BioCardia, Inc. filed a Form 8-K on November 6, 2026, announcing the completion of a clinical consultation process with Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for its CardiAMP Cell Therapy System, with the company advancing toward submission of a marketing approval application.

Key Highlights

  • PMDA consultation complete: BioCardia disclosed it completed a clinical consultation process with Japan's PMDA for the CardiAMP Cell Therapy System.
  • Next step identified: According to the filing, the company is advancing toward submission of a marketing approval application in Japan.
  • Press release attached: A press release dated November 6, 2026 was attached as Exhibit 99.1 to the filing.
  • Event date: The date of the earliest event reported is November 6, 2026.
  • Filing classification: The disclosure was made under Item 8.01 (Other Events) and is not deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934.

BioCardia's CardiAMP System Clears Japan PMDA Clinical Consultation

BioCardia, Inc. (NASDAQ:BCDA) reported in a current report filed November 6, 2026, that it has completed a clinical consultation process with Japan's Pharmaceuticals and Medical Devices Agency, known as the PMDA, for its CardiAMP Cell Therapy System. According to the filing, the company is now advancing toward submission of a marketing approval application in Japan.

The disclosure was made under Item 8.01, covering "Other Events," and was accompanied by a press release dated November 6, 2026, attached as Exhibit 99.1. The filing notes that the information furnished under Item 8.01, including the press release, "shall not be deemed 'filed' for purposes of Section 18 of the Securities Exchange Act of 1934, as amended," and is not automatically incorporated by reference into other company filings unless expressly referenced.

The 8-K was signed by Peter Altman, Ph.D., President and Chief Executive Officer of BioCardia, Inc., on November 6, 2026. BioCardia is incorporated in Delaware and headquartered at 320 Soquel Way, Sunnyvale, California 94085. Its common stock, par value $0.001, trades on the Nasdaq Capital Market under the symbol BCDA.

What Was Disclosed

BioCardia filed an 8-K on November 6, 2026, disclosing completion of the PMDA clinical consultation process for the CardiAMP Cell Therapy System and the company's intent to move toward a Japanese marketing approval application submission.