bcda20250625_8k.htm
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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 25, 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)
 
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
 
 
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 June 25, 2025, BioCardia, Inc. (the “Company”) issued a press release announcing that the United States Patent Office has granted US Patent No. 12,311,127 titled “Radial and Trans-endocardial Delivery Catheter.” A copy of the press release is attached hereto as Exhibit 99.1 to this current report on Form 8-K.
 
Item 9.01   Financial Statements and Exhibits.
 
(d) Exhibits
 
 
Exhibit
Number
 
Description
99.1
 
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: June 25, 2025
 
 
 

Exhibit 99.1

 

 

BioCardia Announces New United States Patent for Helix Biotherapeutic Delivery System

 

Sunnyvale, Calif., June 25, 2025 – BioCardia®, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces that the United States Patent Office has granted US Patent No. 12,311,127 titled “Radial and Trans-endocardial Delivery Catheter”.  

 

US Patent No. 12,311,127 describes the Company’s minimally invasive interventional catheter systems to deliver biologic therapies to target sites in the heart. This minimally invasive delivery approach enables optimal, site specific treatment, minimizes off-target toxicities, and avoids the need for surgical access to the heart. The allowed patent protects BioCardia’s helical needle-tipped catheter technology platform, which the scientific literature supports is the safest1, 2 and most efficient3 approach for biotherapeutic delivery to the heart. 

 

“The Helix catheter system underlies the safety and efficacy outcomes in our autologous CardiAMP Cell Therapy development program with potential to improve the lives of millions of patients with ischemic cardiomyopathies of heart failure and refractory angina” said Dr. Peter Altman, BioCardia CEO. “We are working diligently towards the separate approvals of the CardiAMP Cell Therapy as well as the Helix biotherapeutic delivery system it utilizes, as the latter empowers a seamless transition from bench to commercialization for partners.”

 

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.

 

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 and biotherapeutic delivery capabilities. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements.

 

 

 

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 26, 2025, 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.

 

 

1.

Raval AN and Pepine CJ. Clinical Safety Profile of Transendocardial Catheter Injection Systems: A Plea for Uniform Reporting, Cardiovasc Revasc Med, 2021.

 

 

2.

CardiAMP Cell Therapy Trial

 

 

3.

Mitsutake Y, Pyum WB, Rouy D, et al. Improvement of local cell delivery using Helix Transendocardial Delivery Catheter in a porcine heart, Int Heart J. 2017. 

 

###

 

Media Contact:
Miranda Peto, Investor Relations
Email: [email protected]
Phone: 650-226-0120

 

Investor Contact:
David McClung, Chief Financial Officer
Email: [email protected]
Phone: 650-226-0120