BioCardia partners with CART‑Tech to commercialize Heart3D Fusion Imaging

Rhea-AI Filing Summary

BioCardia, Inc. announced an exclusive development and commercialization agreement with CART‑Tech, B.V. for Heart3D™ Fusion Imaging. The Heart3D system is described as a tool to enhance two‑dimensional x‑ray images used for cardiac biotherapeutic delivery and biopsy procedures by fusing those images with annotated pre‑procedure three‑dimensional heart models created from MRI and CT scans.

The companies issued a joint press release about the agreement, and that press release is attached as Exhibit 99.1 to this report.

Positive

• Exclusive development and commercialization agreement with CART‑Tech for Heart3D Fusion Imaging, indicating strategic partnership
• Technical enhancement described: fusion of 2D x‑ray with annotated 3D MRI/CT heart models to support biotherapeutic delivery and biopsy procedures
• Joint press release filed as Exhibit 99.1, providing a public disclosure record of the agreement

Negative

• No financial terms or commercial economics disclosed in the filing, so immediate revenue impact is unspecified
• No timelines, milestones, or commercialization schedule included to indicate when product development or market roll‑out will occur
• No clinical validation or regulatory status information provided in the disclosure

Insights

Financial Analyst

TL;DR: Product partnership announced; terms and financial impact not disclosed, so near‑term investor impact is unclear.

The filing reports an exclusive development and commercialization agreement between BioCardia and CART‑Tech for Heart3D Fusion Imaging, a technology intended to fuse 2D x‑ray with annotated 3D MRI/CT heart models to support biotherapeutic delivery and biopsy procedures. The exclusive nature could provide commercial differentiation if adoption follows, but the filing contains no transaction economics, commercialization timelines, or revenue projections. Without disclosed financial terms or milestones, it is prudent to treat this as strategic progress rather than an immediately material event.

Cardiac Imaging Industry Specialist

TL;DR: Technically meaningful collaboration for image guidance; potential clinical workflow benefits if integration succeeds.

Heart3D Fusion Imaging aims to augment fluoroscopy by overlaying annotated 3D anatomical heart models from MRI/CT onto live 2D x‑ray, which can improve anatomical context during cardiac biologic delivery and biopsies. The partnership with a vendor‑independent platform provider suggests cross‑platform applicability, which may aid clinical adoption. The filing confirms the partnership and attached press release but does not provide clinical validation data or regulatory status within the disclosure.

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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): August 13, 2025

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 August 13, 2025, BioCardia, Inc., a global leader in cellular and cell-directed therapeutics for the treatment of cardiovascular and pulmonary diseases, and CART-Tech, B.V., a provider of vendor independent platform technology for augmented fluoroscopy during cardiac interventions, today issued a joint press release announcing that they have entered into an exclusive development and commercialization agreement for Heart3D™ Fusion Imaging. The Heart3D system is expected to enhance two-dimensional x-ray images used for cardiac biotherapeutic delivery and biopsy procedures by fusing these images with annotated pre-procedure three-dimensional anatomical heart models created from gold standard MRI and CT images.

A copy of the press release is attached hereto as Exhibit 99.1 to this current report on Form 8-K.

Item 9.01   Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description
99.1 104		BioCardia, Inc. press release dated August 13, 2025 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: August 13, 2025

FAQ

What did BioCardia (BCDAW) announce in this 8‑K?

BioCardia announced an exclusive development and commercialization agreement with CART‑Tech, B.V. for Heart3D™ Fusion Imaging.

What is Heart3D Fusion Imaging?

Heart3D is described as a system that fuses two‑dimensional x‑ray images with annotated pre‑procedure three‑dimensional heart models created from MRI and CT to enhance augmented fluoroscopy during cardiac biotherapeutic delivery and biopsy procedures.

Are the financial terms of the agreement disclosed in the filing?

The filing states a joint press release was issued and attached as Exhibit 99.1; the filing itself does not include detailed financial terms.

Where can I find the companies' announcement?

The joint press release announcing the agreement is attached to the report as Exhibit 99.1.

Does the filing provide commercialization timelines or regulatory status for Heart3D?

No; the filing describes the agreement and the expected imaging enhancement but does not provide timelines, milestones, or regulatory/clinical status.