BCDA Jun 18, 2026BCDAGeneral
BioCardia Letter to Stockholders on 2026 Priorities and Strategic Opportunities
BioCardia's CEO, Peter Altman, outlined the company's strategic priorities in a letter to shareholders, emphasizing the submission for CardiAMP Cell Therapy approval in Japan as a key focus. The company aims to address the needs of ischemic heart failure patients and leverage its innovative delivery systems. With a recent capital raise, BioCardia is well-positioned for upcoming milestones and potential partnerships.
Read more →
BCDA Jun 8, 2026BCDAGeneral
▼ -10.7%on this news· ran to -23% by day 3
BioCardia Announces $4.4 Million Financing
BioCardia, Inc. has successfully raised $4.4 million through the sale of shares, which is expected to extend its cash runway into the first quarter of 2027. This funding will support the anticipated submission of CardiAMP Cell Therapy to the Japan PMDA in Q4 2026. The company continues to develop its innovative cell therapies for cardiovascular and pulmonary diseases.
Read more →
BCDA Jun 5, 2026BCDAFDA Updates
▲ +12.1%on this newsshared move
FDA Confirms CardiAMP HF II May Support Premarket Approval of CardiAMP Cell Therapy for Ischemic HFrEF
BioCardia, Inc. announced that the FDA's minutes from a recent meeting indicate that the ongoing CardiAMP Heart Failure II Trial may support the Premarket Approval of the CardiAMP Cell Therapy for ischemic heart failure with reduced ejection fraction (HFrEF). This therapy utilizes the patient's own bone marrow cells and aims to improve heart function. The FDA's recognition of the trial's potential is significant for the treatment of HFrEF, which affects a large patient population.
Read more →
BCDA May 28, 2026BCDAFDA Updates
BioCardia Announces Japan PMDA Record Of Advice Supports Regulatory Submission For Approval Of CardiAMP Cell Therapy For Ischemic Heart Failure
BioCardia has received support from Japan's PMDA for the regulatory submission of CardiAMP Cell Therapy aimed at treating ischemic heart failure. The PMDA confirmed the credibility of clinical trial outcomes and outlined requirements for the submission. The therapy could potentially benefit around 20,000 patients in Japan, highlighting an urgent clinical need.
Read more →
BCDA May 21, 2026BCDAPhases
BioCardia Announces CardiAMP Chronic Myocardial Ischemia Trial Results Presented at EuroPCR Showed Durable Improvements in Exercise Tolerance with Reduced Angina Frequency
BioCardia has announced promising results from their CardiAMP Cell Therapy in a trial for Chronic Myocardial Ischemia, presented at the EuroPCR conference. The trial's open-label cohort demonstrated durable improvements in exercise tolerance and a significant reduction in angina frequency among patients treated with the novel therapy. Participants showed an average increase in exercise tolerance by 179 seconds and an 82% reduction in angina episodes within six months of treatment. These findings support the continued clinical development of CardiAMP therapy as an innovative solution for patients suffering from refractory angina.
Read more →
BCDA May 19, 2026BCDAConferences/Events
▲ +5.6%on this newsshared move
BioCardia to Participate in a Fireside Chat at the Alliance Global Partners (A.G.P) Healthcare Company Showcase
BioCardia, Inc. will participate in a virtual fireside chat at the A.G.P. Healthcare Company Showcase on May 20, 2026, at 11:40 AM ET. The company is known for its innovative cellular and cell-derived therapeutics aimed at treating cardiovascular and pulmonary diseases. Investors can register to attend the event and learn more about BioCardia's advancements.
Read more →
BCDA May 15, 2026BCDAGeneral
▼ -7.3%on this news· ran to -17% by day 1shared move
BioCardia Reports First Quarter 2026 Business Highlights and Financial Results
BioCardia, Inc. reported its Q1 2026 financial results, highlighting significant progress in its CardiAMP cell therapy for ischemic heart failure. The company received positive feedback from both the FDA and PMDA regarding the therapy's safety and efficacy. BioCardia is advancing towards regulatory approval in Japan and has ongoing clinical trials in the U.S. Despite a net loss of $2.3 million, the company remains optimistic about its future prospects.
Read more →
BCDA May 11, 2026BCDAConferences/Events
BioCardia to Host Q1 2026 Financial Results and Corporate Update Conference Call on May 15, 2026
BioCardia, Inc. will host a conference call on May 15, 2026, to discuss its Q1 financial results and provide a corporate update. The call will include a formal presentation followed by a question-and-answer session. Participants can register online to receive dial-in information, and a replay will be available after the call.
Read more →
BCDA May 8, 2026BCDAFDA Updates
BioCardia and FDA Align on Helix Transendocardial Delivery Catheter Clearance Pathways
BioCardia announced a successful Pre-Submission Meeting with the FDA regarding its Helix Transendocardial Delivery Catheter System. The FDA identified two potential pathways for marketing clearance and expressed no concerns regarding safety or performance. The preferred route aligns Helix approval with the CardiAMP cell therapy system for heart failure treatment.
Read more →
BCDA Apr 28, 2026BCDAFDA Updates
BioCardia Announces Allowance of Japanese Patent on Proprietary Heart3D™ Fusion Imaging Software for Procedure Planning and Realtime Navigation During CardiAMP Cell Therapy Procedures
BioCardia has announced the allowance of a Japanese patent for its Heart3D Fusion Imaging software, which aids in treatment planning and navigation during CardiAMP Cell Therapy procedures. This technology is designed to enhance the visualization of the heart using 3D imaging techniques. The company is also preparing for regulatory submissions in Japan and the U.S. following positive consultations with authorities.
Read more →
BCDA Apr 20, 2026BCDAFDA Updates
▲ +5.9%on this news
BioCardia and Japan PMDA Align on Acceptability of CardiAMP Clinical Data to Support Regulatory Approval in Ischemic Heart Failure
BioCardia, Inc. has received positive feedback from Japan's PMDA regarding its CardiAMP Cell Therapy for ischemic heart failure. The agency believes the clinical data is likely sufficient for market clearance. The meeting confirmed the acceptability of foreign clinical data and outlined the next steps for potential filing in Japan.
Read more →
BCDA Apr 2, 2026BCDAFDA Updates
BioCardia Files Request for Meeting With FDA to Discuss Accelerated Approval Pathway for CardiAMP® System in Ischemic Heart Failure
BioCardia has submitted clinical study data to the FDA and requested a meeting to discuss the accelerated approval pathway for its CardiAMP System, aimed at treating ischemic heart failure. The company aims to receive feedback on its proposed submission based on positive safety and efficacy data from its trials. The CardiAMP System has shown promising results, particularly in high-risk patients, demonstrating significant reductions in cardiac events.
Read more →
BCDA Mar 25, 2026BCDAGeneral
BioCardia Reports 2025 Business Highlights and Financial Results
BioCardia, Inc. reported its financial results for 2025 and highlighted advancements in its CardiAMP autologous cell therapy for ischemic heart failure. The company is in discussions with the FDA and PMDA for potential market release and is conducting the CardiAMP HF II Trial. CEO Peter Altman emphasized the compelling risk-benefit profile for patients with limited options. The company also mentioned its other therapeutic programs and delivery systems that could enhance shareholder value.
Read more →
BCDA Mar 20, 2026BCDAConferences/Events
BioCardia to Host 2025 Financial Results and Corporate Update Conference Call on March 24, 2026
BioCardia, Inc. will host a conference call on March 24, 2026, to discuss its financial results for the year ending December 31, 2025. The call will include a corporate update and a Q&A session for participants. Interested parties can register online to receive dial-in information or join via a live webcast.
Read more →
BCDA Mar 17, 2026BCDAFDA Updates
BioCardia Announces Pre-Submission Approval Package for Helix Transendocardial Delivery Catheter Accepted by FDA
BioCardia, Inc. has announced that the FDA has accepted its pre-submission package for the Helix Transendocardial Delivery Catheter, aimed at delivering therapeutic agents to the heart. This acceptance comes after preliminary discussions with the FDA's CDRH and CBER, suggesting a collaborative approach to the review. The Helix catheter is designed for minimally invasive cardiac procedures and may significantly improve treatment for conditions like ischemic heart failure. If approved, it will support BioCardia's broader initiatives in cellular and cell-derived therapeutics.
Read more →
BCDA Mar 3, 2026BCDAPhases
▼ -5.9%on this news
BioCardia Late Breaking Echocardiography Clinical Results from CardiAMP HF Trial Presented at Technology and Heart Failure Therapeutics (THT)
BioCardia presented late-breaking results from its Phase III CardiAMP HF trial at THT 2026. The trial demonstrated that patients receiving CardiAMP cell therapy showed significant reductions in pathological left ventricular remodeling compared to controls. These findings suggest potential benefits for patients with ischemic heart failure of reduced ejection fraction, particularly those with elevated NTproBNP levels.
Read more →
BCDA Feb 10, 2026BCDAFDA Updates
BioCardia Files Pre-Submission for FDA Approval of Helix™ Transendocardial Delivery Catheter for Therapeutic and Diagnostic Agent Delivery to the Heart
BioCardia has completed its Pre-Submission to the FDA for the Helix Transendocardial Delivery Catheter, aimed at delivering therapeutic and diagnostic agents to the heart. The submission is supported by data from fifteen clinical trials and aims to align with the FDA on the approval pathway. The Helix catheter is designed for minimally invasive procedures and may enhance the approval process for BioCardia's cell therapies.
Read more →
BCDA Feb 3, 2026BCDAConferences/Events
BioCardia Announces Late Breaking Echocardiography Results from the CardiAMP HF Trial to be Presented at Technology and Heart Failure Therapeutics (THT)
BioCardia announced that echocardiography results from the CardiAMP HF trial will be presented at the Technology and Heart Failure Therapeutics meeting in March 2026. The presentation will focus on the potential of autologous cell therapy to mitigate pathological ventricular remodeling in patients with chronic ischemic heart failure. This therapy has received FDA Breakthrough designation and is supported by significant funding.
Read more →
BCDA Dec 16, 2025BCDAPhases
BioCardia Cell Therapy for Ischemic Heart Failure to Progress to Formal Clinical Consultation with Japan PMDA
BioCardia, Inc. has successfully completed a third preliminary consultation with Japan's PMDA regarding its CardiAMP Cell Therapy for heart failure with reduced ejection fraction. The PMDA has granted permission for BioCardia to proceed to formal consultation to assess clinical data for potential regulatory approval. Positive outcomes from previous clinical trials indicate improved survival rates and heart function among patients, highlighting the therapy's potential for treating HFrEF. The ongoing discussions are critical as they may pave the way for new treatment options in Japan.
Read more →
BCDA Dec 3, 2025BCDAGeneral
BioCardia Announces Election of New Board Director, Marvin Slosman and Completion of Term for Outgoing Director, Dr. Richard Krasno
BioCardia, Inc. has appointed Marvin Slosman as a new Board Director, effective December 2, 2025, following the completion of Dr. Richard Krasno's term. Slosman's extensive background in interventional cardiology and his past leadership roles in major medical companies are expected to bolster BioCardia's strategic efforts. The company acknowledges Dr. Krasno's valuable contributions during his tenure, which included guiding clinical developments and expanding therapeutic areas.
Read more →
BCDA Dec 1, 2025BCDAConferences/Events
BioCardia to Present at December 2025 CSI Focus Devices in Heart Failure Congress
BioCardia, Inc. announced its participation at the CSI Focus Devices in Heart Failure congress in Frankfurt, Germany, where CEO Peter Altman will present on intramyocardial cell therapy for ischemic heart failure. This event, occurring on December 5, 2025, highlights advancements in device-based therapies targeting heart failure. BioCardia's presence at this congress underscores its leadership in cellular and cell-derived therapeutics for cardiovascular diseases.
Read more →
BCDA Nov 24, 2025BCDAGeneral
BioCardia Strengthens Leadership Team with The Addition of Farhan Shahab as Vice President of Quality
BioCardia, Inc. has appointed Farhan Shahab as Vice President of Quality. With over 25 years of experience in executive roles, Shahab previously worked at Welldoc and Intuity Medical, among others. His expertise in product quality management is expected to enhance BioCardia's capability to commercialize their investigational therapies. The announcement reflects the company's commitment to strengthening its leadership team and ensuring regulatory compliance in their product development.
Read more →
BCDA Nov 12, 2025BCDAGeneral
BioCardia Reports Third Quarter 2025 Business Highlights and Financial Results
BioCardia, Inc. reported its third quarter 2025 financial results, highlighting a $6 million financing aimed at supporting its CardiAMP cell therapy for heart failure and the Helix Transendocardial Delivery Catheter submission. The company is actively enrolling in its CardiAMP HF II phase 3 trial, with expectations for transformative developments in the upcoming quarters.
Read more →
BCDA Nov 10, 2025BCDAPhases
BioCardia Announces Henry Ford Health Enrolls Their First Patient in Phase 3 CardiAMP HF II Cell Therapy Pivotal Trial
BioCardia has announced the enrollment of the first patient in the Phase 3 CardiAMP HF II trial at Henry Ford Health. This study aims to confirm the safety and efficacy of the CardiAMP autologous cell therapy for patients with ischemic heart failure. Despite not meeting the primary endpoint in earlier studies, the therapy showed promising results in improving patient outcomes, particularly for those with elevated biomarkers of heart stress.
Read more →
BCDA Nov 6, 2025BCDAConferences/Events
BioCardia to Host Q3 2025 Corporate Update and Financial Results Conference Call on November 12, 2025
BioCardia, Inc. has announced a corporate update and financial results conference call scheduled for November 12, 2025. The call will cover results for the third quarter and nine months ending September 30, 2025, and will include a question-and-answer session. Participants can register online to join the call or access it via phone and webcast.
Read more →
BCDA Oct 30, 2025BCDAPhases
BioCardia Announces University of Wisconsin Enrolls Their First Patient in Phase 3 CardiAMP HF II Cell Therapy Pivotal Trial
BioCardia has announced the enrollment of the first patient in its Phase 3 CardiAMP HF II clinical trial at the University of Wisconsin. This trial aims to evaluate the efficacy of CardiAMP cell therapy for patients with ischemic heart failure. The study is designed to confirm previous safety and efficacy results observed in earlier trials.
Read more →
BCDA Oct 21, 2025BCDAPhases
BioCardia Inc. (BCDA): 2025 Product Pipeline and Strategy Analysis Report
BioCardia Inc. has released a comprehensive report detailing its product pipeline and strategic analysis for 2025. The report emphasizes innovative developments in regenerative medicine aimed at addressing cardiovascular and pulmonary diseases. It covers ongoing clinical trials and products in various stages of development, along with insights into competitive landscape and regulatory pathways. Additionally, BioCardia reports positive findings from its CardiAMP chronic myocardial ischemia trial, enhancing the outlook for its therapies.
Read more →
BCDA Oct 2, 2025BCDAGeneral
BioCardia Regains Compliance with Nasdaq Listing Requirements
BioCardia, Inc. has regained compliance with Nasdaq's listing requirements after improving its balance sheet and raising new capital. The Nasdaq confirmed this compliance on October 1, 2025, allowing BioCardia's securities to remain listed under the symbol BCDA. The company focuses on developing cellular therapies for cardiovascular and pulmonary diseases.
Read more →
BCDA Sep 22, 2025BCDAFDA Updates
BioCardia Announces Positive Preliminary Clinical Consultation with Japan Pharmaceutical and Medical Device Agency on Cell Therapy for Ischemic Heart Failure
BioCardia, Inc. has reported a positive preliminary clinical consultation with Japan's PMDA regarding its CardiAMP Heart Failure Trial. The agency requested further details on clinical data and development status in the U.S. BioCardia aims to facilitate access to its innovative cell therapy for ischemic heart failure patients. The company is preparing for a formal consultation by the year's end.
Read more →
BCDA Sep 18, 2025BCDAGeneral
▼ -23.8%on this newsshared move
BioCardia Announces Pricing of Up To $12 Million Public Offering
BioCardia, Inc. has announced a public offering of 4.8 million shares of common stock, priced at $1.25 per share, aiming to raise up to $12 million. The offering includes short-term warrants, which could potentially add another $6 million if exercised. Proceeds will be used for working capital and advancing biotherapeutic candidates.
Read more →
BCDA Sep 18, 2025BCDAPhases
▼ -23.8%on this newsshared move
BioCardia Announces CardiAMP Chronic Myocardial Ischemia Trial Top Line Data of Roll-in Cohort Show Improved Exercise Tolerance and Reduced Angina Episodes at Six-Month Primary Follow-up
BioCardia has announced positive results from the roll-in cohort of its CardiAMP trial for chronic myocardial ischemia. The trial showed improved exercise tolerance and a significant reduction in angina episodes after six months. The therapy was well tolerated, with no major adverse cardiac events reported. These results support the continued development of CardiAMP as a promising treatment for refractory angina.
Read more →
BCDA Sep 4, 2025BCDAConferences/Events
BioCardia CEO Peter Altman to Present at the H. C. Wainwright 27th Annual Global Investment Conference in New York City September 8-10, 2025
BioCardia's CEO, Peter Altman, will present a corporate update at the H. C. Wainwright 27th Annual Global Investment Conference in New York City on September 10, 2025. He will discuss the company's clinical cell therapy programs, regulatory activities for FDA and PMDA approvals, and a recent partnership for Heart3D fusion imaging. The conference will also facilitate one-on-one meetings with investors.
Read more →
BCDA Aug 13, 2025BCDAGeneral
▲ +6.9%on this news
BioCardia and CART-Tech Announce Exclusive Partnership to Develop and Commercialize Heart3D™ Fusion Imaging for Interventional Cardiology
BioCardia and CART-Tech have formed an exclusive partnership to develop Heart3D Fusion Imaging, which aims to enhance cardiac imaging for biotherapeutic interventions. The system will fuse 2D x-ray images with 3D anatomical models to improve procedural accuracy. BioCardia will have exclusive distribution rights for biotherapeutic delivery worldwide and cardiac biopsy in the U.S.
Read more →
BCDA Aug 11, 2025BCDAGeneral
▼ -6.1%on this newsshared move
BioCardia Reports Second Quarter 2025 Business Highlights and Financial Results
BioCardia, Inc. reported its financial results for the second quarter of 2025, highlighting advancements in its CardiAMP autologous cell therapy for ischemic heart failure. Significant clinical trial results show improvements in patient outcomes, prompting plans for approval submissions in Japan and consultations with the FDA. The company is focused on ongoing trials and intellectual property development to enhance its therapeutic offerings in cardiovascular diseases. Financially, while the company experienced an increase in research and development expenses, it also secured additional funding through stock sales.
Read more →
BCDA Aug 6, 2025BCDAConferences/Events
▼ -5.5%on this newsshared move
BioCardia to Host Q2 2025 Corporate Update and Financial Results Conference Call on August 11, 2025
BioCardia, Inc. will host a conference call on August 11, 2025, at 4:30 PM ET to discuss its corporate update and financial results for Q2 2025. Following the formal presentation by management, a question-and-answer session will take place. The call will be accessible via phone and webcast, with details provided for both registered and non-registered participants. BioCardia specializes in cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, highlighting its focus on innovative medical solutions.
Read more →
BCDA Aug 4, 2025BCDAFDA Updates
▼ -8%on this news· ran to -21% by day 3shared move
BioCardia Provides Update on Timing of Regulatory Activities Seeking FDA Approval and Japan PMDA Approval for CardiAMP Cell Therapy for Heart Failure and Helix™ Transendocardial Delivery Catheter
BioCardia has announced updates regarding the anticipated timing for regulatory submissions seeking FDA and Japan PMDA approvals for its CardiAMP Cell Therapy and Helix Delivery Catheter. The company plans to submit applications in Q3 and Q4 of 2025, with the Helix system expected to highlight its safety performance from previous studies. The CardiAMP therapy, granted Breakthrough Designation, aims to address heart failure, with ongoing clinical trials supporting its efficacy. Additionally, BioCardia is preparing for a clinical consultation with the Japan PMDA to discuss potential approval pathways.
Read more →
BCDA Jul 24, 2025BCDAFDA Updates
BioCardia Submits Request for Clinical Data Review Meeting with Japan PMDA To Discuss Approval Pathway for CardiAMP Cell Therapy in Ischemic Heart Failure
BioCardia, Inc. has submitted a request for a clinical data review meeting with Japan's Pharmaceuticals and Medical Devices Agency (PMDA) regarding its CardiAMP autologous cell therapy for heart failure. This submission marks an important milestone in the regulatory approval process for BioCardia's therapy in Japan. The PMDA consultation will evaluate the clinical data from the recently completed CardiAMP HF trial, assessing its efficacy and safety for Japanese patients. Success in this consultation could facilitate BioCardia's submission for market entry in Japan.
Read more →
BCDA Jun 25, 2025BCDAGeneral
BioCardia Announces New United States Patent for Helix Biotherapeutic Delivery System
BioCardia, Inc. has announced the granting of US Patent No. 12,311,127 for its Helix biotherapeutic delivery system. This patent relates to the company's advanced minimally invasive catheter technologies designed for delivering biologic therapies directly to the heart. The technology aims to enhance treatment efficacy while minimizing invasive procedures. The company is actively working towards approvals of both its CardiAMP Cell Therapy and the Helix system, potentially benefiting numerous patients with serious heart conditions.
Read more →
BCDA May 21, 2025BCDAConferences/Events
BioCardia to Participate in Fireside Chat at A.G.P. Virtual Healthcare Company Showcase on May 21, 2025
BioCardia, Inc. announced that CEO Peter Altman will participate in a fireside chat during the A.G.P. Virtual Healthcare Company Showcase on May 21, 2025. The discussion will focus on recent developments in the company's therapeutic pipeline, particularly its CardiAMP autologous cell therapy aimed at treating ischemic heart failure. This engagement aims to provide insights into BioCardia's advancements and strategy in cellular therapeutics.
Read more →
BCDA May 14, 2025BCDAGeneral
BioCardia Reports First Quarter 2025 Business Highlights and Financial Results
BioCardia, Inc. reported its first quarter 2025 financial results, highlighting advancements in its clinical programs, particularly the CardiAMP autologous cell therapy for ischemic heart failure. The company presented positive two-year trial results, demonstrating improved patient outcomes. Additionally, the CardiALLO trial has safely completed its low dose cohort, with plans for further enrollment. BioCardia is also pursuing regulatory submissions for its therapies, aiming for impactful future growth.
Read more →
BCDA May 9, 2025BCDAConferences/Events
BioCardia to Host Q1 2025 Corporate Update and Financial Results Conference Call on May 14, 2025
BioCardia, Inc. has announced it will host a conference call on May 14, 2025, to provide a corporate update and report its financial results for Q1 2025. The call will include a formal presentation followed by a question-and-answer session. Interested participants must register to join the call and will receive dial-in information upon registration. The conference will also be accessible via a live webcast, ensuring broad participation from interested stakeholders.
Read more →
BCDA May 6, 2025BCDAPhases
BioCardia Initiates Patient Enrollment at University of Wisconsin at Madison for Ongoing CardiAMP HF II Pivotal Study
BioCardia has begun patient enrollment for its Phase 3 CardiAMP HF II trial at the University of Wisconsin, focusing on treating ischemic heart failure with reduced ejection fraction. The study aims to confirm previous findings regarding the safety and efficacy of the CardiAMP cell therapy in improving survival and quality of life for heart failure patients. Significant advances have been made in the trial's methodology, including updated treatment dose protocols and enhancements to the delivery system. Dr. Amish Raval will oversee the study at the site.
Read more →
BCDA May 1, 2025BCDAPhases
▼ -9.2%on this news· ran to -23% by day 3shared move
BioCardia Announces First Patient in Phase 3 Randomized Controlled Double-Blind CardiAMP HF II Clinical Trial of the Company’s Lead Cell Therapy for Treatment of Heart Failure
BioCardia, Inc. has announced the enrollment of the first patient in its Phase III CardiAMP HF II clinical trial aimed at treating heart failure. This investigational autologous cell therapy is designed to improve microvascular function and enhance patient outcomes, based on previous promising studies. The trial will involve 250 patients, with a focus on those with ischemic heart failure, and aims to confirm the efficacy and safety of the therapy. BioCardia is also preparing for regulatory submissions in the U.S. and Japan following this milestone.
Read more →
BCDA Apr 15, 2025BCDAPhases
BioCardia Announces Positive DSMB Review of CardiALLO Allogeneic Cell Therapy for Heart Failure Phase 1/2 Clinical Trial
BioCardia, Inc. announced a positive recommendation from an independent Data Safety Monitoring Board (DSMB) to continue its CardiALLO-HF clinical trial for heart failure. The DSMB based its decision on the 30-day safety assessment of participants in a low dosage group, finding no major adverse cardiac events or immune reactions. The company plans to enroll 39 participants in the trial, which aims to evaluate the efficacy and safety of an allogeneic cell therapy. Positive results may facilitate future funding and partnerships for BioCardia's MSC platform.
Read more →
BCDA Apr 11, 2025BCDAPhases
BioCardia Initiates Patient Enrollment at Emory University School of Medicine for Ongoing CardiAMP HF II Pivotal Study
BioCardia, Inc. has commenced patient enrollment for its CardiAMP HF II pivotal trial at Emory University School of Medicine, focusing on treating ischemic heart failure with a reduced ejection fraction. The trial evaluates the CardiAMP cell therapy, aimed at enhancing heart function by using a patient’s own cells. Emory's involvement, spearheaded by Dr. Arshed Quyyumi, is expected to bolster patient enrollment and support the trial's progression towards its target completion in 2027. Previous trial results have indicated promising benefits of the therapy, paving the way for further investigation of its effectiveness.
Read more →
BCDA Mar 31, 2025BCDAPhases
▼ -9.3%on this news· ran to -25% by day 3
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
BioCardia announced the promising results of its two-year Phase 3 CardiAMP-HF trial, showing that the CardiAMP Cell Therapy led to increased survival and reduced major adverse cardiac events in ischemic heart failure patients. Notably, patients with elevated NTproBNP biomarkers experienced substantial benefits, indicating the therapy's potential as a significant treatment option. These findings highlight the durability of the therapy's effects and its capability to improve quality of life for those inadequately managed by current heart failure medications. The results were presented at a notable medical conference and suggest a growing opportunity for the therapy in clinical settings.
Read more →
BCDA Mar 31, 2025BCDAConferences/Events
▼ -9.3%on this news· ran to -25% by day 3
BioCardia’s Conference Call Today, Monday, March 31, 2025 to be Held at 4:30PM EDT Time Today
BioCardia, Inc. has announced a conference call scheduled for today, March 31, 2025, at 4:30 PM EDT to discuss the two-year results of their CardiAMP-HF program. This follows a press release that mistakenly indicated the call would occur at 4:30 PM PDT. The call can be accessed via phone or live webcast, and a replay will be available shortly after its conclusion.
Read more →
BCDA Mar 26, 2025BCDAGeneral
BioCardia Reports 2024 Business Highlights and Financial Results
BioCardia, Inc. announced its 2024 financial results and key business highlights, including progress in its CardiAMP HF Trial for ischemic heart failure. The company is preparing for a data presentation at the American College of Cardiology Scientific Sessions following a favorable consultation with Japan's PMDA regarding product registration. Despite improvements in certain areas, the company reported a substantial decrease in revenues and a net loss, reflecting ongoing challenges in the commercialization of its therapies. Upcoming milestones include further trials and data reviews set for 2025.
Read more →
BCDA Mar 21, 2025BCDAConferences/Events
▲ +7.7%on this newsshared move
BioCardia to Host 2024 Financial Results and Corporate Update Conference Call on March 31, 2025
BioCardia, Inc. plans to report its financial results for 2024 on March 26, 2025, followed by a corporate update conference call on March 31, 2025. The conference call will follow a presentation on a key trial involving an autologous cell therapy for heart failure, held at the American College of Cardiology 2025 Scientific Sessions in Chicago. This event indicates BioCardia's ongoing development in innovative therapeutics for cardiovascular diseases.
Read more →
BCDA Mar 10, 2025BCDAGeneral
BioCardia Announces Japanese Patent for Helix™ Biotherapeutic Delivery System
BioCardia has been granted Japanese Patent No. 7641330 for its Radial and Transendocardial Delivery Catheter, a crucial development for their Helix biotherapeutic delivery system. This patent, set to expire after September 30, 2034, consolidates BioCardia's position in the catheter-based delivery market for cell and gene therapies. The system is designed to enable minimally invasive cardiac treatments while minimizing unintended side effects. The company emphasizes Japan's commitment to innovative cell therapy, making it a strategic market for BioCardia's future growth and partnerships.
Read more →
BCDA Feb 27, 2025BCDAPhases
BioCardia Announces Primary Outcome Measures Data Freeze in CardiAMP Heart Failure Trial for Presentation at the American College of Cardiology 2025 Scientific Sessions
BioCardia has announced the successful completion of source data verification and freezing of primary outcomes data in its Phase 3 CardiAMP HF trial for ischemic heart failure. The results will be presented at the ACC 2025 Scientific Sessions, where the company aims to demonstrate the therapeutic benefits of its autologous cell therapy. The study represents the largest cohort examined for this condition, with a focus on a precision medicine approach. BioCardia plans to use these results to support future approvals in the U.S. and Japan.
Read more →
BCDA Feb 13, 2025BCDAPhases
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)
BioCardia has successfully completed enrollment for the low dose cohort in its CardiALLO Phase I/II clinical trial, which focuses on using allogeneic mesenchymal stem cells to treat ischemic heart failure with reduced ejection fraction. This trial is noted as the first prospective study targeting HFrEF patients with elevated heart stress markers. Experts from the University of Florida are optimistic about the treatment's potential, especially given the advancement of procedural methods using a specialized delivery system. The first independent safety review is scheduled for March 2025.
Read more →
BCDA Jan 27, 2025BCDAPhases
BioCardia Announces Late Breaking Clinical Trial Presentation on CardiAMP Heart Failure Trial at the American College of Cardiology 2025 Scientific Sessions
BioCardia, Inc. has announced that its double-blind randomized placebo-controlled CardiAMP HF Phase 3 study results will be presented at the American College of Cardiology 2025 Scientific Sessions. This recognized event will take place in Chicago from March 29-31, 2025, with the presentation led by Dr. Amish N. Raval. The CardiAMP Cell Therapy aims to treat heart failure by employing the patient's own marrow cells to enhance healing mechanisms in the heart. The therapy is notable for receiving FDA Breakthrough designation, indicating its significant potential in cardiovascular treatment.
Read more →
BCDA Dec 17, 2024BCDAGeneral
BioCardia Announces Commercial Availability of Morph DNA™ Steerable Introducer Product Family
BioCardia, Inc. has announced the commercial availability of its Morph DNA steerable introducer product family, which is currently used in ongoing cell-therapy clinical trials. The company aims to sell these products directly without a dedicated sales force, indicating a cost-efficient strategy. The Morph DNA products feature advanced design elements intended to enhance biotherapeutic delivery, while BioCardia continues its focus on its CardiAMP Heart Failure clinical trials. Final results are anticipated by the first quarter of 2025.
Read more →
BCDA Dec 4, 2024BCDAFDA Updates
BioCardia Announces Positive Consultation with Japan PMDA on CardiAMP Cell Therapy for Ischemic Heart Failure
BioCardia, Inc. has announced a positive outcome from its recent consultation with Japan's PMDA regarding the registration of its lead therapy, BCDA-01, for ischemic heart failure. The PMDA has invited further consultation after the submission of final clinical data, indicating potential pathways for approval. BioCardia is working towards data lock on the CardiAMP Heart Failure Trial, with final results expected by Q1 2025. Additionally, BCDA-01 has received Breakthrough Designation from the FDA, supporting the therapy's development in the U.S.
Read more →
BCDA Nov 13, 2024BCDAGeneral
BioCardia Reports Third Quarter 2024 Business Highlights and Financial Results
BioCardia reported its financial results for Q3 2024, highlighting advancements in its CardiAMP cell therapy trials for heart failure. The FDA has accepted plans for patient follow-up in these trials, with top-line data expected in Q1 2025. Additionally, BioCardia has received approvals for expanding patient eligibility and launching new products. The company maintains optimistic projections for upcoming milestones, including consultations with regulatory agencies in Japan and the U.S.
Read more →
BCDA Nov 6, 2024BCDAConferences/Events
BioCardia to Host Q3 2024 Corporate Update and Financial Results Conference Call on November 13, 2024
BioCardia, Inc. has announced a conference call for November 13, 2024, to provide a corporate update and report financial results for Q3 2024. The call will feature remarks from management followed by a Q&A session, allowing stakeholders to engage directly. The company specializes in cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, with several product candidates in development.
Read more →
BCDA Oct 28, 2024BCDAPhases
▲ +8.7%on this news
BioCardia Completes Phase III Randomized Double-Blind Controlled Trial of Autologous Cell Therapy for Ischemic Heart Failure
BioCardia, Inc. has announced the completion of its Phase III randomized controlled trial, CardiAMP HF, which focuses on the efficacy of its CardiAMP autologous cell therapy system for treating heart failure with reduced ejection fraction. The trial involved 115 advanced heart failure patients and aims to assess the potential benefits of the therapy, including reductions in all-cause mortality and hospitalizations. The outcomes analysis is expected to occur soon, with results due for release in early 2025. BioCardia also plans to engage with regulatory bodies regarding the approvability of the CardiAMP system.
Read more →
BCDA Sep 18, 2024BCDAGeneral
▲ +10.4%on this news
BioCardia Regains Full Compliance with Nasdaq Listing Requirements
BioCardia, Inc. has regained full compliance with the Nasdaq Capital Market's Listing Requirements after successfully improving its balance sheet. The company's compliance was confirmed by Nasdaq, and the matter is now closed. BioCardia's recent activities include FDA approvals, advancements in clinical trial patient enrollment, and securing significant financing to support ongoing development of its therapeutic candidates. The company's focus remains on enhancing therapies for cardiovascular and pulmonary diseases.
Read more →
BCDA Sep 9, 2024BCDAGeneral
▲ +6.2%on this news· ran to +25% by day 3
BioCardia Announces Closing of Upsized $7.2 Million Public Offering Priced At-The-Market Under Nasdaq Rules
BioCardia, Inc. has successfully closed a public offering, raising $7.2 million by selling 2,400,000 shares at a combined price of $3.00 per share. This offering, fully subscribed by management, institutional investors, and existing shareholders, aims to bolster the company's working capital and support the advancement of biotherapeutic candidates. The offering was conducted under Nasdaq rules with the effective registration statement filed with the SEC. The warrants included in the offering have a five-year expiration period, exercisable immediately.
Read more →
BCDA Aug 30, 2024BCDAGeneral
▼ -24.1%on this news· ran to -38% by day 3
BioCardia Announces Pricing of Upsized $7.2 Million Public Offering Priced At-The-Market Under Nasdaq Rules
BioCardia, Inc. has announced a successful pricing of its upsized public offering, raising $7.2 million through the sale of common stock and warrants. Management, directors, and institutional investors participated in the offering, which is priced at $3.00 per share. The proceeds will be allocated towards working capital and advancing the company's investigational biotherapeutic candidates. The offering's closure is anticipated on September 3, 2024, pending customary conditions.
Read more →
BCDA Aug 29, 2024BCDAFDA Updates
▲ +82.7%on this newsshared move
BioCardia Announces FDA Market Clearance of Morph DNA™ Steerable Introducer Product Family
BioCardia has received FDA market clearance for its Morph DNA Steerable Introducer product family, allowing for the introduction of medical devices into the vasculature. This product family includes multiple sizes and is expected to enhance various clinical procedures, particularly in interventional cardiology and vascular surgery. With prior experience from using a single diameter Morph product in about 12,000 procedures, the company anticipates significant market demand. The Morph DNA is designed with advanced features to improve navigation and control during medical interventions.
Read more →
BCDA Aug 13, 2024BCDAGeneral
BioCardia Reports Second Quarter 2024 Business Highlights and Financial Results
BioCardia, Inc. recently shared its financial results for Q2 2024, highlighting ongoing clinical trials and collaborations. The company reported a net loss of approximately $1.6 million and a drop in revenues compared to the previous year. They anticipate key data releases in the upcoming quarters, particularly from their CardiAMP Heart Failure trials. Overall, BioCardia's development efforts appear to be on track despite financial setbacks, showcasing significant advancements in cell therapies for heart conditions.
Read more →
BCDA Aug 7, 2024BCDAConferences/Events
▲ +5.9%on this news
BioCardia to Host Q2 2024 Corporate Update and Financial Results Conference Call on August 13, 2024
BioCardia, Inc. has announced a corporate update and financial results call scheduled for August 13, 2024, at 4:30 PM ET. The call will include formal remarks from management followed by a question-and-answer session. BioCardia specializes in cellular therapies for cardiovascular and pulmonary diseases and is advancing three clinical stage product candidates. Interested parties can register for the call and also access a replay after its conclusion.
Read more →
BCDA Jul 30, 2024BCDAFDA Updates
BioCardia Submits for FDA Approval of Morph DNA™ Steerable Introducer Product Family
BioCardia, Inc. has submitted a 510(k) application to the FDA for its Morph DNA Steerable Introducer Sheath, aimed at improving the introduction of medical instruments in cardiovascular procedures. This innovative product family incorporates advanced Morph DNA technology that allows for enhanced navigation and performance of catheters. The potential market for these devices is significant, including use in structural heart procedures and peripheral vascular interventions. This submission supports BioCardia's commitment to advancing therapeutic solutions for cardiovascular and pulmonary diseases.
Read more →
BCDA Jul 17, 2024BCDAGeneral
BioCardia Announces United States Patent Issuance on Morph DNA Multi-Directional Steerable Catheter Transseptal Application
BioCardia, Inc. announced the issuance of a new patent by the United States Patent Office for its Morph DNA Multi-Directional Steerable Catheter. This patent enhances the company's offerings in the growing market for transseptal access systems, which is expected to expand significantly in the coming years. The technology aims to improve catheter performance and physician control in various cardiac procedures. BioCardia's advances position it favorably in the competitive landscape of cardiovascular therapies.
Read more →
BCDA Jun 7, 2024BCDAGeneral
▼ -14.8%on this news
BioCardia Announces United States Patent Issuance on Intramyocardial Delivery of Cell Aggregates to the Heart Including Minimally Invasive Radial Artery Approach
BioCardia has received a U.S. patent for a novel approach to deliver cell aggregates to the heart using a radial artery technique. This method not only enhances patient recovery by minimizing hospital stays but also protects the company’s therapeutic programs. The patented Helix system enables a safer delivery of cell therapies, although it carries inherent risks of complications from cell leakage. The patent extends protection for the technology until 2036, underscoring BioCardia's commitment to advancing heart therapies.
Read more →
BCDA May 21, 2024BCDAGeneral
BioCardia Announces Reverse Stock Split
BioCardia, Inc. announced a reverse stock split at a ratio of 1-for-15, effective May 30, 2024. This decision follows approval from stockholders and aims to comply with Nasdaq's minimum bid price requirements. Both the common stock and warrants remain listed under their respective symbols. The split will be executed automatically for most shareholders, while others may need to take action to exchange physical certificates. However, the company acknowledges uncertainties regarding stock pricing post-split.
Read more →
BCDA May 14, 2024BCDAGeneral
BioCardia Reports First Quarter 2024 Business Highlights and Financial Results
BioCardia, Inc. reported its first quarter 2024 financial results, revealing positive clinical outcomes from its CardiAMP and CardiALLO cell therapies. Significant findings include an 86% relative risk reduction in mortality for patients treated with CardiAMP for ischemic heart failure. The company activated its confirmatory pivotal trials and aims to submit its therapies for approval in Japan this year. Overall, BioCardia continues to advance its innovative therapeutic developments in the cardiovascular domain.
Read more →
BCDA May 9, 2024BCDAConferences/Events
BioCardia to Host Q1 2024 Financial Results and Corporate Update Conference Call on May 14, 2024
BioCardia, Inc. announced it will host a conference call on May 14, 2024, to discuss its Q1 2024 financial results and corporate updates. The event will include formal remarks by management followed by a Q&A session. Participants can register online or join by phone. The call will also be available via a live webcast and will have a replay accessible for an extended period after the event.
Read more →
BCDA May 1, 2024BCDAPhases
BioCardia’s CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial Results Show Patient Benefits in Important Outcomes
BioCardia, Inc. has announced promising results from its CardiAMP Cell Therapy trial aimed at treating chronic myocardial ischemia. In the open label roll-in cohort, patients experienced a notable increase in exercise tolerance and a significant reduction in angina episodes. These findings were presented by clinical leaders during a webcast and underscore the effectiveness of this innovative cell-based therapy. The trial results boost BioCardia's efforts to redefine treatment paradigms for refractory angina, highlighting the potential benefits for patients suffering from this condition.
Read more →
BCDA Apr 25, 2024BCDAPhases
BioCardia Completes Enrollment of CardiAMP Cell Therapy for the Treatment of Chronic Myocardial Ischemia Trial Open Label Roll-In Cohort
BioCardia, Inc. has completed enrollment for the open label roll-in cohort of the CardiAMP Cell Therapy trial targeting chronic myocardial ischemia. The company will announce results from this cohort and discuss the opportunity during a conference call scheduled for April 30, 2024. CardiAMP Cell Therapy, which utilizes a patient's own bone marrow cells, is tailored to enhance cardiac repair and has shown promising results. The trial addresses a significant unmet need for patients suffering from refractory angina and is supported by Medicare coverage for trial procedures.
Read more →
BCDA Mar 27, 2024BCDAGeneral
BioCardia Reports Fourth Quarter and Full Year 2023 Business Highlights and Financial Results
BioCardia, Inc. reported its financial results for the year ended December 31, 2023, highlighting the interim outcomes of its CardiAMP Heart Failure trial. Although the primary endpoint was missed, treated patients showed improvement in critical health metrics. The company aims to complete study follow-up and seek product approval in Japan while also advancing its earlier biotherapeutic candidates. BioCardia experienced a notable decline in revenues compared to the previous year.
Read more →
BCDA Mar 20, 2024BCDAConferences/Events
BioCardia to Host 2023 Financial Results and Corporate Update Conference Call on March 27, 2024
BioCardia, Inc. announced a conference call scheduled for March 27, 2024, to discuss its financial results for 2023 and provide a corporate update. The call will feature management remarks followed by a question-and-answer session. Interested participants can register online to receive dial-in instructions. BioCardia is known for developing cell-based therapies for cardiovascular and pulmonary diseases.
Read more →
BCDA Mar 13, 2024BCDAGeneral
BioCardia and StemCardia Announce Biotherapeutic Delivery Partnership
BioCardia and StemCardia have announced a partnership to develop bio-therapeutic interventions for heart failure, a condition with few treatment options. BioCardia will act as the exclusive delivery partner for StemCardia's investigational pluripotent stem cell product. The collaboration aims to improve treatment options for millions and accelerate clinical development. The delivery system utilized has a proven safety profile, which supports the initiative's potential success in FDA approval and subsequent clinical trials.
Read more →
BCDA Mar 12, 2024BCDAFDA Updates
▼ -9.5%on this newsshared move
BioCardia Announces CMS Approval of Coverage for CardiAMP Cell Therapy Confirmatory Phase III Heart Failure Study
BioCardia, Inc. announced CMS approval for reimbursement coverage of the confirmatory Phase III clinical trial of CardiAMP cell therapy aimed at treating ischemic heart failure. The trial, which has FDA approval, allows for enrollment of up to 250 patients at 40 centers, with various critical endpoints related to heart health and patient quality of life. Interim results exhibited a significant reduction in adverse cardiac events among treated patients, supporting the therapy's potential efficacy. CEO Peter Altman expressed optimism regarding the therapy's ability to reduce mortality in heart failure patients.
Read more →
BCDA Mar 4, 2024BCDAPhases
▼ -21.5%on this news
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
BioCardia, Inc. has reported promising interim results from its Phase III trial of CardiAMP cell therapy for heart failure. Patients treated with the therapy experienced a 37% reduction in heart death equivalents and an 86% reduction in patients with elevated NTproBNP. The FDA has approved a follow-on Phase III trial to further validate these findings. However, the trial did not meet its primary endpoint concerning six-minute walk distance, indicating some challenges ahead in confirming the therapy's overall effectiveness.
Read more →
BCDA Feb 8, 2024BCDAPhases
▼ -10.3%on this news
BioCardia Announces Activation of CardiAMP Heart Failure II Phase 3 Pivotal Study Recently Approved by FDA
BioCardia has activated the CardiAMP HF II Phase 3 clinical trial for its autologous cell therapy aimed at treating ischemic heart failure, following FDA approval in Q4 2023. The pivotal study will enroll 250 patients and aims to measure heart health outcomes over one to two years. Interim results from a prior trial will be presented in March 2024, which may further support the study's framework. CEO Dr. Peter Altman expresses optimism for rapid enrollment, citing strong network efficiencies and physician-patient motivation.
Read more →
BCDA Jan 31, 2024BCDAConferences/Events
▼ -5.7%on this news
BioCardia Announces Two Scientific Abstracts Have Been Accepted at the 2024 Technology and Heart Failure Therapeutics Conference
BioCardia, Inc. announced that two of its scientific abstracts have been accepted for presentation at the upcoming Technology and Heart Failure Therapeutics Conference in March 2024. The studies focus on the company's CardiAMP and CardiALLO therapies aimed at treating ischemic heart failure. Despite some previous setbacks, including the halting of part of the CardiAMP trial, the presentations will provide new insights into the therapies' efficacy and safety. With FDA approval for the next phase of clinical trials, BioCardia aims to advance its innovative cardiac treatment strategies.
Read more →
BCDA Jan 3, 2024BCDAGeneral
BioCardia Biotherapeutic Delivery and Morph Access Innovations Business Development Update for Shareholders
BioCardia provided a business development update highlighting its three active clinical programs targeting cardiovascular diseases, with a focus on ischemic heart failure. The company expects to share clinical data from these programs in 2024. Additionally, BioCardia's Biotherapeutic Delivery Partnering and Morph Access Innovations initiatives are gaining traction, with two new partnerships anticipated soon. Furthermore, recent patent issuances in Japan and the EU solidify the company's competitive position in the biotherapeutic field.
Read more →
BCDA Dec 19, 2023BCDAPhases
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
BioCardia has initiated its CardiALLO Phase I/II clinical trial with the first patient treated using BCDA-03 allogeneic mesenchymal stem cells for ischemic heart failure with reduced ejection fraction. The trial aims to assess the safety and potential efficacy of these stem cells, capitalizing on promising results from earlier studies. The use of this 'off the shelf' cell therapy is designed to provide immune modulation and improve microvascular function. The company aims to enroll more patients to further evaluate the treatment's impact in the ongoing study.
Read more →
BCDA Dec 18, 2023BCDAFDA Updates
▲ +8.3%on this newsshared move
BioCardia Announces Expected CardiAMP Heart Failure Japan Approval Timeline Based on Pharmaceutical and Medical Device Agency Consultation Minutes
BioCardia announced that its CardiAMP autologous cell therapy may achieve approval in Japan for treating ischemic heart failure, supported by data from the ongoing CardiAMP HF trial. The company plans to confirm the regulatory pathway with the PMDA, holding a consult in mid-2024 to discuss clinical data from multiple trials. While some positive outcomes were noted, such as reduced mortality, the primary endpoint was likely unmet. BioCardia aims for a submission based on available data in Q4 2024, pending consultations and confirmation.
Read more →
BCDA Nov 29, 2023BCDAFDA Updates
BioCardia Shares Update from Japan PMDA Consultation on CardiAMP Autologous Cell Therapy for Ischemic Heart Failure; Foreign Data Expected to be Sufficient for Product Approval
BioCardia, Inc. has provided an update following its consultation with Japan's PMDA regarding the approval of CardiAMP autologous cell therapy for ischemic heart failure. The PMDA has requested further details on preclinical and clinical data but has indicated that they might allow approval based on foreign data, without the need for additional studies in Japan. BioCardia aims to demonstrate the therapy's patient benefits and is anticipating further discussions with PMDA, with formal meeting minutes expected in four weeks.
Read more →
BCDA Nov 16, 2023BCDAGeneral
▼ -15.3%on this news· ran to -33% by day 3
BioCardia Announces $1.3 Million Registered Direct Offering of Common Stock Priced At-the-Market under Nasdaq Rules
BioCardia, Inc. has announced a registered direct offering for 2,000,000 shares of its common stock priced at $0.65 per share, aiming to raise gross proceeds of approximately $1.3 million. The offering is set to close around November 20, 2023, pending customary closing conditions. Proceeds will be used to advance the company's biotherapeutic candidates and their delivery systems. H.C. Wainwright & Co. is the placement agent for this offering.
Read more →
BCDA Nov 14, 2023BCDAFDA Updates
▲ +168.2%on this newsshared move
BioCardia Announces FDA Approval of CardiAMP Heart Failure II Protocol for Autologous Cell Therapy for Ischemic Heart Failure
BioCardia, Inc. has received FDA approval for its CardiAMP Heart Failure II protocol, which will assess autologous cell therapy for patients with ischemic heart failure. The ongoing CardiAMP Heart Failure trial has demonstrated promising interim results, including reductions in heart death risks and improvements in quality of life metrics. Adjustments to the new study include enhanced protocols and statistical adjustments aimed at ensuring efficacy while aiming to simplify execution and costs. The trial has received substantial backing from the clinical community and Medicare, which is expected to offset some clinical expenses.
Read more →
BCDA Nov 8, 2023BCDAPhases
▲ +6.1%on this news
BioCardia Reports Third Quarter 2023 Business Highlights and Financial Results
BioCardia, Inc. has reported its financial results for Q3 2023 and highlighted its ongoing clinical programs, particularly the CardiAMP Cell Therapy for ischemic heart failure. Interim results from the trial indicate promising benefits, showing relative risk reductions in mortality and major adverse cardiac events. However, enrollment in the trial has been paused per the Data Safety Monitoring Board's recommendation, and the company faces the challenge of potentially restarting the trial under its current design. Despite these hurdles, BioCardia is advancing discussions with the FDA on a new protocol that could expedite the path to marketing approval.
Read more →
BCDA Nov 1, 2023BCDAConferences/Events
BioCardia to Host Q3 2023 Corporate Update and Financial Results Conference Call on November 8, 2023
BioCardia, Inc. has announced a conference call scheduled for November 8, 2023, to discuss its corporate update and financial results for the third quarter of 2023. The call will include formal remarks followed by a question-and-answer session, enabling investor engagement. BioCardia is known for its development of cellular and cell-derived therapeutics aimed at cardiovascular and pulmonary diseases, with multiple product candidates under their biotherapeutic platforms.
Read more →
BCDA Oct 11, 2023BCDAPhases
▲ +28.3%on this news
BioCardia Announces Completion of Enrollment in Phase III CardiAMP HF Trial and Plans for CardiAMP HF Trial II
BioCardia has announced the completion of enrollment in its Phase III CardiAMP Heart Failure Trial and is planning a second pivotal study focused on patients with elevated NT-proBNP levels. While interim data suggest good outcomes in both study groups, the primary efficacy endpoint may not be met. Nevertheless, a significant relative risk reduction in mortality and adverse cardiac events was observed for patients in the CardiAMP therapy. Discussions with the FDA are underway to secure approval for the updated study design aimed at enhancing the chances of success.
Read more →
BCDA Sep 6, 2023BCDAPhases
▼ -12.6%on this news· ran to -25% by day 3
BioCardia Announces Clarification and Next Steps on its Autologous CardiAMP Cell Therapy Programs
BioCardia has announced its plans to clarify and advance its autologous CardiAMP cell therapy programs based on recent interim trial results. The company is considering a new Phase III trial protocol that may replace traditional outcome metrics with more objective measurements. This transition aims to enhance the study's chances of successfully demonstrating efficacy for heart failure treatment. Concurrently, BioCardia is progressing with its Chronic Myocardial Ischemia program, anticipating pivotal trial advancements in the near future.
Read more →
BCDA Sep 5, 2023BCDAPhases
▼ -25.5%on this news· ran to -41% by day 3shared move
BioCardia Announces Interim Efficacy Results in Phase III Pivotal CardiAMP Cell Therapy Heart Failure Trial
BioCardia, Inc. reported interim efficacy results from its Phase III trial of CardiAMP Cell Therapy for heart failure, which received FDA Breakthrough Designation. An external review confirmed the quality of data, showing trends towards lower rates of all-cause death and major adverse cardiac events in the treatment group compared to controls. However, the interim analysis suggests the study is unlikely to achieve its primary efficacy endpoint at the one-year mark, as most comparisons lacked statistical significance. The company plans to analyze patient responses further and is focusing on upcoming milestones and trial design improvements.
Read more →
BCDA Aug 9, 2023BCDAPhases
▲ +6.3%on this news
BioCardia Reports Second Quarter 2023 Business Highlights and Financial Results
BioCardia, Inc. reported its second quarter 2023 financial results, announcing a pause in patient enrollment for its BCDA-01 clinical trial due to a DSMB recommendation. Although no safety issues were found and some positive clinical improvements were noted, the trial may not meet its primary endpoint, emphasizing the need for ongoing monitoring and analysis. The company anticipates significant progress in other clinical programs and aims to complete enrollment for BCDA-02 while addressing FDA queries regarding their CardiAMP Cell Therapy System's approval in Japan. Additionally, BioCardia is working on achieving strategic business development goals with planned milestones ahead.
Read more →
BCDA Aug 2, 2023BCDAConferences/Events
BioCardia to Host Q2 2023 Financial Results and Corporate Update Conference Call on August 9, 2023
BioCardia, Inc. is set to release its Q2 2023 financial results and provide a corporate update during a conference call on August 9, 2023. The call will include a question-and-answer session following management's remarks, reflecting the company's commitment to transparency with its investors. The company, located in Sunnyvale, California, focuses on cellular and cell-derived therapeutics aimed at treating cardiovascular and pulmonary diseases. Stakeholders are encouraged to register for the call to participate or listen via a live webcast.
Read more →
BCDA Jul 24, 2023BCDAPhases
▼ -44.7%on this news
BioCardia Announces DSMB Recommendation to Pause New Enrollment in Phase III Pivotal CardiAMP Cell Therapy Heart Failure Trial While Additional Blinded Data is Collected
BioCardia, Inc. has announced that the Data Safety Monitoring Board (DSMB) recommends pausing new patient enrollment in its Phase III CardiAMP Cell Therapy Heart Failure Trial. This decision is pending a one-year outcomes analysis for current trial participants. The DSMB indicated that, based on their initial review, the trial was unlikely to meet its primary efficacy endpoint, although no safety concerns were reported. The company will use this pause to assess ongoing data and continue treating already enrolled patients.
Read more →
BCDA Jul 5, 2023BCDAFDA Updates
BioCardia Completes Submission of CardiAMP Cell Therapy System in Heart Failure to Japan’s Pharmaceutical Medical Device Agency
BioCardia, Inc. has announced the completion of its submission for the CardiAMP Cell Therapy System to Japan’s Pharmaceutical and Medical Device Agency for treating ischemic heart failure with reduced ejection fraction. The anticipated formal consultation is expected in approximately three months, marking the company's third consultation with the PMDA. The therapy utilizes a minimally invasive method, drawing from patients' own bone marrow cells, and has potential advantages given its prior approvals in other indications.
Read more →
BCDA Jun 20, 2023BCDAFDA Updates
▲ +6.4%on this news· ran to +20% by day 1
BioCardia Announces FDA Completes Review of Proposed Adaptive Statistical Analysis Design for Ongoing CardiAMP Cell Therapy in Heart Failure Pivotal Study
BioCardia has announced that the FDA has completed its review of the adaptive statistical analysis design for the ongoing CardiAMP Cell Therapy pivotal study addressing ischemic heart failure. This supplement will be discussed in the upcoming Data Safety Monitoring Board (DSMB) meeting scheduled for July 12, 2023. The adaptive plan may allow for an early stoppage of the trial for efficacy, which could provide patients with earlier access to this FDA designated breakthrough therapy.
Read more →
BCDA Jun 8, 2023BCDAGeneral
▲ +6.5%on this news· ran to +17% by day 3
BioCardia Announces Helix™ Biotherapeutic Delivery Patent Issuance in Japan
BioCardia Inc. announced that the Japan Patent Office granted a patent for its Helix biotherapeutic delivery system, which aids in minimally invasive cell and gene-based therapies for cardiovascular applications. This technology improves the delivery of biologics from within the heart chamber, positioning BioCardia favorably in the race for market approvals in Japan. The Helix system is believed to provide enhanced safety and efficacy over traditional delivery methods. BioCardia is actively advancing multiple therapeutic programs, including therapies for ischemic heart failure and chronic myocardial ischemia, with significant patient benefit potential.
Read more →
BCDA May 23, 2023BCDAPhases
BioCardia Announces Timing of the Next Data Safety Monitoring Board Meeting for the CardiAMP Cell Therapy in Heart Failure Pivotal Study
BioCardia, Inc. announced the upcoming Data Safety Monitoring Board meeting for its CardiAMP Cell Therapy Trial set for July 12. The company anticipates receiving feedback from the FDA concerning its adaptive statistical analysis plan in early to mid-June. CardiAMP, which utilizes autologous bone marrow cells, aims to improve heart failure treatments and has received FDA Breakthrough Device designation, indicating its potential clinical significance.
Read more →
BCDA May 10, 2023BCDAPhases
BioCardia Reports First Quarter 2023 Business Highlights and Financial Results
BioCardia, Inc. reported its financial results for Q1 2023, highlighting advancements in cellular therapy programs, particularly the CardiAMP cell therapy for heart failure, which has shown positive results over two years. The trial, active at multiple clinical sites, has been granted Breakthrough designation by the FDA, supporting its ongoing research. Financially, the company reported a net loss of approximately $3.5 million, with increased R&D expenses due to support of ongoing trials. Upcoming milestones include a DSMB review and submissions for international approvals, indicating proactive progress in the company's development pipeline.
Read more →
BCDA May 9, 2023BCDAGeneral
BioCardia Announces US Patent on Bone Marrow Derived Neurokinin-1 Receptor Positive (NK1R+) Mesenchymal Stem Cells for Therapeutic Applications
BioCardia, Inc. has announced the granting of a US patent for Bone Marrow Derived Neurokinin-1 Receptor Positive (NK1R+) Mesenchymal Stem Cells. This patent protects methods for using these cells to treat various diseases, including cardiovascular conditions and arthritis, with a term extending to 2039. The CEO highlighted the significance of this development as a potential breakthrough in mesenchymal stem cell therapy, indicating plans to explore partnerships beyond their current focus. The company continues to develop its cellular and cell-derived therapeutics targeting cardiovascular and pulmonary diseases.
Read more →
BCDA May 4, 2023BCDAConferences/Events
BioCardia to Host Q1 2023 Financial Results and Corporate Update Conference Call on May 10, 2023
BioCardia, Inc. has announced a conference call scheduled for May 10, 2023, to discuss its financial results for the first quarter of 2023 and provide a corporate update. The call will include a formal presentation followed by a question-and-answer session. Participants can register online or join the call through provided phone numbers. The company is known for its biotherapeutic platforms aimed at treating cardiovascular and pulmonary diseases.
Read more →
BCDA Apr 28, 2023BCDAConferences/Events
BioCardia Presentations at Next Generation Cardiovascular Drug Development Summit Now Available
BioCardia, Inc. announced the availability of two presentations from the recent 'Next Generation Cardiovascular Drug Development Summit' held on April 26-27, 2023. The summit focused on advancements in cardiac regeneration therapies, including insights into cell-based treatments and biomarker utilization. CEO Peter Altman highlighted the company's innovative therapeutic candidates that aim to improve cardiovascular disease treatments. The presentations covered their autologous and allogeneic cellular therapies, emphasizing their commitment to enhancing clinical success rates.
Read more →
BCDA Apr 4, 2023BCDAGeneral
BioCardia Announces Issuance of Two Patents Related to Technology That Guides Interventional Therapies
BioCardia, Inc. announced the issuance of two patents for steerable catheter technologies that enhance the delivery of its cell therapies for cardiovascular diseases. The U.S. Patent Office granted a patent for a multi-directional steerable catheter, while an Indian Patent Office patent focuses on a robust design for introducer sheaths. These patents are expected to boost BioCardia's product offerings and secure intellectual property in the competitive market for cardiac therapeutic devices. The technologies demonstrated effective performance in the company's Morph Access Pro product, potentially increasing their value in the industry.
Read more →
BCDA Mar 29, 2023BCDAGeneral
BioCardia Reports Fourth Quarter and Full Year 2022 Business Highlights and Financial Results
BioCardia reported its financial results for 2022, showcasing advancements in its cellular therapies for cardiovascular and pulmonary diseases. The company emphasized its progress in clinical trials, specifically the CardiAMP Cell Therapy, which has shown promising results in patient outcomes. BioCardia is also moving forward with regulatory submissions for market clearance and reimbursement codes to support therapy access. Additionally, the company is preparing for expanded trials in various therapeutic areas, indicating a robust pipeline for future developments.
Read more →
BCDA Mar 16, 2023BCDAConferences/Events
BioCardia to Host 2022 Financial Results and Corporate Update Conference Call on March 29, 2023
BioCardia, Inc. will host a conference call on March 29, 2023, to discuss its financial results for the year 2022 and provide updates on corporate activities. The company specializes in cellular therapies for cardiovascular and pulmonary conditions. Following formal remarks from management, there will be a Q&A session allowing for direct communication with participants. The call will be accessible via registration or phone, with additional web access options provided.
Read more →
BCDA Feb 1, 2023BCDAPhases
▼ -7.5%on this news
BioCardia and CellProthera Enhance Collaboration for Development of ProtheraCytes™ for the Treatment of Acute Myocardial Infarction in Europe and Potential Early Access for Patients
BioCardia and CellProthera have announced an amended partnership to enhance the development of ProtheraCytes for treating Acute Myocardial Infarction in Europe. The agreement aims to support ongoing clinical trials and explore early access commercialization starting in 2024. BioCardia's Helix delivery system is key to this collaboration, improving the delivery and retention of cell therapies in cardiac tissues, which could greatly benefit patients lacking alternative treatment options.
Read more →
BCDA Dec 22, 2022BCDAGeneral
BioCardia Letter to Shareholders
SUNNYVALE, Calif., Dec. 22, 2022 (GLOBE NEWSWIRE) -- BioCardia, Inc. (Nasdaq: BCDA), a clinical-stage developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases issued the following letter to shareholders:
BioCardia is now adva
Read more →
BCDA Dec 15, 2022BCDAGeneral
BioCardia Announces $3.6 Million Private Placement of Common Stock
SUNNYVALE, Calif., Dec. 15, 2022 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA] (the “Company”), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that it has entered into a Securities Purchase an
Read more →
BCDA Nov 9, 2022BCDAGeneral
BioCardia Reports Third Quarter 2022 Business Highlights and Financial Results
SUNNYVALE, Calif., Nov. 09, 2022 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reports financial results for the third quarter of 2022 and filed its quart
Read more →
BCDA Nov 2, 2022BCDAConferences/Events
BioCardia to Host Q3 2022 Financial Results and Corporate Update Conference Call on November 9, 2022
SUNNYVALE, Calif., Nov. 02, 2022 (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 three and nine month
Read more →
BCDA Oct 3, 2022BCDAConferences/Events
▲ +5.7%on this news
BioCardia Presents Positive CardiAMP Cell Therapy Heart Failure Trial Two-Year Data at HFSA Annual Meeting
SUNNYVALE, Calif., Oct. 03, 2022 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces data from its FDA designated Breakthrough CardiAMP® Cell Therapy
Read more →
BCDA Sep 9, 2022BCDAConferences/Events
BioCardia Announces Participation at H.C. Wainwright Global Investment Conference September 12-14, 2022 (HYBRID CONFERENCE)
SUNNYVALE, Calif., Sept. 09, 2022 (GLOBE NEWSWIRE) -- BioCardia, Inc. (NASDAQ, BCDA), today announced it will be featured as a presenting company at the H.C. Wainwright 24th Annual Global Investment Conference. The conference is being held on September 12-14, 2022. The in-person
Read more →
BCDA Sep 8, 2022BCDAConferences/Events
BioCardia to Participate in Cantor Fitzgerald’s Cell and Genetic Medicines Conference
SUNNYVALE, Calif., Sept. 08, 2022 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], today announced it will participate on a panel as a presenting company at Cantor Fitzgerald’s Cell and Genetic Medicines Conference. The conference is being held in person on September 15, 2022
Read more →
BCDA Aug 31, 2022BCDAPhases
BioCardia Announces Positive DSMB Review and Recommendation to Continue Phase III Pivotal CardiAMP Cell Therapy Heart Failure Trial
Adaptive Statistical Analysis Plan Recommended
SUNNYVALE, Calif., Aug. 31, 2022 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease, today announces that the independ
Read more →
BCDA Aug 24, 2022BCDAGeneral
BioCardia Enters Agreement with BlueRock Therapeutics to Provide Enabling Catheter Biotherapeutic Delivery Product Candidates for BlueRock’s Cell Therapy to Treat Heart Failure
SUNNYVALE, Calif., Aug. 24, 2022 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], today announced that it has entered into an agreement with BlueRock Therapeutics LP for the delivery of BlueRock’s cell therapy product candidates for the treatment of heart failure utilizing Bi
Read more →
BCDA Aug 10, 2022BCDAGeneral
BioCardia Reports Second Quarter 2022 Business Highlights And Financial Results
SUNNYVALE, Calif., Aug. 10, 2022 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reports financial results for the second quarter of 2022 and filed its quar
Read more →
BCDA Aug 4, 2022BCDAConferences/Events
▲ +5.9%on this news
BioCardia to Host Q2 2022 Financial Results and Corporate Update Conference Call on August 10, 2022
SUNNYVALE, Calif., Aug. 04, 2022 (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 three and six months
Read more →
BCDA Aug 1, 2022BCDAGeneral
BioCardia Announces First Canadian Clinical Site for CardiAMP Cell Therapy Heart Failure Trial
SUNNYVALE, Calif., Aug. 01, 2022 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces the activation of Ottawa Heart Institute, the first Canadian cli
Read more →
BCDA Jul 12, 2022BCDAConferences/Events
BioCardia to Participate in Upcoming Heart and Pulmonary Therapy Development Symposia
SUNNYVALE, Calif., July 12, 2022 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], Sunnyvale, Calif. – BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that Compan
Read more →
BCDA Jun 15, 2022BCDAGeneral
BioCardia Announces US Patent on Imaging System for Targeting Cardiac Therapies
SUNNYVALE, Calif., June 15, 2022 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces that the United States Patent Office has granted Patent Number 1
Read more →
BCDA May 11, 2022BCDAGeneral
▼ -11.9%on this news
BioCardia Reports First Quarter 2022 Business Highlights and Financial Results
SUNNYVALE, Calif., May 11, 2022 (GLOBE NEWSWIRE) -- 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 first quarter of 2022 and filed its quar
Read more →
BCDA May 4, 2022BCDAConferences/Events
BioCardia to Host Q1 2022 Financial Results and Corporate Update Conference Call on May 11, 2022
SUNNYVALE, Calif., May 04, 2022 (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 three months ended Ma
Read more →
BCDA Apr 12, 2022BCDAFDA Updates
▼ -7.4%on this news· ran to -33% by day 3
BioCardia Announces FDA Approval of Its IND for NK1R+ Mesenchymal Stem Cells for the Treatment of Patients Recovering from Acute Respiratory Distress due to COVID-19
SUNNYVALE, Calif., April 12, 2022 (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 the U.S. Food and Drug Administration (FDA) has approved t
Read more →
BCDA Mar 29, 2022BCDAGeneral
BioCardia Reports 2021 Financial Results and Recent Business Highlights
SUNNYVALE, Calif., March 29, 2022 (GLOBE NEWSWIRE) -- 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 year ended December 31, 2021 and filed
Read more →
BCDA Mar 24, 2022BCDAConferences/Events
BioCardia to Host 2021 Financial Results and Corporate Update Conference Call on March 29, 2022
SUNNYVALE, Calif., March 24, 2022 (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
Read more →
BCDA Mar 22, 2022BCDAGeneral
BioCardia Announces New Center for Medicare and Medicaid Services Reimbursement Code Applicable to the CardiAMP Cell Therapy Procedure
SUNNYVALE, Calif., March 22, 2022 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease, announces the designation of a new reimbursement code for the CardiAMP® Cell The
Read more →
BCDA Mar 1, 2022BCDAGeneral
▲ +5.8%on this news
BioCardia Receives No Objection Letter from Health Canada, Enabling Company to Expand CardiAMP Cell Therapy Heart Failure Trial into Canada
SUNNYVALE, Calif., March 01, 2022 (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 it has received a No Objection Letter from Health Canada,
Read more →
BCDA Feb 14, 2022BCDAPhases
▼ -12.3%on this news
BioCardia Announces Positive DSMB Review and Recommendation to Continue Phase III Pivotal CardiAMP Cell Therapy Heart Failure Study as Designed
SUNNYVALE, Calif., Feb. 14, 2022 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease, today announces that the independent Data Safety Monitoring Board (DSMB) has comp
Read more →
BCDA Jan 10, 2022BCDAConferences/Events
BioCardia Announces Participation at the Upcoming Digital Medicine & Medtech Showcase and the H.C. Wainwright BioConnect Virtual Conference
SUNNYVALE, Calif. , Jan. 10, 2022 (GLOBE NEWSWIRE) -- BioCardia®, Inc. (Nasdaq: BCDA), a company focused on developing cellular and cell derived therapeutics for the treatment of cardiovascular and respiratory diseases, today announced it will be delivering virtual presentations
Read more →
BCDA Dec 15, 2021BCDAGeneral
BioCardia Establishes New Manufacturing Facility to Enable Its Cell Therapy Product Candidates
SAN CARLOS, Calif., Dec. 15, 2021 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces that it has entered into a long-term lease for a new facility in
Read more →
BCDA Nov 10, 2021BCDAGeneral
BioCardia Reports Third Quarter 2021 Financial Results and Business Highlights
SAN CARLOS, Calif., Nov. 10, 2021 (GLOBE NEWSWIRE) -- 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 2021 and filed its qua
Read more →
BCDA Nov 8, 2021BCDAGeneral
BioCardia To Release Third Quarter 2021 Financial Results November 10, 2021
SAN CARLOS, Calif., Nov. 08, 2021 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [NASDAQ:BCDA], a company focused on developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces it will release third quarter 2021 financial re
Read more →
BCDA Oct 21, 2021BCDAPhases
BioCardia Announces First Patient Treated in CardiAMP Cell Therapy Trial for Chronic Myocardial Ischemia
SAN CARLOS, Calif., Oct. 21, 2021 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA] a company focused on developing cellular and cell derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the treatment of the first patient in its Phase
Read more →
BCDA Oct 12, 2021BCDAGeneral
BioCardia Issued New U.S. Patent for Technology that Enhances Control for Interventional Catheter Based Therapies
SAN CARLOS, Calif., Oct. 12, 2021 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA] a company focused on developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the issuance of U.S. Patent No: 11,141,568 for
Read more →
BCDA Oct 7, 2021BCDAGeneral
▲ +6.5%on this newsshared move
BioCardia Announces First Cross-Over Patient Treated in CardiAMP Cell Therapy Heart Failure Trial
SAN CARLOS, Calif., Oct. 07, 2021 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA] a company focused on developing cellular and cell derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the treatment of the first cross-over patient i
Read more →
BCDA Oct 6, 2021BCDAConferences/Events
BioCardia Announces Participation at the A.G.P. Biotech & Specialty Pharma Conference October 13, 2021 (Virtual Conference)
SAN CARLOS, Calif., Oct. 06, 2021 (GLOBE NEWSWIRE) -- BioCardia®, Inc. (Nasdaq: BCDA), a company focused on developing cellular and cell derived therapeutics for the treatment of cardiovascular diseases, today announced it will be participating in the A.G.P Biotech & Specialty Ph
Read more →
BCDA Sep 9, 2021BCDAConferences/Events
BioCardia Announces Participation at the H.C. Wainwright 23rd Annual Global Investment Conference September 13-15, 2021 (Virtual Conference)
SAN CARLOS, Calif., Sept. 09, 2021 (GLOBE NEWSWIRE) -- BioCardia®, Inc. (Nasdaq: BCDA), today announced it has recorded a company presentation that will be available on demand at the H.C. Wainwright 23rd Annual Global Investment Virtual Conference. The conference is being held as
Read more →
BCDA Aug 13, 2021BCDAConferences/Events
BioCardia to Participate in Upcoming Investor Conferences
SAN CARLOS, Calif., Aug. 13, 2021 (GLOBE NEWSWIRE) -- BioCardia®, Inc. (Nasdaq: BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced today that the Company’s management team will participate in the foll
Read more →
BCDA Aug 12, 2021BCDAGeneral
BioCardia Reports Second Quarter 2021 Financial Results and Business Highlights
SAN CARLOS, Calif., Aug. 12, 2021 (GLOBE NEWSWIRE) -- 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 second quarter of 2021 and filed its qu
Read more →
BCDA Aug 4, 2021BCDAConferences/Events
BioCardia to Participate in a Fireside Chat at the BTIG Virtual Biotechnology Conference on August 10, 2021
SAN CARLOS, Calif., Aug. 04, 2021 (GLOBE NEWSWIRE) -- BioCardia®, Inc. (Nasdaq: BCDA), a leader in the development of comprehensive solutions for cardiovascular and pulmonary cell based therapies, announced today that Chief Executive Officer, Peter Altman, will participate in a f
Read more →
BCDA Jul 15, 2021BCDAGeneral
BioCardia Announces Japanese Patent on Imaging System for Targeting Cardiac Therapies
SAN CARLOS, Calif., July 15, 2021 (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 Japan Patent Office has granted Patent No: 688721
Read more →
BCDA Jun 23, 2021BCDAPhases
BioCardia Announces Fourth Positive DSMB Review and Recommendation to Continue Phase III Pivotal CardiAMP Cell Therapy Heart Failure Study as Designed
SAN CARLOS, Calif., June 23, 2021 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a company focused on developing cellular and cell derived therapeutics for the treatment of cardiovascular and pulmonary disease, today announces that the independent Data Safety Monitoring Boa
Read more →
BCDA Jun 22, 2021BCDAPhases
BioCardia to Present CardiAMP Cell Therapy Clinical Trial Data at European Society of Cardiology Heart Failure 2021
SAN CARLOS, Calif., June 22, 2021 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a company focused on developing cellular and cell derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces data from its CardiAMP Cell Therapy Heart Fail
Read more →
BCDA Jun 21, 2021BCDAGeneral
BioCardia Announces European Patent Office Decision to Grant Patent on Autologous Cell Therapy Patient Selection Diagnostic Assay
SAN CARLOS, Calif., June 21, 2021 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a company focused on cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that the European patent office has issued a Decision to
Read more →
BCDA Jun 14, 2021BCDAGeneral
BioCardia to Be Added to the Russell Microcap Index
SAN CARLOS, Calif., June 14, 2021 (GLOBE NEWSWIRE) -- BioCardia®, Inc. (Nasdaq: BCDA), a leader in the development of comprehensive solutions for cardiovascular and pulmonary cell based therapies, today announced it is to join the Russell Microcap® Index. This milestone will take
Read more →
BCDA Jun 2, 2021BCDAConferences/Events
BioCardia to Present at the LD Micro Virtual Invitational Conference on June 8, 2021
SAN CARLOS, Calif., June 02, 2021 (GLOBE NEWSWIRE) -- BioCardia®, Inc. (Nasdaq: BCDA), a leader in the development of comprehensive solutions for cardiovascular and pulmonary cell based therapies, announced today that Chief Executive Officer Peter Altman will present a corporate
Read more →
BCDA May 13, 2021BCDAGeneral
BioCardia Reports First Quarter 2021 Financial Results and Business Highlights
SAN CARLOS, Calif., May 13, 2021 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a leader in the development of comprehensive solutions for cardiovascular and pulmonary cell based therapies, today reported financial results for the first quarter of 2021 and filed its quarter
Read more →
BCDA Apr 26, 2021BCDAGeneral
BioCardia Signs Agreement with Leading Japanese Biotechnology Company for Catheter Biotherapeutic Delivery Product Candidates
SAN CARLOS, Calif., April 26, 2021 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], today announced that it has entered into an agreement with a leading Japanese biotechnology company related to BioCardia Helix catheter biotherapeutic delivery product candidates. Under the t
Read more →
BCDA Mar 30, 2021BCDAGeneral
BioCardia Reports 2020 Financial Results and Recent Business Highlights
SAN CARLOS, Calif., March 30, 2021 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a leader in the development of comprehensive solutions for cardiovascular and pulmonary regenerative therapies, today reported financial results for the fourth quarter and full year ended Dece
Read more →
BCDA Mar 15, 2021BCDAConferences/Events
BioCardia to Present at Maxim Group’s Inaugural Emerging Growth Virtual Conference
SAN CARLOS, Calif., March 15, 2021 (GLOBE NEWSWIRE) -- BioCardia®, Inc. (Nasdaq: BCDA), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, announces that CEO Dr. Peter Altman will present at Maxim Group’s Inaugural Emerging Growth Vi
Read more →
BCDA Feb 23, 2021BCDAGeneral
BioCardia Signs Agreement With Leading Japanese Pharmaceutical Company for Catheter Biotherapeutic Delivery Product Candidates
SAN CARLOS, Calif., Feb. 23, 2021 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], today announced that it has entered into an agreement with a leading Japanese pharmaceutical company related to BioCardia Helix catheter biotherapeutic delivery product candidates. Under the te
Read more →
BCDA Feb 17, 2021BCDAGeneral
BioCardia Announces Clinical Leadership Changes
SAN CARLOS, Calif., Feb. 17, 2021 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA] a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced clinical leadership changes.
Dr. Sujith Shetty who has been with the Company fo
Read more →
BCDA Feb 2, 2021BCDAGeneral
BioCardia Update on Cell Therapy Product Development and 2021 Milestones
SAN CARLOS, Calif., Feb. 02, 2021 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA] a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today provides an update on its cell therapy product development and 2021 milestones.
BCDA-01,
Read more →
BCDA Dec 30, 2020BCDAGeneral
BioCardia Issued New U.S. Patent for Technology that Enhances Control for Cardiac Therapies
SAN CARLOS, Calif., Dec. 30, 2020 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA] a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced the issuance of U.S. Patent No: 10,874, 831 for “Devices and Methods for Accessi
Read more →
BCDA Dec 17, 2020BCDAPhases
BioCardia Announces Positive DSMB Review and Recommendation to Continue Phase III Pivotal CardiAMP Heart Failure Study as Designed
SAN CARLOS, Calif., Dec. 17, 2020 (GLOBE NEWSWIRE) -- BioCardia (Nasdaq: BCDA), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced that the independent Data Safety Monitoring Board (DSMB) has completed its prespecifie
Read more →
BCDA Dec 16, 2020BCDAGeneral
BioCardia, Inc. Announces $10.5 Million Registered Direct Offering Priced At-The-Market Under Nasdaq Rules
SAN CARLOS, Calif., Dec. 16, 2020 (GLOBE NEWSWIRE) -- BioCardia®, Inc. (Nasdaq: BCDA) (BioCardia or the “Company”) today announced it has entered into definitive agreements with investors for the purchase and sale of 2,038,836 shares of its common stock at a purchase price of $5.
Read more →
BCDA Dec 15, 2020BCDAGeneral
BioCardia, Inc. Announces $8.5 Million Registered Direct Offering Priced At-The-Market Under Nasdaq Rules [Revised]
SAN CARLOS, Calif., Dec. 15, 2020 (GLOBE NEWSWIRE) -- BioCardia®, Inc. (Nasdaq: BCDA)(BioCardia or the “Company”) today announced it has entered into definitive agreements with investors for the purchase and sale of 1,789,474 shares of its common stock at a purchase price of $4.7
Read more →
BCDA Dec 14, 2020BCDAPhases
BioCardia Anticipates DSMB Feedback on Interim Data From Pivotal Phase 3 CardiAMP Heart Failure Trial
SAN CARLOS, Calif., Dec. 14, 2020 (GLOBE NEWSWIRE) -- BioCardia®, Inc. (Nasdaq: BCDA)(BioCardia or the “Company”) today announces that it anticipates data safety monitoring board (DSMB) verbal feedback by the end of December 15, 2020 on interim data from the Company’s pivotal Pha
Read more →
BCDA Dec 1, 2020BCDAPhases
BioCardia Reports Published Study Showing Helix Biotherapeutic Delivery System Used in CardiAMP Phase III Heart Failure Trial Has Fewest Adverse Events Among Competitive Delivery Systems
SAN CARLOS, Calif., Dec. 01, 2020 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA] today announced that the Company’s proprietary Helix Biotherapeutic Delivery System (the Helix System) demonstrated the best safety profile among clinical transendocardial catheter injection sys
Read more →
BCDA Nov 10, 2020BCDAGeneral
BioCardia Reports Third Quarter 2020 Financial Results and Business Highlights
SAN CARLOS, Calif., Nov. 10, 2020 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [NASDAQ: BCDA], a leader in the development of autologous and allogenic cell therapies, today reported financial results and business highlights for the third quarter of 2020 and filed its quarterly report on
Read more →
BCDA Sep 29, 2020BCDAGeneral
BioCardia Issued New Patent for Delivery of Cardiac Cell Therapy Through Wrist Artery
SAN CARLOS, Calif., Sept. 29, 2020 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA] a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced the issuance of U.S. Patent No: 10,780,248 for a “Radial and Transendocardial D
Read more →
BCDA Aug 26, 2020BCDAConferences/Events
BioCardia to Present at the LD Micro 500 Virtual Conference on September 1, 2020
SAN CARLOS, Calif., Aug. 26, 2020 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies today announced that Peter Altman, Ph.D., Biocardia’s Chief Executive Officer will give a virtua
Read more →
BCDA Aug 13, 2020BCDAGeneral
BioCardia Reports Second Quarter 2020 Financial Results and Business Highlights
SAN CARLOS, Calif., Aug. 13, 2020 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [NASDAQ: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today reported financial results and business highlights for the second quarter of 2020 and fil
Read more →
BCDA Aug 7, 2020BCDAConferences/Events
BioCardia To Conduct Mid-Year Conference Call and Corporate Update August 13, 2020
SAN CARLOS, Calif., Aug. 07, 2020 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [NASDAQ:BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced it will be conducting a mid-year corporate update conference call on Thursday, A
Read more →
BCDA Jul 1, 2020BCDAPhases
BioCardia Announces Activation of Pivotal Trial Studying CardiAMP Cell Therapy Trial to Treat Chronic Myocardial Ischemia
SAN CARLOS, Calif., July 01, 2020 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [NASDAQ:BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced activation of a pivotal trial studying the Company’s investigational CardiAMP® c
Read more →
BCDA Jun 29, 2020BCDAPhases
BioCardia Announces CardiAMP Heart Failure Pivotal Trial Continues with First Patient Randomized in COVID-19 Era
SAN CARLOS, Calif., June 29, 2020 (GLOBE NEWSWIRE) -- BioCardia®, Inc., (OTC: BCDA), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced that the Company has resumed cases in the CardiAMP Heart Failure Trial. The first
Read more →
BCDA Jun 17, 2020BCDAGeneral
BioCardia Announces Pricing of $10 Million Public Offering
SAN CARLOS, Calif., June 17, 2020 (GLOBE NEWSWIRE) -- BioCardia®, Inc. NasdaqCM: BCDA (the “Company”), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced the pricing of its public offering of 4,762,000 shares of commo
Read more →
BCDA May 15, 2020BCDAGeneral
BioCardia Reports First Quarter 2020 Financial Results and Business Highlights
SAN CARLOS, Calif., May 15, 2020 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today reported financial results and business highlights for the first quarter of 2020 and filed
Read more →
BCDA May 5, 2020BCDAGeneral
BioCardia Announces Positive Preclinical Results Supporting Investigational New Drug Application for Anti-Inflammatory Cell Therapy in Heart Failure
SAN CARLOS, Calif., May 05, 2020 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced data from a recent animal study performed by the Company that demonstrate meanin
Read more →
BCDA Apr 30, 2020BCDAFDA Updates
Biocardia Announces FDA-Recommended Modifications to Primary Endpoint for Cardiamp Cell Therapy Heart Failure Trial to Support Marketing Approval
SAN CARLOS, Calif., April 30, 2020 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today reported that it has accepted and implemented FDA-recommended modifications to the prima
Read more →
BCDA Apr 28, 2020BCDAGeneral
BioCardia Awarded New U.S. Patent Covering Helix System for Local Biotherapeutic Delivery of Autologous and Allogenic Cells to the Heart
SAN CARLOS, Calif., April 28, 2020 (GLOBE NEWSWIRE) -- BioCardia®, Inc., (OTC: BCDA), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced the issuance of United States Patent No. 10,632,281, entitled “Drug Delivery Cat
Read more →
BCDA Apr 14, 2020BCDAGeneral
BioCardia Announces Litigation Financing in the Case Captioned Boston Scientific Corp., et al., v. BioCardia Inc.
SAN CARLOS, Calif., April 14, 2020 (GLOBE NEWSWIRE) -- BioCardia®, Inc. (Nasdaq: BCDA), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today reported it has entered into an agreement for litigation financing which has been filed
Read more →
BCDA Apr 9, 2020BCDAGeneral
BIOCARDIA REPORTS 2019 FINANCIAL RESULTS AND RECENT BUSINESS HIGHLIGHTS
SAN CARLOS, Calif., April 09, 2020 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today reported financial results for the fourth quarter and full year ended December 31, 2019
Read more →
BCDA Mar 31, 2020BCDAPhases
BIOCARDIA ANNOUNCES POSITIVE DSMB RECOMMENDATION TO CONTINUE PHASE III PIVOTAL CARDIAMP HEART FAILURE STUDY, AS PLANNED
SAN CARLOS, Calif., March 31, 2020 (GLOBE NEWSWIRE) -- BioCardia (Nasdaq: BCDA), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced that the independent Data Safety Monitoring Board (DSMB) has completed its prespecifi
Read more →
BCDA Mar 12, 2020BCDAPhases
BIOCARDIA ANNOUNCES TIMING FOR PRESPECIFIED DATA SAFETY MONITORING BOARD REPORT ON PIVOTAL CARDIAMP HEART FAILURE TRIAL
Company to Host a Conference Call with National Co-Principal Investigators on March 31, 2020 at 4:15 p.m. ET
Fourth Quarter 2019 Financial Results to be Issued March 30, 2020
SAN CARLOS, Calif., March 12, 2020 (GLOBE NEWSWIRE) -- BioCardia (Nasdaq: BCDA), a leader in the develo
Read more →
BCDA Jan 14, 2020BCDAFDA Updates
Biocardia Announces FDA Clearance for Morph DNA Deflectable Guide Catheter
SAN CARLOS, Calif., Jan. 14, 2020 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the M
Read more →
BCDA Jan 8, 2020BCDAGeneral
BioCardia Announces New U.S. Patent Covering CardiAMP Cell Therapy and Issuance of Two Asian Patents Covering Radial Artery Approach for Cardiac Cell and Gene Therapy Delivery
SAN CARLOS, Calif., Jan. 08, 2020 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [NASDAQ: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced the issuance of three new patents for the company’s technologies in the U.S., C
Read more →
BCDA Nov 19, 2019BCDAGeneral
BioCardia Reports 2019 Third Quarter Financial Results and Business Highlights
SAN CARLOS, Calif., Nov. 19, 2019 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today reported financial results and business highlights for the third quarter 2019 and filed i
Read more →
BCDA Oct 28, 2019BCDAConferences/Events
BioCardia to Present at Dawson James Securities 5th Annual Small Cap Growth Conference
SAN CARLOS, Calif., Oct. 28, 2019 (GLOBE NEWSWIRE) -- BioCardia®, Inc. (Nasdaq: BCDA), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced that company CEO Peter Altman, PhD, is scheduled to present at the Dawson James
Read more →
BCDA Oct 8, 2019BCDAGeneral
BioCardia Receives CE Mark Renewal For Helix Biotherapeutic Delivery Catheter And Morph Guide Catheter Through May 2024
SAN CARLOS, Calif., Oct. 08, 2019 (GLOBE NEWSWIRE) -- BioCardia (Nasdaq: BCDA), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced renewal of the CE Mark for the Helix™ Biotherapeutic Delivery Catheter and Morph® Univ
Read more →
BCDA Oct 2, 2019BCDAGeneral
BioCardia Announces the Appointment of Two New Board Members
SAN CARLOS, Calif., Oct. 02, 2019 (GLOBE NEWSWIRE) -- BioCardia (Nasdaq: BCDA), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced the appointment of experienced CEOs Jim Allen and Andrew Blank to its Board of Directo
Read more →
BCDA Oct 1, 2019BCDAGeneral
BioCardia Initiates Commercial Release of AVANCE Steerable Introducer Designed to Enhance Physician Control for Complex Cardiac Procedures
SAN CARLOS, Calif., Oct. 01, 2019 (GLOBE NEWSWIRE) -- BioCardia (Nasdaq: BCDA), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced the U.S. commercial availability of its AVANCE™ Bi-Directional Steerable Introducer Sh
Read more →
BCDA Sep 16, 2019BCDAPhases
BioCardia Announces Positive DSMB Recommendation to Continue Phase 3 Pivotal CardiAMP Heart Failure Study as Planned
SAN CARLOS, Calif., Sept. 16, 2019 (GLOBE NEWSWIRE) -- BioCardia (Nasdaq: BCDA), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced that the independent Data Safety Monitoring Board (DSMB) has completed its prespecifi
Read more →
BCDA Aug 21, 2019BCDAGeneral
BioCardia Reports 2019 Second Quarter Financial Results and Business Highlights
SAN CARLOS, Calif., Aug. 21, 2019 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today reported financial results and business highlights for the second quarter 2019 and filed
Read more →
BCDA Aug 8, 2019BCDAGeneral
BioCardia Announces Issuance of European Patent for Breakthrough Diagnostic Assay for Patient Selection Prior to Cardiac Cell Therapy Delivery
SAN CARLOS, Calif., Aug. 08, 2019 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced that the European Patent Office has issued the Company Patent No: 3063172 for “Met
Read more →
BCDA Aug 6, 2019BCDAGeneral
BioCardia Announces Closing of $10.0 Million Public Offering
SAN CARLOS, Calif., Aug. 06, 2019 (GLOBE NEWSWIRE) -- BioCardia, Inc. (NasdaqCM: BCDA, BCDAW), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced the closing of its previously announced public offering of 1,666,667 un
Read more →
BCDA Aug 2, 2019BCDAGeneral
BioCardia Announces Pricing of $10.0 Million Public Offering and Uplisting to Nasdaq
SAN CARLOS, Calif., Aug. 02, 2019 (GLOBE NEWSWIRE) -- BioCardia, Inc. (NasdaqCM: BCDA, BCDAW), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced the pricing of its public offering of 1,666,667 units at a price to the
Read more →
BCDA Jul 25, 2019BCDAGeneral
BioCardia Signs Exclusive Development Agreement With AstraZeneca
SAN CARLOS, Calif., July 25, 2019 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced it has signed an extension to a 2017 development agreement with AstraZeneca [NYSE:
Read more →
BCDA Jun 12, 2019BCDAGeneral
BioCardia Announces Issuance of Chinese Patent for Image-Guided Biotherapeutic Delivery
SAN CARLOS, Calif., June 12, 2019 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced that the China National Intellectual Property Administration has recently issued t
Read more →
BCDA Jun 6, 2019BCDAGeneral
BioCardia Announces Reverse Stock Split and Plan for Listing on a Major Stock Exchange
SAN CARLOS, Calif., June 06, 2019 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced that a reverse stock split of its common stock, $0.001 par value, at a ratio of on
Read more →
BCDA May 20, 2019BCDAGeneral
BioCardia Reports 2019 First Quarter Financial Results and Business Highlights
SAN CARLOS, Calif., May 20, 2019 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today reported financial results and business highlights for the first quarter of 2019 and filed it
Read more →
BCDA May 8, 2019BCDAFDA Updates
BioCardia Receives FDA Clearance for AVANCE Steerable Introducer for Transseptal Access to Heart
SAN CARLOS, Calif., May 08, 2019 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the AVANCE™ steerable i
Read more →
BCDA Nov 7, 2017BCDAGeneral
EX-3.1 2 ex_99489.htm EXHIBIT 3.1 ex_99489.htm Exhibit 3.1 CERTIFICATE OF AMENDMENT OF AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF BIOCARDIA , INC . BioCardia , Inc., a Delaware corporation (the " Corporation ")
CERTIFICATE OF AMENDMENT OF
AMENDED AND RESTATED CERTIFICATE OF INCORPORATION
BioCardia, Inc., a Delaware corporation (the "Corporation"), hereby certifies as follows:
1. The name of the Corporation is BioCardia, Inc. The Corporation was originally incorporated under the name
Read more →
BCDA Dec 29, 2016BCDAPhases
CardiAMP Pivotal Heart Failure Trial Initiated at Two US Centers SAN CARLOS, CA - December 29 , 2016 - BioCardia , Inc. [OTC:BCDA], a leader in the development of comprehensive solutions for cardiov
CardiAMP Pivotal Heart Failure Trial Initiated at Two US Centers
SAN CARLOS, CA - December 29, 2016 - BioCardia , Inc. [OTC:BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced the initiation of the CardiAMP Hea
Read more →
BCDA Oct 27, 2016BCDAGeneral
attached to our Current Report on Form 8-K filed with the Securities and Exchange Commission on
BioCardia Lifesciences, Inc.
Page Unaudited Condensed Financial Statements Unaudited Condensed Balance Sheets as of September 30, 2016 and December 31, 2015 2 Unaudited Condensed Statements of Operations for the three and nine month periods ended September 30, 2016 and 2015 3
Read more →
BCDA Oct 27, 2016BCDAGeneral
BioCardia, Inc. Index
December 31, 2015 and 2014
Page Report of Independent Registered Public Accounting Firm 2 Balance Sheets 3 Statements of Operations 4 Statements of Convertible Preferred Stock and Stockholders' Deficit 5 Statements of Cash Flows 6 Notes to Financial Statements 7
Report of Inde
Read more →
BCDA Aug 23, 2016BCDAGeneral
BioCardia, Inc. Signs Merger Agreement with Tiger X Medical, Inc., Secures Funding to Support Further Development of CardiAMP Cell Therapy System for the Treatment of Heart Failure San Carlos and Miami
BioCardia, Inc. Signs Merger Agreement with Tiger X Medical, Inc., Secures Funding to Support Further Development of CardiAMP Cell Therapy System for the Treatment of Heart Failure
San Carlos and Miami August 23,
2016 BioCardia, Inc., a clinical-stage regenerative medicine comp
Read more →
BCDA Oct 6, 2015BCDAConferences/Events
BioCardia to Present at 2015 Stem Cell Meeting on the Mesa
SAN CARLOS, Calif., Oct. 05, 2015 (GLOBE NEWSWIRE) -- BioCardia, Inc., a clinical-stage regenerative medicine company developing novel therapeutics for cardiovascular diseases announced today that Peter Altman, Chief Executive Officer will present at the annual Partnering Forum o
Read more →
BCDA Jun 16, 2015BCDAGeneral
BioCardia, Inc. Files Registration Statement for Proposed Initial Public Offering
SAN CARLOS, CA--(Marketwired - Jun 16, 2015) - BioCardia, Inc., a clinical-stage regenerative medicine company developing novel therapeutics for cardiovascular diseases with large unmet medical needs, announced today that it has filed a registration statement on Form S-1 with the
Read more →
BCDA Jun 16, 2011BCDAGeneral
Pro Forma Unaudited Consolidated Financial Information The following unaudited pro forma consolidated financial statements have been prepared from the historical financial statements of Cardo Medical, Inc. ( Cardo ), as
Pro Forma Unaudited Consolidated Financial Information
The following unaudited pro forma consolidated financial statements have been prepared from
the historical financial statements of Cardo Medical, Inc. ( Cardo ), as adjusted, to give effect
to the sale of substantially all
Read more →
BCDA Apr 4, 2011BCDAGeneral
Pro Forma Unaudited Consolidated Financial Information The following unaudited pro forma consolidated financial statements have been prepared from the historical financial statements of Cardo Medical, Inc., as adjusted,
Pro Forma Unaudited Consolidated Financial Information
The following unaudited pro forma consolidated financial statements have been prepared
from the historical financial statements of Cardo Medical, Inc., as adjusted, to give effect to the
sale of substantially all of the as
Read more →
BCDA Oct 7, 2010BCDAGeneral
Cardo Medical, Inc. Announces Layoffs
Cardo Medical, Inc. Announces Layoffs
LOS ANGELES, October 7, 2010 /Globe Newswire/ -- Cardo Medical, Inc. (OTCBB:
CDOM), an orthopedic medical device company based in Beverly Hills, California, announced today that it terminated 15
of its 30 employees in varying functions and
Read more →
BCDA Nov 19, 2009BCDAGeneral
Cardo Medical, Inc. Announces Closing of $6.2 Million Private Placement Proceeds Will Fund Working Capital of the Company LOS ANGELES, Nov. 16 /PRNewswire-FirstCall/ -- Cardo Medical, Inc. (OTC Bulletin Board: CDOM), an
Cardo Medical, Inc. Announces Closing of $6.2 Million Private Placement
Proceeds Will Fund Working Capital of the Company
LOS ANGELES, Nov. 16 /PRNewswire-FirstCall/ -- Cardo Medical, Inc. (OTC Bulletin Board: CDOM), an
orthopedic medical device company based in Beverly Hills,
Read more →
BCDA Sep 2, 2008BCDAGeneral
CLICKNSETTLE.COM, INC. AND CARDO MEDICAL, LLC ANNOUNCE COMPLETION OF MERGER Miami, FL and Los Angeles, CA
CLICKNSETTLE.COM, INC. AND CARDO MEDICAL, LLC
ANNOUNCE COMPLETION OF MERGER
Miami, FL and Los Angeles, CA September 2, 2008 Cardo Medical, LLC, a company engaged in the
development of orthopedic medical devices, and clickNsettle.com, Inc., a publicly-traded company
with no ac
Read more →
BCDA Jun 18, 2008BCDAGeneral
CLICKNSETTLE.COM, INC. AND CARDO MEDICAL, LLC ANNOUNCE MERGER AGREEMENT Miami, FL and Los Angeles, CA
CLICKNSETTLE.COM, INC. AND CARDO MEDICAL, LLC
ANNOUNCE MERGER AGREEMENT
Miami, FL and Los Angeles, CA June 18, 2008 Cardo Medical, LLC, a company engaged in the
development of orthopedic medical devices, and clickNsettle.com, Inc. (OTCBB: CKST), a
publicly-traded company with
Read more →
BCDA Mar 18, 2008BCDAGeneral
clickNsettle.com, Inc. Closes Sale of 51% of the Company to Investor Group Led by Dr. Phillip Frost MIAMI, FL
clickNsettle.com, Inc. Closes Sale of 51% of the Company to Investor Group Led by Dr. Phillip Frost
MIAMI, FL March 18, 2008 clickNsettle.com, Inc. (CKST.OTC.BB) today announced that it
closed a Stock Purchase Agreement with a small group of investors, led by Dr. Phillip Frost.
Read more →
BCDA Dec 20, 2007BCDAGeneral
clickNsettle.com, Inc. Announces Proposed Sale of 51% of the Company to Investor Group Led by Dr. Phillip Frost MIAMI, FL
clickNsettle.com, Inc. Announces Proposed Sale of 51% of the Company to Investor Group Led by Dr.
MIAMI, FL December 20, 2007 clickNsettle.com, Inc. (CLIK.OTC.BB) today announced that it
entered into a Stock Purchase Agreement with a small group of investors, led by Dr. Phillip
Read more →
BCDA Sep 26, 2007BCDAGeneral
Glenn Halpryn and Jerry Glauser Purchase Control of clickNsettle.com, Inc. MIAMI, FLORIDA
Glenn Halpryn and Jerry Glauser
clickNsettle.com, Inc.
MIAMI, FLORIDA-September 26, 2007 [Symbol: CLIK.OTC.BB]-- On September 26, 2007,
Glenn Halpryn of Miami, Florida, and Jerry Glauser of Denver, Colorado, along
with other business associates, purchased 51.65% of the outsta
Read more →