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): February 19, 2020

 

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)

 

(310)-620-9320

(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 8.01                      Other Events.

 

On February 19, 2020, BioSig Technologies, Inc. (the “Company”) issued a press release announcing that the Company has completed 100 patient cases with its PURE EP™ System. A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

 

Item 9.01             Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit Number

 

Description

99.1

 

Press Release, dated February 19, 2020

 

 

 

 

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: February 19, 2020                                  By:  /s/ Kenneth L. Londoner                

Name: Kenneth L. Londoner 

Title: Executive Chairman

 

 

 

Exhibit 99.1

 

 

BioSig Completes 100th Patient Case with PURE EP(tm) System

 

 

-

Commercialization and install plan ahead of schedule

 

-

Installations at new centers are driving patient enrollments and clinical data collection

 

Westport, CT, February 19, 2020 /GLOBE NEWSWIRE/ — BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company developing 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 the Company successfully completed 100 patient cases with its PURE EP(tm) System.

 

The Company initiated its first clinical trial in November 2019, and is currently enrolling patients at Texas Cardiac Arrhythmia Institute at St. David’s Medical Center and Mayo Clinic’s Florida campus. Earlier in 2019 the Company conducted patient cases at Indiana University School of Medicine, Greenville Memorial Hospital, Santa Barbara Cottage Hospital and Texas Cardiac Arrhythmia Institute at St. David’s Medical Center. The Company’s PURE EP(tm) System was used during the procedures on patients with persistent atrial fibrillation, ischemic ventricular tachycardias, PVC, atypical flutters and other types of complex arrhythmias.

 

Clinical observations collected with PURE EP(tm) System were recently presented by Andrea Natale, M.D., Executive Medical Director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center during the 25th Annual International AF Symposium. Management is encouraged by the level of interest in commercial deployments from over 40 leading U.S. based medical centers generated at this event.

 

“We are responding to the requests in a methodical fashion in order to assess and meet the needs of these centers. We are running ahead of our plans stated in our November 2019 shareholder letter, based on the number of centers we are currently engaging to discuss potential new installations,” commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc. The Company’s most recent Shareholder Letter stated the intentions to install PURE EP(tm) System at up to nine new centers leading up to the Heart Rhythm Society’s annual convention in May 2020.

 

About BioSig Technologies
BioSig Technologies is a medical technology company developing a proprietary biomedical signal processing platform designed to improve the electrophysiology (EP) marketplace (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) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; and (v) 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, x119