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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 the commencement of patient enrollment in its Phase II trial for merimepodib, an oral antiviral treatment for COVID-19. The trial includes sites from the Mayo Clinic and Atlantic Health System. Merimepodib has shown effectiveness in reducing SARS-CoV-2 replication in preclinical studies. Previously developed for hepatitis C, it has undergone 12 clinical trials with over 400 patients. The company cites potential risks in its forward-looking statements regarding operations, competition, and regulatory approvals.
BioSig Technologies, Inc. (Nasdaq: BSGM) announced the initiation of Phase II clinical trials for its antiviral candidate, merimepodib, aimed at treating COVID-19 in hospitalized adults. These trials will partner merimepodib with remdesivir and involve multiple sites across the U.S., with results expected in Q3 2020. A conference call is scheduled for June 9, 2020, to discuss these developments. The company previously secured FDA clearance for the IND of merimepodib and has expanded patient enrollment sites, including St. David’s South Austin Medical Center.
BioSig Technologies, Inc. (Nasdaq: BSGM) has expanded its patient enrollment for its Phase II trial of merimepodib, an oral antiviral candidate for COVID-19, to St. David’s South Austin Medical Center. This facility is part of one of Texas's largest healthcare systems. The trial aims to include a diverse patient population, potentially accelerating results. Preclinical studies indicate that merimepodib effectively reduces SARS-CoV-2 replication. The trial's lead investigator is Dr. Brian Metzger, supported by a skilled clinical team from St. David's.
BioSig Technologies, Inc. (NASDAQ: BSGM) announced that two scientific sessions featuring its PURE EP(tm) System have been accepted for presentation at the Heart Rhythm Society 2020 Science. The sessions, titled ‘Cardiac Signal Acquisition and Clinical Considerations for Accurate Interpretation’, will take place on June 12 and July 1, 2020. Presented by esteemed electrophysiologists from Mayo Clinic, these sessions will address issues in cardiac signal acquisition and the implications of filter application in EP labs. This initiative reflects BioSig's commitment to advancing clinical data and technology in electrophysiology.
BioSig Technologies, Inc. (NASDAQ: BSGM) announced the issuance of U.S. Patent No. 10,645,017 for its PURE EP™ System, enhancing the protection of its technology aimed at improving electrocardiogram (ECG) fidelity during cardiac procedures. The patent addresses foundational systems for accurately recording low-amplitude signals during ablation. Additionally, BioSig's subsidiary, ViralClear Pharmaceuticals, filed five new provisional patent applications for its anti-viral treatment for COVID-19 using merimepodib, which shows efficacy in lab tests. These developments strengthen BioSig's innovation and market potential.
BioSig Technologies (Nasdaq: BSGM) announces plans to initiate a Phase II clinical trial for merimepodib, targeting adult hospitalized COVID-19 patients. This trial will assess the effectiveness of merimepodib in combination with remdesivir across multiple sites, with anticipated data release in Q3 2020. A recent article published by F1000 Research highlights the combination's success in reducing SARS-CoV-2 replication to undetectable levels in pre-clinical testing. The trial is led by Dr. Andrew D. Badley at the Mayo Clinic.
BioSig Technologies, Inc. has appointed Mr. Michael R. Dougherty to the Board of its subsidiary, ViralClear Pharmaceuticals. With over 30 years in the pharmaceutical industry, Dougherty has held significant roles at Celator Pharmaceuticals and Kalidex Pharmaceuticals. His expertise is expected to benefit ViralClear during an essential phase of clinical planning. Notably, ViralClear’s candidate, merimepodib, has shown promising results against RNA viruses, including COVID-19, with in-vitro studies indicating a 98% reduction in viral production.
BioSig Technologies announced the successful closing of a $10.8 million financing for its subsidiary, ViralClear Pharmaceuticals, at a pre-money valuation of $100 million. The funds will support Phase II clinical trials for merimepodib, an oral antiviral treatment targeting COVID-19, beginning at Mayo Clinic sites. The FDA recently cleared the IND application for the trials, highlighting investor confidence in BioSig's clinical program amid the ongoing pandemic.
BioSig Technologies announced FDA approval to proceed with a Phase II clinical trial for its antiviral drug, merimepodib, aimed at treating COVID-19 in hospitalized patients requiring oxygen support. This study will be randomized and placebo-controlled, involving multiple centers including three Mayo Clinic sites. The trial's success could signify a breakthrough in COVID-19 treatment options. The company emphasizes the drug's broad-spectrum activity against COVID-19, positioning it as a potential pivotal solution amid the pandemic.
BioSig Technologies (BSGM) announced positive pre-clinical results for merimepodib in combination with remdesivir, showing a significant reduction of SARS-CoV-2 viral production to undetectable levels. This study, conducted at the Galveston National Laboratory, underscores the potential of merimepodib as both a standalone treatment and in synergy with remdesivir. The first clinical trial is planned for hospitalized patients requiring supplemental oxygen, evaluating the drug's effectiveness. The results aim to pave the way for a phase 2 study upon FDA clearance.
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