Financial Performance - For the twelve months ended December 31, 2023, the net loss available to common stockholders was $29,050, an increase of $1,779 or 6.5% compared to a net loss of $27,271 for the same period in 2022[90]. - The Company has generated minimal revenue to date and has incurred net losses and negative cash flows from operations since inception, indicating a need for additional financing to fund future operations[92]. - Total revenue for 2023 was $18,000, a decrease of 93.7% compared to $286,000 in 2022[187]. - Gross profit for 2023 was $18,000, down from $229,000 in 2022, reflecting a significant decline in product revenue[187]. - Operating expenses increased to $28,530, up 3.8% from $27,494 in 2022, driven by higher general and administrative costs[187]. - Net loss attributable to BioSig Technologies, Inc. for 2023 was $29,041, compared to a net loss of $27,052 in 2022, representing a 7.3% increase in losses[187]. - Net loss per common share, basic and diluted, improved to $(3.95) in 2023 from $(6.33) in 2022[187]. - Cash used in operating activities for 2023 was $17,313, a decrease from $21,705 in 2022, indicating improved cash management[193]. - Research and development expenses for 2023 were $5,092, down from $5,821 in 2022, reflecting a strategic focus on cost management[187]. - The accumulated deficit increased from $215,974,000 in 2022 to $245,015,000 in 2023, reflecting a rise of approximately 13%[182]. Capital and Financing - In 2023, the Company raised a total of $13,140,441 through the sale of 1,613,906 shares of common stock at an average price of $8.7571 per share, along with warrants for 806,981 shares at an average exercise price of $8.1324[98]. - The Company sold 699,693 shares in a registered direct offering on November 8, 2023, at a purchase price of $3.573 per share, generating net proceeds of approximately $2.2 million after fees and expenses[100][103]. - Cash provided by financing activities totaled $17,332, including $15,301 from the sale of common stock, compared to $8,283 in the previous year[114]. - The Company entered into a Controlled Equity Offering Sales Agreement with Cantor Fitzgerald to sell up to $30 million of common stock, but terminated this agreement on September 15, 2023[105][110]. - The Company issued a promissory note for $500,000 on March 7, 2024, with a 12% interest rate due in 2026[111][112]. - The Series C Preferred Stock has an aggregate stated value of $105,000 as of December 31, 2023, with potential triggering events that may require redemption[117]. - The Company sold 28,911 shares through the Ascendiant Sales Agreement for $60,876, after incurring transactional costs of $70,806[109]. - The company raised gross proceeds of $1,040,000 from a securities purchase agreement on January 12, 2024, selling 260,720 shares at $3.989 per share[139]. Operational Challenges - The Company is facing potential delisting from Nasdaq due to non-compliance with minimum bid price and stockholders' equity requirements, with a hearing scheduled for May 7, 2024[76][79]. - The Company has laid off its entire workforce except for the CEO due to a lack of funding, currently operating with only 4 employees and 4 key consultants[83][84]. - The Company had a working capital deficit of $(4,054) as of December 31, 2023, with cash of $190 compared to $357 at the end of 2022[114]. - As of December 31, 2023, the company had cash of $0.2 million and a working capital deficit of $4.1 million, raising substantial doubt about its ability to continue as a going concern[205]. - The company has experienced net losses and negative cash flows from operations since inception and expects these conditions to continue for the foreseeable future[206]. Product Development and Market Potential - The PURE EP™ System, the Company's first product, is designed to enhance clinical decision-making and improve workflow for various arrhythmias, integrating with existing systems in electrophysiology labs[66][67]. - The Company launched PURE EP™ Software Version 7 in late 2023, representing the most advanced iteration of its digital signal processing technology[69]. - The global electrophysiology market is projected to grow from over $8 billion in 2023 to $16 billion by 2028, representing a CAGR of 15%[157]. - The company believes that the PURE EP™ System may improve outcomes during EP studies and ablation procedures for various arrhythmias[159]. - The company anticipates an increasing proportion of diagnosed AF cases being treated via ablation as physician confidence and device efficacy improve[161]. - The PURE EP™ System has been used in over 3,000 procedures across 21 hospitals in the United States[224]. - The company reported a 75% overall improvement in intracardiac signal quality when using the PURE EP System compared to conventional sources[223]. - The method used by conventional recorders may contribute to the need for multiple ablation procedures, impacting patient treatment outcomes[236]. Subsidiary and Partnerships - As of April 15, 2024, the Company retains a 69.08% ownership in its subsidiary ViralClear Pharmaceuticals, which was formed to pursue applications of the PURE EP™ technology outside of cardiac electrophysiology[62]. - ViralClear retains 69.08% ownership and is focusing on developing a novel nerve recording system based on the PURE EP™ signal processing technology[239]. - The company has partnered with Plexus Corp for the design, development, and manufacturing of N-SENSE™[245]. - The company signed a research agreement with the University of Minnesota to develop novel therapies for sympathetic nervous system diseases[243]. Regulatory and Compliance - The PURE EP™ System received FDA 510(k) clearance in August 2018, enabling its market introduction[168]. - The company is assessing the impact of recent accounting pronouncements, including ASU 2023-09, which will affect disclosures starting in 2025[121]. - The company plans to appeal the Nasdaq delisting determination, with a hearing scheduled for May 7, 2024[203].

Westport, CT, April 04, 2024 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (NASDAQ:BSGM) ("BioSig" or the "Company"), a medical technology company delivering unprecedented accuracy and precision to intracardiac signal visualization, announced today that it appointed Bridge Associates International Pharmaceutical Consulting (BAIPC) to advise on business model strategies.  BAIPC will work to deploy a series of solutions to transform BioSig's future course with additional strategies - including operations, sta ...

Westport, CT, Feb. 06, 2024 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (NASDAQ:BSGM) ("BioSig" or the "Company"), a medical technology company committed to delivering unprecedented accuracy and precision to intracardiac signal visualization, today announced that physicians have completed over 100 cases with the Near Field Tracking ("NFT") algorithm, an innovative and proprietary feature recently launched on the Company's PURE EP™ Platform.  Available by subscription, PURE EP™'s NFT algorithm monitors cha ...

Westport, CT, Jan. 31, 2024 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (NASDAQ:BSGM) ("BioSig" or the "Company"), a medical technology company committed to delivering unprecedented accuracy and precision to intracardiac signal visualization, today announced that it intends to effect a reverse stock split of its common stock at a ratio of 1 post-split share for every 10 pre-split shares. The reverse stock split will become effective at 4:05 p.m. New York Time on Thursday, February 1, 2024. BioSig's common ...

Cost Savings Targeted to Reduce Cash Burn by 50% Core Strategy Shifts to Business Development and Distribution Partnerships Westport, CT, Jan. 30, 2024 (GLOBE NEWSWIRE) --  BioSig Technologies, Inc. (NASDAQ:BSGM) ("BioSig" or the "Company"), a medical technology company committed to delivering unprecedented accuracy and precision to intracardiac signal visualization, today announced a workforce reduction, intended to reduce annual cash burn by 50%.  The Company is reducing its internal workforce, which is ...

BioSig AI Sciences, Inc. Warrants (BioSig AI) The following table summarizes information with respect to outstanding warrants to purchase common stock of BioSig AI at September 30, 2023: | --- | --- | --- | --- | |-------|------------------|----------------------|------------------| | | Exercise Price | Number Outstanding | Expiration Date | | $ | 1.00 | 130,500 | June-July 2028 | In June and July 2023, the BioSig AI issued warrants to purchase an aggregate of 130,500 shares of its common stock for investme ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 BIOSIG TECHNOLOGIES, INC. (Exact name of registrant as specified in its charter) (203) 409-5444 (Registrant's telephone number, including area code) Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See def ...

Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.001 per share BSGM The NASDAQ Capital Market FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 For the transition period from to Commission file number: 001-38659 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Mark One) ☐ T ...

Financial Performance - The company reported a net loss of $27.3 million and net cash used in operating activities of $21.7 million for the year ended December 31, 2022[96]. - The company anticipates generating revenues from the commercial sale of its PURE EP System, although it may not be sufficient to cover operating expenses[101]. - The company may need to finance future cash needs through public or private equity offerings, debt financings, or corporate collaborations, which may not be on favorable terms[102]. - The company completed nine private placement transactions from November 2022 to March 2023, raising approximately $9.78 million through the sale of 14,203,367 shares of common stock[197]. Product Development and Clinical Trials - The company has completed one clinical trial of its product, but future clinical studies may not support the usefulness of its technology[95]. - The company is actively expanding its clinical evaluation agreements with leading medical centers in the Midwest, including the Cleveland Clinic[174]. - The PURE EP 2.0 Study involved 51 cardiac ablation procedures, collecting intracardiac signal data to evaluate the clinical utility of the PURE EP™ System[252]. - The company has collaborated with leading medical institutions such as Mayo Clinic and Cleveland Clinic to further research and develop its technology[266]. Regulatory and Compliance Challenges - The company faces significant regulatory hurdles, as its products must receive FDA clearance or approval before commercialization, which can be a lengthy and resource-intensive process[109]. - The company has identified a material weakness in its internal control over financial reporting, which could adversely affect its ability to report results accurately[95]. - The company has received 510(k) clearance for the PURE EP System but may need additional approvals for new indications, which could be costly and time-consuming[131]. - The company may face significant legal and regulatory risks in medical device marketing and sales, which could impact its ability to operate[149]. Market Potential and Competition - The company estimates its addressable market size for the EP market, but this estimate may prove to be inaccurate, impacting future growth potential[115]. - The global electrophysiology equipment and recording systems market was valued at $6.1 billion in 2022 and is projected to reach $17.55 billion by 2032, representing a CAGR of 10.94%[211]. - The medical device industry is highly competitive, and the company may face challenges in attracting and retaining qualified personnel[137][139]. Operational and Strategic Initiatives - The company is in the early commercialization stage and expects to incur substantial additional operating expenses over the next several years as it develops its PURE EP System and other product candidates[98]. - The company expects to rapidly expand operations, requiring significant hiring of qualified personnel to support growth[119]. - The expansion may strain management systems and infrastructure, necessitating timely improvements to support business growth[120]. - The company plans to invest significantly in sales and marketing programs to achieve revenue growth and margin improvement targets[121]. Technology and Innovation - The PURE EP™ System features a low-noise architecture that enables acquisition of high-fidelity signals in their original format, which may enhance the identification of ablation targets[223]. - The introduction of PURE EP™ Software Version 6 with ACCUVIZ™ Module in late 2022 enhances real-time analysis of intracardiac signals and improves visualization of cardiac signal information[225]. - The PURE EP™ System has shown improved signal quality with less baseline wander, noise, and artifacts compared to conventional electrophysiology recorders, which may enhance diagnostic accuracy[233]. - The company has a patent portfolio that includes 25 issued utility patents and 34 pending applications related to the PURE EP System, with a focus on enhancing signal processing and visualization[282]. Collaborations and Partnerships - The company relies on collaboration with Mayo Clinic for the research and development of advanced features of its PURE EP System, and failure in this collaboration could hinder market potential[95]. - The company has entered into licensing agreements with Mayo Clinic to develop solutions for autonomic nervous system diseases, integrating hardware, software, and algorithmic solutions into the PURE EP platform[267]. - The company has established a new product pipeline focusing on improving therapies through clearer ENG recordings, which are essential for visualizing electrical activities of neurons[263]. Adoption and Usage - The PURE EP™ System has been used in over 3,000 procedures by more than 80 physicians across 21 hospitals in the U.S.[186]. - A randomized study indicated that the PURE EP™ System reduced mean procedure time by 11.3 minutes, suggesting potential cost savings of approximately $418.10 per procedure[191]. - The PURE EP™ System has received positive feedback from electrophysiologists regarding improved signal detection and fidelity during early evaluations[237]. - The PURE EP™ System has been contracted for purchase by St. David's Healthcare and Mayo Foundation, marking the company's first commercial sales with three units sold in February 2021 and three additional units sold in 2021[270].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.001 per share BSGM The NASDAQ Capital Market FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXC ...