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0000925741
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2026-11-06
2026-11-06
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): November 6, 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 8.01 Other Events.
On November 6, 2026, BioCardia, Inc. issued a press release announcing completion of clinical consultation process with Japan's PMDA for CardiAMP Cell Therapy System, advancing toward submission of marketing approval application.
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 8.01, 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 November 6, 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: November 6, 2026 | |
Exhibit 99.1
BioCardia Completes Clinical Consultation Process with Japan's PMDA for CardiAMP Cell Therapy System, Advancing Toward Submission of Marketing Approval Application
SUNNYVALE, Calif., November 6, 2026 (GLOBE NEWSWIRE) -- BioCardia®, Inc. (NASDAQ: BCDA), a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that it has completed the process with Japan's Pharmaceuticals and Medical Devices Agency (PMDA) concerning the application materials required to obtain regulatory approval in Japan for its CardiAMP Cell Therapy System ("CardiAMP") for the treatment of ischemic heart failure.
This milestone represents significant progress toward regulatory approval and commercialization of CardiAMP in Japan, one of the world's largest and most sophisticated cardiovascular medical device markets and a country at the forefront of regenerative medicine, including induced pluripotent stem (iPS) cell therapies.
"With the completion of consultations with PMDA regarding our application materials, we are closer to the day when we can provide CardiAMP cell therapy to heart failure patients in Japan," said Peter Altman, Ph.D., Chief Executive Officer of BioCardia. "The extensive work completed with PMDA positions us to initiate the process toward final regulatory approval review. We are targeting the treatment of our first patients in Japan and the realization of commercial revenues in 2028."
CardiAMP is intended to provide patients with ischemic heart failure a minimally invasive, catheter-based autologous cell therapy option. This patient population continues to have significant unmet medical needs despite advances in modern medical and device-based therapies. The therapy has been evaluated in three clinical trials involving more than 200 patient procedures, including two randomized, double-blind, placebo-controlled trials.
Completion of the consultation process does not constitute regulatory approval. The CardiAMP Cell Therapy System remains subject to PMDA review and applicable Japanese regulatory requirements.
About BioCardia
BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company's biotherapeutic platforms, with three cardiac clinical-stage product candidates in development. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms, and its Heart3D™ fusion imaging platform under development.
Forward-Looking Statements
This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, statements relating to the anticipated submission and potential marketing approval of the CardiAMP Cell Therapy System in Japan, the anticipated duration and outcome of regulatory review, potential reimbursement, commercialization, market opportunity, patient eligibility, and the timing of initial treatments and revenues.
These forward-looking statements are made as of the date of this press release.
Risk factors that could materially affect actual results can be found in BioCardia's Form 10-K filed with the Securities and Exchange Commission on March 24, 2026, under the caption "Risk Factors," and in its subsequently filed Quarterly Reports on Form 10-Q.
BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
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MEDIA CONTACT:
Miranda Peto, Investor Relations
mpeto@biocardia.com
(650) 226-0120
INVESTOR CONTACT:
David McClung, Chief Financial Officer
investors@biocardia.com
(650) 226-0120
