Tag: BioCardia

BioCardia Announces United States Patent Issuance on Morph DNA Multi-Directional Steerable Catheter Transseptal Application

Coronary/Structural Heart by Comments are Disabled

SUNNYVALE, Calif., July 17, 2024 (GLOBE NEWSWIRE) — BioCardia, Inc. [Nasdaq: BCDA], a company focused on cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases today announces that the Unites States Patent Office has 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. The present invention relates to medical methods for transseptal access to the heart using steerable introducers based on the Company’s Morph DNA technology. This additional patent protection for BioCardia’s current and future products in this important existing market enhances shareholder value. Procedures that leverage transseptal delivery include atrial fibrillation ablation, patent foramen ovale (PFO) and atrial septal defect (ASD) repair, percutaneous mitral valve repair, left atrial appendage closure, and percutaneous left ventricular assist device placement, among others. Worldwide revenue from the transseptal access systems market was $941.3 million in 2022, with the global market estimated to expand at a Compound Annual Growth Rate of 7.3%, reaching $2.1 billion by the end of 2033(1). Morph DNA designs enable the tensioning elements in the catheter to rotate around the catheter shaft, allowing consistent catheter performance in any direction. The DNA name reflects this design, as these tensioning elements appear as a double helix like that in a strand of DNA. This design is intended to enable smooth navigation and prevent “whip,” when the build-up of mechanical forces in the device causes a catheter to suddenly jump from one orientation to another. “All of the biotherapeutic interventions we support for treatment of heart failure, refractory angina, and acute myocardial infarction going forward are expected to utilize this same introducer technology platform,” said Peter Altman, PhD, BioCardia’s President and Chief Executive Officer. “This is an elegant solution to a long-standing technical issue. The solution enhances the level of physician control in our procedures, and BioCardia is working to provide or partner this solution for the roughly five hundred thousand transseptal procedures performed in the United States each year, and for other vascular access markets that can benefit from the advantages our patented solution provides.” 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 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 the Company’s investigational product candidates, the advantages of the Morph DNA design, and the potential transseptal access delivery vascular market for the Morph DNA steerable introducer product Family. 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 its 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. (1) Persistence Market Research (2022). “Transseptal Access Systems Market Outlook (2023-2033).” New York, NY. Persistence Market Research Pvt. Ltd.

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BioCardia Announces United States Patent Issuance on Intramyocardial Delivery of Cell Aggregates to the Heart Including Minimally Invasive Radial Artery Approach

Coronary/Structural Heart by Comments are Disabled

SUNNYVALE, Calif., June 07, 2024 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a company focused on cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces that the Unites States Patent Office has granted Patent No: 11,986,611 titled “Radial and Transendocardial Delivery Catheter,” with a patent term that will expire in 2036.   The present 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. Radial artery delivery is a means by which cardiac catheters are advanced through a blood vessel in a patient’s wrist to treat the heart. This approach has significant advantages for patients, enabling them to leave the hospital soon after the procedure with a band aid on their wrist and their arm in a simple sling, allowing them to immediately return to their active lives. In addition, a radial approach permits hospitals and other care centers to greatly reduce costs by eliminating the need for an overnight stay by the patient. For these reasons, trans-radial access is becoming the default approach in many cardiac centers worldwide. Enabling radial access has enormous potential advantages for biotherapeutic delivery to the heart.   BioCardia’s Helix system, used in our ongoing clinical trials, is the only known system with patented designs that can enable radial transendocardial biotherapeutic delivery. The issued patent claims further protect this approach and add value to both BioCardia’s therapeutic programs and those of our biotherapeutic delivery partners. Therapeutic cell aggregates have the potential advantage over single cell suspensions by enhancing retention in the heart to maximize therapeutic benefit. However, the delivery of cell aggregates carries greater risks of potentially life-threatening strokes should they leak into the ventricular chamber. As 20% of the blood in the heart chamber goes to the brain, 20% of any cell or cell aggregates released in the heart are expected to obstruct the first cerebral artery that is too small to allow the cell or cell aggregate to pass. The larger the cell aggregate, the larger the vessel they are capable of obstructing, with greater risk of a significant life-threatening stroke. BioCardia’s delivery systems are designed to prevent leakage of therapeutic agents into the ventricular chamber by providing stable and safe engagement to the heart tissue during the delivery process. The issued patent claims further protect this design and add value to both BioCardia’s therapeutic programs and those of our biotherapeutic delivery partners. “Our minimally invasive biotherapeutic delivery platforms enable the successful development of cell and gene-based therapies for the heart,” said Dr. Peter Altman, BioCardia CEO. “The Helix platform underlies BioCardia’s cell therapy clinical programs and this recent patent issuance provides additional protection to our technology and product offerings in the United States for at least another dozen years. This is just one of many patent applications we are advancing to protect our value creation for the benefit of shareholders, which in turn enables these advances to be supported for expected benefit to millions of patients.” About BioCardia® BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases. CardiAMP™ autologous and CardiALLO allogeneic cell therapies are the Company’s biotherapeutic platforms in three clinical stage product candidates in development. BioCardia also partners with other biotherapeutic companies to provide its delivery systems and development support to their programs. 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 the Company’s investigational product candidates, the benefits and risks of cell aggregates, the benefits of radial artery access, the level and duration of patent protection that the Company’s patents provide to its product candidates, and the expected safety of BioCardia’s delivery device designs. 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 its 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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BioCardia Announces Reverse Stock Split

Financial by Comments are Disabled

SUNNYVALE, Calif., May 21, 2024 (GLOBE NEWSWIRE) — BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that, following approval by the Company’s stockholders and its Board of Directors, the Company intends to effect a reverse stock split of its common stock at a ratio of 1 post-split share for every 15 pre-split shares. The reverse stock split will become effective at 12:01 a.m. Eastern Daylight Time on Thursday, May 30, 2024. The Company’s common stock will begin trading on a split-adjusted basis when the market opens on Thursday, May 30, 2024. The Company’s common stock and warrants will continue to be traded on The Nasdaq Capital Market under the ticker symbols “BCDA” and “BCDAW,” respectively. The reverse stock split is intended to increase the minimum bid price requirement for continued listing on The Nasdaq Capital Market. The Company, however, cannot assure that the price of its common stock after the reverse stock split will reflect the corresponding split ratio, that the price per share following the effective time will be maintained for any period of time, or that the price will remain above the pre-split trading price. At the effective time of the reverse stock split, every 15 shares of the Company’s issued and outstanding common stock will be converted automatically into one issued and outstanding share of common stock. Stockholders holding their shares electronically in book-entry form are not required to take any action to receive post-split shares. Stockholders owning shares through a bank, broker, or other nominee will have their positions automatically adjusted to reflect the reverse stock split, subject to brokers’ particular processes, and will not be required to take any action in connection with the reverse stock split. For those stockholders holding physical stock certificates, the Company’s transfer agent, Continental Stock Transfer & Trust Co., will send instructions for exchanging those certificates for shares held electronically in book-entry form or for new certificates, in either case representing the post-split number of shares, and any payments in cash in lieu of fractional shares, if applicable. The reverse stock split will affect all stockholders uniformly and will not alter any stockholder’s percentage interest in the Company’s equity, except to the extent that the reverse stock split would result in a stockholder owning a fractional share. No fractional shares will be issued in connection with the reverse stock split. Stockholders who would otherwise hold a fractional share of the Company’s common stock following the reverse stock split will receive a cash payment in lieu thereof at a price equal to that fractional share to which the stockholder would otherwise be entitled multiplied by the closing sale price of the common stock on The Nasdaq Capital Market, as adjusted for the reverse stock split, May 29, 2024. Proportional adjustments will be made to the number of shares of common stock issuable upon exercise or conversion of the Company’s equity awards and warrants, the applicable exercise or conversion price and the number of shares issuable under the Company’s equity plans. Following the reverse stock split, the Company’s common stock will have a new CUSIP number (09060U 606). The CUSIP number for the Company’s public warrants will not change. In connection with the reverse stock split, the Company will effect an adjustment to its authorized shares of common stock, such that the 100,000,000 authorized shares of common stock will be reduced to 50,000,000 authorized shares of common stock. The par value per share of common stock and number of authorized shares of preferred stock will not change. Additional information about the reverse stock split can be found in the Company’s definitive proxy statement filed with the SEC on April 15, 2024, which is available free of charge at the SEC’s website, www.sec.gov, and on the Company’s website at https://www.biocardia.com/investors/finanicals-filings/id/1021.   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 CardiALLO allogeneic cell therapies are the Company’s biotherapeutic platforms for the treatment of heart disease. BioCardia also works with partners to provide its proprietary biotherapeutic delivery system along with preclinical and clinical development services for biotherapeutic delivery to the heart. 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, statements regarding the timing and effectiveness of the reverse stock split and the Company’s ability to regain compliance with Nasdaq’s minimum bid price. These forward-looking statements are made as of the date of this press release. 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. Factors that could cause or contribute to such differences include, but are not limited to, the Company’s liquidity position and its ability to raise additional funds, as well as the Company’s ability to successfully advance its clinical trials. 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, 2023, under the caption titled “Risk Factors,” and in its subsequently filed Quarterly Reports on Form 10-Q. The Company expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.

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BioCardia’s CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial Results Show Patient Benefits in Important Outcomes

Coronary/Structural Heart by Comments are Disabled

SUNNYVALE, Calif., May 01, 2024 (GLOBE NEWSWIRE) — BioCardia, Inc. (NASDAQ: BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the primary endpoint results of the open label roll-in cohort of the CardiAMP® Cell Therapy in Chronic Myocardial Ischemia Trial.

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BioCardia to Host 2023 Financial Results and Corporate Update Conference Call on March 27, 2024

Financial by Comments are Disabled

SUNNYVALE, Calif., March 20, 2024 (GLOBE NEWSWIRE) — BioCardia®, Inc. [NASDAQ:BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced it will report its financial results for the year ended December 31, 2023 and provide a corporate update by conference call on Wednesday, March 27, 2024 at 4:30 PM ET. Following management’s formal remarks, there will be a question-and-answer session. Participants can register for the conference by navigating to https://dpregister.com/sreg/10187416/fbec8cfa30. 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. 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=Ya3BT5pb. A webcast replay of the call will be available approximately one hour after the end of the call through June 26, 2024 at the above links. A telephonic replay of the call will be available through April 10, 2024 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 3499879. 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 CardiALLO allogeneic cell therapies are the Company’s biotherapeutic platforms for the treatment of heart disease. BioCardia also works with partners to provide its proprietary Helix transendocardial biotherapeutic delivery system, as well as technology and services for the development and commercialization of partners’ therapeutic agents. For more information visit www.biocardia.com. MEDIA CONTACT:Miranda Peto, Marketing / Investor Relations mpeto@biocardia.com (650) 226-0120 INVESTOR CONTACT:David McClung, Chief Financial Officerinvestors@biocardia.com (650) 226-0120

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BioCardia and StemCardia Announce Biotherapeutic Delivery Partnership

Financial by Comments are Disabled

Partnership targets heart failure, the leading cause of death and a condition with limited treatment optionsBioCardia’s biotherapeutic delivery system with established safety profile enables minimally invasive transplantation of StemCardia’s off-the-shelf cardiac muscle cells SUNNYVALE, Calif., March 13, 2024 (GLOBE NEWSWIRE) — BioCardia, Inc. (Nasdaq: BCDA), a biotechnology company focused on advancing late-stage cell therapy interventions for cardiovascular disorders, and StemCardia, Inc., a biotechnology company focused on cell and gene therapy to re-muscularize the failing heart, today announced a long-term partnership to advance StemCardia’s investigational pluripotent stem cell product candidate for the treatment of heart failure. Under the partnership, BioCardia is the exclusive biotherapeutic delivery partner for StemCardia’s cell therapy candidate through studies expected to result in FDA approval of an investigational new drug application (IND) and the anticipated Phase I/II clinical development to follow. “BioCardia has established safe and minimally invasive delivery of cellular medicines directly into the heart,” said Chuck Murry, MD, PhD, StemCardia’s Founder and CEO. “Having worked with BioCardia to successfully deliver our bona fide cardiac muscle cells in large animal models of heart failure, we are excited for this partnership to accelerate clinical development and broaden future commercial access to an off-the-shelf heart regeneration treatment.”       “StemCardia’s team encompasses recognized leaders in the field of cardiac regenerative medicine who are pursuing an elegant strategy to repair the failing heart. We look forward to supporting their efforts with our experienced team and proven, proprietary Helix™ biotherapeutic delivery system,” said BioCardia CEO Peter Altman, PhD. “This partnership is expected to enhance future treatment options for millions of people suffering from heart failure, offset the costs of biotherapeutic delivery development for our own programs, and provide our investors with meaningful revenue sharing should our efforts together contribute to StemCardia’s successful therapeutic development.” About StemCardia StemCardia, Inc., is developing cell and gene therapies engineered to repair the heart. The company’s mission is to advance off-the-shelf treatments for heart failure, bringing together leading experts in heart regeneration, cell manufacturing, and genetic medicine. Few treatments are available today, and none are curative. Inspired by the observation that the heart does not regenerate itself, our unique approach is to manufacture and transplant cardiac muscle cells to directly re-muscularize the failing heart and restore its function. 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 CardiALLO allogeneic cell therapies are the Company’s biotherapeutic platforms for the treatment of heart disease. BioCardia also works with partners to provide its proprietary Helix transendocardial biotherapeutic delivery system, as well as technology and services for the development and commercialization of partners’ therapeutic agents. About Helix The Helix transendocardial biotherapeutic delivery system is a therapeutic-enabling platform for minimally invasive targeted delivery of biologic agents to the heart. Helix empowers a seamless transition from bench to commercialization for partners. 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, the potential for the therapy and the partnership, future revenues and cost offsetting and future clinical trials. 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, and overall market conditions. 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. Factors that could cause or contribute to such differences include, but are not limited to, the Company’s liquidity position and its ability to raise additional funds, as well as the Company’s ability to successfully progress its clinical trials. 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, 2023, under the caption titled “Risk Factors” and in its 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 Investor Relations and Media Contact:David McClung, Chief Financial Officerinvestors@biocardia.com, 650-226-0120 StemCardia Investor Relations and Media Contact:Raj Mistry, Chief Financial Officer info@stemcardia.com

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BioCardia Announces CMS Approval of Coverage for CardiAMP Cell Therapy Confirmatory Phase III Heart Failure Study

Financial by Comments are Disabled

SUNNYVALE, Calif., March 12, 2024 (GLOBE NEWSWIRE) — BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced Centers for Medicare & Medicaid Services (CMS) approval for reimbursement coverage of the confirmatory Phase III clinical trial of CardiAMP autologous cell therapy for the treatment of patients with ischemic heart failure. CMS has reviewed the CardiAMP Heart Failure II Trial and approved the investigational product, related and routine items and services for purposes of Medicare coverage. CMS previously published a New Technology APC (Ambulatory Payment Classifications) code that covers the CardiAMP Cell Therapy investigational study procedure, including the BioCardia investigational products utilized to perform the study procedure, allowing the study centers to be reimbursed for the study procedure and products. The CardiAMP Heart Failure II Trial is FDA approved to enroll up to 250 patients at up to 40 clinical centers. The study includes an eligibility requirement that patients demonstrate a pre-specified NT-proBNP level at baseline. The primary endpoint is a hierarchical composite assessment consisting of all-cause death, the cardiac death equivalents of heart transplant and left ventricular assist device (LVAD) implantation, heart failure hospitalizations, worsening heart failure events treated as an outpatient, and change in quality-of-life, with a follow-up duration ranging from a minimum of 12 to a maximum of 24 months. The CMS coverage approval is supported by the scientific rigor of the protocol design and the results from the interim data from the CardiAMP Heart Failure Trial recently presented at the Technology and Heart Failure Therapeutics 2024 annual meeting. Across all patients there was a reduction in cardiac death equivalents and major adverse cardiac and cerebrovascular events. In the subgroup of patients targeted in the CardiAMP Heart Failure II Trial, results showed large absolute and relative risk reduction of heart death equivalents of the patients in the treated group. Treated patients also had reduced major adverse cardiac events and greatly improved quality of life. “We are pleased that CMS has provided coverage support for the confirmatory CardiAMP Heart Failure II study.” said Peter Altman, PhD., BioCardia’s President and Chief Executive Officer. “To my knowledge, no therapy has been proven to reduce mortality in these patients, and CardiAMP Heart Failure II has great potential to achieve this outcome by confirming our CardiAMP Heart Failure Trial results.” About the CardiAMP Cell Therapy Program Designated by the FDA as a Breakthrough Therapy, CardiAMP Cell Therapy uses a patient’s own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response. CardiAMP Cell Therapy incorporates three proprietary elements not previously utilized in investigational cardiac cell therapy: a pre-procedural cell analysis 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 CardiAMP clinical development for heart failure is supported by the Maryland Stem Cell Research Fund and is reimbursed by CMS for both treatment and control procedures. CAUTION – Limited by United States law to investigational use.  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 CardiALLO allogeneic cell therapies are the Company’s biotherapeutic platforms for the treatment of heart disease. BioCardia also works with partners to provide its proprietary biotherapeutic delivery system along with preclinical and clinical development services for biotherapeutic delivery to the heart. 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, statements relating to completing follow-up in the CardiAMP Heart Failure Trial, the probability of success of the CardiAMP clinical trials, ability to offset clinical costs utilizing Medicare reimbursement, anticipated milestones and events, and the ultimate success of our clinical cell therapy programs. These forward-looking statements are made as of the date of this press release. 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. Factors that could cause or contribute to such differences include, but are not limited to, the Company’s liquidity position and its ability to raise additional funds, as well as the Company’s ability to successfully advance its clinical trials. 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, 2023, under the caption titled “Risk Factors” and in its 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: Miranda Peto, Marketing / Investor RelationsEmail: mpeto@BioCardia.comPhone: 650-226-0120 Investor Contact: David McClung, Chief Financial OfficerEmail: investors@BioCardia.comPhone: 650-226-0120

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BioCardia Reports Positive Interim Results from Phase III CardiAMP Cell Therapy Heart Failure Trial, with Compelling Data in Subgroup with Elevated NTproBNP Biomarker for Heart Failure

Coronary/Structural Heart by Comments are Disabled

CardiAMP cell therapy-treated patients had 37% relative risk reduction in heart death equivalent (death, heart transplant, left ventricular assist device implantation) and 9% relative risk reduction in non-fatal major adverse cardiac and cerebrovascular events (MACCE) at mean 20-month follow-up compared […]

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BioCardia Announces Activation of CardiAMP Heart Failure II Phase 3 Pivotal Study Recently Approved by FDA

Coronary/Structural Heart Regulatory by Comments are Disabled

SUNNYVALE, Calif., Feb. 08, 2024 (GLOBE NEWSWIRE) — BioCardia, Inc. (“BioCardia” or the “Company”) (Nasdaq: BCDA), a biotechnology company focused on advancing late-stage cell therapy interventions for cardiovascular disorders, is targeting heart failure and chronic myocardial ischemia as potential indications for […]

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BioCardia Doses First Patient in CardiALLO Phase I/II Clinical Trial of BCDA-03 Allogeneic Mesenchymal Stem Cells for the Treatment of Ischemic Heart Failure of Reduced Ejection Fraction

Coronary/Structural Heart by Comments are Disabled

SUNNYVALE, Calif., Dec. 19, 2023 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease, today announced that the first patient was enrolled and treated in its CardiALLO™ Allogeneic […]

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