# EDGAR Filing Document

**Accession Number:** 0001378325
**File Stem:** 0001378325-25-000031
**Filing Date:** 2025-11
**Character Count:** 13020
**Document Hash:** 3f4b442c03ba5de5333cb6a4bd4d8813
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001378325-25-000031.hdr.sgml**: 20251110

**ACCESSION NUMBER**: 0001378325-25-000031

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20251110

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20251110

**DATE AS OF CHANGE**: 20251110

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** CapsoVision, Inc
- **CENTRAL INDEX KEY:** 0001378325
- **STANDARD INDUSTRIAL CLASSIFICATION:** ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845]
- **ORGANIZATION NAME:** 08 Industrial Applications and Services
- **EIN:** 203369494
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-42705
- **FILM NUMBER:** 251466258

**BUSINESS ADDRESS:**
- **STREET 1:** 18805 COX AVENUE SUITE 250
- **CITY:** SARATOGA
- **STATE:** CA
- **ZIP:** 95070
- **BUSINESS PHONE:** (408) 370-4790

**MAIL ADDRESS:**
- **STREET 1:** 18805 COX AVENUE SUITE 250
- **CITY:** SARATOGA
- **STATE:** CA
- **ZIP:** 95070

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Capso Vision Inc
- **DATE OF NAME CHANGE:** 20061016

?xml version='1.0' encoding='ASCII'? cv-20251110

**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 10, 2025**

_________________________

**CapsoVision, Inc.**

**(Exact name of registrant as specified in its charter)**

_________________________

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| | | |
|:---|:---|:---|
| **Delaware** | **001-42705** | **20-3369494** |
| **(State or other jurisdiction<br>of incorporation)** | **(Commission<br>File Number)** | **(IRS Employer<br>Identification Number)** |

---

---

| | |
|:---|:---|
| **18805 Cox Avenue, Suite 250**<br>**Saratoga, California** | **95070** |
| **(Address of Principal Executive Offices)** | **(Zip Code)** |

---

**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:

□ 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<br>Symbol** | **Name of each exchange<br>on which registered** |
| common stock, $0.001 par value per share | CV | The Nasdaq Stock Market LLC |

---

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 8.01.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Other Events.** 

On November 10, 2025, the Company issued a press release announcing the 510(k) FDA application for Breakthrough Device Designation for Pancreatic Cancer Screening Capsule.

Copies of the press releases are attached hereto as Exhibit 99.1. The information provided under this Item 8.01, including the accompanying press releases, is being furnished and 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 liability of that section. This information will not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except to the extent that the registrant specifically incorporates it by reference.

**Item 9.01&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Financial Statements and Exhibits.** 

(d)The following exhibits are being filed herewith:

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| | |
|:---|:---|
| **Exhibit<br>No.** | **Description** |
| 99.1 | <u>[Press Release issued on November](cv-20251110xex991.htm)[10](cv-20251110xex991.htm)[, 2025.](cv-20251110xex991.htm)</u> |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

---

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**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.

---

| | | |
|:---|:---|:---|
| | **CAPSOVISION, INC.** | **CAPSOVISION, INC.** |
| Date: November 10, 2025 | By: | /s/ Kang-Huai (Johnny) Wang |
|  | Name: | Kang-Huai (Johnny) Wang |
|  | Title | President and Chief Executive Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

![img0.jpg](img0.jpg)

**CapsoVision Submits Breakthrough Device Designation Application to FDA for Pancreatic Cancer Screening Capsule**

*Non-invasive capsule endoscopy system aims to enable earlier detection of pancreatic ductal adenocarcinoma - among the most fatal cancers worldwide*

SARATOGA, Calif., November 10, 2025 -- CapsoVision, Inc. (NASDAQ: CV), a commercial-stage medical technology company developing advanced imaging and AI-enabled capsule endoscopy solutions, today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) on November 6, 2025 requesting Breakthrough Device Designation (BDD) to accelerate development of the Company's CapsoCam UGI capsule endoscopy system for use in early-stage pancreatic cancer detection.

This submission represents an important milestone in CapsoVision's mission to expand its capsule-based diagnostics platform beyond the small bowel and address some of the most challenging diseases in gastroenterology. Pancreatic ductal adenocarcinoma — the most common form of pancreatic cancer — is among the deadliest cancers worldwide, with a five-year survival rate of only 8%, largely because it is diagnosed at advanced stages that cannot be treated. Currently, no early screening tools are recommended to identify the disease at a treatable stage in the general population.

CapsoVision is pursuing the potential use of its CapsoCam UGI endoscopy to identify pancreatic disease at an earlier stage. The device's unique panoramic imaging capability enables clear visualization of the duodenal papilla, a small bowel landmark that controls release of digestive fluids. Changes in the papilla's appearance can be associated with pancreatic abnormalities and may serve as an early indicator of disease.

Unlike traditional endoscopic or imaging procedures, CapsoCam UGI is completely non-invasive. Patients simply swallow a pill-sized camera, eliminating the need for sedation, intubation, or recovery time, while enabling physicians to review detailed images through a secure, cloud-based system.

The FDA's Breakthrough Devices Program is designed to expedite the development and review of technologies that may offer more effective diagnosis or treatment for life-threatening conditions where no adequate alternatives exist. If granted, the designation would allow CapsoVision to work closely with the FDA to accelerate development and shape upcoming clinical studies, leading the regulatory review process.

**Pancreatic Cancer Screenings**

Pancreatic cancer remains one of the most lethal malignancies, with a five-year survival rate of only 10%¹, a figure that has seen little improvement in decades. It is now the third leading cause of cancer-related death in the United States², despite accounting for just over 3% of all cancer cases. Approximately 80% of diagnoses occur at advanced stages³ when the disease is already unresectable or metastatic, leaving limited options for curative treatment. Existing diagnostic methods including CT, MRI, and endoscopic ultrasound are invasive, costly, and lack the sensitivity needed to detect small or early-stage lesions⁴.

Early detection can improve survival more than fourteen-fold<sup>5</sup>, yet no non-invasive screening method for the general population is currently recommended. This underscores an urgent global need for innovative, patient-friendly diagnostic technologies that can visualize pancreatic abnormalities earlier, before symptoms emerge and while curative treatment is still possible.

------

**About CapsoVision**

CapsoVision is a commercial-stage medical technology company focused on developing advanced imaging and AI-enabled solutions to transform the detection and diagnosis of gastrointestinal diseases. Its flagship product, CapsoCam Plus®, is a wire-free, panoramic capsule endoscope that enables high-resolution visualization of the small bowel and supports cloud-based or direct capsule video retrieval. The Company's next pipeline product, CapsoCam Colon™ with enhanced AI, is designed to enable non-invasive colon imaging and polyp detection. With a proprietary platform targeted to expand across multiple GI indications, including esophageal and pancreatic disorders, CapsoVision is advancing a new era in capsule-based diagnostics. For more information on CapsoVision, please visit www.capsovision.com.

**Forward-Looking Statements**

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In this context, forward-looking statements mean statements related to future events, which may impact our expected future business and financial performance, and often contain words such as "expected", "anticipates", "intends", "plans", "believes", "potential", "will", "should", "could", "would" or "may" and other words of similar meaning. Examples of these forward-looking statements include, but are not limited to, statements concerning possible or assumed future results of operations, including the timing and receipt of regulatory approvals, the Company's plans, strategies and timing for its pipeline development, and the success of the Company's plans and strategies. These forward-looking statements are based on the Company's current expectations and inherently involve significant risks and uncertainties, including those beyond the Company's control. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, market conditions and the failure to receive regulatory clearance. Specifically, the Company's proposed capsule endoscopy solution may not meet the eligibility requirements for the Breakthrough Device Designation and, even if a Breakthrough Device Designation is received, it may not receive the FDA authorization required to market the proposed capsule endoscopy solution. These and other risks and uncertainties are described more fully in the Company's filings with the Securities and Exchange Commission ("SEC"), including the "Risk Factors" section of the Company's prospectus filed on July 3, 2025 with the SEC, as part of the Company's Registration Statement on Form S-1 (File No. 333-287148), and the Company's most recent Form 10-Q. Forward-looking statements speak only as of the date of this press release, and the Company undertakes no obligation to update or revise these statements, except as required by law.

**Investor Relations Contact**

Leigh Salvo

New Street Investor Relations

<u>Investors@CapsoVision.com</u>

**Media Contact**

Leslie Strickler and Paul Spicer

Être Communications

<u>leslies@etrecommunications.com</u> \| (804) 240-0807

<u>pauls@etrecommunications.com</u> \| (804) 503-9231

**Sources**

1. SEER Cancer Statistics Review, 2025. National Cancer Institute. https://seer.cancer.gov/statfacts/html/pancreas.html

2. Rawla P, Sunkara T, Gaduputi V. Epidemiology of pancreatic cancer: global trends, etiology and risk factors. World Journal of Oncology. 2019;10(1):10.

3. MD Anderson Cancer Center. Pancreatic Cancer Overview. Accessed July 2025. https://www.mdanderson.org/cancer-types/pancreatic-cancer.html

4. Olakowski M, Bułdak Ł. Current status of inherited pancreatic cancer. Hereditary Cancer in Clinical Practice. 2022;20(1):26.

5. SEER Statistics Network Explorer. U.S. Cancer Statistics. https://seer.cancer.gov/statistics-network/explorer

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