BioCardia, Inc.

false 0000925741 0000925741 2026-05-08 2026-05-08 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 8, 2026 BIOCARDIA, INC. (Exact name of registrant as specified in its charter) Delaware 001-38999 23-2753988 (State or other jurisdiction of incorporation) (Commission File Number) (IRS Employer Identification No.) 320 Soquel Way Sunnyvale , California 94085 (Address of principal executive offices and zip code) Registrant ’ s telephone number, including area code: ( 650 ) 226-0120 Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: ☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock , par value $0.001 BCDA The Nasdaq Capital Market Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2 of this chapter) ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ Item 7.01 Regulation FD Disclosure. On May 8, 2026, BioCardia, Inc. issued a press release reporting the outcome of its Pre-Submission Meeting with FDA on the Helix Transendocardial Delivery Catheter System (Helix). FDA agreed that there are two pathways for Helix marketing clearance and raised no concerns on Helix safety data, device performance, or compatibility with general classes of agents. FDA’s preferred route of Helix approval was simultaneous with the approval of the CardiAMP cell therapy system for the treatment of heart failure. FDA also suggested a follow-on pre-submission incorporating agency advice could enable Helix approval via the DeNovo pathway. A copy of the press release is attached hereto as Exhibit 99.1 to this current report on Form 8-K. The information furnished pursuant to this Item 7.01, including Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities under that section, nor shall it be deemed to be incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise expressly set forth by specific reference in such filing. Item 9.01 Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1 BioCardia, Inc. press release dated May 8, 2026 104 Cover Page Interactive Data File (embedded within the Inline XBRL document) SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. BIOCARDIA, INC. /s/ Peter Altman, Ph.D. Peter Altman, Ph.D. President and Chief Executive Officer Date: May 8, 2026