# EDGAR Filing Document

**Accession Number:** 0000925741
**File Stem:** 0001437749-25-022772
**Filing Date:** 2025-7
**Character Count:** 12424
**Document Hash:** 9139b979a136d24238a251986913681d
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001437749-25-022772.hdr.sgml**: 20250716

**ACCESSION NUMBER**: 0001437749-25-022772

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20250716

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250716

**DATE AS OF CHANGE**: 20250716

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** BioCardia, Inc.
- **CENTRAL INDEX KEY:** 0000925741
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 232753988
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-38999
- **FILM NUMBER:** 251126217

**BUSINESS ADDRESS:**
- **STREET 1:** 320 SOQUEL WAY
- **CITY:** SUNNYVALE
- **STATE:** CA
- **ZIP:** 94085
- **BUSINESS PHONE:** 650-226-0123

**MAIL ADDRESS:**
- **STREET 1:** 320 SOQUEL WAY
- **CITY:** SUNNYVALE
- **STATE:** CA
- **ZIP:** 94085

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Tiger X Medical, Inc.
- **DATE OF NAME CHANGE:** 20110616

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Cardo Medical, Inc.
- **DATE OF NAME CHANGE:** 20081027

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** CLICKNSETTLE COM INC
- **DATE OF NAME CHANGE:** 20000823

?xml version='1.0' encoding='ASCII'? bcda20250716_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): **July 16, 2025**

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| |
|:---|
| **BIOCARDIA, INC.** |
| (Exact name of registrant as specified in its charter) |

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| | | |
|:---|:---|:---|
| **Delaware** | **001-38999** | **23-2753988** |
| (State or other jurisdiction<br> of incorporation) | (Commission<br> File Number) | (IRS Employer<br> Identification No.) |

---

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| |
|:---|
| **320 Soquel Way** <br> **Sunnyvale, California 94085** |
| (Address of principal executive offices and zip code) |

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**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:

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| | |
|:---|:---|
| Title of each class | Name of each exchange on which registered |
| Common Stock, par value $0.001<br> BCDA | The Nasdaq Capital Market |

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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. ☐

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**Item 8.01**&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; **Other Events.**

On July 16, 2025, BioCardia, Inc. issued a press release announcing that Henry Ford Health in Detroit, Michigan is now enrolling patients with ischemic heart failure in the Company's ongoing pivotal Phase 3 CardiAMP HF II trial.

A copy of the press release is attached hereto as Exhibit 99.1 to this current report on Form 8-K.

The information in this Item 8.01, including Exhibit 99.1 attached hereto, is being furnished and 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 of such 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 specific reference in such filing.

**Item 9.01 Financial Statements and Exhibits.**

(d) Exhibits

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| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| 99.1<br> 104 | [BioCardia, Inc. press release dated July 16, 2025](ex_839316.htm)<br> Cover Page Interactive Data File (embedded within the Inline XBRL document) |

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**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.

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| |
|:---|
| **BIOCARDIA, INC.** |
| /s/ Peter Altman, Ph.D. |
| Peter Altman, Ph.D. |
| President and Chief Executive Officer |
| Date: July 16, 2025 |

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## Exhibit 99.1

**Exhibit 99.1**

**Henry Ford Health Initiates Patient Enrollment for BioCardia's CardiAMP HF II Pivotal Study for Ischemic Heart Failure of Reduced Ejection Fraction**

**Sunnyvale, Calif.** – **July 16, 2025 -** <u>BioCardia, Inc.</u> [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced today that Henry Ford Health in Detroit, Michigan is now enrolling patients with ischemic HFrEF in the Company's ongoing pivotal CardiAMP HF II trial.

"The CardiAMP HF cell therapy trials are important for patients with ischemic heart failure in need of new therapies," said Gerald Koenig, M.D., Director of the Cardiac Catheterization Laboratory, Henry Ford West Bloomfield Hospital, and Principal Investigator of CardiAMP HF II for Henry Ford Health System. "Together with the other investigators in this trial, we hope to confirm the promising results in the CardiAMP HF trial and enable our patients early access to this novel investigational autologous cell therapy."

The CardiAMP HF II trial is a confirmatory trial of autologous bone marrow derived mononuclear cell therapy for patients suffering from ischemic heart failure. The investigational therapy is intended to promote microvascular repair, reduce fibrosis, and increase capillary density. Patients who qualify for the study have cells harvested the day of the procedure, processed at their bedside, and delivered in the same procedure using minimally invasive catheter delivery systems. At the end of the procedure, nothing is left behind other than high doses of the patients' own cells adjacent to damaged zones in their hearts.

"We are delighted to continue our partnership with Dr. Koenig and the world class cardiovascular clinical research team at Henry Ford Health in CardiAMP HF II," said Peter Altman, PhD, BioCardia's CEO. "We share the common mission of enhancing therapies to treat cardiovascular disease. The results from our completed TABMMI, TACHFT, and CardiAMP HF trials underlie the potential to improve the lives of patients with heart failure and the families who care for them."

**About the CardiAMP Heart Failure II Study**

CardiAMP HF II is a 250-patient randomized multicenter procedure placebo-controlled study of the CardiAMP autologous cell therapy as a one-time treatment for patients with ischemic HFrEF on guideline directed medical therapy having elevated NTproBNP. The study is intended to confirm the safety and efficacy results in these patients observed in the CardiAMP HF study. The CardiAMP HF II study uses a similar three-tier composite primary outcome measure to CardiAMP HF, with tier 1 all cause death, tier 2 nonfatal major adverse cardiac events, and with tier 3 using a validated quality of life patient self-assessment instrument. In CardiAMP HF, this composite efficacy endpoint was achieved with statistical significance in the patients with elevated NTproBNP that are the focus of the CardiAMP HF II study.

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**About Heart Failure**

According to the Centers for Disease Control and Prevention, about 6.2 million adults in the U.S. over 20 years old have heart failure. It is the cause of an estimated one in eight deaths in U.S., and each year, there are approximately 960,000 new cases of heart failure diagnosed, according to the American Heart Association. Current treatments for heart failure include lifestyle changes, medications, and certain devices or surgical procedures. While improving quality of life and longevity for many, these treatments often fail to halt the progression of the disease, and some patients do not respond well, experience adverse effects from medications, or have complications from invasive procedures, often requiring ongoing and more aggressive interventions.

**About CardiAMP Autologous Cell Therapy**

Granted FDA Breakthrough designation, CardiAMP Cell Therapy uses a patient's own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to 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 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 our investigational product candidates, the potential benefits and mechanism of actions of the CardiAMP cell therapy, and the safety and efficacy of our product candidates and therapies. 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.

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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.

###

**Media Contact:** <br> Miranda Peto, Investor Relations<br> Email: <u>mpeto@BioCardia.com</u><br> Phone: 650-226-0120

**Investor Contact:** <br> David McClung, Chief Financial Officer<br> Email: <u>investors@BioCardia.com</u><br> Phone: 650-226-0120