重大事件即時報告 8-K 2026-05-21

報告日期：2026年5月21日

AI 繁中摘要

📄 申報類型：8-K（即時報告）
🏢 公司：BioCardia, Inc.（納斯達克代號：BCDA）
📅 報告日期：2026年5月21日

BioCardia 於 Euro PCR 巴黎會議上，公佈其 CardiAMP 細胞療法於慢性心肌缺血（CMI）試驗的初步開放標籤組結果。該口頭報告由威斯康辛大學醫學院 Amish Raval 教授代表研究團隊發表。

🔬 臨床重點：
- 微創 CardiAMP 自體細胞療法耐受性良好，至今未出現與治療相關的主要不良心臟事件（MACE）。
- 病人運動耐量平均增加 179 秒，改善效果持續至兩年跟進期。
- 治療後六個月，心絞痛發作頻率平均減少 82%。
- 所有病人在治療前均已接受指引導向藥物治療，並已用盡所有合適的經皮或外科介入選項。

💡 對投資者的潛在意義：
該初步數據顯示自體細胞療法有望為已無其他治療選項的慢性心肌缺血病人提供顯著功能改善與生活質素提升。若後續隨機對照試驗能重複此正面結果，將有助 BioCardia 推動監管申請及商業化進程。目前股價或受此消息正面影響，惟仍需關注後續試驗完整數據及 FDA 審批進度。

展開英文正文

bcda20260520_8k.htm

 

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0000925741

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2026-05-21
2026-05-21

 

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 21, 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 21, 2026, BioCardia, Inc. issued a press release announcing the oral presentation of the results of the CardiAMP Cell Therapy in Chronic Myocardial Ischemia Trial (CardiAMP CMI) preliminary open label cohort at Euro PCR, a leading interventional cardiovascular medicine conference held in Paris. The presentation was made by Dr. Amish Raval, M.D., Professor of Medicine at University of Wisconsin School of Medicine and Public Health.

 

The results presented by Dr. Raval, on behalf of the CardiAMP CMI Investigators, showed that the minimally invasive CardiAMP Cell Therapy procedure was well tolerated with no treatment emergent major adverse cardiac events and patients demonstrated positive clinical outcomes including increased exercise tolerance and reduced frequency of angina episodes with the autologous cell therapy up through two years follow-up. Prior to treatment, all patients were on guideline-directed medical therapy and had received all available percutaneous and/or surgical options as appropriate for their medical condition. Patients experienced increased exercise tolerance, improving by an average of 179 seconds, which persisted for the two-year study follow-up. Angina episodes were reduced by an average of 82% by six-months after treatment.

 

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 21, 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 21, 2026