8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

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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): March 13, 2026

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CapsoVision, Inc.

(Exact name of registrant as specified in its charter)

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Registrant’s telephone number, including area code: (408)-624-1488

n/a

(Former Name or Former Address, if Changed Since Last Report)

_________________________

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:

Securities registered pursuant to Section 12(b) of the Act:

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☒

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 1.01.           Entry into a Material Definitive Agreement.

As previously reported on Form 8-K filed by CapsoVision, Inc. (the “Company”) on July 15, 2026 (the “July 15th 2025 8-K”), the Company entered into a development agreement (the “Agreement”) with Canon Inc., a Japanese corporation (“Canon”), for the development of complementary metal-oxide-semiconductor (“CMOS”) image sensor samples to allow the Company to evaluate functionality and performance, conduct clinical evaluation of capsule endoscopies that incorporate Canon image sensors and obtain FDA 510(k) clearance thereof.

Under the Agreement, the Company agreed to pay Canon a fee of approximately $4.1 million for Canon’s development efforts, which is comprised of (a) an initial fee of $1 million to be paid in cash upon the Agreement’s effectiveness and (b) following delivery of a specified number of CMOS image sensors meeting agreed specifications within the required timeframe, a remaining development fee of approximately $3.1 million. In addition, and subject to such delivery, the parties have undertaken to enter into a related master purchase agreement providing for the Company to purchase a specified minimum number of CMOS image sensors from Canon. The remaining development fee will be paid over time by adding an additional agreed amount to the unit price of CMOS image sensors supplied by Canon under the master purchase agreement.

On March 9, 2026, the Company entered into the amendment to the original development agreement (the “Amendment”) with Canon, Inc, a Japanese corporation pursuant to which the Company agreed that the total fee shall be increased by the amount of $1 million due to the increased features in the specification. As a result of this increase, the remaining development fee of the Agreement shall also be increased accordingly. The parties also agreed that, taking into account the foregoing (and that there has been no other increase or decrease from the effective date of the original Agreement), the remaining development fee as of the Amendment effective date shall be paid by CapsoVision pursuant to Article 12.4 through 12.6 of the original Agreement. For the avoidance of doubt, notwithstanding the increase of the total fee, the Additional Amount (as defined in section 12.5 of the Agreement) shall remain unchanged and all the other terms under the Agreement shall remain in full force and effect.

The foregoing summary of the terms of the original Agreement and its Amendment subject to, and qualified in its entirety by, the Amendment that is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 9.01           Financial Statements and Exhibits.

(d)The following exhibits are being filed herewith:

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Document

Exhibit 10.1

Certain confidential information contained in this document, marked by [* * *], has been omitted pursuant to Item 601 (b)(10)(iv) of Regulation S-K because it is both (i) not material and (ii) the type of information that the registrant treats as private or confidential.

AMENDMENT TO SAMPLE PURCHASE AGREEMENT

This AMENDMENT TO SAMPLE PURCHASE AGREEMENT (“Amendment”) is effective as of the date last signed below (“Amendment Effective Date”) by and between Canon Inc., a Japanese corporation having its principal place of business at 30-2 Shimomaruko 3-chome, Ohta-ku, Tokyo 146-8501, Japan (“Canon”) and CapsoVision, Inc., a Delaware corporation having its principal place of business at 18805 Cox Avenue 250 Saratoga, CA 95070, U.S.A. (“Capso”), each sometimes referred to hereinafter as a "Party" and jointly as the “Parties”.

1.The Parties entered into the "SAMPLE PURCHASE AGREEMENT" as of July 15, 2025 (the "Original Agreement"). Unless otherwise defined herein, capitalized terms used in this Amendment shall have the same meanings ascribed to them in the Original Agreement. Pursuant to the Original Agreement, the Parties agreed to supply and purchase the "Samples" for the "Purposes" as described in the Original Agreement. The Parties hereby agree that the "Total Fee" shall be increased by [* * *] due to the additional costs incurred by Canon. As a result of this increase, the "Remaining Balance" shall also be increased accordingly. For clarity, if the additional cost is converted into U.S. Dollars using "Canon's Exchange Rate" for the first quarter of 2026 (i.e., [* * *]), it is one million (1,000,000) U.S. dollars.

Furthermore, it is also agreed by the Parties that, taking into account the foregoing (and that there has been no other increase or decrease from the Effective Date of the Original Agreement), the Remaining Balance as of the Amendment Effective Date is [* * *] , which shall be paid by Capso pursuant to Article 12.4 through 12.6 of the Original Agreement. For the avoidance of doubt, notwithstanding the increase to the Total Fee described above, the Additional Amount shall not change.

2.Except as expressly amended herein, all terms of the Original Agreement shall remain in full force and effect.

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed in electronic form as of the date below.

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