0001185185-21-001694.txt : 20211116 0001185185-21-001694.hdr.sgml : 20211116 20211116152950 ACCESSION NUMBER: 0001185185-21-001694 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20211116 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20211116 DATE AS OF CHANGE: 20211116 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BioSig Technologies, Inc. CENTRAL INDEX KEY: 0001530766 STANDARD INDUSTRIAL CLASSIFICATION: ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845] IRS NUMBER: 264333375 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-38659 FILM NUMBER: 211415815 BUSINESS ADDRESS: STREET 1: 55 GREENS FARMS ROAD CITY: WESTPORT STATE: CT ZIP: 06880 BUSINESS PHONE: (203) 409-5444 MAIL ADDRESS: STREET 1: 55 GREENS FARMS ROAD CITY: WESTPORT STATE: CT ZIP: 06880 8-K 1 biosig20211116_8k.htm FORM 8-K biosig20211116_8k.htm

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): November 16, 2021

 

BioSig Technologies, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

001-38659

26-4333375

(State or other jurisdiction

(Commission File Number)

(IRS Employer

of incorporation)

  

Identification No.)

 

55 Greens Farms Road

Westport, Connecticut

  

06880

(Address of principal executive offices)

  

(Zip Code)

 

(203) 409-5444

(Registrant’s telephone number, including area code)

 

54 Wilton Road, 2nd Floor

Westport, Connecticut 

(Former name or former address, if changed since last report)

 

 

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:

 

Title of each class

  

Trading Symbol(s)

  

Name of exchange on which registered

Common Stock, par value $0.001 per share

  

BSGM

  

The NASDAQ Capital Market  

 

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 7.01             Regulation FD Disclosure.

 

On November 16, 2021, BioSig Technologies, Inc. (the “Company”) issued a press release, attached hereto as Exhibit 99.1, announcing that it is partnering with a leading academic institution on research and development of AI-driven methods for atrial fibrillation procedures. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.1.

 

In accordance with General Instruction B.2 of Form 8-K, the information in this Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by reference in such a filing. Furthermore, the furnishing of information under Item 7.01 of this Current Report on Form 8-K is not intended to constitute a determination by the Company that the information contained herein, including the exhibits hereto, is material or that the dissemination of such information is required by Regulation FD.

 

Item 9.01             Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit Number

  

Description

99.1

  

Press Release, dated November 16, 2021 (furnished herewith pursuant to Item 7.01)

104

  

Cover Page Interactive Data File (formatted as Inline XBRL)                  

 

 

 
 

 

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.

 

 

 

BIOSIG TECHNOLOGIES, INC.
   
   

Date: November 16, 2021

By:  /s/ Kenneth L. Londoner                             

Name: Kenneth L. Londoner 

Title: Executive Chairman
   

 

 

 

 

 
false 0001530766 0001530766 2021-11-16 2021-11-16
EX-99.1 2 ex_308549.htm EXHIBIT 99.1 ex_308549.htm

 

Exhibit 99.1

 

 

logo.jpg

 

BioSig Initiates Artificial Intelligence Development Program with Technion – Israel Institute of Technology

 

Company partners with the leading academic institution on research and development of AI-driven methods for atrial fibrillation procedures

 

Westport, CT, November 16, 2021 /GLOBE NEWSWIRE/ — BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company commercializing an innovative biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced that the Company entered into a feasibility study with The Technion Research & Development Foundation Ltd.

 

Based in Haifa, Israel, Technion – Israel Institute of Technology is a public research university offering degrees in science, engineering, and related fields, such as medicine, industrial management, and education. Over the years, the Technion established itself as a leading academic institution in Artificial Intelligence (AI). It is currently ranked as number one in AI in Europe and 15th in the world, with 100 faculty members engaged in areas across the AI spectrum.

 

The feasibility program with BioSig will be led by Asst. Prof. Joachim Behar, Head of the Artificial Intelligence in Medicine Laboratory (AIMLab) at the Technion. Under the terms of the program, the ECG signals supplied by the PURE EP™ System, the Company’s signal processing technology for arrhythmia care, will be analyzed in the context of developing AI-powered algorithms for atrial fibrillation ablation procedures.

 

“Artificial Intelligence is promptly becoming an essential tool for increasing efficiency and driving value in many sectors of healthcare, but predictive insights that form the foundation for machine learning solutions are dependant on the high-quality input data. Our clinical work provides us with vast volumes of smaller, often undetectable cardiac signals that hold additional diagnostic information, and we are thrilled to partner with Prof. Behar and his Technion team to take our AI work to the next level. Their expertise in developing deep learning systems for ECG records is invaluable to this program, and we look forward to reporting on the progress of this promising new project,” commented Kenneth L. Londoner, Chairman, and CEO of BioSig Technologies, Inc.

 

“The laboratory for artificial intelligence in medicine (AIMLab.) at the Technion focuses on the usage of advanced signal processing and machine learning in medicine within the context of physiological time series analysis with a specific focus in cardiology where we have 10 years of expertise in processing and analysing the ECG signal. In particular, in our most recent research we have developed robust deep learning algorithms for AF diagnosis and risk prediction working on large databases - totalling over a million ECG recordings. We look forward to contributing our expertise to support leading industry in the field providing novel clinical ECG analysis tools. Our new partnership with BioSig is aligned with this desire to contribute and impact the medical field through AI powered algorithms to support clinical decision making in cardiology," commented Asst. Prof. Behar.

 

 
 

 

One in 18 Americans suffers from a cardiac arrhythmia. Atrial fibrillation is the most common arrhythmia type, affecting over 33 million people worldwide, including over 6 million in the U.S. The number of people suffering from atrial fibrillation is expected to reach 8-12 million by 20501. According to the Centers for Disease Control and Prevention (CDC), atrial fibrillation causes more than 750,000 hospitalizations in the U.S. each year, resulting in approximately $6 billion in healthcare spending annually2.

 

The PURE EP™ is an FDA 510(k) cleared non-invasive class II device that aims to drive procedural efficiency and efficacy in cardiac electrophysiology. To date, over 70 physicians have completed over 1600 patient cases with the PURE EP™ System. Clinical data acquired by the PURE EP™ System in a multi-center study at Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Mayo Clinic Jacksonville and Massachusetts General Hospital was recently published in the Journal of Cardiovascular Electrophysiology and is available electronically with open access via the Wiley Online Library. Study results showed 93% consensus across the blinded reviewers with a 75% overall improvement in intracardiac signal quality and confidence in interpreting PURE EP™ signals over conventional sources.

 

About Technion – Israel Institute of Technology

 

Founded in 1912, Technion-Israel Institute of Technology is Israel’s first university and its largest center of applied research. Technion is ranked among the leading technological universities worldwide. A major source of the innovation and brainpower that drives the Israeli economy, Technion is the engine behind Israel’s renown as the iconic “Startup Nation.” Technion people, ideas, and inventions have made, and continue to make tremendous scientific contributions in fields such as medicine, sustainable energy, computer science, water conservation, and nanotechnology. It is one of a handful of technological institutes worldwide with a medical school, facilitating the rapid development of advanced therapies and devices, from the laboratory to the patient's bedside.

 

Technion’s success is attributed to its unwavering commitment to excellence in education and research. The University is proud of its four Nobel laureates – Aaron Ciechanover, Avram Hershko, Dan Shechtman, and Arieh Warshel. Technion currently ties with MIT in 8th place for the number of Nobel prizewinners this century.

 

In 2011, Technion and Cornell University partnered to establish an applied science and engineering institution in New York City: The Joan and Irwin Jacobs Technion Cornell Institute (JTCI). In 2013, Technion joined with Shantou University to establish the Guangdong Technion-Israel Institute of Technology (GTIT) in China.

 

The Technion Research and Development Foundation (TRDF) manages university research programs and performs testing and research services for industry and government. T3, the technology transfer arm of TRDF, takes the university’s game-breaking scientific ideas and matches them with investors and entrepreneurs, licensing intellectual property and supporting the establishment of startup companies.

 

 

1 Top 10 Things You should Know About Heart Rhythm; Scripps Health.

2 Managing Atrial Fibrillation; Lisa Eramom MA, Medical Economics Journal, February 25, 2019, Volume 96, Issue 4

 

 
 

 

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

55 Greens Farms Road

Westport, CT 06880

aballou@biosigtech.com

203-409-5444, x133

 

 

 
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Document And Entity Information
Nov. 16, 2021
Document Information Line Items  
Entity Registrant Name BioSig Technologies, Inc.
Trading Symbol BSGM
Document Type 8-K
Amendment Flag false
Entity Central Index Key 0001530766
Document Period End Date Nov. 16, 2021
Entity Emerging Growth Company false
Entity Incorporation, State or Country Code DE
Entity File Number 001-38659
Entity Tax Identification Number 26-4333375
Entity Address, Address Line One 55 Greens Farms Road
Entity Address, City or Town Westport
Entity Address, State or Province CT
Entity Address, Postal Zip Code 06880
City Area Code (203)
Local Phone Number 409-5444
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, par value $0.001 per share
Security Exchange Name NASDAQ
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