false 0000925741 0000925741 2025-02-27 2025-02-27
 
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 27, 2025
 
BIOCARDIA, INC.
(Exact name of registrant as specified in its charter)
 
Delaware
  
001-38999
  
23-2753988
(State or other jurisdiction
of incorporation)
  
(Commission
File Number)
  
(IRS Employer
Identification No.)
 
320 Soquel Way
Sunnyvale, California 94085
  
(Address of principal executive offices and zip code)
  
 
Registrant’s 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
 
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 8.01   Other Events.
 
On February 27, 2025, BioCardia, Inc. (the “Company”) issued a press release announcing the completion of source data verification and freezing of primary outcomes data in the double-blind randomized placebo-controlled Phase 3 CardiAMP HF study of its autologous minimally invasive cell therapy for the treatment of ischemic heart failure of reduced ejection fraction (HFrEF).
 
A copy of the press release is attached hereto as Exhibit 99.1.
 
Item 9.01   Financial Statements and Exhibits.
 
(d) Exhibits
 
Exhibit
Number
   Description
99.1   BioCardia, Inc. press release dated February 27, 2025
104   Cover Page Interactive Data File (embedded within the Inline XBRL Document.
 
 
 
 
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: February 27, 2025
  
 
 

Exhibit 99.1

 

BioCardia Announces Primary Outcome Measures Data Freeze in CardiAMP Heart Failure Trial for Presentation at the American College of Cardiology 2025 Scientific Sessions

 

Sunnyvale, Calif., February 27, 2025 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the completion of source data verification and freezing of primary outcomes data in the double-blind randomized placebo-controlled Phase 3 CardiAMP HF study of its autologous minimally invasive cell therapy for the treatment of ischemic heart failure of reduced ejection fraction (HFrEF). Data from the 115 randomized patients in the study has been transferred to the Statistical Data Analysis Center core laboratory for analysis. Results are scheduled to be presented at the Late-Breaking Clinical Trials symposium at the American College of Cardiology (ACC) 2025 Scientific Sessions in Chicago on March 30, 2025. 

 

We believe this data represents the largest ischemic HFrEF patient cohort studied in a randomized trial of an autologous cell therapy, and the first to use a precision medicine approach to identify patients likely to respond to therapy based on the nature of their cells. Should the results presented at ACC confirm the interim analysis, the trial will provide evidence of meaningful therapeutic benefit of this cell therapy for HFrEF patients insufficiently responsive to medication as characterized by elevated NT-proBNP.

 

“This clinical study is intended to provide evidence supporting the safety and effectiveness of our CardiAMP cell therapy system for future approvals in the United States and Japan,” said Peter Altman, PhD, BioCardia President and CEO. “The results are also expected to support the safety and effectiveness of the Helix biotherapeutic delivery system for standalone approval for the intramyocardial delivery of agents to the heart.”

 

About CardiAMP Autologous Cell Therapy

 

Granted FDA Breakthrough designation, CardiAMP Cell Therapy uses a patient’s own marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response to increase capillary density, reduce tissue fibrosis, and ultimately treat microvascular dysfunction. The mechanisms that lead to microvascular dysfunction, including fibrotic, inflammatory, apoptotic, and endothelial autonomic dysfunction, are all targets of CardiAMP cell therapy, largely through production of growth factors, cytokines, chemokines, and other factors that directly counteract each of these mechanisms.

 

 
 

 

The CardiAMP clinical development for heart failure is supported by the Maryland Stem Cell Research Fund and is reimbursed by Centers for Medicare and Medicaid Services (CMS). 

 

CAUTION - Limited by United States law to investigational use. 

 

About BioCardia BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three clinical stage product candidates in development. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms.  For more information visit: www.BioCardia.com.

 

Forward Looking Statements 

 

This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to the Company’s investigational product candidates, the timing of availability of data from this trial, the likelihood of safety and patient benefit, statements related to the mechanisms of action of the CardiAMP Cell Therapy, references to the presentation at the American College of Cardiology and potential future regulatory approvals. These forward-looking statements are made as of the date of this press release.

 

We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 27, 2024, under the caption titled “Risk Factors,” and in our subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.  

 

 

###

 

 
 

 

Media Contact:
Miranda Peto, Marketing / Investor Relations
Email: mpeto@BioCardia.com
Phone: 650-226-0120

 

Investor Contact:
David McClung, Chief Financial Officer
Email: investors@BioCardia.com
Phone: 650-226-0120

 

 
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Document And Entity Information
Feb. 27, 2025
Document Information [Line Items]  
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Document, Type 8-K
Document, Period End Date Feb. 27, 2025
Entity, Incorporation, State or Country Code DE
Entity, File Number 001-38999
Entity, Tax Identification Number 23-2753988
Entity, Address, Address Line One 320 Soquel Way
Entity, Address, City or Town Sunnyvale
Entity, Address, State or Province CA
Entity, Address, Postal Zip Code 94085
City Area Code 650
Local Phone Number 226-0120
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Title of 12(b) Security Common Stock
Trading Symbol BCDA
Security Exchange Name NASDAQ
Entity, Emerging Growth Company false
Amendment Flag false
Entity, Central Index Key 0000925741
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