Biocardia, INC 8-K filings

BioCardia announced the presentation of its CardiAMP HF II trial design at the Heart Failure Society of America Annual Scientific Meeting, signaling progress in its cardiovascular therapeutic development.

BioCardia has finalized its revised De Novo Pre-Submission to the FDA for its Helix Catheter, a device for therapeutic and diagnostic agent delivery to the heart.

BioCardia, Inc. confirms timelines for its FDA Helix pre-submission and PMDA CardiAMP HF Shonin submission, with potential market clearance for CardiAMP HF by Q4 2027.

BioCardia, Inc. has successfully regained compliance with the Nasdaq Capital Market's minimum bid price requirement, closing a matter that previously threatened its listing.

BioCardia announced its CEO will present regulatory and corporate progress, including updates on its CardiAMP therapy and delivery platforms, at the H.C. Wainwright conference.

BioCardia announced the FDA has confirmed meeting minutes for its Helix Transendocardial Delivery Catheter, supporting a follow-on De Novo pre-submission for approval.

BioCardia, Inc. received a notice from Nasdaq indicating its common stock has fallen below the $1.00 minimum bid price requirement, triggering a 180-day compliance period.

BioCardia announced strong Q2 2026 business highlights and financial results, detailing significant regulatory advancements in Japan and the US for its CardiAMP Cell Therapy and Helix delivery system.

BioCardia, Inc. outlines its business strategy, prioritizing the submission of CardiAMP Cell Therapy for approval in Japan and advancing its US clinical trials, alongside exploring strategic partnerships for its delivery platforms.

BioCardia, Inc. has regained compliance with Nasdaq's minimum stockholders' equity requirement following a successful capital raise.

BioCardia announced a $4.4 million financing, selling shares at an average price of $1.279, to extend its cash runway into early 2027 and beyond potential Japan PMDA submission.

BioCardia announced that the FDA confirmed its ongoing CardiAMP Heart Failure II trial may support Premarket Approval for its cell therapy system.

BioCardia received a positive Consultation Record from Japan's PMDA, clearing a path for regulatory submission of its CardiAMP cell therapy in Q4 2026.

BioCardia's CardiAMP CMI trial preliminary results show durable improvements in exercise tolerance and reduced angina in patients with chronic myocardial ischemia.

BioCardia, Inc. announced its first quarter 2026 financial results, highlighting significant progress in regulatory discussions for its CardiAMP cell therapy and Helix delivery system with both the FDA and Japan's PMDA.

BioCardia announced alignment with the FDA on two pathways for its Helix Transendocardial Delivery Catheter System clearance, with no safety concerns raised.

BioCardia announced the allowance of a Japanese patent for its Heart3D Fusion Imaging software, enhancing its proprietary technology for cardiovascular procedures.

BioCardia announced a positive outcome from its formal clinical consultation with Japan's PMDA, indicating that clinical data for CardiAMP Cell Therapy in ischemic heart failure is likely sufficient for market clearance.

BioCardia, Inc. has been notified by Nasdaq that it fails to meet the minimum stockholders' equity requirement for continued listing.

BioCardia has submitted CardiAMP HF clinical trial data to the FDA and requested a meeting to discuss an accelerated approval pathway for its heart failure therapy.

BioCardia, Inc. reported its 2025 financial results, including an increased net loss and no revenue, while highlighting significant progress in its CardiAMP and CardiALLO cell therapy clinical programs and regulatory discussions in the US and Japan.

BioCardia, Inc. announced the FDA has accepted its pre-submission package for the Helix Transendocardial Delivery Catheter, a key step towards market clearance.

BioCardia reported positive echocardiography results from its Phase III CardiAMP HF trial, showing reduced negative heart remodeling in treated patients.

BioCardia, Inc. announced the completion of its Pre-Submission to the FDA for its Helix Transendocardial Delivery Catheter, aiming for market clearance.

BioCardia, Inc. announced that echocardiography data from its CardiAMP Cell Therapy for heart failure has been accepted for a Late Breaking Clinical Trial Oral Presentation at the upcoming THT Meeting.

BioCardia's CardiAMP Cell Therapy for ischemic heart failure is set to proceed to formal clinical consultation with Japan's PMDA after a positive preliminary meeting.

BioCardia, Inc. announced the election of Marvin Slosman to its Board of Directors and the departure of Dr. Richard Krasno, alongside key approvals from its Annual Meeting.

BioCardia, Inc. announced the appointment of Farhan Shahab as Vice President of Quality, bringing over 25 years of executive experience to the company.

BioCardia reports significant clinical advancements for its heart failure therapies and delivery systems, supported by a recent $6 million financing, despite an increased nine-month net loss.

BioCardia, Inc. announced the enrollment of the first patient at Henry Ford Health in its pivotal Phase 3 CardiAMP HF II clinical trial for ischemic heart failure.