# EDGAR Filing Document

**Accession Number:** 0000925741
**File Stem:** 0001437749-25-037910
**Filing Date:** 2025-12
**Character Count:** 14719
**Document Hash:** 4ac0e80e5905cf29f8c2a4c447f75f94
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001437749-25-037910.hdr.sgml**: 20251216

**ACCESSION NUMBER**: 0001437749-25-037910

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20251216

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20251216

**DATE AS OF CHANGE**: 20251216

**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:** 251573372

**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'? bcda20251216_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): **December 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**

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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 7.01**&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; **Regulation FD Disclosure.**

On December 16, 2025, BioCardia, Inc. issued a press release announcing it has completed a third preliminary clinical consultation with Japan's Pharmaceutical and Medical Device Agency (PMDA) on the CardiAMP Cell Therapy intended for the treatment of Heart Failure with Reduced Ejection Fraction (HFrEF). Based on the discussions in this most recent meeting, the PMDA said it will allow BioCardia to advance to a formal clinical consultation. Should the PMDA agree in formal consultation that the available data provides sufficient evidence of safety and efficacy, the Company will be able to file for regulatory approval in Japan.

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

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

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| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| [<u>99.1</u>](ex_899241.htm)<br> 104 | [<u>BioCardia, Inc. press release dated December 16, 2025</u>](ex_899241.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: December 16, 2025 |

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## Exhibit 99.1

**Exhibit 99.1**

**BioCardia Cell Therapy for Ischemic Heart Failure to Progress to Formal Clinical Consultation with Japan PMDA** 

December 16, 2025

**BioCardia**®**, Inc. [NASDAQ: BCDA]**, a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announces it has completed a third preliminary clinical consultation with Japan's Pharmaceutical and Medical Device Agency (PMDA) on our CardiAMP Cell Therapy intended for treatment of Heart Failure with Reduced Ejection Fraction (HFrEF). The meeting was held in further preparation for formal clinical consultation on acceptability of the existing clinical data for submission of an application for approval. Based on the discussions in the most recent meeting, PMDA said it will allow BioCardia to advance to formal clinical consultation. Should PMDA agree in formal consultation that the available data provides sufficient evidence of safety and efficacy, BioCardia would be able to file for regulatory approval in Japan.

"Our autologous minimally invasive cell therapy presents a new mechanism of action of microvascular repair for ischemic heart failure patients evidencing active heart failure while on guideline directed medical therapy who have few additional therapeutic options." said Peter Altman, PhD, BioCardia's Chief Executive Officer. "The data from the three completed Phase I, II and III trials support positive outcomes in significant clinical efficacy endpoints, including improved survival and reduced major adverse cardiovascular events, along with improved heart function and quality of life measures relative to control patients."

The existing clinical data supporting safety and efficacy of CardiAMP Cell Therapy for HFrEF is subject to ongoing regulatory discussions in Japan and the United States. The compilation includes data from the three clinical studies that BioCardia believes demonstrate a favorable benefit to risk profile.

**About CardiAMP Autologous Cell Therapy**

Granted FDA Breakthrough designation, CardiAMP Cell Therapy uses a patient's own bone marrow cells as treatment delivered to the heart in a minimally invasive, catheter-based procedure intended to increase capillary density and reduce tissue fibrosis of myocardial tissue to address microvascular dysfunction. Clinical development of the CardiAMP Cell Therapy 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.

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**CardiAMP Cell Therapy Clinical Development Highlights**

Phase 1: TABMMI Heart Failure Trial; open label, n=20 (NCT00507468) <sup>1</sup>

&nbsp;&nbsp;&nbsp;&nbsp;• 90% of treated patients alive and well at three years

&nbsp;&nbsp;&nbsp;&nbsp;• Left ventricular ejection fraction (LVEF) improved by 7% at 24 months (p=0.001)

&nbsp;&nbsp;&nbsp;&nbsp;• Exercise tolerance improved 125 seconds at 24 months (p=0.006)

Phase 2: TACHFT Trial; double-blind placebo-controlled, n=33 with 29 randomized (NCT00768066) <sup>2,3</sup>

&nbsp;&nbsp;&nbsp;&nbsp;• All (100%) treated patients alive at one year (end of study); major adverse cardiac events (MACE) reduced 20% relative to controls

&nbsp;&nbsp;&nbsp;&nbsp;• Six-minute walk distance improved 56.3 meters at 12 months for treated patients compared to controls (p = 0.049)

&nbsp;&nbsp;&nbsp;&nbsp;• Quality of life measured using Minnesota Living with Heart Failure Quality of Life Questionnaire improved by 17.4 points (p=0.039) for treated patients compared to controls

Phase 3: CardiAMP HF Trial; multi-center, double-blind placebo-procedure controlled with 24-month follow-up, N=125, with 115 randomized (NCT02438306) <sup>4, 5</sup>

&nbsp;&nbsp;&nbsp;&nbsp;• Roll-in cohort patients demonstrated improved heart function measures, and the study procedure was feasible with an excellent safety profile

&nbsp;&nbsp;&nbsp;&nbsp;• Treated patients in the full study cohort had reduced fatal and nonfatal MACE, along with improved quality of life and echocardiography heart function measures on top of guideline-directed medical therapy compared to controls

&nbsp;&nbsp;&nbsp;&nbsp;• The primary Finkelstein Schoenfeld composite outcome endpoint including 6-minute walk test distance (6MWT) was not met due to potential confounding of this effort-based measure.

The subgroup of randomized patients with elevated NTproBNP before study enrollment (n=57) demonstrated strong efficacy signals, including:

&nbsp;&nbsp;&nbsp;&nbsp;• Met Finkelstein Schoenfeld composite endpoint consisting of fatal cardiac death, non-fatal MACE, and quality of life (p = 0.04)

&nbsp;&nbsp;&nbsp;&nbsp;• Demonstrated improved left ventricular systolic and diastolic volume measures at 24 months (LVESVi, p=0.01; LVEDVi, p=0.01) as assessed by the blinded echocardiography core lab, suggesting significantly improved heart function compared to controls through the end of the study

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**About BioCardia**®<br> <u>BioCardia, Inc.</u>, 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 cardiac clinical stage product candidates in development. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms, and soon the Heart3D™ fusion imaging platform. BioCardia selectively partners on biotherapeutic delivery with peers developing important biologic therapies. For more information visit <u>www.biocardia.com</u>.

**References**

De la Fuente LM, Stertzer SH, Argentieri J. et al. Transendocardial autologous bone marrow in myocardial infarction induced heart failure, two-year follow-up in an open-label phase I safety study (the TABMMI study). EuroIntervention. 2011; 7(7):805-812.

<sup>2</sup> Wong Po Foo C, Rouy D, Hare JM, et al. The transendocardial autologous bone marrow mononuclear cells in ischemic heart failure trial (TAC-HFT-BMC). Regenerative Medicine. 2015; 10(7S): S169.

<sup>3</sup> Heldman AW, DiFede DL, Fishman JE, et al. Transendocardial mesenchymal stem cells and mononuclear bone marrow cells for ischemic cardiomyopathy: the TAC-HFT randomized trial. JAMA. 2014; 311(1):62-73.

<sup>4</sup> Raval AN, Johnston PV, Duckers HJ, Cook TD, Traverse JH, Altman PA, Dhingra R, Hematti P, Borrello I, Anderson RD, Pepine CJ. Point of care, bone marrow mononuclear cell therapy in ischemic heart failure patients personalized for cell potency: 12-month feasibility results from CardiAMP heart failure roll-in cohort. Int J Cardiol. 2021 Mar 1;326:131-138. doi: 10.1016/j.ijcard.2020.10.043. Epub 2020 Oct 20. PMID: 33091520.

<sup>5</sup> Raval AN on behalf of the CardiAMP HF Investigators: A Double-blind, Randomized Controlled Trial of an Autologous Cell Therapy in Patients with HFrEF: Principal Results from the CardiAMP-HF Trial, American College of Cardiology Late Breaking Clinical Trials 2025.

**Forward Looking Statements**<br> This press release contains forward-looking statements that are subject to risks and uncertainties. Forward-looking statements include, among other things, references to the Company's investigational product candidates, future regulatory submissions, future regulatory meetings, and outcomes of these regulatory discussions. 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.

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**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