STOCK TITAN

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.

Rhea-AI Summary
BioCardia, Inc. (Nasdaq: BCDA) provided an update after its recent consultation with Japan’s Pharmaceutical and Medical Device Agency (PMDA) towards approval of its CardiAMP autologous cell therapy for the treatment of patients with ischemic heart failure of reduced ejection fraction (HFrEF). PMDA requested further details on elements included in BioCardia’s CardiAMP preclinical and clinical packages. BioCardia management believes these can be readily addressed. PMDA indicated they would like to see detailed interim and the final results from the CardiAMP Heart Failure Trial, which has completed patient enrollment and is finishing up study patient follow-up visits. Formal minutes from the PMDA meeting are expected in four weeks and a follow-up consultation is being planned.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-1.45%
Tags
none
-
Rhea-AI Summary
BioCardia, Inc. [Nasdaq: BCDA] Announces Registered Direct Offering of Common Stock
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-15.79%
Tags
-
Rhea-AI Summary
BioCardia, Inc. (Nasdaq: BCDA) announces FDA approval of Phase III clinical trial for CardiAMP autologous cell therapy in the treatment of ischemic heart failure. Interim analysis shows significant clinical improvements over controls, including a 59% relative risk reduction in heart death and a 54% relative risk reduction of Major Adverse Cardiovascular or Cerebrovascular events (MACCE). FDA approves proposed CardiAMP Heart Failure II study protocol with modified primary efficacy endpoint and eligibility requirements.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
167.5%
Tags
Rhea-AI Summary
BioCardia, Inc. [Nasdaq: BCDA] reports Q3 2023 financial results and operational updates, including progress in CardiAMP Cell Therapy program for heart failure and chronic myocardial ischemia. The company also highlights strategic efforts to secure partnerships and grants for clinical development.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-6.82%
Tags
-
Rhea-AI Summary
BioCardia, Inc. will provide a corporate update and report its financial results for Q3 and 9 months ended September 30, 2023. The conference call will take place on November 8, 2023, at 4:30 PM ET. Participants can register for the conference call through the provided link. The call will also be available through a live webcast, with a replay available afterwards.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-- %
Tags
conferences earnings
-
Rhea-AI Summary
BioCardia completes enrollment in CardiAMP Heart Failure Trial and initiates discussion with FDA for second pivotal study
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
28.21%
Tags
Rhea-AI Summary
BioCardia announces clarification and next steps on its autologous CardiAMP cell therapy programs. Interim results show potential for a successful trial for product registration in the United States. FDA prefers replacing 6MWD with Cardiopulmonary Exercise Testing. BCDA-02 shows great potential for success. BioCardia expects to focus on accelerating pivotal program. Anticipated upcoming milestones and events provided.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-12.07%
Tags
none
-
Rhea-AI Summary
BioCardia announces interim data review for Phase III trial of CardiAMP Cell Therapy for Heart Failure
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-25.64%
Tags
-
Rhea-AI Summary
BioCardia reports financial results for Q2 2023 and provides updates on clinical trials. Enrollment in autologous cell therapy trial for ischemic heart failure paused based on DSMB recommendation. Other clinical programs reaching important milestones. Business development active around Helix biotherapeutic delivery platform.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-- %
Tags
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
2.06%
Tags
conferences earnings

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)
Link
United States
SUNNYVALE