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BioSig Technologies, Inc.

BSGM / NasdaqCM / $3.84

March 25, 2020

 

Business Overview

 

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BioSig Technologies, Inc. (the Company) is developing a proprietary technology platform in the rapidly growing field of bioelectronic medicine, which targets how electrical signals in the body can help diagnose and treat a wide range of maladies. The Company has advanced signal processing capabilities and is working to help clinicians to better understand patterns and how to change them.

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The initial focus is on cardiac electrophysiology (EP), the science of diagnosing and treating the electrical activities of the heart. The BioSig core competency is on signal processing, which can play a key role in enhancing outcomes from catheter ablation for the treatment of arrhythmias (atrial fibrillation and ventricular tachycardia). The failure rate of catheter ablation for the treatment of arrhythmias is quite high, resulting in costly repeat procedures. The BioSig FDA 510(k)-cleared PURE EP System (the System) is designed to provide the physician with clearer signal information than competitive catheter ablation devices (from Biosense Webster, Abbott, Medtronic, Boston Scientific, and others), enabling physicians to work with greater speed and accuracy.

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The potential market for a system that provides enhanced signal processing capabilities for catheter ablations is very large. An estimated 33 million people worldwide suffer from atrial fibrillation, and related healthcare costs range from $15,000 to $25,000 per patient. Global growth in complex cardiac ablation procedures is estimated by a 2018 MD&D report to grow from approximately 441,000 in 2017 to 830,000 in 2022 (13.5% growth rate).

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In fourth-quarter 2019, the Company conducted the first clinical trial patient cases using the System at the Texas Cardiac Arrhythmia Research Foundation, and the lead physician said that the System helped to identify cardiac signals that were previously undetectable, and that it had potential to change diagnostic and treatment strategies of arrhythmias.

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Mayo Clinic recently began to conduct patient cases under the clinical trial, with patient enrollments that began in January 2020.

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NeuroClear Technologies, a wholly-owned subsidiary founded in November 2018, aims to capitalize on the core competencies validated by the System. NeuroClear will focus on electroneurogram (ENG) recordings, which are methods used to visualize directly recorded electrical activities of neurons in the central nervous system (brain, spinal cord) and/or the peripheral nervous system (nerves, ganglions). As of the Q3 2019 10Q filing, NeuroClear successfully raised $3.7 million in 2019, the proceeds of which are being used to build additional IP and to fund pre-clinical studies.

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On March 25, 2020, the Company announced that its NeuroClear subsidiary acquired rights to develop a broad-spectrum anti-viral agent that demonstrated strong activity against COVID-19 in cell cultures. The agent has already completed Phase I and three Phase II trials in other indications, and the Company intends to pursue development of this agent through its own clinical trials under a new NeuroClear subsidiary named ViralClear Pharmaceuticals, Inc.

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The Systems are manufactured in the U.S. by Minnetronix Medical, and they have a purchase price, depending upon configuration, within the area of recording and mapping systems, which range from $175,000-$350,000 (leases and rents also available). BioSig can generate additional revenue from training, installation, and software enhancements.

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BioSig has a wealth of intellectual property, including 26 allowed/issued worldwide design and utility patents. The intellectual property advisor is Sherpa Technology Group LLC, and the patent firm is Washington DC-based Sterne Kessler Goldstein & Fox P.L.L.C. In addition, in 2017, the Company signed a 10-year strategic collaboration with experts at Mayo Clinic to develop upgrades to the capabilities of the System and explore new areas.

 

 

2020 Focus

 

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Management is focused on placing commercial Systems in targeted locations, as well as supporting existing installations. A goal will be to impress many of the key opinion leaders in influential treatment centers, success of which should contribute to strengthening market demand for the Systems in 2021 and beyond.

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Presentations at leading conferences are designed to boost physician awareness and support.

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R&D efforts are ongoing in both the treatment of arrhythmia and other areas of bioelectronic medicine, which should lead to a growing portfolio of intellectual property and future marketing opportunities. To wit, BioSig recently announced a key collaboration with the University of Mennesota to research and develop novel catheter-based renal nerve ablation therapies for the treatment of hypertension.

 

 

Management

 

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The backgrounds of the management and directors are outlined on the BioSig website. Ken Londoner, founder & CEO, has significant experience in early stage companies, cardiac software, corporate finance and capital markets. The marketing personnel are highly experienced in closely related businesses, and the Company has a plethora of other very experienced executives.

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The five Advisory Board members have impressive backgrounds, and a nine-member Board of Directors has a broad range of relevant experience.

 

 

Financials

 

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Income Statement (12 months through 12/31/19 vs. 12/31/18)

 

Research & development: 9,738,819 vs. 4,368,784

General & administrative: 24,810,712 vs. 12,881,027

Operating income (loss): (34,603,880) vs. (17,262,214)

Interest income (net): 132,751 vs. 10,897

Net income (loss): (34,470,677) vs. (17,251,317)

Net income (loss) attributable to BioSig: (34,079,991) vs. (18,136,053)

Earnings (loss) per basic common share: (1.65) vs. (1.25)

 

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Balance Sheet (12/31/19) (prior to the 2/25/20 equity issuance noted below)

 

Cash & equivalents: 12,108,582

Total current assets: 12,827,493

Total assets: 14,217,113

Current liabilities: 2,029,542

Lease liability, long term: 311,131

Series C preferred stock: 215,000

Equity attributable to BioSig: 11,146,612

Non-controlling interest: 514,828

Number of common shares outstanding (03/13/20): 25,965,418

 

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On February 25, 2020, the Company closed on the issuance of 2.5 million common shares at $4.00 apiece. Gross proceeds, before the underwriting discount and offering expenses, were $10 million.

 

 

Valuation Considerations

 

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The market for bioelectronic medicine is large and growing, and BioSig is expanding its proprietary technology platform in that arena.

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The System is making inroads into influential treatment centers with promising initial results.

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The newly acquired anti-viral agent has shown strong activity against COVID-19 in cell cultures in laboratory testing.

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There have been a number of M&A transactions at significant valuations in the EP sector during recent years.

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The February 2020 issuance of common shares strengthened the financial position. In March 2020, management stated that it believes that the Company has sufficient funds meet its R&D and other funding requirements for at least the next 12 months.

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The stock price is well below its 2019 high, despite considerable recent progress on the fundamental front.

 

 

Contact

 

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Executive offices: 54 Wilton Road, 2nd Floor, Westport, CT 06880

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Investor contact: Andrew Ballou, VP/Investor Relations; info@biosigtech.com; 203.409.5444 x133

 

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TickerBuzz, LLC ("TickerBuzz"), a Florida limited liability company is the author of this Profile. TickerBuzz is not and does not act as a broker-dealer, investment advisor, placement agent, or crowdfunding portal. Furthermore, it does not offer any securities, nor does it provide any investment advice or analysis. The source material for this Profile is the Company presentation materials. Certain information, particularly information relating to future performance and other business matters, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act. TickerBuzz cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties that may change over time and cause actual results to differ materially from the results discussed herein. The forward-looking statements are neither predictions nor guarantees of future events or performance. TickerBuzz has no obligation to update any forward-looking statements after they are made, except as required by applicable law. All of this information is intended for discussion purposes only, is not a solicitation to buy or sell any security, and must not be relied upon for financial, legal, tax, or any other professional advice. The Company paid TickerBuzz $3,500 for publication of this Profile. Analyst: William J. Ritger.

 

 

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Contact: William J. Ritger, writger@gmail.com, 561.891.1903

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