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6 days ago

BioCardia Seeks Accelerated FDA Path for CardiAMP Cell Therapy in Ischemic Heart Failure BioCardia, Inc. (NASDAQ: BCDA) has submitted full CardiAMP Heart Failure clinical data to the U.S. Food and Drug Administration and requested a meeting this qua

#BioCardia (NASDAQ: #BCDA) has filed a meeting request with FDA to review CardiAMP HF data and discuss accelerated approval for ischemic HFrEF. Focus is on high‑risk patients with elevated NT‑proBNP who saw meaningful event and QoL benefits.

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1 week ago

BioCardia Files Request for Meeting With FDA to Discuss Accelerated Approval Pathway for CardiAMP® System in Ischemic Heart Failure BioCardia (Nasdaq: BCDA) submitted CardiAMP HF clinical study data and requested an FDA meeting to discuss an accelerated approval pathway for the CardiAMP System in ischemic HFrEF. The meeting is expected this quarter under the device's Breakthrough Designation.Key data: 125 ischemic HFrEF patients enrolled; subgroup with elevated heart-stress biomarkers showed a 47% relative reduction in all-cause cardiac death, 37% relative reduction in non-fatal major adverse cardiac events, and quality-of-life improvement (p=0.04). Results were presented at THT 2026.

#BCDA BioCardia Files Request for Meeting With FDA to Discuss Accelerated Approval Pathway for CardiAMP® System in Ischemic Heart Failure

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2 weeks ago

BioCardia Reports 2025 Business Highlights and Financial Results BioCardia (Nasdaq: BCDA) reported 2025 results and business highlights on March 24, 2026, and filed its 2025 Form 10-K. Key clinical advances include enrollment starts in the CardiAMP HF II trial, PMDA preliminary clinical consultation in Japan, FDA acceptance of a Helix Pre-Submission, and Yale core‑lab echocardiography results showing reduced pathological remodeling in treated patients.Financially, net cash used in operations was approximately $7.4M, cash and cash equivalents were approximately $2.5M, R&D expenses were $5.0M, and the net loss was approximately $8.2M for 2025.

#BCDA BioCardia Reports 2025 Business Highlights and Financial Results

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3 weeks ago

BioCardia Announces Pre-Submission Approval Package for Helix Transendocardial Delivery Catheter Accepted by FDA BioCardia (NASDAQ: BCDA) announced that the FDA accepted its pre-submission package for the Helix Transendocardial Delivery Catheter on March 17, 2026. A substantive review and an FDA meeting are scheduled for early Q2, with CDRH expected to lead review in consultation with CBER.CDRH acknowledged CBER's CardiAMP Cell Therapy Breakthrough Designation enabled by Helix. Company leadership said FDA clearance of Helix could materially support minimally invasive intramyocardial delivery and potentially streamline approval for its CardiAMP cell therapy for ischemic heart failure.

#BCDA BioCardia Announces Pre-Submission Approval Package for Helix Transendocardial Delivery Catheter Accepted by FDA

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1 month ago

BioCardia Late Breaking Echocardiography Clinical Results from CardiAMP HF Trial Presented at Technology and Heart Failure Therapeutics (THT) BioCardia (Nasdaq: BCDA) presented late‑breaking echocardiography results from the Phase III CardiAMP HF trial on March 3, 2026 at THT. Core‑lab measured left ventricular volumes showed treated patients had less adverse remodeling overall and statistically significant, clinically meaningful volume reductions in a prespecified subgroup with elevated NTproBNP.For that subgroup differences exceeded 20 ml/m2 (LVEDV) and 15 ml/m2 (LVESV) with p=0.02 and p=0.01, respectively; overall LVEDV and LVESV comparisons were not statistically significant (p=0.06 and p=0.09).

#BCDA BioCardia Late Breaking Echocardiography Clinical Results from CardiAMP HF Trial Presented at Technology and Heart Failure Therapeutics (THT)

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3 months ago

#BCDA BioCardia Cell Therapy for Ischemic Heart Failure to Progress to Formal Clinical Consultation with Japan PMDA

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4 months ago

BioCardia (NASDAQ: BCDA) elects Marvin Slosman to board, honors Dr. Krasno BioCardia appoints InspireMD CEO Marvin Slosman to its board as longtime director Dr. Richard Krasno departs after guiding key FDA and clinical milestones.

#BCDA BioCardia Announces Election of New Board Director, Marvin Slosman and Completion of Term for Outgoing Director, Dr. Richard Krasno

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4 months ago

BioCardia Reports Third Quarter 2025 Business Highlights and Financial Results 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 third quarter of 2025 and filed its quarterly report on

#BCDA BioCardia Reports Third Quarter 2025 Business Highlights and Financial Results

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4 months ago

#BCDA BioCardia Announces Henry Ford Health Enrolls Their First Patient in Phase 3 CardiAMP HF II Cell Therapy Pivotal Trial

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6 months ago

BioCardia Announces Pricing of Up To $12 Million Public Offering BioCardia (NASDAQ:BCDA), a cardiovascular and pulmonary disease therapeutics developer, has announced a $12 million public offering. The offering consists of 4.8 million shares of common stock and short-term warrants at a combined price of $1.25 per share and warrant.The initial offering will raise $6 million in gross proceeds, with potential for an additional $6 million if all warrants are exercised. The warrants have an exercise price of $1.25 per share and a two-year expiration period. H.C. Wainwright & Co. serves as the exclusive placement agent, with closing expected around September 19, 2025.Proceeds will support working capital and general corporate purposes, including advancement of BioCardia's investigational biotherapeutic candidates and delivery partnering business.

#BCDA BioCardia Announces Pricing of Up To $12 Million Public Offering

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7 months ago

Revolutionary 3D Heart Imaging System Could Generate $100M Annually, BioCardia-CART-Tech Partnership Reveals New Heart3D™ Fusion Imaging system combines 2D X-rays with 3D heart models for precise cardiac biotherapeutic delivery. Partnership targets $100M annual revenue potential. Learn more.

#BCDA BioCardia and CART-Tech Announce Exclusive Partnership to Develop and Commercialize Heart3D™ Fusion Imaging for Interventional Cardiology

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7 months ago

BioCardia Narrows Loss in Fiscal Q2 | The Motley Fool

#BCDA #9e4fece1-0d53-4161-ba8f-f6d5f8ddd9e5 #data-news

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7 months ago

BioCardia Reports Second Quarter 2025 Business Highlights and Financial Results BioCardia (NASDAQ:BCDA) reported Q2 2025 financial results and significant progress in its cardiovascular therapeutics pipeline. The company's flagship CardiAMP HF Trial showed promising two-year results, with treatment groups demonstrating lower incidence of death and complications, particularly significant in patients with elevated NTproBNP (p=0.02).Financial highlights include increased R&D expenses to $1.4M in Q2 2025, a net loss of $2.0M, and a current cash balance of approximately $1.1M providing runway into October 2025. The company strengthened its intellectual property portfolio with a new US patent for its biotherapeutic delivery catheter systems.Key upcoming milestones include FDA meetings on CardiAMP HF approvability in Q4 2025, Japan PMDA clinical review, and planned FDA submission for the Helix biotherapeutic delivery system in Q3 2025.

#BCDA BioCardia Reports Second Quarter 2025 Business Highlights and Financial Results

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Small Cap Strategist

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8 months ago

Small-cap stocks with strong volume declines, Mon Aug 4th - #CPHI #PC #MURA #YMAB #WHLC #TTEC #MDWD #BCDA #SBXD - More: crystalequityresearch.com/leading-indi... - #smallcap

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8 months ago

BioCardia's Revolutionary Heart Failure Cell Therapy Advances Toward Japanese Market - Key PMDA Meeting Ahead BioCardia's CardiAMP cell therapy for heart failure enters crucial PMDA review phase. Potential Japanese market entry could begin next year. See expansion details.

#BCDA BioCardia Submits Request for Clinical Data Review Meeting with Japan PMDA To Discuss Approval Pathway for CardiAMP® Cell Therapy in Ischemic Heart Failure

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8 months ago

Henry Ford Health Initiates Patient Enrollment for BioCardia’s CardiAMP HF II Pivotal Study for Ischemic Heart Failure of Reduced Ejection Fraction BioCardia (NASDAQ:BCDA) announced that Henry Ford Health in Detroit has begun enrolling patients with ischemic heart failure in the pivotal CardiAMP HF II trial. The study investigates an autologous cell therapy using patients' own bone marrow cells to treat ischemic heart failure with reduced ejection fraction (HFrEF).The investigational therapy aims to promote microvascular repair, reduce fibrosis, and increase capillary density. The procedure involves harvesting and processing patients' cells at bedside, followed by minimally invasive catheter delivery to damaged heart areas. This confirmatory trial builds on promising results from previous TABMMI, TACHFT, and CardiAMP HF trials.

#BCDA Henry Ford Health Initiates Patient Enrollment for BioCardia’s CardiAMP HF II Pivotal Study for Ischemic Heart Failure of Reduced Ejection Fraction

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9 months ago

BioCardia's New Patent Could Transform Heart Disease Treatment for Millions: Inside the Breakthrough Delivery System Groundbreaking Helix catheter system patent strengthens BioCardia's position in cardiac biotherapeutics delivery. See how this technology could revolutionize heart treatment.

#BCDA BioCardia Announces New United States Patent for Helix Biotherapeutic Delivery System

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Small Cap Strategist

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10 months ago

Small-cap stocks with bearish moving average convergence divergence crossovers, Thu May 15th - #MAMA #ARCO #BAK #LENZ #MODG #JRVR #NUV #GCO #ODV #EDAP #PERF #CASH #SJT #BCDA #OCCI #SIEB #TYRA #STAA - More: crystalequityresearch.com/SmCpStr/ - #smallcap

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10 months ago

BioCardia Reports First Quarter 2025 Business Highlights and Financial Results BioCardia (NASDAQ: BCDA) reported its Q1 2025 financial results and key developments. The company's CardiAMP HF Trial showed significant two-year results, demonstrating increased survival, decreased cardiovascular events, and improved quality of life for heart failure patients. Notable improvements were seen in patients with active heart stress (50% of enrolled patients). The company's CardiAMP HF II Trial is progressing with three active enrollment sites. Financial results showed R&D expenses of $1.5M (vs $1.2M in Q1 2024), SG&A expenses of $1.2M (vs $1.1M in Q1 2024), and a net loss of $2.7M (vs $2.3M in Q1 2024). The company's CardiALLO Cell Therapy completed its low-dose cohort with no adverse events, and their Helix delivery system demonstrated strong safety performance. BioCardia's IP portfolio includes over 60 patents and applications worldwide, with recent patent approval in Japan.

#BCDA BioCardia Reports First Quarter 2025 Business Highlights and Financial Results

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11 months ago

Major Breakthrough: University of Wisconsin Joins Phase 3 Heart Failure Cell Therapy Trial - New Hope for HFrEF Patients New site accelerates Phase 3 CardiAMP cell therapy trial for heart failure. Minimally invasive treatment shows promising survival benefits. Get trial details.

#BCDA BioCardia Initiates Patient Enrollment at University of Wisconsin at Madison for Ongoing CardiAMP HF II Pivotal Study

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11 months ago

Major Safety Milestone: Revolutionary Heart Failure Cell Therapy Advances to Next Phase CardiALLO therapy shows perfect safety profile in initial cohort. Novel allogeneic treatment targets inflammation in heart failure patients. See full trial details.

#BCDA BioCardia Announces Positive DSMB Review of CardiALLO Allogeneic Cell Therapy for Heart Failure Phase 1/2 Clinical Trial

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11 months ago

Major Breakthrough: Emory Joins Phase III Trial for Revolutionary Heart Failure Treatment Prestigious Emory University begins enrolling patients in CardiAMP cell therapy trial for heart failure treatment. Latest data shows promising results. Full analysis inside.

#BCDA BioCardia Initiates Patient Enrollment at Emory University School of Medicine for Ongoing CardiAMP HF II Pivotal Study

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1 year ago

BioCardia Reports 2024 Business Highlights and Financial Results BioCardia (NASDAQ: BCDA) has reported its financial results for 2024, showing a reduced net loss of $7.9 million compared to $11.6 million in 2023. The company's net cash used in operations decreased to $8.0 million from $10.0 million in 2023.Key financial metrics include:Cash and cash equivalents: $2.4 million at year-endRevenues: $58,000 (down from $477,000 in 2023)R&D expenses: $4.4 million (decreased from $7.7 million)SG&A expenses: $3.7 million (reduced from $4.4 million)Notable developments include completion of the CardiAMP HF Trial's last protocol-specified follow-up visit, with results to be presented at the ACC Scientific Sessions. The company has also completed treatment of the low-dose cohort in the CardiALLO Cell Therapy trial and launched commercial Morph DNA steerable introducer devices. Japan's PMDA has shown openness to considering existing trial results for potential product registration.

#BCDA BioCardia Reports 2024 Business Highlights and Financial Results

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1 year ago

BioCardia Announces Japanese Patent for Helix™ Biotherapeutic Delivery System BioCardia (BCDA) has been granted Japanese Patent No. 7641330 for its Helix™ Biotherapeutic Delivery System, extending protection until at least September 30, 2034. The patent covers minimally invasive catheter-based delivery systems for cell and gene-based therapies to the heart.The Helix System, featuring helical needle-tipped catheter technology, is currently the only catheter-based intramyocardial delivery system in active clinical use. The technology enables targeted treatment while minimizing off-target toxicities and avoiding surgical heart access.Japan represents a strategic market for these therapies due to its national commitment to supporting novel cell therapy solutions for its aging population while developing its stem cell industry.

#BCDA BioCardia Announces Japanese Patent for Helix™ Biotherapeutic Delivery System

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1 year ago

BioCardia Announces Primary Outcome Measures Data Freeze in CardiAMP Heart Failure Trial for Presentation at the American College of Cardiology 2025 Scientific Sessions BioCardia (BCDA) has completed data verification for its Phase 3 CardiAMP HF study, a double-blind randomized placebo-controlled trial evaluating an autologous cell therapy for ischemic heart failure. The study, involving 115 randomized patients, represents the largest cohort of ischemic HFrEF patients in a randomized autologous cell therapy trial.The trial data has been transferred to the Statistical Data Analysis Center for analysis, with results scheduled for presentation at the Late-Breaking Clinical Trials symposium at the American College of Cardiology 2025 Scientific Sessions on March 30, 2025. The study is notable for using a precision medicine approach to identify potential responders based on cell characteristics.The trial aims to demonstrate therapeutic benefit for HFrEF patients with elevated NT-proBNP who haven't responded sufficiently to medication. Results will support regulatory approvals in the US and Japan for both the CardiAMP cell therapy system and the Helix biotherapeutic delivery system.

#BCDA BioCardia Announces Primary Outcome Measures Data Freeze in CardiAMP Heart Failure Trial for Presentation at the American College of Cardiology 2025 Scientific Sessions

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1 year ago

BioCardia to Present CardiAMP Phase 3 Heart Failure Trial Results at ACC 2025 BioCardia's groundbreaking CardiAMP cell therapy trial results for heart failure patients secured a prestigious late-breaking presentation slot at ACC Scientific Sessions.

#BCDA BioCardia Announces Late Breaking Clinical Trial Presentation on CardiAMP Heart Failure Trial at the American College of Cardiology 2025 Scientific Sessions

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1 year ago

BioCardia Launches Revolutionary Morph DNA Steerable Introducer, Advances Breakthrough Heart Failure Therapy BioCardia debuts innovative Morph DNA product line while progressing FDA-designated breakthrough cell therapy trials for heart failure treatment. Key results expected Q1 2025.

#BCDA BioCardia Announces Commercial Availability of Morph® DNA™ Steerable Introducer Product Family

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