviral activity against SARS-CoV-2. The company aims to enhance signal fidelity in medical procedures through its proprietary platform.
BioSig Technologies (NASDAQ: BSGM) announced a stockholder Rights Agreement to protect shareholders against unfair takeover tactics. The Board believes the current stock price does not reflect the company's intrinsic value. The agreement, expiring on July 9, 2021, provides one right for each outstanding common share, allowing shareholders to negotiate fair terms in case of a takeover. Additionally, the company delayed the ViralClear S-1 filing pending results from the Phase II clinical trial of merimepodib, a potential COVID-19 treatment. Strategic options will be evaluated post-trial.
BioSig Technologies, Inc. (BSGM) announced the enrollment of patients in its Phase II trial for merimepodib, an orally administered antiviral drug for COVID-19. The trial is being conducted at four sites across Texas, Arizona, and Florida, regions currently facing high COVID-19 cases. Merimepodib has shown strong in-vitro activity against SARS-CoV-2. The study is double-blind and aims to evaluate the drug's effectiveness in hospitalized patients requiring oxygen. Results are expected later this summer, with promising preclinical data indicating significant reduction in viral replication.
BioSig Technologies (BSGM) has submitted its application to the Systems for Award Management (SAM), allowing the company and its subsidiary ViralClear to conduct business with the federal government. This registration will enable BioSig to apply for government contracts and grants, enhancing its market opportunities. The company expects to receive its Commercial and Government Entity (CAGE) code within two weeks, facilitating its entry into federal business operations.
BioSig Technologies (BSGM) announced a partnership with Albany Molecular Research Inc. (AMRI) to conduct research on merimepodib as a potential treatment for COVID-19. This collaboration aims to explore merimepodib's efficacy as a standalone treatment or in combination with other antiviral agents. BioSig's subsidiary, ViralClear Pharmaceuticals, emphasizes using US-based contract development and manufacturing organizations to support its commercialization strategy. Merimepodib has shown broad-spectrum antiviral activity, particularly against SARS-CoV-2, and previously underwent extensive clinical testing for other indications.
BioSig Technologies, Inc. (NASDAQ: BSGM) has appointed Mr. Anthony Zook to its Board of Directors, enhancing its leadership with his extensive commercialization experience in the life sciences sector, particularly from his tenure at AstraZeneca. Zook's insights are expected to support the company's subsidiary, ViralClear Pharmaceuticals, in its ongoing Phase II clinical trial aimed at developing a treatment for COVID-19. The trial recently opened patient enrollment in multiple hospitals.
Additionally, BioSig is collaborating with Catalent for further drug development.
BioSig Technologies, Inc. (Nasdaq: BSGM) announced the closing of a registered direct offering of 2,187,500 shares at $8.00 per share, resulting in gross proceeds of $17.5 million. The funds will be used for commercialization, working capital, and corporate purposes. The company reported strong business performance in Q2 2020, with growing demand for its PURE EP Systems. Additionally, its subsidiary, ViralClear Pharmaceuticals, is progressing with a Phase II clinical trial for its COVID-19 treatment candidate, merimepodib. The offering was facilitated by The Special Equities Group.
BioSig Technologies, Inc. (Nasdaq: BSGM) announced a registered direct offering of 2,187,500 shares of its common stock at $8.00 per share, totaling expected gross proceeds of $17.5 million. The company plans to use the net proceeds for commercialization, working capital, and general corporate purposes. The closing of this offering is anticipated around June 26, 2020, contingent on customary conditions. The offering is conducted under a previously filed shelf registration statement with the SEC.
BioSig Technologies (Nasdaq: BSGM) announced a collaboration with Catalent to develop a treatment for COVID-19 using its antiviral agent, merimepodib. Catalent will create two oral dosage forms of merimepodib, which has shown in vitro effectiveness against SARS-CoV-2. The partnership emphasizes US-based manufacturing and aims to expedite clinical trials. Catalent's St. Petersburg facility will handle production, leveraging its expertise in lipid-based formulations. This initiative aligns with urgent global needs for COVID-19 treatments, enhancing BioSig's potential market positioning.
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