Every 8-K that BioCardia, Inc. (BCDA) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow BCDA and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full BCDA filings page.
BioCardia, Inc. plans to present the design and scientific support for its CardiAMP HF II study in a poster at the Heart Failure Society of America Annual Scientific Meeting in Phoenix, Arizona, October 9–12, 2026. The study aims to determine the efficacy of high-dose autologous cell treatment for patients with ischemic HFrEF who remain on guideline-directed medical therapy but have elevated biomarkers of heart stress. The presentation will be available through the Scientific Publications section of BioCardia’s website.
BioCardia says FDA has approved a category B designation for the CardiAMP cell therapy system in three separate clinical trials, based on either resolved underlying questions of safety and effectiveness or a determination that the device type can be safe and effective. The company also reports that FDA recently agreed the ongoing CardiAMP HF II trial may be sufficient to support FDA approval.
BioCardia, Inc. (BCDA) completed a revised De Novo pre-submission to FDA’s Center for Devices and Radiological Health under its Q-Submission program for the Helix Catheter, which is intended to deliver therapeutic and diagnostic agents to the heart. The revision incorporates FDA advice from a May 2026 meeting; in August 2026, FDA confirmed and accepted the meeting minutes as summarized by BioCardia.
FDA agreed there are two pathways for Helix marketing clearance and raised no concerns regarding its safety data, device performance, or compatibility with general classes of agents. BioCardia cited clinical data and safety experience from 15 clinical trials involving nearly 500 patients. Independent FDA clearance could expand partnership opportunities with developers of investigational therapies requiring targeted delivery to the heart.
BioCardia, Inc. (BCDA) announced an update on timing for the FDA Helix Pre-Submission and PMDA CardiAMP HF Shonin Submission milestones. The company describes CardiAMP and CardiALLO as its biotherapeutic platforms and says three cardiac clinical-stage product candidates are in development.
BioCardia, Inc. (BCDA) reports that Nasdaq has determined the company has regained compliance with the Nasdaq Capital Market’s $1.00 minimum bid price requirement. The Nasdaq staff confirmed that BioCardia’s common stock closed at or above $1.00 per share for at least 10 consecutive business days, and the deficiency matter is now closed. The stock continues to trade on the Nasdaq Capital Market under the symbol BCDA. The company notes there is no assurance it will be able to maintain compliance with this requirement in the future.
BioCardia, Inc. (BCDA) reported that President and Chief Executive Officer Peter Altman, Ph.D., will present at the H.C. Wainwright 28th Annual Global Investment Conference in New York City from September 14-16, 2026.
Altman is expected to discuss regulatory progress for the CardiAMP autologous cell therapy in Japan and the United States, the ongoing CardiAMP HF II pivotal trial, and the company’s Helix transendocardial delivery and Heart3D fusion imaging platforms, as well as related business development activities. BioCardia’s prerecorded presentation is expected to be available to conference participants beginning September 11, 2026, and management plans to hold one-on-one investor meetings during the event.
BioCardia, Inc. (BCDA) reports that the FDA has confirmed and accepted the meeting minutes from its Pre-Submission Meeting for the Helix Transendocardial Delivery Catheter System, making those minutes final.
BioCardia plans to submit a follow-on pre-submission for Helix this quarter, incorporating FDA advice, which the company states could enable Helix approval via the De Novo pathway. Management believes that, if successful, independent Helix market clearance may support development and commercial partnering for investigational cell, gene, and protein therapeutics. The company also highlights a broader pipeline and lists anticipated catalysts, including CardiAMP and CardiALLO cell therapy milestones, Helix regulatory steps, and Heart3D fusion imaging first-in-man readiness.
BioCardia, Inc. (BCDA) reports that Nasdaq has notified the company that its common stock has failed to meet the $1.00 per share Minimum Bid Price Requirement for the last 30 consecutive business days, putting its Nasdaq Capital Market listing at risk under Nasdaq Listing Rule 5550(a)(2).
BioCardia has an initial 180-day grace period, until February 16, 2027, to regain compliance by having a closing bid of at least $1.00 for at least ten consecutive business days. The notice does not immediately affect trading. If still noncompliant, BioCardia may seek an additional 180 days, potentially including a reverse stock split, and could appeal any delisting determination.
BioCardia, Inc. reported second quarter 2026 results highlighting supportive regulatory feedback and a narrower loss. Japan’s PMDA indicated it supports a regulatory submission for CardiAMP Cell Therapy for ischemic heart failure, the FDA indicated the CardiAMP HF II trial may be sufficient for U.S. approval, and the FDA also said DeNovo approval of the Helix transendocardial delivery catheter is possible. The company is preparing a PMDA submission for the fourth quarter, continues enrolling the CardiAMP HF II trial, and is awaiting FDA minutes on the Helix DeNovo pre-submission.
For the quarter ended June 30, 2026, net loss was $1.6 million compared with $2.0 million a year earlier, with net loss per share of $0.13 versus $0.40. Research and development expenses were $0.9 million and selling, general and administrative expenses were $0.7 million. For the first six months of 2026, net loss was $3.9 million versus $4.8 million. As of June 30, 2026, cash and cash equivalents were $4.1 million and total stockholders’ equity was $2.7 million.
BioCardia, Inc. provided shareholders with a strategic update outlining its 2026 priorities and regulatory plans. The company is preparing a CardiAMP Cell Therapy approval submission to Japan’s PMDA for ischemic heart failure, initially targeting about 20,000 patients out of an estimated 300,000 in Japan.
Management highlights Japan’s role as a reference country and MDSAP member, which may streamline registrations in other regions if approval is obtained and manufacturing passes a single audit. BioCardia is also enrolling the CardiAMP HF II confirmatory trial in the United States and expanding participating centers.
The letter emphasizes the Helix delivery and Heart3D imaging platforms as a “pipeline-in-a-product” for multiple cardiac gene and cell therapies, along with an off‑the‑shelf MSC platform supported by two FDA‑approved INDs. Recent financing is described as sufficient to advance the Japan submission, U.S. enrollment, and ongoing partnering discussions.
BioCardia, Inc. reported an update on its Nasdaq listing compliance. The company previously fell below the $2.5 million stockholders’ equity requirement under Nasdaq Listing Rule 5550(b)(1) but submitted a plan and received an extension from Nasdaq staff until October 7, 2026 to regain compliance.
Through its at-the-market equity program with H.C. Wainwright & Co., BioCardia sold 4,004,330 shares of common stock between April 1 and June 5, 2026 at an average price of about $1.27 per share, generating net proceeds of $4.9 million. The company believes these transactions have raised stockholders’ equity above $2.5 million as of this report, though Nasdaq will continue to monitor compliance and could delist the stock if a future periodic report does not show the required equity level.
BioCardia, Inc. reported that it raised approximately $4.4 million through an at-the-market stock sale. The company sold 3,509,604 shares at an average price of $1.279 per share on June 5, 2026, under its at-the-market offering agreement with H.C. Wainwright & Co.
Management anticipates that net proceeds will extend BioCardia’s cash runway into the first quarter of 2027, beyond its planned Japan PMDA submission for CardiAMP Cell Therapy. The company also noted that no warrants were issued in this capital raise, and if currently outstanding warrants from prior financings are fully exercised for cash, the cash runway is expected to extend well beyond PMDA approval and into initial commercial sales.
BioCardia, Inc. announced that FDA Center for Biologics Evaluation and Research meeting minutes confirm the ongoing CardiAMP Heart Failure II Trial may be used to support a Premarket Approval (PMA) application for the CardiAMP Cell Therapy System in ischemic heart failure with reduced ejection fraction.
The company notes that FDA typically prefers two well-designed trials for large indications such as HFrEF, where there are potentially over one million U.S. patients who could benefit from CardiAMP Cell Therapy, so FDA’s acknowledgement of this single ongoing trial as potentially sufficient is an important regulatory step.
CardiAMP Cell Therapy has FDA Breakthrough designation and uses a patient’s own bone marrow cells delivered via a minimally invasive catheter procedure to improve microvascular function in myocardial tissue. Regulatory discussions in Japan suggest three completed heart failure trials may provide enough safety and efficacy evidence for approval there, while U.S. trials have received reimbursement from the Centers for Medicare and Medicaid Services.
BioCardia reported that Japan’s Pharmaceutical and Medical Device Agency (PMDA) issued a Consultation Record that supports submission for regulatory approval of its CardiAMP cell therapy for ischemic heart failure with reduced ejection fraction. The agency confirmed alignment on remaining questions and noted the trial’s positive outcomes were credible.
The company plans to submit in approximately seven months, with the regulatory submission anticipated in Q4 2026. BioCardia estimates that 20,000 of 300,000 ischemic heart failure patients in Japan could initially be eligible if approved. Prior trials showed the minimally invasive procedure was well tolerated, with average exercise tolerance improving 179 seconds and angina episodes reduced by 82%.
BioCardia, Inc. reported preliminary open-label results from its CardiAMP Cell Therapy trial in chronic myocardial ischemia, presented at the EuroPCR conference. The minimally invasive, autologous cell therapy was well tolerated, with no treatment emergent major adverse cardiac events through two years of follow-up.
Patients had already exhausted guideline-directed medical, percutaneous, and surgical options before treatment. After CardiAMP therapy, average exercise tolerance increased by 179 seconds and this benefit persisted over two years. Angina episodes fell by an average of 82% by six months, suggesting meaningful symptom relief for severely symptomatic refractory angina patients.
BioCardia, Inc. reported first quarter 2026 results, showing a smaller net loss while its balance sheet weakened. Net loss was 2,259 thousand for the three months ended March 31, 2026, compared with 2,712 thousand a year earlier, and net loss per share improved to $0.21 from $0.59. Total costs and expenses fell to 2,266 thousand from 2,726 thousand, reflecting lower research and development and selling, general and administrative spending. Cash and cash equivalents were 951 thousand as of March 31, 2026, down from 2,496 thousand at December 31, 2025, and total assets declined to 1,712 thousand from 3,413 thousand. Stockholders’ equity turned into a deficit of 1,066 thousand at March 31, 2026, compared with positive equity of 895 thousand at year-end 2025, while current liabilities increased to 2,778 thousand. The company highlighted a robust intellectual property portfolio with more than 60 patents and patent applications worldwide, including a newly allowed Japanese patent covering its Heart3D Fusion Imaging software to support CardiAMP Cell Therapy procedures.
BioCardia, Inc. describes alignment with FDA on marketing clearance pathways for its Helix Transendocardial Delivery Catheter System. FDA agreed there are two potential routes and raised no concerns about Helix safety data, device performance, or compatibility with general classes of agents.
FDA’s preferred path would link Helix approval to approval of BioCardia’s CardiAMP cell therapy system for treating heart failure. FDA also indicated that a follow-on pre-submission, incorporating its advice, could support Helix clearance through the DeNovo pathway, which could position Helix for broader use with other investigational biologic therapies.
BioCardia, Inc. reported that Japan has allowed a patent titled “Target Site Selection, Entry, and Update with Automatic Remote Image Annotation,” covering its proprietary Heart3D™ Fusion Imaging software. Heart3D is intended for treatment planning and real-time navigation during CardiAMP® Cell Therapy procedures and use with the Helix™ intramyocardial delivery system.
The company noted recent positive consultation with the Japanese Pharmaceutical and Medical Device Agency, and is working to submit CardiAMP Cell Therapy and its Helix delivery system for approval in Japan. The Japanese agency indicated that results from three completed ischemic heart failure trials likely provide sufficient safety and efficacy evidence to support a successful approval submission.
BioCardia, Inc. reported a positive outcome from a formal clinical consultation with Japan’s Pharmaceutical and Medical Device Agency (PMDA) regarding its CardiAMP Cell Therapy for ischemic heart failure. PMDA determined that existing clinical safety and efficacy data are likely sufficient to support market clearance in Japan.
The parties reached alignment on using CardiAMP clinical data generated in the United States, the intended patient indications, how to introduce the therapy in Japan, and the need for post-marketing studies there. BioCardia will await PMDA’s written meeting minutes for detailed feedback and a potential filing timeline.
CardiAMP Cell Therapy, which has FDA Breakthrough designation, uses a patient’s own bone marrow cells delivered via a minimally invasive catheter-based procedure to improve myocardial microvascular function. Development is supported by the Maryland Stem Cell Research Fund and reimbursement from the U.S. Centers for Medicare and Medicaid Services.
BioCardia, Inc. reported that Nasdaq notified the company on April 10, 2026 that it no longer meets the Nasdaq Capital Market’s continued listing standard requiring stockholders’ equity of at least $2.5 million. BioCardia’s stockholders’ equity was $895,000 as of December 31, 2025.
The company has until May 25, 2026 to submit a plan to regain compliance and, if Nasdaq accepts the plan, may receive up to 180 calendar days from April 10, 2026 to show it again meets the requirement. BioCardia’s common stock will continue trading on the Nasdaq Capital Market under the symbol BCDA while Nasdaq reviews the situation.
BioCardia, Inc. submitted CardiAMP HF clinical study data to the FDA and requested a meeting to discuss an accelerated approval pathway for the CardiAMP System to treat ischemic chronic heart failure with reduced ejection fraction. The planned meeting is expected during the current quarter under the program’s existing FDA Breakthrough Designation.
BioCardia aims to confirm whether its proposed approval submission is acceptable based on safety from the CardiAMP HF Trial, clinical response data in 125 ischemic HFrEF patients, and a favorable benefit–risk profile in a subgroup with elevated biomarkers of heart stress. In this higher‑risk subgroup, cells delivered showed a 47% relative risk reduction in all‑cause cardiac death, a 37% relative risk reduction in non‑fatal major adverse cardiac events, and meaningful quality‑of‑life improvement with a reported p=0.04.
BioCardia reported full-year 2025 results, highlighting ongoing investment in its cell therapy pipeline while remaining a development-stage company with minimal revenue. Collaboration agreement revenue was $0 in 2025, down from $58,000 in 2024.
Total operating costs and expenses were $8.3M, slightly above $8.1M in 2024, driven by research and development of its CardiAMP, CardiALLO and Helix delivery programs plus selling, general and administrative spending. The company posted a net loss of $8.2M, compared with a $7.9M loss a year earlier, while net loss per share improved to $(1.23) from $(2.90) as the share count increased.
BioCardia ended 2025 with cash and cash equivalents of $2.5M and total assets of $3.4M, against current liabilities of $2.4M and total stockholders’ equity of $0.9M. Management emphasized progress on regulatory discussions and the confirmatory CardiAMP HF II trial, along with additional therapeutic programs and its Morph vascular navigation platform.
BioCardia, Inc. reported that the FDA has accepted its pre-submission package for approval of the Helix Transendocardial Delivery Catheter, a device designed to deliver therapeutic and diagnostic agents directly into heart muscle.
The FDA’s Center for Devices and Radiological Health will lead a substantive review, with a meeting scheduled for early Q2 in consultation with the Center for Biologics Evaluation and Research. Management notes that Helix marketing clearance could be meaningful for the business and may also support the approval pathway for the CardiAMP Cell Therapy program.
BioCardia, Inc. reported late-breaking echocardiography results from its Phase III CardiAMP HF trial in ischemic heart failure with reduced ejection fraction. The data, presented at the Technology and Heart Failure Therapeutics conference, focus on how the investigational autologous cell therapy affects heart structure over time.
Patients receiving CardiAMP therapy showed positive evidence of decreased pathological left ventricular remodeling compared to controls, aligning with previously reported reductions in major adverse cardiovascular events and improved quality-of-life measures. In a prespecified subgroup with elevated myocardial stress biomarkers, differences in ventricular volumes were both clinically meaningful and statistically significant, supporting BioCardia’s belief in the therapy’s potential benefit.
BioCardia, Inc. filed an 8-K reporting that it has completed a Pre-Submission to the U.S. Food and Drug Administration under the Q-Submission program for approval of its Helix transendocardial delivery catheter for intramyocardial therapeutic and diagnostic agent delivery.
The Pre-Submission is supported by data from fifteen well-controlled clinical trials in three primary cardiac indications and is made under the CardiAMP Cell Therapy System FDA Breakthrough Designation. BioCardia seeks to align with FDA on the regulatory pathway and timing for approval within the next 45 days, after which an application for market clearance could follow.
The company states this process should support Helix becoming the first approved transendocardial delivery catheter system in the United States and may streamline future approvals of its CardiAMP and CardiALLO cell therapies and potential partners’ cardiovascular cell, gene, and protein programs.
BioCardia, Inc. reported that echocardiography data from its CardiAMP Cell Therapy program for the treatment of heart failure has been accepted as a Late Breaking Clinical Trial oral presentation at the Technology and Heart Failure Therapeutics (THT) Meeting. This conference is scheduled for March 2-4, 2026, in Boston, Massachusetts.
The company furnished a press release as an exhibit, which provides additional detail on the CardiAMP heart failure data to be discussed at the meeting. This disclosure is characterized as an informational event rather than a financial or transactional update.
BioCardia, Inc. reported that Japan’s Pharmaceutical and Medical Device Agency has agreed to let the company move its CardiAMP Cell Therapy for the treatment of heart failure with reduced ejection fraction into a formal clinical consultation process. This follows completion of a third preliminary clinical consultation with the agency. If, in that formal consultation, the PMDA concludes that the available data provide sufficient evidence of safety and efficacy, BioCardia would be able to file for regulatory approval in Japan for this cell therapy.
BioCardia, Inc. (BCDA) reported an organizational update. The company announced in an 8-K that, on November 24, 2025, it issued a press release appointing Farhan Shahab as Vice President of Quality. This role typically oversees and supports quality systems and compliance for products and operations, which is important for companies operating in regulated medical and life science markets.
The press release describing the appointment is included as Exhibit 99.1, and the company notes that this information is being furnished, not filed, under securities laws, meaning it is provided for disclosure purposes without triggering certain liability provisions.
BioCardia, Inc. filed a current report to furnish its latest quarterly results update. On November 12, 2025, the company issued a press release announcing its financial results for the quarter ended September 30, 2025, and attached that release as an exhibit.
The press release is provided as Exhibit 99.1 and is treated as "furnished" rather than "filed" under securities law, which limits certain legal liabilities and incorporation by reference into other SEC documents unless specifically cited.
BioCardia (BCDA) reported an operational milestone: it announced the first patient enrolled at Henry Ford Health in its ongoing Phase 3 CardiAMP HF II clinical trial for patients with “ischemia heart failure of reduced ejection fraction.”
The announcement was made via a press release furnished as Exhibit 99.1. The information is being furnished under Item 8.01 and is not deemed filed under the Exchange Act.
BioCardia (BCDA) announced the first patient was enrolled at the University of Wisconsin School of Medicine and Public Health in its ongoing Phase 3 CardiAMP HF II clinical trial. The update was disclosed under Item 8.01 as a furnished report, and a press release is included as Exhibit 99.1 dated October 30, 2025. The information is furnished, not filed, under the Exchange Act.
BioCardia, Inc. set its 2025 Annual Meeting of Stockholders for Tuesday, December 2, 2025 at 9:00 a.m. Pacific Time, to be held at Wilson Sonsini Goodrich & Rosati in Palo Alto, California. The company established the close of business on October 8, 2025 as the record date for stockholders entitled to receive notice of and vote at the meeting.
Stockholders who wish to submit proposals for inclusion in the company’s proxy statement under SEC Rule 14a-8, nominate directors, or bring other business at the meeting must ensure their notices are received at BioCardia’s Sunnyvale headquarters by October 17, 2025, and comply with SEC rules, Delaware law, and the company’s bylaws. Stockholders intending to use the universal proxy process to solicit proxies for their own director nominees must also provide the required Rule 14a-19 notice by October 17, 2025.
BioCardia, Inc. announced that on October 2, 2025 it received formal written notice from The Nasdaq Stock Market staff that the company has regained compliance with Listing Rule 5550(b)(1). As a result, the company's common stock will continue to be listed on The Nasdaq Stock Market. The filing states a press release describing the action is attached as Exhibit 99.1 to the current report. The notice signals Nasdaq’s staff has accepted whatever corrective steps the company previously took to meet the Equity Rule and preserves the company’s ongoing access to Nasdaq’s market for its common shares.
BioCardia, Inc. filed a Current Report stating that, as of the report date, it believes it has regained compliance with Nasdaq's minimum $2.5 million stockholders' equity requirement for continued listing. The company notes that stockholders' equity exceeds $2.5 million as of the date of the report but warns Nasdaq will continue to monitor ongoing compliance and could initiate delisting proceedings if compliance is not maintained at the time of its next periodic report. The filing also includes standard forward-looking statement disclaimers referencing the company's annual and quarterly reports.
BioCardia, Inc. filed an 8-K to report that it has had a positive preliminary clinical consultation with Japan’s Pharmaceutical and Medical Devices Agency (PMDA) regarding the CardiAMP Heart Failure Trial results previously provided to the agency.
The meeting was held to prepare for a formal clinical consultation on whether the trial data will be acceptable for submission of an application for product approval in Japan. BioCardia also furnished the related press release as an exhibit to this report.
BioCardia, Inc. completed a registered offering on September 19, 2025, selling 4,800,000 shares of common stock together with warrants to purchase up to 4,800,000 shares at a combined price of $1.25 per share and warrant, generating approximately $6.0 million in gross proceeds. Certain directors and executive officers purchased 734,400 shares and warrants for roughly $0.9 million. The company expects net proceeds of about $5.1 million after placement agent fees and offering expenses. Each warrant is exercisable at $1.25, immediately exercisable, and expires September 20, 2027, subject to customary anti-dilution adjustments and beneficial ownership exercise limits (default 4.99% or elective 9.99% with notice). The Purchase Agreements include customary representations, indemnities and closing conditions, and contain lock-up and variable-rate transaction restrictions through November 18, 2025 and March 19, 2026, respectively, which the placement agent may waive.
BioCardia, Inc. filed a Form 8-K to report that on September 18, 2025 it issued a press release announcing the pricing of a public offering involving its common stock and warrants. The filing presents this as a Regulation FD disclosure, meaning the company is sharing this capital markets update broadly with investors. The press release is included as Exhibit 99.1, along with an Inline XBRL cover page data file listed as Exhibit 104.
BioCardia, Inc. filed a current report describing a communication about one of its clinical programs. The company furnished a press release announcing primary endpoint results from the open label roll-in cohort of its CardiAMP Cell Therapy in Chronic Myocardial Ischemia Trial. The press release is included as Exhibit 99.1 and is treated as furnished, not filed, under securities law.