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Biocardia Inc - BCDA STOCK NEWS

Welcome to our dedicated page for Biocardia news (Ticker: BCDA), a resource for investors and traders seeking the latest updates and insights on Biocardia stock.

Overview

BioCardia, Inc. (Nasdaq: BCDA) is a clinical‐stage regenerative medicine company dedicated to advancing cellular and cell‐derived therapeutics for cardiovascular and pulmonary diseases with significant unmet medical needs. Leveraging cutting‑edge stem cell technologies, the company is focused on developing innovative therapies through its proprietary CardiAMP autologous and CardiALLO allogeneic platforms. These biotherapeutic solutions are designed to address conditions such as ischemic heart failure and refractory angina, using state‑of‑the‑art delivery systems and precision medicine approaches.

Core Business and Technology

At the heart of BioCardia’s operations is its development of novel cell therapies that utilize the patient’s own marrow‐derived cells or allogeneic mesenchymal stem cells. Its pioneering therapeutic solutions are enabled by advanced delivery systems including the Helix™ biotherapeutic delivery platform and the Morph® vascular navigation system. These systems not only improve the safety and efficacy of cell delivery through minimally invasive catheter‑based procedures, but also ensure enhanced cell retention and precise dosing.

Clinical Development and Value Proposition

BioCardia is progressing multiple clinical-stage product candidates through rigorous, randomized controlled trials. Its CardiAMP cell therapy has garnered significant regulatory recognition, including breakthrough designations from the FDA, underscoring its potential to improve survival rates, reduce major adverse cardiac events, and enhance overall quality of life. The company’s approach features a personalized treatment strategy that incorporates pre‑procedural cell population analysis for optimal patient selection and dosing, thereby maximizing therapeutic benefit.

Market Position and Competitive Landscape

Positioned within the competitive landscape of biointerventional cardiology and regenerative medicine, BioCardia distinguishes itself through its robust intellectual property portfolio and innovative therapeutic modalities. The company’s comprehensive range of technologies supports a variety of cardiovascular interventions, setting it apart from peers by addressing multiple clinical indications with both autologous and off‑the‑shelf solutions. This diversification helps the company meet a broad spectrum of clinical needs, ensuring a solid foundation within its niche market segment.

Operational Insights and Technological Advancements

BioCardia’s operational model emphasizes efficiency, low operational cash burn, and strategic collaboration with leading clinical and research institutions. The development of the Morph® DNA™ steerable introducers—characterized by bidirectional steering, precise torque response, and innovative design elements—illustrates the company’s commitment to technological advancement. These devices enable smoother navigation through the complex vasculature and minimize procedural complications, thereby contributing to superior patient outcomes during minimally invasive interventions.

Industry Relevance and Conclusion

For investors, analysts, and healthcare professionals, BioCardia represents an intersection of advanced regenerative medicine and precision interventional cardiology. Its focused approach on cellular therapeutics, combined with a well‑defined delivery system and supportive clinical data, provides a clear understanding of its role in addressing unmet clinical needs. BioCardia, Inc. maintains a deep commitment to improving patient care through innovative biotherapeutic solutions, supported by a rigorous clinical development process and strategic technological partnerships.

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BioCardia, Inc. (BCDA) reported financial results for 2023, focusing on its CardiAMP Heart Failure trial, which showed positive interim data despite missing the primary endpoint. The company aims to seek approval in Japan and advance the CardiAMP Heart Failure II Trial in 2024. BioCardia also highlighted its CardiALLO and Helix Biotherapeutic Delivery businesses. Financially, revenues decreased to $0.5 million in 2023, with a net loss of $11.6 million. The company ended the year with $1.1 million in cash and intends to remain listed on Nasdaq.
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BioCardia, Inc. [NASDAQ:BCDA] will report its 2023 financial results and provide a corporate update on March 27, 2024. The conference call will include a Q&A session, and participants can register online. The call will be accessible via phone and webcast, with replays available.
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BioCardia, Inc. (BCDA) and StemCardia, Inc. partner to advance investigational stem cell therapy for heart failure, leveraging BioCardia's biotherapeutic delivery system. The partnership aims to accelerate clinical development and broaden future commercial access to an off-the-shelf heart regeneration treatment.
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BioCardia, Inc. (BCDA) receives CMS approval for reimbursement coverage of the CardiAMP Phase III clinical trial for ischemic heart failure treatment. The trial aims to enroll up to 250 patients at 40 clinical centers, focusing on reducing mortality and improving quality of life.
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BioCardia, Inc. (Nasdaq: BCDA) announced positive interim results from the Phase III trial of CardiAMP cell therapy in patients with chronic heart failure, showing significant risk reductions in heart death equivalents and non-fatal events. The therapy demonstrated promising outcomes, especially in patients with elevated NTproBNP levels, leading to the launch of a follow-on Phase III trial. The company also reported progress in the safety phase of a Phase I/II study of CardiALLO MSC therapy.
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BioCardia, Inc. announces the activation of CardiAMP HF II, a pivotal trial of its CardiAMP autologous cell therapy for patients with ischemic heart failure. The study was approved by the FDA in Q4 2023 and aims to target heart failure and chronic myocardial ischemia as potential indications for its biotherapeutic candidates. The trial size is 250 patients with a statistical probability of success greater than 90 percent. The interim results of the ongoing CardiAMP Heart Failure autologous cell therapy study will be shared at the upcoming Technology and Heart Failure Therapeutics meeting on March 4, 2024, with final results expected in Q4 2024.
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BioCardia, Inc. (Nasdaq: BCDA) is targeting heart failure and chronic myocardial ischemia as potential indications for its biotherapeutic candidates. The company announced that two scientific abstracts on its CardiAMP and CardiALLO clinical stage therapeutic programs have been accepted for presentation at the Technology and Heart Failure Therapeutics Conference. The abstracts will be presented in the Late-Breaking Clinical Science/First-In-Human & Early Feasibility Studies session. The company's CardiAMP Phase 3 autologous cell therapy study showed benefits of reduced all-cause heart death equivalents and reduced major adverse cardiac events without safety concerns, but the study was halted as it was not likely to meet its primary endpoint. The CardiALLO Phase I/II allogeneic mesenchymal stem cell therapy study began enrollment in a 3+3 dose escalation design in December. Both cell therapy candidates are delivered with the company's proprietary minimally invasive Helix transendocardial biotherapeutic delivery system, approved for use in Europe and for investigational use in the United States.
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BioCardia, Inc. (Nasdaq: BCDA) completed 2023 with three active clinical programs for cellular and cell-derived therapeutics to treat heart disease, expecting to report clinical data in 2024. The company also provided an update on its Biotherapeutic Delivery Partnering (BDP) and Morph Access Innovations (Morph) businesses, with new partnerships anticipated and recent patent issuances in Japan and the EU.
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BioCardia, Inc. (Nasdaq: BCDA) Enrolls First Patient in CardiALLO Allogeneic Mesenchymal Cell Therapy Phase I/II Trial
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BioCardia, Inc. [Nasdaq: BCDA] announced that PMDA minutes support the understanding that CardiAMP autologous cell therapy may be approved for ischemic heart failure with reduced ejection fraction based on follow-up data from the CardiAMP Heart Failure Trial. Despite not meeting the primary endpoint, treated patients showed reduced mortality and major adverse cardiovascular events. The FDA approved the CardiAMP Heart Failure II Study protocol, and BioCardia expects to submit for approval in Japan based on the data available in late Q4 2024.
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FAQ

What is the current stock price of Biocardia (BCDA)?

The current stock price of Biocardia (BCDA) is $2.01 as of April 4, 2025.

What is the market cap of Biocardia (BCDA)?

The market cap of Biocardia (BCDA) is approximately 9.8M.

What is the primary focus of BioCardia Inc?

BioCardia Inc focuses on developing cellular and cell-derived therapeutics for treating cardiovascular and pulmonary diseases with significant unmet medical needs.

Which therapeutic platforms does BioCardia utilize?

The company employs its proprietary CardiAMP autologous cell therapy and CardiALLO allogeneic cell therapy platforms, supported by advanced delivery technologies.

How does BioCardia's delivery technology work?

BioCardia’s delivery systems, including the Helix™ and Morph® platforms, enable minimally invasive, catheter-based procedures that enhance cell retention and target precision.

What distinguishes BioCardia in the competitive landscape?

BioCardia stands out due to its innovative precision medicine approach, robust intellectual property portfolio, and breakthrough regulatory designations that validate its therapeutic potential.

What clinical indications are being addressed by BioCardia's therapies?

Their therapies target various cardiovascular conditions including ischemic heart failure and refractory angina, with ongoing trials to assess safety and efficacy.

Has BioCardia received any regulatory recognition?

Yes, BioCardia’s CardiAMP cell therapy has received breakthrough designations from the FDA, underscoring its innovative approach in treating cardiac conditions.

What role do the Morph® DNA™ steerable introducers play?

These introducers enhance the precision and safety of cell delivery procedures by allowing bidirectional steering and improved torque response, which are critical for navigating complex vascular structures.

Does BioCardia collaborate with other institutions?

Yes, BioCardia works with leading clinical centers and strategic partners to conduct rigorous clinical trials and ensure robust data collection for its innovative therapies.
Biocardia Inc

Nasdaq:BCDA

BCDA Rankings

BCDA Stock Data

9.79M
3.68M
21.73%
2.72%
0.52%
Biotechnology
Biological Products, (no Disgnostic Substances)
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United States
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