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EX-99.1 - EXHIBIT 99.1 - BioCardia, Inc.ex_259266.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): June 23, 2021

 

BIOCARDIA, INC.

(Exact name of registrant as specified in its charter)

 

Delaware

 

0-21419

 

23-2753988

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

125 Shoreway Road, Suite B
San Carlos, California 94070

(Address of principal executive offices and zip code)

 

Registrants telephone number, including area code: (650) 226-0120

 


 

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 each exchange on which registered

Common Stock, par value $0.001

BCDA

The Nasdaq Capital Market

Warrant to Purchase Common Stock

BCDAW

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 (17 CFR §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2 of this chapter) ☐

 

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.

 

Today, June 23, 2021, BioCardia, Inc. (the “Company”) has issued a press release announcing that the Company’s independent Data Safety Monitoring Board (DSMB) completed its fourth prespecified data review for the Phase III pivotal CardiAMP™ Heart Failure Trial based on a review of all data available for the 97 patients enrolled in the trial to date. The DSMB performed a risk-benefit assessment, indicated no safety concerns, and recommended that the study continue as designed. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

 

The information furnished pursuant to this Item 7.01, including Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities under that section, nor shall it be deemed to be incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise expressly set forth by specific reference in such filing.

 

 

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits

   
     

Exhibit No.

 

Exhibit Description

99.1

 

Press Release of BioCardia, Inc. dated June 23, 2021.

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

BIOCARDIA, INC.

 
   

/s/ Peter Altman, Ph.D.

 

Peter Altman, Ph.D.

 

President and Chief Executive Officer

 
   

Date: June 23, 2021