UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 4, 2020
BioSig Technologies, Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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001-38659
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26-4333375
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(State or other jurisdiction
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(Commission File Number)
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(IRS Employer
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of incorporation)
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Identification No.)
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54 Wilton Road, 2nd Floor
Westport, Connecticut
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06880
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(Address of principal executive offices)
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(Zip Code)
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(203) 409-5444
(Registrant’s telephone number, including area code)
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N/A
(Former name or former address, if changed since last report)
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4 (c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading Symbol(s)
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Name of exchange on which registered
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Common Stock, par value $0.001 per share
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BSGM
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The NASDAQ Capital Market
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01 Other Events
On June 4, 2020, BioSig Technologies, Inc. (the “Company”) issued a press release announcing that two scientific sessions highlighting the Company’s PURE EP(tm) System have been accepted into Heart Rhythm Society 2020 Science. A copy of this press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.
On June 5, 2020, the Company and its majority-owned subsidiary, ViralClear Pharmaceuticals, Inc. (“ViralClear”), issued a press release announcing that ViralClear has expanded its patient enrollment centers to include St. David’s South Austin Medical Center in Austin. A copy of this press release is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated by reference herein.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Date: June 5, 2020
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By:
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/s/ Kenneth L. Londoner
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Name: Kenneth L. Londoner
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Title: Executive Chairman
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Exhibit 99.1
BioSig Technologies’s PURE EP System to be Presented in Heart Rhythm Society 2020 Science Sessions
Company’s flagship biomedical signal processing platform highlighted in two scientific sessions presented by key opinion leaders from Mayo Clinic
Westport, CT, June 4, 2020 (GLOBE NEWSWIRE) --BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced that two scientific sessions highlighting PURE EP(tm) System have been accepted into Heart Rhythm Society 2020 Science.
The two part set of videos titled ‘Cardiac Signal Acquisition and Clinical Considerations for Accurate Interpretation’ will be presented during the HRS Rhythm Theater Sessions on June 12 and July 1, 2020. The sessions will cover the challenges of acquiring clean signals in the EP lab environment, foundational principles of cardiac signal acquisition and clinical implications of applying filters to cardiac signals. The content of the series will be complemented by the clinical examples acquired by PURE EP(tm) System. The series will be presented by Samuel J. Asirvatham, M.D., Cardiac Electrophysiologist, Professor of Medicine at Mayo Clinic Rochester, MN and K.L. Venkatachalam, BSEE, M.D., Cardiac Electrophysiologist, Associate Professor of Medicine at Mayo Clinic’s Florida campus.
“The annual Heart Rhythm Society conventions are the highlights in our industry calendars, and we are pleased that the HRS committee is bringing the electrophysiology community together through its virtual scientific sessions this summer,” commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc. “BioSig has been busy seeking to generate vast amounts of clinical data and initiating new installations, and we are particularly thankful to Drs. Asirvatham and Venkatachalam for their commitment to innovation and their ongoing support of our clinical efforts.”
About Heart Rhythm Society’s Scientific Sessions
The Heart Rhythm Society’s Annual Scientific Sessions is a Heart Rhythm Society program. Heart Rhythm Society (HRS) is a 501c3 international nonprofit organization with a mission to improve the care of patients by promoting research, education, and optimal health care policies and standards. Founded in 1979, HRS is a leading resource on cardiac pacing and electrophysiology. This specialty organization represents medical, allied health, and science professionals from more than 70 countries who specialize in cardiac rhythm disorders.
About BioSig Technologies
BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).
The Company’s first product, PURE EP(tm) System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.
Forward-looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
Contact:
Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
54 Wilton Road, 2nd floor
Westport, CT 06880
aballou@biosigtech.com
203-409-5444, x133
Exhibit 99.2
ViralClear adds St. David's HealthCare in Austin, Texas,
to its Planned Phase II trial for its Broad-Spectrum Oral Anti-Viral Candidate for COVID-19
Randomized, double-blind, placebo-controlled Phase II trial of
merimepodib to be conducted in adults with COVID-19
who are hospitalized and require supplemental oxygen
or are on non-invasive ventilation or high-flow oxygen devices
Westport, CT, June 05, 2020 — BioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or the “Company”) and its majority owned subsidiary, ViralClear Pharmaceuticals, Inc., today announced that it has expanded its patient enrollment centers to include St. David’s South Austin Medical Center in Austin. The hospital is part of St. David’s HealthCare, one of the largest healthcare systems in Texas. The Company intends to commence its Phase II clinical trial for merimepodib, its broad-spectrum oral anti-viral candidate for the treatment of COVID-19 in adult patients in the coming weeks.
The clinical trial team consists of Brian Metzger, M.D., MPH, Medical Director of Infectious Diseases at St. David's Medical Center, who is is the principal investigator, as well as Andrea Natale, M.D., F.H.R.S., F.A.C.C., F.E.S.C., Cardiac Electrophysiologist and Executive Medical Director of the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, and Matthew Robinson, M.D., Medical Director of Infectious Diseases at St. David's South Austin Medical Center, who are co-investigators for the study.
“The safety and quality of treatment for our patients is our top priority, and we take numerous measures to ensure the highest level of care. As such, we remain steadfast in the pursuit against the coronavirus, and we look forward to working with ViralClear on the Phase II trial of its antiviral candidate as a potential solution against this virus,” commented Dr. Metzger.
“Adding St. David’s South Austin Medical Center as an investigating center in the ViralClear clinical trial with merimepodib has the potential to allow the Company to accelerate clinical development and generate results from a more diverse population of patients," commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc. and Director at ViralClear Pharmaceuticals, Inc. “We have been innovating with Dr. Andrea Natale since we started BioSig over eleven years ago. His guidance has been vital to us through all stages of product development and in the early commercialization of our PURE EP(tm) System. We are thankful for Dr. Natale’s leadership during these unprecedented times and look forward to collaborating with the whole St. David’s team on this important mission.”
The Phase II randomized, double-blind, placebo-controlled study is designed to enroll adult patients with advanced Coronavirus Disease 2019 (COVID-19). A description of this clinical trial can be accessed via www.clinicaltrials.gov.
Preclinical in vitro laboratory studies performed by the Galveston National Laboratory at The University of Texas Medical Branch demonstrated that merimepodib, provided in combination with remdesivir, showed reduction in SARS-CoV-2 replication to undetectable levels. Peer reviewed publication of these findings can be found at F1000 Research: https://f1000research.com/articles/9-361
About St. David’s HealthCare
St. David’s HealthCare includes seven of the area’s leading hospitals and is one of the largest health systems in Texas. The organization has been recognized with a Malcolm Baldrige National Quality Award—the nation’s highest presidential honor for performance excellence. St. David’s HealthCare is the third-largest private employer in the Austin area, with more than 10,600 colleagues across 132 sites of care.
St. David’s HealthCare is a unique partnership between hospital management company HCA Healthcare and two local non-profits—St. David’s Foundation and Georgetown Health Foundation. The proceeds from the operations of the hospitals fund the foundations, which, in turn, invest those dollars back into the community. Since the inception of St. David’s HealthCare in 1996, more than $535 million has been given back to the community to improve the health and healthcare of Central Texans.
About BioSig Technologies
BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).
The Company’s first product, PURE EP(tm) System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.
About Viral Clear Pharmaceuticals and Merimepodib (MMPD)
BioSig’s subsidiary, ViralClear Pharmaceuticals, Inc., is seeking to develop a novel pharmaceutical called merimepodib to treat patients with COVID-19. Merimepodib is intended to be orally administered, and has demonstrated broad-spectrum in vitro antiviral activity, including strong activity against SARS-CoV-2 in cell cultures. Merimepodib was previously in development as a treatment for chronic hepatitis C and psoriasis by Vertex Pharmaceuticals Incorporated (Vertex), with 12 clinical trials (7 in phase 1 and 5 in phase 2) with over 400 subjects and patients and an extensive preclinical safety package was completed. A manuscript titled, “The IMPDH inhibitor merimepodib provided in combination with the adenosine analogue remdesivir reduces SARS-CoV-2 replication to undetectable levels in vitro”, was submitted to an online peer-reviewed life sciences journal. This manuscript is authored by Natalya Bukreyeva, Rachel A. Sattler, Emily K. Mantlo, John T. Manning, Cheng Huang and Slobodan Paessler of the UTMB Galveston National Laboratory and Dr. Jerome Zeldis of ViralClear Pharmaceuticals, Inc. (“ViralClear”) as a corresponding author. This article highlights pre-clinical data generated under contract with Galveston National Laboratory at The University of Texas Medical Branch.
Forward-looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
Contact:
Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
54 Wilton Road, 2nd floor
Westport, CT 06880
aballou@biosigtech.com
203-409-5444, x133