Independent Data Safety Monitoring Board (DSMB) recommends that the study proceeds as designed based on 30-day data safety assessment of participants treated in low dosage group. The company plans to progress the trial to enrollment of 39 participants in the United States. SUNNYVALE, Calif., April 15, 2025 (GLOBE NEWSWIRE) — BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that the study’s independent DSMB, which conducted a planned review of the 30-day safety data from the roll-in 20 million cell dosing cohort in the CardiALLO-HF trial, recommended that the study continue as designed. There have been no treatment emergent major adverse cardiac events observed nor has there been any clinical evidence of immune reactions to the allogeneic cells implanted. “We are pleased with the DSMB’s recommendation, an important step forward in advancing this allogeneic off the shelf mesenchymal stromal/stem cell therapy,” said Peter Altman, BioCardia Chief Executive Officer. “Today’s result has potential to be helpful with ongoing discussions around nondilutive funding and partnering opportunities for our MSC platform. Success in this trial can enable future pivotal trial design and funding in the USA, conditional time limited approval with reimbursement in Japan, as well as the advancement of CardiALLO MSC therapy for the likely orphan indications of pediatric and adult congenital heart disease.” Previous clinical results of MSC in ischemic heart failure from our co-sponsored TRIDENT trial1 demonstrated that higher MSC cell dosages reduced myocardial scar and increased left ventricular ejection fraction, and peer results2 have indicated that patients with active inflammation have sustained reduction in cardiovascular major morbidity. CardiALLO HF at high dosage is anticipated to have at least twice the effective dosage of these previous studies and will be the first trial to target patients with active inflammation. About CardiALLO HFThe CardiALLO Heart Failure Trial is a Phase I/II study with an open label Phase I nine-patient dose escalation cohort, followed by a thirty-patient randomized double-blinded placebo procedure-controlled cohort, intended to develop support for safety and efficacy of this treatment. For Phase I, three patients are to be treated at one of three escalating doses of 20 million cells, 100 million cells, and 200 million cells, using the efficient Helix minimally invasive delivery system. The proprietary CardiALLO human MSCs and their dedicated proprietary catheter delivery system are manufactured at BioCardia’s facility in Sunnyvale, California. About BioCardiaBioCardia, Inc., 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 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 whether these results are helpful with ongoing discussions around nondilutive funding and partnering opportunities, what success in the CardiALLO HF trial enables, and what the ultimate dosage in CardiALLO HF is relative to other studies. 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.” BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. (1) Florea V, Rieger AC, DiFede DL, El-Khorazaty J, Natsumeda M, Banerjee MN, Tompkins BA, Khan A, Schulman IH, Landin AM, Mushtaq M, Golpanian S, Lowery MH, Byrnes JJ, Hendel RC, Cohen MG, Valasaki K, Pujol MV, Ghersin E, Miki R, Delgado C, Abuzeid F, Vidro-Casiano M, Saltzman RG, DaFonseca D, Caceres LV, Ramdas KN, Mendizabal A, Heldman AW, Mitrani RD, Hare JM. Dose Comparison Study of Allogeneic Mesenchymal Stem Cells in Patients With Ischemic Cardiomyopathy (The TRIDENT Study). Circ Res. 2017 Nov 10;121(11):1279-1290. doi: 10.1161/CIRCRESAHA.117.311827. Epub 2017 Sep 18. PMID: 28923793; PMCID: PMC8742223. (2) Perin EC, Borow KM, Henry TD, Jenkins M, Rutman O, Hayes J, James CW, Rose E, Skali H, Itescu S, Greenberg B. Mesenchymal precursor cells reduce mortality and major morbidity in ischaemic heart failure with inflammation: DREAM-HF. Eur J Heart Fail. 2024 Nov 26. doi: 10.1002/ejhf.3522. Epub ahead of print. PMID: 39593178. Media Contact: Miranda Peto, Investor RelationsEmail: mpeto@BioCardia.com Phone: 650-226-0120 Investor Contact: David McClung, Chief Financial OfficerEmail: investors@BioCardia.comPhone: 650-226-0120
Tag: BioCardia
BioCardia Initiates Patient Enrollment at Emory University School of Medicine for Ongoing CardiAMP HF II Pivotal Study
CardiAMP HF II is Evaluating the CardiAMP™ Cell Therapy Product for Treating Patients with Ischemic Heart Failure of Reduced Ejection Fraction and Elevated Markers of Cardiac Stress Dr. Arshed Quyyumi, Professor of Medicine, Division of Cardiology, Department of Medicine, Emory University School of Medicine, and Co-Director of the Emory Clinical Cardiovascular Research Institute to Serve as Principal Investigator SUNNYVALE, Calif., April 11, 2025 (GLOBE NEWSWIRE) — BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced today that Emory University School of Medicine in Atlanta Georgia is now enrolling patients with ischemic heart failure in the Company’s ongoing pivotal Phase III CardiAMP HF II trial. Emory University joins esteemed clinical sites throughout the United States participating in the study. The CardiAMP HF II Study is evaluating the Company’s lead therapeutic product candidate, a system designed for the harvest, processing, and minimally invasive delivery of autologous mononuclear cells to the heart intended to enhance microvascular density and reduce fibrosis. The study is comparing treatment with CardiAMP Therapy to a placebo procedure with all patients on stable guideline directed medical therapy. “The CardiAMP cell therapy has shown compelling benefits for the treated patients in the trial results recently presented at the American College of Cardiology Scientific Sessions,” said Dr. Arshed Quyyumi, MD, Professor of Medicine, Division of Cardiology, Department of Medicine, Emory University School of Medicine, and Co-Director Emory Clinical Cardiovascular Research Institute. “The screening for CD34+ cell composition and high dosage being delivered in a interventional cardiology setting is in alignment with our own past research and enhances both my confidence in the results recently presented and the potential for treated patients to do well in the study ahead. Our team at Emory is looking forward to offering patients with heart failure the opportunity to participate in this minimally invasive autologous cell therapy trial.” “Dr. Quyyumi’s significant expertise in these trials and inspiring leadership, coupled with the world-class capabilities at Emory University School of Medicine, a leading institution in the development of the field of interventional cardiology in the United States, is a great addition to the CardiAMP-HF II trial,” said Peter Altman, PhD, President and CEO of BioCardia. “We believe this collaboration will assist the Company on many levels, including their anticipated strong support in accelerating patient enrollment in the CardiAMP HF II trial towards its target completion in 2027.” About Chronic Heart Failure of Reduced Ejection Fraction (HFrEF) Heart failure of reduced ejection fraction (HFrEF) is a clinical condition in which the output of blood from the heart is insufficient to meet the metabolic demands of the body. In 2022, the American Heart Association report on heart disease statistics estimated that 3 million American adults ages 20 and older have heart failure of reduced ejection fraction with a prevalence expected to increase to more than 4 million people by 2030. During heart failure progression, the heart steadily loses its ability to respond to increased metabolic demand, and mild exercise soon exceeds the heart’s ability to maintain adequate output. Towards the end stage of the disease, the heart cannot pump enough blood to meet the body’s needs at rest. At this stage, fluids accumulate in the extremities or in the lungs making the patient bedridden and unable to perform the activities of daily living. Despite guideline-directed therapies employing a wide range of pharmacologic, device, and surgical options, many patients deteriorate over time and develop advanced heart failure symptoms that cannot be effectively managed by existing medical therapies. About CardiAMP Cell Therapy Granted Breakthrough Designation by the FDA, the 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. Clinical development to date in randomized controlled double blinded trials has shown trends towards enhanced patient survival, reduced major adverse cardiac events, and improved quality of life. The CardiAMP clinical development for heart failure is supported by the Maryland Stem Cell Research Fund and is reimbursed by Centers for Medicare and Medicaid Services (CMS) for both treatment and control procedures. CAUTION – Limited by United States law to investigational use. About CardiAMP Heart Failure Clinical Development Final study results from the randomized double blinded controlled one hundred and twenty-five subjects CardiAMP Heart Failure Study were presented at the American College of Cardiology in March 2025. Results demonstrated increased survival and reduced major adverse cardiac and cerebrovascular events (MACCE) observed study-wide. Statistically significant improvement in composite outcome measure comprised of survival, MACCE, and quality of life seen in patients suffering from active heart stress (those with elevated NTproBNP and BNP biomarkers) treated with CardiAMP Cell Therapy (p=0.02). CardiAMP HF II will focus on these patient responders. BioCardia’s clinical and regulatory team is actively working to share final results with both the FDA and Japan’s Pharmaceutical and Medical Device Agency in support of approval of the CardiAMP Cell Therapy for these patients with elevated NTproBNP, for whom existing medications may not be sufficient, and also in support of separate approval for the Helix transendocardial biotherapeutic delivery system, whose approval will have value for many biotherapeutic delivery partners. About BioCardia BioCardia, Inc., 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 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 potential benefits of CardiAMP cell therapy for patients with ischemic HFrEF, the rate of enrollment in clinical trials ahead, and the approvability of the Company’s investigational product candidates in Japan and the United States. 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.” BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. CONTACT: Media Contact:
Miranda Peto, 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
Biocardia Phase 3 CardiAMP-HF Trial of Novel Cardiac Cell Therapy for Ischemic Heart Failure Shows Increased Survival, Decreased Cardiac Events, and Improved Quality of Life at Two Years
Increased survival and reduced major adverse cardiac and cerebrovascular events (MACCE) observed study-wide, despite primary composite efficacy endpoint not reaching statistical significanceStatistically significant improvement in composite outcome measure comprised of survival, MACCE, and quality of life seen in patients suffering from active heart stress (those with elevated NTproBNP and BNP biomarkers) treated with CardiAMP Cell TherapyPatient improvements through two years suggest single dose of CardiAMP therapy offers durable benefits SUNNYVALE, Calif., March 31, 2025 (GLOBE NEWSWIRE) — BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced two-year outcomes from the double-blind randomized placebo-controlled Phase 3 CardiAMP-HF study of its CardiAMP autologous minimally invasive cell therapy for the treatment of ischemic heart failure in patients with reduced ejection fraction (HFrEF). Results were presented yesterday as a late-breaking clinical trial at the American College of Cardiology’s Annual Scientific Session and Expo by co-principal investigator Amish N. Raval, MD, FACC, professor of medicine at the University of Wisconsin School of Medicine and Public Health. “This clinical trial was conducted because there remains a large group of heart failure patients today who are insufficiently responsive to optimized heart failure medication. In this rigorous CardiAMP-HF Trial, patients who received the novel cell therapy adjunctive to medication experienced decreased mortality and MACCE, with improved quality of life, when compared to those on medication alone. These benefits appeared to be greater in patients with elevated NTproBNP – comprising fully half of treated patients – reaching statistical significance in the composite measure of these outcomes,” Dr. Raval said. “The trial shows us that CardiAMP therapy has the potential to safely and significantly improve survival and quality of life for heart failure patients in distress, encompassing a large group of patients we see in daily practice.” The CardiAMP-HF Trial studied 115 ischemic heart failure patients with reduced ejection fraction (HFrEF) enrolled at 18 centers in the United States and Canada. All patients studied were maintained on heart failure medication, with treated patients receiving a single dose of CardiAMP Cell Therapy adjunctive to medication. Two-year results from the trial demonstrated: In patients with elevated NTproBNP biomarkers (50% of enrolled patients) compared to patients on optimized heart failure medication regimens alone: 13% fewer heart death equivalents (all-cause death, heart transplantation, left ventricular assist device implantation); 47% relative risk reduction in heart death equivalents2% fewer non-fatal major adverse cardiac and cerebrovascular events MACCE; 16% relative risk reduction in MACCEClinically meaningful 10.5-point improvement in quality-of-life score, as measured by Minnesota Living with Heart Failure Questionnaire (MLHFQ)13.9-meter improvement in Six Minute Walk Distance In all treated patients compared to patients on optimized heart failure medication regimen alone: 3.6% fewer heart death equivalents; 20.9% relative risk reduction in heart death equivalents8.7% fewer non-fatal MACCE; 44.6% relative risk reduction in non-fatal MACCEClinically meaningful 5.5-point improvement in quality of life score, as measured by MLHFQ14% fewer non-sustained ventricular tachyarrythmias and 5.5% fewer sustained ventricular tachyarrhythmiasAlthough both treated and controlled patients saw modest improvements in left ventricular ejection fraction, treated patients also showed evidence of reduced left ventricular end diastolic and end systolic volumes “It is interesting to note that the results for this therapy were durable at two years, suggesting the therapy may have lasting benefits for the heart that may help prevent disease progression,” said Carl Pepine, MD, co-principal investigator of the CardiAMP-HF Trial and professor of medicine with the University of Florida. “It is an exciting prospect to anticipate an addition to our heart failure armamentarium that can meaningfully improve patients’ lives to an extent that many don’t enjoy today.” Designated by the FDA as a Breakthrough Therapy with significant potential to improve upon current therapies, CardiAMP Cell Therapy incorporates three proprietary elements not previously utilized in cardiac cell therapy: 1) a pre-procedural cell analysis to identify likely responders, 2) a high target dosage of cells, and 3) a minimally-invasive system for cell therapy delivery to the damaged area of the heart that has been shown to be safer and promote greater cell retention than other intramyocardial delivery systems. “The patient benefits suggested by this trial help to clinically validate our therapy’s observed mechanism of action for improving capillary density and promoting greater blood flow, and decreasing fibrosis leading to healthier cardiac tissue,” said Peter Altman, PhD, BioCardia President and CEO. “The group of high responders to CardiAMP therapy represents a market of approximately one million patients in the United States alone, who today cost the healthcare system $30 billion per year for their care, most of which is inpatient care1. These figures highlight that CardiAMP cell therapy also has potential to make a significant contribution toward reducing the cost of heart failure to society by improving the health of these patients. We look forward to sharing the CardiAMP-HF two-year data with both the U.S. FDA and Japan PMDA soon to align on the pathways that could make it available for physicians and their patients as soon as possible.” About CardiAMP Autologous Cell TherapyGranted FDA Breakthrough designation, CardiAMP Cell Therapy uses a patient’s own marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response to increase capillary density, reduce tissue fibrosis, and ultimately treat microvascular dysfunction. The mechanisms that lead to microvascular dysfunction, including fibrotic, inflammatory, apoptotic, and endothelial autonomic dysfunction, are all targets of CardiAMP cell therapy, largely through production of growth factors, cytokines, chemokines, and other factors that directly counteract each of these mechanisms. The CardiAMP clinical development 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. The two-year CardiAMP-HF results will be addressed in a conference call scheduled for Monday, March 31, 2025 at 4:30pm PDT. To access the call:Participants can register for the conference by navigating to https://dpregister.com/sreg/10194429/fdf5f0e427. 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=fmwk6hNm.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 6220156. About BioCardia®BioCardia, Inc., 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. For more information, visit www.biocardia.com. Forward Looking StatementsThis 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 timing of availability of data from this trial, the likelihood, magnitude and durability of safety and patient benefit, potential reductions in future health care costs, market opportunities, statements related to the mechanisms of action of the CardiAMP Cell Therapy and potential future regulatory approvals. 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. 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.” BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. References: (1) Heidenreich PA, Fonarow GC, Opsha Y, Sandhu AT, Sweitzer NK, Warraich HJ; HFSA Scientific Statement Committee Members Chair. Economic Issues in Heart Failure in the United States. J Card Fail. 2022 Mar;28(3):453-466. doi: 10.1016/j.cardfail.2021.12.017. Epub 2022 Jan 24. PMID: 35085762; PMCID: PMC9031347. CONTACT: Media Contact:
Michelle McAdam, Chronic Communications Inc.
michelle@chronic-comm.com, 310-902-1274
Investor Relations Contact:
David McClung, Chief Financial Officer
investors@biocardia.com, 650-226-0120
BioCardia Announces Japanese Patent for Helix™ Biotherapeutic Delivery System
SUNNYVALE, Calif., March 10, 2025 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces that the Japan Patent Office has granted Japanese Patent No. 7641330 titled “Radial and Transendocardial Delivery Catheter” with a patent term that will expire on or after September 30, 2034. “This new patent in Japan adds to our growing patent position with respect to minimally invasive catheter-based delivery systems for cell and gene-based therapies to the heart,” said Dr. Peter Altman, BioCardia CEO. “Our clinical cell therapy candidates for the treatment of ischemic cardiomyopathies benefit greatly from the performance of these systems, as will current and future biotherapeutic partners supported by our extensive preclinical and clinical experience. Japan is an important initial market for these therapies because of their national commitment to support novel and cost-effective cell therapy solutions for their aging population while also developing the Japanese stem cell industry (1).” BioCardia’s newly issued Japanese Patent No. 7641330 describes minimally invasive interventional biotherapeutic delivery catheters to deliver biologic therapies to target sites in the heart. This minimally invasive delivery approach enables optimal treatment at the sites where needed, minimizes off-target toxicities, and avoids the need for surgical access to the heart. The allowed claims cover BioCardia’s helical needle-tipped catheter technology platform, which available data supports is the safest and most efficient approach for biotherapeutic delivery to the heart (2, 3). BioCardia believes its Helix System to be the only catheter-based intramyocardial delivery system in active clinical use. BioCardia has secured an extensive portfolio of issued patents and pending patent applications around cell, exosome, and microRNA biotherapeutic candidates, minimally invasive biotherapeutic delivery platforms, and advanced cardiac imaging technologies. These inventions have resulted from the pursuit of its ongoing mission to develop new therapies for the patients suffering from cardiovascular disease. About BioCardia BioCardia, Inc., 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 clinical stage product candidates in development. These therapies are enabled by its Helix biotherapeutic delivery and Morph® vascular navigation product platforms. 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 and biotherapeutic delivery capabilities. 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. Konomi K, Tobita M, Kimura K, Sato D. New Japanese initiatives on stem cell therapies. Cell Stem Cell. 2015 Apr 2;16(4):350-2.Mitsutake Y, Pyum WB, Rouy D, Wong Po Foo C, Stertzer SH, Altman P, Ikeno F. Improvement of local cell delivery using Helix Transendocardial Delivery Catheter in a porcine heart, Int Heart J. 2017. Raval AN and Pepine CJ. Clinical Safety Profile of Transendocardial Catheter Injection Systems: A Plea for Uniform Reporting, Cardiovasc Revasc Med, 2021. CONTACT: 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
BioCardia Announces Primary Outcome Measures Data Freeze in CardiAMP Heart Failure Trial for Presentation at the American College of Cardiology 2025 Scientific Sessions
SUNNYVALE, Calif., Feb. 27, 2025 (GLOBE NEWSWIRE) — BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the completion of source data verification and freezing of primary outcomes data in the double-blind randomized placebo-controlled Phase 3 CardiAMP HF study of its autologous minimally invasive cell therapy for the treatment of ischemic heart failure of reduced ejection fraction (HFrEF). Data from the 115 randomized patients in the study has been transferred to the Statistical Data Analysis Center core laboratory for analysis. Results are scheduled to be presented at the Late-Breaking Clinical Trials symposium at the American College of Cardiology (ACC) 2025 Scientific Sessions in Chicago on March 30, 2025. We believe this data represents the largest ischemic HFrEF patient cohort studied in a randomized trial of an autologous cell therapy, and the first to use a precision medicine approach to identify patients likely to respond to therapy based on the nature of their cells. Should the results presented at ACC confirm the interim analysis, the trial will provide evidence of meaningful therapeutic benefit of this cell therapy for HFrEF patients insufficiently responsive to medication as characterized by elevated NT-proBNP. “This clinical study is intended to provide evidence supporting the safety and effectiveness of our CardiAMP cell therapy system for future approvals in the United States and Japan,” said Peter Altman, PhD, BioCardia President and CEO. “The results are also expected to support the safety and effectiveness of the Helix biotherapeutic delivery system for standalone approval for the intramyocardial delivery of agents to the heart.” About CardiAMP Autologous Cell Therapy Granted FDA Breakthrough designation, CardiAMP Cell Therapy uses a patient’s own marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response to increase capillary density, reduce tissue fibrosis, and ultimately treat microvascular dysfunction. The mechanisms that lead to microvascular dysfunction, including fibrotic, inflammatory, apoptotic, and endothelial autonomic dysfunction, are all targets of CardiAMP cell therapy, largely through production of growth factors, cytokines, chemokines, and other factors that directly counteract each of these mechanisms. The CardiAMP clinical development 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. About BioCardia BioCardia, Inc., 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 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: https://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 timing of availability of data from this trial, the likelihood of safety and patient benefit, statements related to the mechanisms of action of the CardiAMP Cell Therapy, references to the presentation at the American College of Cardiology and potential future regulatory approvals. 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. 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. 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
BioCardia Reports Completion of Low Dose Cohort Enrollment for CardiALLO Phase I/II Clinical Trial of BCDA-03 Allogeneic Mesenchymal Stem Cells to Treat Ischemic Heart Failure of Reduced Ejection Fraction (HFrEF)
Focus on Patients with Elevated Markers of Heart Stress and Inflammation Procedural enhancement using FDA Approved Morph DNA steerable guide for therapeutic delivery SUNNYVALE, Calif., Feb. 13, 2025 (GLOBE NEWSWIRE) — BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced today completion of enrollment and dosing in the low dose cohort in its CardiALLO™ Allogeneic Mesenchymal Cell Therapy Phase I/II trial. The trial is designed to treat patients with ischemic heart failure of reduced ejection fraction (HFrEF) and is believed to be the world’s first prospective trial of allogeneic mesenchymal stem cells (MSC) intended for treating HFrEF patients having elevated markers of heart stress and systemic inflammation. “This novel investigational cell therapy has great potential to help these patients, who suffer from significant lifestyle limitations despite receiving guideline directed medical therapy,” said Carl Pepine, M.D., Professor of Medicine at the University of Florida Division of Cardiovascular Medicine at Gainesville, and National Principal Investigator for the study. “The higher dosing and precision medicine for patients most likely to be responsive to this novel allogeneic therapy are very promising enhancements.” “The treatment procedures have gone well, and we look forward to the first independent safety review,” said R. David Anderson, M.D., Professor of Medicine in the University of Florida Division of Cardiovascular Medicine and the Director of Interventional Cardiology and Cardiac Catheterization, and Principal Investigator for the study at the University of Florida at Gainesville. “As part of this therapy, we are utilizing the Morph DNA guide to navigate, enhancing physician control for cell delivery. Based on experience to date in this study, it is a compelling product improvement.” The CardiALLO Heart Failure Trial is a Phase I/II study with an open label Phase I nine-patient dose escalation cohort, followed by a thirty-patient randomized double-blinded placebo procedure-controlled cohort, intended to develop support for safety and efficacy of this treatment. For Phase I, three patients are to be treated at one of three escalating doses of 20 million cells, 100 million cells, and 200 million cells, using BioCardia’s minimally invasive delivery system which enters the heart through a blood vessel. A two-week waiting period between each dose cohort is built into the study design with a formal Data Safety Monitoring Board (DSMB) review following each dose. These proprietary CardiALLO human cells and their dedicated proprietary catheter delivery system are manufactured at BioCardia’s facility in Sunnyvale, California. The first DSMB review is expected to take place in March 2025. The “off the shelf” mesenchymal stem cells utilized for the study treatment are believed to act by providing immunomodulatory benefits in inflammatory disease mediated heart failure as well as microvascular repair promoting enhanced capillary density and reduced fibrosis. This program follows two previous clinical trials of allogeneic MSC delivered intramyocardially for patients with ischemic heart failure sponsored by BioCardia1,2. These completed trials provide evidence for safety and trends of efficacy for these allogeneic cells which have not required immunosuppression or produced arrhythmias. “We have confidence in the CardiALLO MSC program whose current study is intended to position this therapy for pivotal clinical studies in the United States and conditional time limited approval in Japan,” said Peter Altman, PhD, BioCardia President and CEO. “Our enhanced manufacturing of these MSC is expected to be commercially scalable. The CardiALLO MSC development is synergistic to our autologous CardiAMP mononuclear cell therapy development, which has shown great promise and has potential to be many years closer to market, particularly if the upcoming data to be presented at the American College of Cardiology meeting in March confirms the interim results.” BioCardia’s allogeneic MSC manufacturing for the CardiALLO MSC program is able to support partnering for its PulmAllo™ MSC acute respiratory distress IND3, an indication where a conditional approval in Japan is expected for MSC4, as well as other preclinical and clinical indications where partners may have interest. A first MSC therapy was recently approved in the United States5. 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 acts as a biotherapeutic delivery partner supporting therapies for the treatment of heart failure, chronic myocardial ischemia, and acute myocardial infarction. 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, statements relating to the mechanisms of action of CardiALLO MSC therapy, future enrollment in our ongoing clinical trial, anticipated milestones and events, the likelihood of safety and patient benefit, future regulatory approvals, 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 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 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. References: Hare JM, Fishman JE, Gerstenblith G, DiFede Velazquez DL, Zambrano JP, Suncion VY, Tracy M, Ghersin E, Johnston PV, Brinker JA, Breton E, Davis-Sproul J, Schulman IH, Byrnes J, Mendizabal AM, Lowery MH, Rouy D, Altman P, Wong Po Foo C, Ruiz P, Amador A, Da Silva J, McNiece IK, Heldman AW, George R, Lardo A. Comparison of allogeneic vs autologous bone marrow–derived mesenchymal stem cells delivered by transendocardial injection in patients with ischemic cardiomyopathy: the POSEIDON randomized trial. JAMA. 2012 Dec 12;308(22):2369-79. Erratum in: JAMA. 2013 Aug 21;310(7):750. George, Richard [added]; Lardo, Albert [added]. PMID: 23117550; PMCID: PMC4762261.Florea V, Rieger AC, DiFede DL, El-Khorazaty J, Natsumeda M, Banerjee MN, Tompkins BA, Khan A, Schulman IH, Landin AM, Mushtaq M, Golpanian S, Lowery MH, Byrnes JJ, Hendel RC, Cohen MG, Valasaki K, Pujol MV, Ghersin E, Miki R, Delgado C, Abuzeid F, Vidro-Casiano M, Saltzman RG, DaFonseca D, Caceres LV, Ramdas KN, Mendizabal A, Heldman AW, Mitrani RD, Hare JM. Dose Comparison Study of Allogeneic Mesenchymal Stem Cells in Patients With Ischemic Cardiomyopathy (The TRIDENT Study). Circ Res. 2017 Nov 10;121(11):1279-1290.NCT 05491681: AllogeneiC Expanded Human MSC Therapy in Patients Recovering From COVID-19 Acute Respiratory Distress Trial (ACE_CARD)Helios Press release January 15, 2025: “Status of Conditional and Time-Limited Approval Application for ARDS in Japan (Clinical Part)”https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/ryoncil CONTACT: Media Contact:
Miranda Peto, 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
BioCardia Announces Late Breaking Clinical Trial Presentation on CardiAMP Heart Failure Trial at the American College of Cardiology 2025 Scientific Sessions
SUNNYVALE, Calif., Jan. 27, 2025 (GLOBE NEWSWIRE) — BioCardia, Inc. [NASDAQ: BCDA] today announced that the results of its double-blind randomized placebo-controlled CardiAMP HF Phase 3 study have been accepted for presentation in a late-breaking symposium at the American College of Cardiology 2025 Scientific Sessions, taking place in Chicago, March 29-31, 2025.
BioCardia to Host Q3 2024 Corporate Update and Financial Results Conference Call on November 13, 2024
SUNNYVALE, Calif., Nov. 06, 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 provide a corporate update and report its financial results for the three and nine months ended September 30, 2024 by conference call on Wednesday, November 13, 2024 at 4:30 PM ET. Following management’s formal remarks, there will be a question-and-answer session.
BioCardia Completes Phase III Randomized Double-Blind Controlled Trial of Autologous Cell Therapy for Ischemic Heart Failure
BioCardia announced today the completion of its last protocol specified follow-up visit in CardiAMP HF multi-center trial.
BioCardia Regains Full Compliance with Nasdaq Listing Requirements
SUNNYVALE, Calif., Sept. 18, 2024 (GLOBE NEWSWIRE) — BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced today that the Company has regained full compliance with the Nasdaq Capital Market’s Listing Requirements as required by the Hearing Panel’s (the “Panel”) decision on May 13, 2024.