Exhibit 99.1

BioCardia Reports Second Quarter 2024 Business Highlights and Financial Results

Sunnyvale, Calif. – August 13, 2024 - BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported financial results for the second quarter of 2024 and filed its quarterly report on Form 10-Q for the three and six months ended June 30, 2024 with the Securities and Exchange Commission. The Company will also hold a conference call at 4:30 PM ET today in which it will discuss business highlights. Following management’s formal remarks, there will be a question-and-answer session.

Recent Business Highlights

BCDA-01: CardiAMP® autologous cell therapy in ischemic heart failure of reduced ejection fraction

BCDA-02: CardiAMP autologous cell therapy in chronic myocardial ischemic with refractory angina

BCDA-03: CardiALLO Cell Therapy in Ischemic Heart Failure

Helix Biotherapeutic Delivery

Morph Access Innovations

Business

“Since the end of the first quarter, we have accomplished a great deal on a significantly reduced operational cash burn.” said BioCardia CEO Peter Altman, Ph.D. “We intend to regain compliance with NASDAQ and soon deliver final data in CardiAMP Heart Failure I randomized placebo-controlled trial.”

Altman continues, “BioCardia is well poised to deliver significant shareholder returns based on our late stage clinical development efforts, biotherapeutic delivery partnering, and approved products. There are many working on cell and gene therapy to the heart which are pursuing important efforts. However, to our knowledge, in this biointerventional cardiology space, only BioCardia has secured a breakthrough designation from FDA, received Medicare reimbursements for not just one, but two clinical indications. BioCardia is one of two companies that has successfully treated hundreds of patients with its lead cardiac cell therapy for heart failure and enrolled a Phase III clinical trial. To our knowledge, only BioCardia has shown trends towards both reduced mortality and reduced major adverse cardiac events in its primary endpoint across all patients in a randomized double blinded clinical trial. Only BioCardia is today enrolling in a confirmatory pivotal trial for approval of a heart failure cell therapy, using what I believe is the only clinical use transendocardial delivery system in the world. This delivery system, developed and manufactured by the Company, enables our efforts and those of biointerventional therapeutic partners in three unique cardiac indications today. We remain optimistic and see many pathways towards building great shareholder value in the near future and helping millions of patient. ”

Intellectual Property

The Company’s intellectual property portfolio is robust, with more than 60 patents and patent applications worldwide.

In June, the Company announced that the Unites States Patent Office granted Patent No: 11,986,611 titled “Radial and Transendocardial Delivery Catheter,” with a patent term that will expire in 2036. This invention relates to medical methods and systems suitable for substance delivery to the heart via a radial artery and for the intracardiac delivery of cellular aggregates and other agglomerated materials.  

In July, the Company announced that the Unites States Patent Office granted Patent No: 12,036,371 titled “Method of Accessing the Left Atrium with a Multi-Directional Steerable Catheter,” with a patent term that will expire in 2035. This invention relates to medical methods for transseptal access to the heart using steerable introducers based on the Company’s Morph DNA technology.  

Second Quarter 2024 Financial Results:

ANTICIPATED UPCOMING MILESTONES AND EVENTS:

About BioCardia®

BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP™ autologous and NK1R+ allogeneic cell therapies are the Company’s biotherapeutic platforms that enable four product candidates in development. BioCardia also partners with other biotherapeutic companies to provide its delivery systems and development support to their programs studying therapies for the treatment of heart failure, chronic myocardial ischemia and acute myocardial infarction. The CardiAMP Cell Therapy Trial for Heart Failure has been supported financially by the Maryland Stem Cell Research Fund and the Center for Medicare and Medicaid Services. For more information visit: www.BioCardia.com.

Conference call access:

Participants can register for the conference by navigating to https://dpregister.com/sreg/10191562/fd3d36338a. Please note that registered participants will receive their dial-in number upon registration. For those who have not registered, to listen to the call by phone, interested parties within the U.S. should call 1-833-316-0559 and international callers should call 1-412-317-5730 and ask to be connected to the BioCardia call. All callers should dial in approximately 10 minutes prior to the scheduled start time and ask to be joined into the BioCardia call. The conference call will also be available through a live webcast, which can be accessed through the following link: https://event.choruscall.com/mediaframe/webcast.html?webcastid=BLDb4kwc.

A webcast replay of the call will be available approximately one hour after the end of the call at the above links. To access the replay internationally, please use the link https://services.choruscall.com/ccforms/replay.html. A telephonic replay of the call will be available and may be accessed by calling 1-877-344-7529 (domestic), 1-412-317-0088 (international) or 855-669-9658 (Canada) by using access code 5376275.

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 enrollment in our clinical trials, the availability of data from our clinical trials, filings and communications with the FDA and Japan’s Pharmaceutical and Medical Device Agency, FDA and Japanese product clearances, the efficacy and safety of our products and therapies, preliminary conclusions about new data, the achievement of any of the anticipated upcoming milestones, our positioning for growth or the market for our products and therapies, the expected benefits of our intellectual property, future prospects, regulatory timelines, and other statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. Such risks and uncertainties include, 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’s business and product development plans, the ability to enter into licensing and partnering arrangements and overall market conditions. We may find it difficult to enroll patients in our clinical trials due to many factors, some of which are outside of our control. Slower than targeted enrollment could delay completion of our clinical trials and delay or prevent the development of our therapeutic candidates. 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 27, 2024, 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.  

BioCardia, Inc.

Condensed Consolidated Statements of Operations
(Unaudited in thousands, except share and per share amounts)

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Media Contact:
Miranda Peto, Marketing / Investor Relations
Email: mpeto@BioCardia.com
Phone: 650-226-0120

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