# EDGAR Filing Document

**Accession Number:** 0000925741
**File Stem:** 0001437749-23-005465
**Filing Date:** 2023-3
**Character Count:** 13429
**Document Hash:** 8daf5adbb5ce6decd794120dc6e5a2cd
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001437749-23-005465.hdr.sgml**: 20230306

**ACCESSION NUMBER**: 0001437749-23-005465

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20230306

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230306

**DATE AS OF CHANGE**: 20230306

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** BioCardia, Inc.
- **CENTRAL INDEX KEY:** 0000925741
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **IRS NUMBER:** 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:** 23707508

**BUSINESS ADDRESS:**
- **STREET 1:** 125 SHOREWAY ROAD
- **STREET 2:** SUITE B
- **CITY:** SAN CARLOS
- **STATE:** CA
- **ZIP:** 94070
- **BUSINESS PHONE:** 650-226-0123

**MAIL ADDRESS:**
- **STREET 1:** 125 SHOREWAY ROAD
- **STREET 2:** SUITE B
- **CITY:** SAN CARLOS
- **STATE:** CA
- **ZIP:** 94070

**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

bcda20230305_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): **March 6, 2023**

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

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| | | |
|:---|:---|:---|
| **Delaware** | **0-21419** | **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 | 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 |

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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 Regulation FD Disclosure.**

On March 6, 2023, BioCardia, Inc. (the "Company") issued a press release announcing that detailed echocardiography data from the roll-in cohort of its Phase III CardiAMP© Cell Therapy Heart Failure Trial (ClinicalTrials.gov Identifier: NCT02438306) will be presented at the American College of Cardiology Annual Meeting later that same day. 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> | [<u>BioCardia, Inc. press release dated March 6, 2023</u>](ex_484134.htm) |
| 104 | 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: March 6, 2023 |

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## Exhibit 99.1

**Exhibit 99.1**

**Positive Echocardiography Data from BioCardia Phase III CardiAMP Cell Therapy Heart Failure Trial Presented at American College of Cardiology Annual Meeting**

**New Data from Roll-in Cohort of Trial Shows Progression of Patients from Baseline through One and Two Years** 

**Results Suggest CardiAMP Cell Therapy May Have Ability to Restore and Maintain Heart Function to Previously Non-Functioning Areas of the Heart Up to Two Years After Treatment**

**SUNNYVALE, Calif.** – **March 6, 2023** – BioCardia®, Inc. [Nasdaq: BCDA], developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announces that detailed echocardiography data from the roll-in cohort of the Phase III CardiAMP® Cell Therapy Heart Failure Trial is being presented today at the American College of Cardiology annual meeting by Peter Johnston, M.D., Assistant Professor of Medicine and Site Principal Investigator at Johns Hopkins University. The echocardiography results from baseline through one and two years showed a more than doubling in the number of heart segments functioning normally and restoration of function to 30 percent of previously non-functioning segments. This data expands upon data previously presented at the Heart Failure Society of America annual meeting last fall.

Dr. Johnston stated, "The substantial improvements in segmental wall motion and overall left ventricular ejection fraction (LVEF) seen at one year continued to improve at two years. This resulted in a median LVEF of 37% at two years as compared to 27% at baseline. While this is an early cohort in the Phase III trial, it is remarkable that the benefits from improved heart function continue to be realized two years after a single treatment of autologous CardiAMP cell therapy."

Results from the 10-patient roll-in cohort of the clinical trial showed that myocardial wall motion in the 16 regions of the heart was more often characterized as normal after the study treatment at one year follow-up, and at two-year follow-up, as measured by the blinded echocardiography core lab at Yale University:

● In this series, only 13 percent of heart segments in these patients were contracting normally before treatment; at one year, 25 percent were contracting normally and at two years, 29 percent were contracting normally– indicating a more than doubling of the number of heart segments characterized as having normal function post-procedure. In completely non-functioning heart segments, 17 of 56, or 30 percent, of those heart segments resumed wall motion by two years.

● The overall wall motion score index for all 16 segments in the heart was improved, decreasing from 2.4 at baseline to 2.0 at one year to 1.9 at two years.

● As a result of the restoration of myocardial wall motion, patients experienced an improvement in median left ventricular ejection fraction, which increased from 27 percent at baseline to 34 percent at one year, to 37 percent at two years.

In the previously presented data, patient demographics at study start demonstrated characteristics typical of the target population of NYHA class II and III ischemic heart failure patients with reduced ejection fraction. No serious adverse events were observed related to any of the procedures performed. Despite severe, symptomatic ischemic heart failure with reduced ejection fraction (HFrEF), two-year survival was 100 percent, and all patients completed 24 months of follow-up. Changes in guideline-directed medical therapy experienced by these patients were minimal during the two-year study period. These outcomes are consistent with the improvement in functional capacity as measured by median change in six-minute walk distance of +37.5 meters at 12 months and +31 meters at 24 months, and improvement in quality of life as measured by the Minnesota Living with Heart Failure Questionnaire in seven of ten patients at one year and six of ten patients at two years presented previously.

"These early results lend further support to the potential efficacy of the autologous CardiAMP cell therapy and to our mission of restoring heart health," said BioCardia CEO Peter Altman, PhD. "BioCardia continues to move this clinical trial forward, with recent FDA approval of a supplement designed to add clarity to inclusion criteria for clinical sites in this trial, and submission of an adaptive statistical analysis plan for the trial to the FDA for consideration."

**About the CardiAMP Cell Therapy Program**

CardiAMP cell therapy – designated as an FDA Breakthrough Device – uses a patient's own (autologous) bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body's natural healing response. The CardiAMP Cell Therapy Heart Failure Trial is the first multicenter clinical trial of a stem cell therapy to prospectively screen for stem cell therapeutic potency in order to improve patient outcomes. CardiAMP Cell Therapy incorporates three proprietary elements not previously utilized in investigational cardiac cell therapy: a pre-procedural diagnostic for patient selection, a high target dosage of cells, and a proprietary delivery system that has been shown to be safer than other intramyocardial delivery systems and exponentially more successful in cell retention. The trial is supported by the Maryland Stem Cell Research Fund and the Centers for Medicare and Medicaid Services.

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**About BioCardia**

BioCardia, Inc., headquartered in Sunnyvale, California, is a developer of two biotherapeutic platforms – the CardiAMP autologous bone marrow derived mononuclear cell therapy for cardiovascular indications, and the NK1R+ allogeneic bone marrow derived mesenchymal stem cell therapies for cardiovascular and pulmonary diseases. These platforms underly four product candidates, each with the potential to meaningfully benefit millions of patients. Three of these investigational therapies are enabled by the Company's proprietary biotherapeutic delivery platforms, which the Company also selectively licenses to other biotherapeutic development firms.

**Forward Looking Statements:**

This press release contains forward-looking statements and that are subject to many risks and uncertainties. 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. Furthermore, data presented here from the small open label roll in cohort of the CardiAMP Heart Failure Trial may not be repeatable in future trials including the ongoing randomized double-blind cohort of the CardiAMP Heart Failure Trial. 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 29, 2022, under the caption titled "Risk Factors." BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.

CAUTION - Limited by United States law to investigational use.

M**edia Contact**:<br> Anne Laluc, Marketing<br> Email: info@BioCardia.com<br> Phone: 650-226-0120

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