Core Viewpoint - Biosig Technologies, Inc. (BSGM) has been upgraded to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system tracks the Zacks Consensus Estimate, which reflects EPS estimates from sell-side analysts for the current and following years, indicating a changing earnings picture [1][2]. - A strong correlation exists between changes in earnings estimates and near-term stock price movements, with institutional investors using these estimates to determine fair value [4][6]. Company Performance and Outlook - The upgrade for Biosig Technologies suggests an improvement in the company's underlying business, which could lead to increased buying pressure and a rise in stock price [5][10]. - For the fiscal year ending December 2025, Biosig Technologies is expected to earn -$0.20 per share, reflecting a 73.3% change from the previous year, with a 72.6% increase in the Zacks Consensus Estimate over the past three months [8][10]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [7]. - Biosig Technologies' upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [9][10].

Financial Performance and Funding - BioSig Technologies has generated minimal revenue to date, indicating operations are in an early commercialization stage[17]. - On March 7, 2024, the company issued a promissory note for $500,000 at a 12% interest rate, which was later converted into 348,624 shares of common stock[25][27]. - The company raised approximately $1,040,000 from the sale of 260,720 shares at $3.989 per share on January 12, 2024[28]. - A total of 4,403,166 ATM Shares were sold at an average price of $0.91 per share, generating gross proceeds of $4,019,063 from January 17, 2025, to April 14, 2025[34]. - The company incurred a net loss of $10.3 million and used $4.8 million in cash for operating activities for the year ended December 31, 2024[141]. - As of December 31, 2024, the company's cash and cash equivalents were approximately $0.1 million, which is insufficient to fund operations in the near future[148]. - The company expects to incur substantial additional operating expenses over the next several years as it focuses on marketing, commercialization, and customer development for its PURE EP product[144]. - Future revenue generation from the PURE EP and other products is uncertain and subject to market acceptance and competitive pressures[142]. - The company may need to raise additional funds through public or private equity offerings, debt financings, or corporate collaborations, which may not be on favorable terms[149]. Corporate Structure and Ownership - The company has a majority ownership of 69.08% in ViralClear Pharmaceuticals and 84.5% in BioSig AI Sciences as of April 14, 2025[18][19]. - ViralClear Pharmaceuticals, Inc. is currently dormant, with the company retaining 69.08% ownership as of April 14, 2025[97]. - BioSig AI Sciences, Inc. holds an 84.5% majority interest as of April 14, 2025, but its business operations are currently on hold due to lack of resources[100][101]. Intellectual Property and Patents - The patent portfolio includes 41 issued utility patents and 31 pending applications related to the PURE EP System, with additional patents focused on artificial intelligence[24]. - The company has signed three patent and know-how license agreements with Mayo Foundation, focusing on novel ablation therapy methods[104]. - The company currently holds 41 issued/allowed utility patents and has 31 additional U.S. and foreign utility patent applications pending related to its PURE EP System[206]. - The company has one U.S. patent and one pending application directed to artificial intelligence (AI), along with 30 issued worldwide design patents[206]. - The company plans to file additional patent applications to provide market exclusivity for its products, but cannot predict the outcome of these applications[207]. - The company faces risks related to the enforcement of its intellectual property rights, particularly in foreign jurisdictions where legal systems may not favor patent enforcement[209]. - The company relies on trade secret protection and confidentiality agreements to safeguard proprietary information, but these measures may not provide adequate protection[213]. - The company may face challenges from competitors who could successfully challenge its patent applications or produce similar products[214]. - If the company infringes upon third-party patents, it could face litigation and be prevented from selling its products[216]. Regulatory and Compliance Issues - The company is subject to various U.S. healthcare fraud and abuse laws, which impose civil and criminal penalties for false claims[131]. - The company must comply with Quality System Regulation (QSR) and other FDA requirements for medical device manufacturing[127]. - The company’s PURE EP product is affected by the European Union Medical Device Directive, which requires CE marking for commercial distribution[134]. - The medical device industry is highly regulated, and compliance with FDA regulations is essential for the company's operations and product marketing[162]. - The company may face increased compliance costs due to changing regulations, which could impact its ability to obtain or maintain regulatory approvals for its products[163]. - The company is classified as a "smaller reporting company," which may make it more challenging for investors to analyze its financial prospects due to reduced disclosure requirements[195]. - The company must navigate complex state healthcare laws that may impose broader restrictions than federal laws, increasing compliance risks[184]. - The company has identified a material weakness in its internal control over financial reporting, which could adversely affect its ability to report results accurately and timely[200]. - Remediation of the identified material weakness will require substantial effort throughout 2025 and beyond, with ongoing testing of the effectiveness of new and existing controls[202]. Market and Competitive Landscape - The global electrophysiology laboratory devices market is projected to grow at a CAGR of 15.1% from 2025 to 2030, reaching an estimated USD 12.9 billion in 2024[62]. - Atrial fibrillation (AF) affects nearly 40 million individuals globally, with an estimated 12.1 million cases in the U.S. by 2030, leading to significant healthcare impacts[65]. - The average selling price of competing electrophysiology recording systems is approximately $160,000, indicating a competitive market landscape[93]. - The competitive landscape in the EP market includes major players like GE and Medtronic, which possess greater resources and may develop superior products[167]. - The addressable market size estimate for the EP market may be inaccurate, potentially limiting future growth prospects[165]. Product Development and Clinical Trials - The PURE EP™ Platform aims to improve the quality of cardiac signal recordings, addressing limitations in current electrophysiology recording systems[75]. - Clinical evaluations showed a 75% overall improvement in intracardiac signal quality and an 83% improved confidence in interpreting complex signals compared to conventional sources[88]. - The PURE EP™ System has been tested in 24 pre-clinical studies, with 21 conducted at Mayo Clinic, validating its clinical effectiveness[82]. - The system's design allows for the acquisition of high-fidelity signals with minimal noise, enhancing the diagnostic value of cardiac signals[76]. - The PURE EP™ System has shown potential to reduce the need for multiple ablation procedures, improving patient outcomes[79]. - The company has completed one clinical trial, but further studies may not support the usefulness of its technology[139]. - The company relies on collaboration with Mayo Clinic for research and development of PURE EP's advanced features[140]. Operational Challenges and Workforce - The Company faced workforce reductions, laying off 42 employees in early 2024 due to funding issues, leaving only the CEO[51][53]. - The Company currently has 5 employees and 3 key consultants, with plans to hire 4-6 additional staff depending on funding[58]. - The company is highly dependent on key personnel, and their loss could adversely affect product development and operational efficiency[168]. Risks and Uncertainties - The company faces substantial doubt about its ability to continue as a going concern due to its development stage[139]. - The company expects to incur operating losses as it reverts to a development stage[139]. - The company faces risks related to the development and commercialization of its technology, including potential delays and the need for additional capital[151]. - Cybersecurity risks are a growing concern, with potential impacts on financial condition and operational integrity[179]. - The company may face product liability claims, which could result in significant financial liabilities and reputational damage[178]. - Violations of healthcare laws could result in substantial penalties, including exclusion from federal healthcare programs like Medicare and Medicaid, and reputational harm[186]. - Changes in U.S. healthcare legislation, such as the Healthcare Reform Law, could negatively impact the company's revenue and market for its products[191]. - Global economic uncertainty and geopolitical tensions could hinder the company's ability to raise capital and disrupt its supply chain for research and development[197].

Core Viewpoint - BioSig Technologies, Inc. has regained compliance with Nasdaq listing requirements, allowing its common stock to continue trading on The Nasdaq Capital Market [1][2][3] Company Compliance - On March 24, 2025, BioSig received confirmation from Nasdaq that it met the minimum stockholders' equity threshold of $2.5 million, resolving a previously disclosed deficiency [2] - The company is now in full compliance with all applicable Nasdaq continued listing standards [2] Leadership Statement - CEO Anthony Amato expressed satisfaction with the company's regained compliance, emphasizing a commitment to corporate governance and financial stability [3] - The company aims to deliver long-term value to shareholders and is focused on advancing operational goals and strengthening market position [3] Strategic Focus - BioSig is committed to innovation, strategic partnerships, and investments in advanced technologies to meet shareholder expectations [3] - Further details on specific initiatives and partnerships will be announced as they progress [3] Company Overview - BioSig Technologies is a medical device technology company with the PURE EP™ Platform, which enhances signal processing for electrophysiologists in treating cardiovascular arrhythmias [4][5] - The PURE EP™ Platform allows for real-time acquisition of raw signal data, improving procedural success and efficiency [5]

Revenue Performance - Revenue for the three months ended September 30, 2024 was $0, compared to $1 for the same period in 2023, indicating a significant decline in recognized service revenue [203]. - Revenue for the nine months ended September 30, 2024 was $27, compared to $6 for the same period in 2023 [217]. Acquisitions and Business Development - The company announced the intent to acquire Neuro-Kinesis Corporation, with a purchase price involving the issuance of shares and potential cash contributions of $2.5 million to $6 million [176]. - The company plans to hire 4-6 additional employees to support business development and commercialization of the PURE EP System, contingent on funding availability [200]. - The company expects to incur additional marketing and commercialization expenses related to the PURE EP system, along with increased general and administrative expenses as it expands [247]. Financial Condition and Compliance - The company has been notified of non-compliance with Nasdaq listing requirements, including a minimum bid price of $1.00 per share and a market value of listed securities of at least $35 million [179][181]. - The company has received a grace period until March 7, 2025, to regain compliance with Nasdaq's market value listing requirements [185]. - The company’s common stock began trading on the OTCQB on July 23, 2024, after being delisted from Nasdaq [185]. - The accumulated deficit as of September 30, 2024 was $254.24 million, with expectations of continued losses until products reach full commercial profitability [241]. - The company has incurred net losses and negative cash flows from operations since inception, raising substantial doubt about its ability to continue as a going concern [242]. Expenses and Financial Performance - Research and development expenses for Q3 2024 were $156, a decrease of $989 or 86.38% from $1,145 in Q3 2023 [206]. - General and administrative expenses for Q3 2024 were $2,763, a decrease of $52 or 1.85% from $2,815 in Q3 2023 [208]. - Payroll related expenses increased to $1,744 in Q3 2024 from $1,302 in Q3 2023, an increase of $442 or 33.95% [209]. - Net loss attributable to common shareholders for Q3 2024 was $1,940 compared to a net loss of $4,569 in Q3 2023 [216]. - Research and development expenses for the nine months ended September 30, 2024 were $736, a decrease of $3,180 or 81.21% from $3,916 in the same period in 2023 [220]. - General and administrative expenses for the nine months ended September 30, 2024 were $10,559, a decrease of $7,608 or 41.88% from $18,167 in the same period in 2023 [222]. - Net loss attributable to common shareholders for the nine months ended September 30, 2024 was $9,395 compared to a net loss of $22,999 in the same period in 2023 [233]. - Cash used in operations for the nine months ended September 30, 2024 was $4,284, a decrease from $14,371 in the same period in 2023 [239]. Legal Matters - The company received a threat of litigation on December 4, 2023, seeking $775,782 for alleged wrongful termination, which was concluded to be without merit [277]. - A second threat of litigation was received on February 22, 2024, claiming losses of $1,440,000 due to unlawful actions by the board of directors, which the company believes is also without merit [278]. - A lawsuit was filed on March 22, 2024, seeking at least $288,000 in damages related to stock certificate issuance, which the company intends to contest vigorously [279]. - The company believes that the final disposition of legal proceedings should not have a material adverse effect on its financial position or results of operations [280]. - The company is unable to provide an evaluation of the outcome of ongoing litigation or estimate potential losses at this time [279]. - The company has moved to dismiss the claims made by the plaintiff in the recent lawsuit, with a hearing set for September 2024 [279]. - There are no material proceedings involving directors, officers, or significant shareholders that are adverse to the company's interests [281]. Internal Controls and Management - Management identified material weaknesses in internal control over financial reporting, including inadequate identification and reporting of stock-based compensation [271]. - The company intends to add sufficient staff and oversight controls in 2025 to remediate identified deficiencies in internal controls [272]. - The company may experience negative impacts on its ability to accurately report financial results due to material weaknesses in internal controls [273]. - Management has remediation plans that will be implemented in 2025 to address identified weaknesses [275]. - There have been no changes in internal control over financial reporting that materially negatively affected the company during the last completed fiscal quarter [275]. Funding and Capital Requirements - The company completed a securities purchase agreement on May 1, 2024, selling 783,406 shares at $1.4605 per share, raising a total of $1,144,164 [190]. - The company raised gross proceeds of approximately $3.0 million from a registered direct offering and concurrent private placement on May 30, 2024 [253]. - A promissory note for $500,000 was issued on March 7, 2024, with a 12% interest rate due in 2026 [254]. - Future capital requirements will depend on various factors, including the progress of research and development and the timing of regulatory approvals [248]. - The company may need to delay or reduce research and development programs if additional financing is not available on acceptable terms [250]. Strategic Focus - The company plans to shift focus from technology development to commercialization, resulting in meaningful reductions in annual expenses [243].

Core Viewpoint - BioSig Technologies, Inc. has regained compliance with Nasdaq's minimum bid price requirement, indicating a positive development for the company's stock status [1][2]. Company Overview - BioSig Technologies is a medical technology company focused on enhancing intra-cardiac signal visualization, particularly in heart rhythms, through innovative software solutions [3]. - The company's FDA 510(k) cleared PURE EP™ Platform offers superior real-time signal visualization, improving the efficiency and efficacy of cardiac ablation procedures [4]. Compliance Achievement - To regain compliance, BioSig's common stock needed to maintain a minimum closing bid price of $1.00 for at least 10 consecutive business days, which was achieved as of November 13, 2024 [2]. - Nasdaq has closed the prior bid price deficiency matter, confirming the company's compliance status [2]. Leadership Statement - The CEO of BioSig expressed gratitude for the support received during the relisting process and emphasized the company's commitment to increasing shareholder value [3].

Core Insights - BioSig Technologies, Inc. successfully appealed to the NASDAQ Panel, allowing its common stock to resume trading on the NASDAQ Capital Market Exchange starting October 23, 2024 [1] - The company received an extension until March 7, 2025, providing a 360-day grace period for compliance with the Market Value of Listed Securities requirement [1] Company Overview - BioSig Technologies is a medical technology company focused on enhancing the accuracy of intra-cardiac signal visualization, particularly in heart rhythms [2] - The company utilizes a unique software platform to provide clear cardiac signal clarity, addressing significant healthcare challenges such as time, cost, and life-saving measures [2] Product Information - The FDA 510(k) cleared PURE EP™ Platform offers superior real-time signal visualization, enabling physicians to conduct targeted cardiac ablation procedures with improved efficiency and efficacy [3]

Financial Performance - Revenue for the three months ended June 30, 2024, was $13, compared to $0 for the same period in 2023, indicating a significant increase in recognized service revenue[148] - Net loss attributable to common shareholders for the three months ended June 30, 2024 was $3,918 compared to a net loss of $11,096 for the same period in 2023[154] - Revenue for the six months ended June 30, 2024 was $27, compared to $5 for the same period in 2023[155] - Other income for the six months ended June 30, 2024 totaled $1,403, an increase of $1,621 over the expense of $(218) incurred in the same period in 2023[163] - Cash used in operations for the six months ended June 30, 2024 was $2,795, a decrease from $10,543 in the same period in 2023[167] Expenses - Research and development expenses decreased by $1,367, or 79.99%, to $342 for the three months ended June 30, 2024, down from $1,709 in the same period of 2023[149] - General and administrative expenses were $4,914 for the three months ended June 30, 2024, a decrease of $4,193 or 46.04% from $9,107 in the same period of 2023[150] - Payroll related expenses decreased to $3,971 from $5,936, a decrease of $1,965, or 33.11%[151] - Research and development expenses for the six months ended June 30, 2024 were $580, a decrease of $2,191, or 79.07% from $2,771 for the same period in 2023[156] - General and administrative expenses for the six months ended June 30, 2024 were $7,796, a decrease of $7,556 or 49.22% from $15,352 for the same period in 2023[157] - Stock-based compensation for research and development personnel decreased from $761 in Q2 2023 to $133 in Q2 2024[149] Workforce and Operations - The company has reduced its workforce significantly, laying off 16 employees in January 2024 and an additional 26 employees in February 2024 due to funding issues[140] - The company is currently operating with only 5 employees and 6 key consultants, with plans to hire 4-6 additional staff depending on funding[144] Legal Matters - The company received a threat of litigation on December 4, 2023, with a claim for $775,782, which was concluded to be without merit[200] - Another threat of litigation was received on February 22, 2024, seeking restitution for losses totaling $1.44 million, which the company believes is without merit[201] - Plaintiff Michael Gray Fleming filed a lawsuit against the Company seeking at least $288,000 in damages related to stock certificate issuance[202] - The Company believes the allegations are baseless and intends to contest them vigorously[202] - A hearing for the motion to dismiss the Plaintiff's claims is scheduled for September 2024[202] - The Company does not anticipate that the final disposition of other legal proceedings will materially affect its financial position or results of operations[203] - There are no material legal proceedings involving directors, officers, or significant shareholders that are adverse to the Company's interests[203] Capital and Funding - The company announced the intent to acquire Neuro-Kinesis Corporation, with a potential cash contribution of $2.5 million to $6 million upon closing[132] - On January 12, 2024, the company raised gross proceeds of $1.04 million by selling 260,720 shares of common stock and warrants[178] - On May 1, 2024, the company raised $1.14 million by selling 783,406 shares of common stock and warrants, including $634,999 in cash[179] - On May 30, 2024, the company closed an offering raising approximately $3.0 million for working capital and general corporate purposes[181] - A promissory note for $500,000 was issued on March 7, 2024, with a 12% interest rate due in 2026[182] Internal Controls and Compliance - Management identified material weaknesses in internal control over financial reporting, including inadequate identification and reporting of stock-based compensation[193] - The company’s common stock was delisted from Nasdaq due to non-compliance with minimum stockholders' equity requirements, and it is now trading on the OTC Markets[137] Future Outlook - The company expects to incur losses from operations in the near future, with increased marketing, commercialization, and R&D expenses related to the PURE EP system[174] - Future capital requirements will depend on R&D progress, regulatory approvals, and competitive product status[175] Intellectual Property - The company currently holds 41 issued/allowed utility patents and has 27 additional patent applications pending related to the PURE EP System[133]

Acquisition Intent - BioSig Technologies has executed a non-binding letter of intent to acquire the assets of Neuro-Kinesis Corporation (NKC), with the purchase price to be paid through the issuance of BioSig's common stock [1][8] - NKC will provide BioSig with a minimum of $2.5 million and potentially up to $6 million in unrestricted cash at closing [1] Management and Expertise - NKC is managed by a team of seasoned professionals with extensive backgrounds in medical technology, electrophysiology, clinical research, regulatory affairs, and technology commercialization [3] - The management team includes notable figures such as Josh Shachar, the CEO, and Dr. Eli Gang, the Chief Medical Officer, who bring significant expertise in their respective fields [24][25] Technology Overview - NKC's Huygens™ Catheter aims to improve the resolution of signal detection in electrophysiology (EP) procedures, addressing limitations of current mapping technologies [23] - The Proteus™ Robotic Arm enhances catheter navigation, providing precision control during EP diagnostic procedures [16][30] - The Huygens™ Catheter incorporates micro-electronics for signal amplification and digital processing, reducing noise contamination and improving signal clarity [28] Market Potential - The acquisition is expected to accelerate the market entry of NKC's breakthrough technology for diagnosing and treating complex cardiac arrhythmias [9] - NKC's technology is positioned to address the needs of the 35% of patients suffering from complex arrhythmias, where traditional ablation therapies are often ineffective [14][23] Future Developments - NKC plans to develop automated EP mapping systems utilizing AI-based applications to enhance the efficiency and efficacy of EP procedures [32] - The company holds an extensive portfolio of 47 issued patents related to its catheter and robotic arm technologies, along with nearly 200 additional patents in the smart surgical device arena [31]

This limited or inaccurate mapping is especially true for any signal capture that occurs in the lower ranges below 100µV (microvolts), which leads to the second problem. Most simple arrhythmia issues are found to be in the area above the 100µV range and as high as 1000µV. These large signals are easily able to be seen above the noise threshold so the EP physician can determine where ablation can be effective. But for the 35% of patients who suffer from complex arrhythmias, traditional ablation therapy is no ...

One substantial savings recognized is for the successful termination of the office lease expense for the former headquarters in Westport, Connecticut as of July 15, 2024 which was set to end on December 31, 2024. BioSig's CEO, Anthony Amato stated, "Maintaining a strong and flexible balance sheet is a priority for our new management team. In a difficult market for companies like ours, we look for other ways to help our company and its shareholders. This reduction will provide more flexibility in evaluating ...