<SEC-DOCUMENT>0001437749-20-025512.txt : 20201217
<SEC-HEADER>0001437749-20-025512.hdr.sgml : 20201217
<ACCEPTANCE-DATETIME>20201217083017
ACCESSION NUMBER:		0001437749-20-025512
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20201217
ITEM INFORMATION:		Regulation FD Disclosure
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20201217
DATE AS OF CHANGE:		20201217

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:		201394304

	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
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>bcda20201216_8k.htm
<DESCRIPTION>FORM 8-K
<TEXT>
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<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">&nbsp;</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>UNITED STATES</b></p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>SECURITIES AND EXCHANGE COMMISSION </b></p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>Washington, D.C. 20549</b></p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">&nbsp;</p>

<p style="font-family: &quot;Times New Roman&quot;; font-size: 14pt; margin: 0pt; text-align: center;"><b>FORM 8-K</b></p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;">&nbsp;</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>CURRENT REPORT</b></p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;">Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">&nbsp;</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;">Date of Report (Date of earliest event reported): <b>December 1</b><b>7</b><b>,</b><b> 20</b><b>20</b></p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">&nbsp;</p>

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			<p style="font-family: &quot;Times New Roman&quot;; font-size: 14pt; margin: 0pt; text-align: center;"><b>BIOCARDIA</b><b>, INC.</b></p>
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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;">(Exact name of registrant as specified in its charter)</p>
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<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">&nbsp;</p>

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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>Delaware</b></p>
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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;">&nbsp;</p>
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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>0</b><b>-</b><b>21419</b></p>
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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;">&nbsp;</p>
			</td>
			<td style="vertical-align: middle; border-bottom: 1px solid rgb(0, 0, 0); width: 30%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">
			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>2</b><b>3-</b><b>2753988</b></p>
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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;">(State or other jurisdiction</p>

			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;">of incorporation)</p>
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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;">(Commission</p>

			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;">File Number)</p>
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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;">(IRS Employer</p>

			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;">Identification No.)</p>
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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>125 Shoreway Road, Suite B&nbsp;</b><br>
			<b>San Carlos, California 94070</b></p>
			</td>
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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;">(Address of principal executive offices and zip code)</p>
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<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">&nbsp;</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>Registrant&#8217;s telephone number, including area code</b><b>:</b><b> </b><b>(650) 226</b><b>-</b><b>0120</b></p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">&nbsp;</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;">_____________________________________________</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">&nbsp;</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">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:</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">&nbsp;</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">&#9744;&nbsp; Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">&nbsp;</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">&#9744;&nbsp; Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">&nbsp;</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">&#9744;&nbsp; Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">&nbsp;</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">&#9744;&nbsp; Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">&nbsp;</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">&nbsp;Securities registered pursuant to Section 12(b) of the Act:</p>

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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;">Title of each class</p>
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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;">Trading Symbol(s)</p>
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			<td style="vertical-align: middle; border-width: 1px; border-style: solid; border-color: black black rgb(0, 0, 0); width: 34%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">
			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;">Name of each exchange on which registered</p>
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			<td style="vertical-align: middle; border-bottom: 1px solid rgb(0, 0, 0); width: 34%; border-left: 1px solid black; border-right: 1px solid black; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">
			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;">Common Stock, par value $0.001</p>
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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;">BCDA</p>
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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;">The Nasdaq Capital Market</p>
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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;">Warrant to Purchase Common Stock</p>
			</td>
			<td style="vertical-align: middle; border-bottom: 1px solid rgb(0, 0, 0); width: 32%; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">
			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;">BCDAW</p>
			</td>
			<td style="vertical-align: middle; border-bottom: 1px solid rgb(0, 0, 0); width: 34%; border-left: 1px solid black; border-right: 1px solid black; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">
			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;">The Nasdaq Capital Market</p>
			</td>
		</tr>

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<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">&nbsp;</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">&nbsp;</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">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 &#167;230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR &#167;240.12b-2 of this chapter)&nbsp;&#9744;</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">&nbsp;</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">&nbsp;</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">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. &#9744;</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;"><b>&nbsp;</b></p>

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<p style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin: 0pt; text-align: left">&nbsp;</p>

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			<p style="margin: 0pt; text-align: left; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;"><b>Item&nbsp;</b><b>7</b><b>.</b><b>01</b><b> </b></p>
			</td>
			<td>
			<p style="margin: 0pt; text-align: left; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;"><b>Regulation FD Disclosure</b><b>.</b></p>
			</td>
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<p style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</p>

<p style="background-color:#FFFFFF;font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;text-indent:24.5pt;">Today, December 17, 2020, BioCardia, Inc. (the &#8220;Company&#8221;) has issued a press release announcing that the Company&#8217;s independent Data Safety Monitoring Board (DSMB) completed its prespecified data review for the Phase III pivotal CardiAMP<sup style="vertical-align:top;line-height:120%;font-size:pt">TM</sup> Heart Failure Trial based on a review of all data for the 86 patients enrolled in the trial, including 60 randomized patients who have reached their one-year follow-up. The DSMB performed a risk-benefit assessment, indicated no safety concerns, and recommended in writing that the study continue as planned. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.</p>

<p style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;">&nbsp;</p>

<p style="background-color:#FFFFFF;font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;text-indent:24.5pt;">The information furnished pursuant to this Item 7.01, including Exhibit 99.1 hereto, shall not be deemed &#8220;filed&#8221; for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the &#8220;Exchange Act&#8221;), 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.</p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;"><b>&nbsp;</b></p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;"><b>&nbsp;</b></p>

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			<p style="margin: 0pt; text-align: left; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;"><b>Item 9.01. </b></p>
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			<td>
			<p style="margin: 0pt; text-align: left; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;"><b>Financial Statements and Exhibits.</b></p>
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<p style="margin: 0pt; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</p>

<p style="margin: 0pt; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;"><b>(d)</b><b> Exhibits</b></p>

<p style="margin: 0pt; font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt;">&nbsp;</p>

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			<td colspan="1" style="vertical-align: bottom; border-bottom: 1px solid rgb(0, 0, 0); width: 9%;">
			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>Exhibit No.</b></p>
			</td>
			<td style="vertical-align: bottom; border-bottom: 1px solid rgb(0, 0, 0); width: 1%;">&nbsp;</td>
			<td style="vertical-align: bottom; border-bottom: 1px solid rgb(0, 0, 0); width: 79%;">
			<p style="font-family: &quot;Times New Roman&quot;, Times, serif; font-size: 10pt; margin: 0pt; text-align: left;"><b>Exhibit Description</b></p>
			</td>
			<td colspan="2" style="vertical-align: bottom; width: 11%;">
			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">&nbsp;</p>
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			<td style="vertical-align: top; width: 9%;">
			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;">99.1</p>
			</td>
			<td style="vertical-align: top; width: 1%;">&nbsp;</td>
			<td style="vertical-align: top; width: 79%;">
			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;"><a href="ex_218085.htm" style="-sec-extract:exhibit;">Press Release of BioCardia, Inc. dated December 17, 2020.</a></p>
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<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>SIGNATURES</b></p>

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<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;text-indent:36pt;">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.</p>

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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;"><b>BIOCARDIA</b><b>, INC.</b></p>
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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">/s/ Peter Altman, Ph.D.</p>
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			<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Date:&nbsp;December 17, 2020</p>
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<DESCRIPTION>EXHIBIT 99.1
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<p style="background-color:#FFFFFF;font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;"><u><b>FOR IMMEDIATE RELEASE</b></u></p>

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<p style="background-color:#FFFFFF;font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>BIOCARDIA ANNOUNCES POSITIVE DSMB </b><b>FUTILITY ANALYSIS REVIEW AND </b><b>RECOMMENDATION</b><b> TO</b><b> CONTIN</b><b>UE</b><b> PHASE </b><b>III</b></p>

<p style="background-color:#FFFFFF;font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:center;"><b>PIVOTAL CARDIAMP HEART FAILURE STUDY AS DESIGNED</b></p>

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<p style="background-color:#FFFFFF;font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><b>SAN CARLOS, Calif. &#8211; December 17, 2020</b> &#8211; BioCardia (Nasdaq: BCDA),<b> </b>a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced that the independent Data Safety Monitoring Board (DSMB) has completed its prespecified data review for the Phase III pivotal CardiAMP&#8482; Heart Failure Trial. The DSMB based its review on all available data for the 86 patients enrolled in the trial, including 60 randomized patients who have reached their one-year follow-up. The DSMB performed a risk-benefit assessment, indicated no safety concerns, and recommended that the study continue as designed.</p>

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<p style="background-color:#FFFFFF;font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">&#8220;I am delighted with the positive recommendation from the distinguished CardiAMP DSMB to continue this important study,&#8221; said BioCardia CEO Peter Altman, PhD. &#8220;The successful risk-benefit review is a testament to the dedication of the many CardiAMP investigators and clinical teams at leading institutions across the U.S. The DSMB was able to review the primary efficacy data from twice as many patients at one-year follow up as were available in our Phase II study to arrive at their positive recommendation, with no change or action required. We believe that the DSMB recommendation further enhances the probability of our clinical cell therapy program becoming a valuable therapy for millions of patients suffering from cardiac disease.&#8221;</p>

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<p style="background-color:#FFFFFF;font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">&#8220;In addition to the DSMB report, we are enthusiastic about the significant momentum we are seeing in CardiAMP HF Trial enrollment, with a dozen patients currently in the pipeline for randomization. The trial is also generating compelling data on the high CD34+ cell dosage being studied that we intend to submit to an upcoming scientific conference or journal for publication,&#8221; Altman added.</p>

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<p style="background-color:#FFFFFF;font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">The ongoing multi-center, double-blinded, randomized (3:2), controlled pivotal CardiAMP Heart Failure Trial is expected to enroll 260 patients at up to 40 centers nationwide. The trial&#8217;s primary endpoint is an outcomes composite score based on a three-tiered Finkelstein-Schoenfeld (FS) hierarchical analysis, an established outcomes design that has been used in other leading heart failure programs. The FS procedure is a ranked analysis that first compares each subject to each other subject for occurrence of first-tier events (time to death, in this case) and then compares patient outcomes for subsequent tiers. The tiers, starting with the most serious events, would be (1) all-cause death, including cardiac death equivalents such as heart transplant or left ventricular assist device placement, ordered by time to event; (2) non-fatal Major Adverse Coronary and Cerebrovascular Events (MACCE), excluding those deemed procedure-related occurring within the first seven days post-procedure (heart failure hospitalization, stroke or myocardial infarction), ordered by time to event; and (3) change from baseline in Six Minute Walk Distance at 12 months.&nbsp;Data submitted to the DSMB provided the group with visibility into the risks and benefits of the trial at its primary endpoint.</p>

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<p style="background-color:#FFFFFF;font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;">The DSMB consists of two world renowned cardiologists with experience in heart failure and interventional cardiology, as well as a world renowned biostatistician with considerable experience evaluating trial data for chronic diseases, including heart failure. Their primary responsibility is to ensure patient safety and to halt or pause the clinical investigation if the risk of the therapy appears to outweigh its potential benefit. Such risk-benefit analysis typically includes an analysis of futility to reach the primary endpoint of the clinical trial as designed.</p>

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<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Patients interested in learning about the study can visit <u>www.cardiamp.com</u> or <u>www.clinicaltrials.gov</u> for more information.</p>

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<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;"><b>About the CardiAMP Therapy Program</b></p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">CardiAMP cell therapy uses a patient&#8217;s own (autologous) bone marrow cells delivered to the heart in a minimally-invasive, catheter-based procedure to potentially stimulate the body&#8217;s natural healing response. The CardiAMP 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.&nbsp;&nbsp;&nbsp;&nbsp;</p>

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<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;"><b>About BioCardia&#174;</b></p>

<p style="background-color:#FFFFFF;font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">BioCardia, Inc., headquartered in San Carlos, California, is developing regenerative biologic therapies to treat cardiovascular and respiratory disease. CardiAMP autologous and Neurokinin-1 Receptor Positive allogenic cell therapies are the Company&#8217;s biotherapeutic platforms in clinical development. The Company's products include the Helix Biotherapeutic Delivery System and its steerable guide and sheath catheter portfolio. BioCardia also partners with other biotherapeutic companies to provide its Helix system and clinical support for their programs studying therapies for the treatment of heart failure, chronic myocardial ischemia and acute myocardial infarction. For more information, visit <u>www.BioCardia.com</u>.</p>

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<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;"><b>Forward Looking Statements:</b><br>
This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. These forward-looking statements include, without limitation, statements relating to study enrollment expectations and the likelihood of success and the value of our clinical cell therapy programs.</p>

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<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">We may use terms such as &#8220;believes,&#8221; &#8220;estimates,&#8221; &#8220;anticipates,&#8221; &#8220;expects,&#8221; &#8220;plans,&#8221; &#8220;intends,&#8221; &#8220;may,&#8221; &#8220;could,&#8221; &#8220;might,&#8221; &#8220;will,&#8221; &#8220;should,&#8221; &#8220;approximately&#8221; or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. These forward-looking statements reflect our view as of the time such statement is made and are not guarantees of future performance or developments. You are strongly cautioned that reliance on any forward-looking statements involves known and unknown risks and uncertainties. Actual results and events may differ materially from information contained in the forward-looking statements as a result of a number of factors including, among others, the inherent uncertainties associated with developing new products or technologies, regulatory approvals, unexpected expenditures, the ability to raise the additional funding needed to continue to pursue BioCardia&#8217;s business and product development plans and overall market conditions. As a result of these factors, we cannot assure you that the forward-looking statements in this presentation will prove to be accurate. Additional factors that could materially affect actual results can be found in our documents filed with the SEC, including our recent filings on Form 8-K, Form 10-K and Form 10-Q, particularly any statements under the caption entitled &#8220;Risk Factors&#8221; Therein.&#8221; BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.&nbsp;</p>

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<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;"><b>INVESTOR CONTACT:</b><br>
David McClung, Chief Financial Officer<br>
investors@BioCardia.com, (650) 226-0120</p>

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<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;"><b>MEDIA CONTACT:</b></p>

<p style="font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:left;">Michelle McAdam, Chronic Communications, Inc.</p>

<p style="background-color:#FFFFFF;font-family:'Times New Roman', Times, serif;font-size:10pt;margin:0pt;text-align:justify;"><u>michelle@chronic-comm.com</u>, (310) 545-6654</p>

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