0001185185-21-001274.txt : 20210913 0001185185-21-001274.hdr.sgml : 20210913 20210913080054 ACCESSION NUMBER: 0001185185-21-001274 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20210913 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20210913 DATE AS OF CHANGE: 20210913 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: 211248648 BUSINESS ADDRESS: STREET 1: 54 WILTON ROAD, 2ND FLOOR CITY: WESTPORT STATE: CT ZIP: 06880 BUSINESS PHONE: (203) 409-5444 MAIL ADDRESS: STREET 1: 54 WILTON ROAD, 2ND FLOOR CITY: WESTPORT STATE: CT ZIP: 06880 8-K 1 biosig20210909_8k.htm FORM 8-K biosig20210909_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): September 13, 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.)

 

54 Wilton Road, 2nd Floor

Westport, Connecticut

  

06880

(Address of principal executive offices)

  

(Zip Code)

 

(203) 409-5444

(Registrant’s telephone number, including area code)

 

N/A

(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 September 13, 2021, BioSig Technologies, Inc. (the “Company”) issued a press release, attached hereto as Exhibit 99.1, announcing that the Company intends to install a PURE EP™ System at St. Elizabeth’s Medical Center in Boston, MA. 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 September 13, 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: September 13, 2021

By:  /s/ Kenneth L. Londoner                

       Name: Kenneth L. Londoner 

       Title: Executive Chairman

 

 

 

 
false 0001530766 0001530766 2021-09-13 2021-09-13
EX-99.1 2 ex_282995.htm EXHIBIT 99.1 ex_282995.htm

Exhibit 99.1

 

ex_282995img001.jpg

 

 

BioSig Increases Installation Footprint Adding St. Elizabeth’s Medical Center to Roster of Premium Medical Institutions Utilizing the PURE EP System

 

The Company expands into exploration of its novel signal processing technology in physiologic pacing procedures

 

Westport, CT, September 13, 2021 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or the “Company”), a medical technology company commercializing an innovative signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced the Company would be installing a PURE EP™ System for evaluation at St. Elizabeth’s Medical Center in Boston, MA.

 

The Company initiated this new evaluation program under the leadership of Michael Orlov, M.D., aiming to assess the PURE EP™ System during a series of physiologic pacing procedures. Physiologic pacing is an emerging pacing technique designed to activate the normal cardiac conduction system and synchronize contraction of the ventricles. This approach to pacing the heart has demonstrated improved clinical and hemodynamic benefits beyond standard pacing techniques.

 

“We are pleased to grow our clinical presence in Boston and collaborate with Dr. Orlov on this expanded use of the PURE EP™ System. The physiologic pacing procedure could benefit from advanced signal information to optimize lead placement and improve procedural outcomes. We look forward to combining our cardiac signal acquisition technology with advanced pacing therapies to treat more cardiac rhythm disorders,” commented Kenneth L. Londoner, Chairman, and CEO of BioSig Technologies, Inc.

“This marks our 13th hospital partner, and we remain on track to achieve our 2021 goals of targeted market expansion.”

 

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 60 physicians have completed over 1300 patient cases with the PURE EP™ System across twelve clinical sites.

 

The Company recently completed its first multi-centered, prospective clinical trial and presented preliminary clinical data during the annual Heart Rhythm 2021 convention in July in Boston, MA.

 

The Company is in a focused commercial launch of the PURE EP™ System in the Northeast, Texas, and Florida and is in regular use in some of the country’s leading centers of excellence, including the Mayo Clinic in Rochester, MN, and St. David’s Medical Center in Austin, TX.

 

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.

 

About St. Elizabeth's Medical Center
St. Elizabeth's Medical Center, a Boston University Teaching Hospital, offers patients access to some of Boston's most respected physicians and advanced treatments for a full range of medical specialties, including family medicine, cardiovascular care, women and infants' health, cancer care, neurology care, and orthopedics. The 308-bed tertiary care facility is part of Steward Health Care. 

 

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™ System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording, and storing electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

 

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

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

 
 

 

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

 

 

 

 
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Sep. 13, 2021
Document Information Line Items  
Entity Registrant Name BioSig Technologies, Inc.
Trading Symbol BSGM
Document Type 8-K
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Entity Central Index Key 0001530766
Document Period End Date Sep. 13, 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 54 Wilton Road, 2nd Floor
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
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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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