BioCardia, Inc. SEC filings document a clinical-stage biotechnology and medical-device business focused on cell therapies and related delivery technologies for cardiovascular and pulmonary disease. Recent Form 8-K reports cover Regulation FD disclosures and other events involving CardiAMP clinical data, FDA and PMDA regulatory interactions, the Helix transendocardial delivery catheter, and patent protection for Heart3D Fusion Imaging software.
The company’s filings also record annual operating results, research and development activity, liquidity-related financial disclosures, and Nasdaq continued-listing compliance matters. These documents frame BCDA’s public-company record around product-development programs, regulatory pathways, intellectual property, capital and listing status, risk disclosures, and corporate reporting obligations.
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. President and CEO Peter Altman purchased 1,000 shares of common stock on September 29, 2026, at a weighted-average price of $1.03 per share. The trades ranged from $1.02 to $1.05 per share. His direct holdings following the purchase were 384,885 shares; no Rule 10b5-1 plan is reported.
BioCardia, Inc. director and President and CEO Peter Altman purchased 1,900 shares of common stock on September 23, 2026, at a reported weighted average price of $1.05 per share. The purchase consisted of multiple trades ranging from $1.04 to $1.08 per share. His reported direct holdings after the purchase were 383,885 shares. No Rule 10b5-1 plan is reported.
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) reported that President and CEO Peter Altman purchased 800 shares of common stock in a direct, open-market transaction on September 3, 2026, at a weighted average price of $1.09 per share, with individual trade prices ranging from $1.09 to $1.10. Following this purchase and a correction adding 70 previously omitted shares, he directly holds 381,985 shares of BioCardia common stock.
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.