CV 最新10-Q变化
将 CV 最新的定期申报(10-K/10-Q)与上一份同类型申报逐章节对比:每个章节新增/删除的段落数与原文摘录。全部为确定性文本对比——无相似度评分、无方向判断、非投资建议。
对比:10-Q · 2026-05-14 与上一份 10-Q · 2025-11-13
| 章节 | 结果 | 新增 | 删除 | 微调 | 未变 |
|---|---|---|---|---|---|
| 管理层讨论与分析 | 文字有新增/删除 | +24 | −30 | ~16 | 46 |
| 控制与程序 | 文字有新增/删除 | +3 | −3 | ~2 | 6 |
| 法律诉讼 | 无段落级文字变化 | 0 | 0 | 0 | 1 |
| 风险因素 | 文字有新增/删除 | +182 | −164 | ~25 | 153 |
| 其他信息 | 文字有新增/删除 | 0 | −1 | ~1 | 0 |
计数单位为段落;"新增/删除"指相对上一份文件新增/删除的文字,不含方向或好坏判断。
未列出(无法可靠提取或缺失):市场风险(第3项)
代表性摘录
每个章节最多 5 条、每条约 300 字符的原文摘录,直接来自两份 SEC 文件。
管理层讨论与分析
相对上期新增的文字 · 来源:10-Q · 2026-05-14
In the second quarter of 2025 we filed our 510(k) submission to the U.S. Food and Drug Administration (the “FDA”) for our initial CapsoCam Colon capsule endoscopy solution (the “First-Generation Product”). We received responses from the FDA in September 2025. During our meeting with the FDA in Decem…
Quarterly Report, over 600 patients have been enrolled in the second arm pivotal study. We currently expects to submit the 510(k) application for the Second-Generation Product in the third quarter of 2026.
Since we continue to invest in AI to improve our existing products, we completed a clinical study to demonstrate the benefits of our incorporation of AI technology into CapsoCam Plus, our existing product for the small bowel. We submitted the related 510(k) application to the FDA in December 2025. W…
Longer term, we believe our CapsoCam family of products, incorporating our panoramic imaging solution, can be adapted to address new GI medical indications. Potential new medical indications include esophageal medical conditions (such as esophageal varices) and pancreatic cancer. In connection with …
As of March 31, 2026, we had an accumulated deficit of $162.7 million. To date, we have funded our operations primarily through proceeds from the sale of shares of our convertible preferred stock, IPO and Private Placement proceeds and cash generated from the sale of CapsoCam capsules and the use of…
相对上期删除的文字 · 来源:10-Q · 2025-11-13
In the second quarter of 2025 we filed our 510(k) submission to the FDA for our initial CapsoCam Colon capsule endoscopy solution (“the First-Generation Product”) review. In the third quarter of 2025 we began the second arm of our CapsoCam Colon pivotal study involving the second-generation of Capso…
Since we continue to invest in AI to improve our existing products, we made significant progress with a clinical study to demonstrate the benefits of our incorporation of AI technology into CapsoCam Plus, our existing product for small bowel. We currently plan to submit the related 510(k) applicatio…
Longer term, we believe our CapsoCam family of products, incorporating our panoramic imaging solution, can be adapted to address new GI medical indications. Potential new medical indications include esophageal medical conditions (such as esophageal varices) and pancreatic cancer. In connection with …
On July 15, 2025, the Company entered into a development agreement with Canon Inc, for the development of complementary metal-oxide-semiconductor (“CMOS”) image sensor samples with higher resolution and higher dynamic range to allow the Company to evaluate functionality and performance, conduct clin…
In late August 2025, Kevin Lundquist stepped down as Chief Financial Officer of the Company. The responsibilities of principal financial officer and principal accounting officer were assumed by David Garcia, Senior VP of Finance who joined the Company on November 3, 2025.
控制与程序
相对上期新增的文字 · 来源:10-Q · 2026-05-14
Based on our management’s evaluation (with the participation of our principal executive officer and our principal financial officer) of our disclosure controls and procedures as required by Rule 13a-15 under the Exchange Act
and the material weaknesses previously identified and further discussed below, our principal executive officer and our principal financial officer have concluded that our disclosure controls and procedures were not effective at the reasonable level of assurance as of March 31, 2026, the end of the p…
To remediate the material weaknesses described above and prevent similar deficiencies in the future, we have devoted, and plan to continue to devote, significant effort and resources to the remediation and improvement of our internal control over financial reporting. For example, in addition to hiri…
相对上期删除的文字 · 来源:10-Q · 2025-11-13
Based on our management’s evaluation (with the participation of our Chief Executive Officer and our principal financial officer) of our disclosure controls and procedures as required by Rule 13a-15 under the Exchange Act and the material weaknesses previously identified and further discussed below, …
To remediate the material weaknesses described above and prevent similar deficiencies in the future, we have devoted, and plan to continue to devote, significant effort and resources to the remediation and improvement of our internal control over financial reporting. For example, in addition to hiri…
months ended March 31, 2025, we are also evaluating the current and future accounting and financial reporting personnel to ensure proper segregation of duties. We decided to replace our existing ERP system which would help address many of the control issues contributing to these material weaknesses.…
风险因素
相对上期新增的文字 · 来源:10-Q · 2026-05-14
Below is a summary of the principal risks and uncertainties that make an investment in our securities speculative or risky. Importantly, this summary does not address all of the risks that we face. Additional discussion of the risks and uncertainties summarized in this risk factor summary, as well a…
The following is a summary of the principal risks and uncertainties described in more detail in this Quarterly Report on Form 10-Q:
•We have a history of net losses, and we expect to incur additional losses in the foreseeable future.
•Our Quarterly Report, our unaudited financial statements for the three months ended March 31, 2026 and our audited financial statements for the year ended December 31, 2025 and include a footnote raising substantial doubt about our ability to continue as a “going concern” and we will likely need to…
related revenues until the middle of 2027 based on the anticipated timing of FDA clearance for the second generation of our CapsoCam Colon solution.
相对上期删除的文字 · 来源:10-Q · 2025-11-13
Our business is subject to numerous risks and uncertainties. This summary provides an overview of such risks. You should read this risk factor summary together with the more detailed discussion of risks and uncertainties following this summary.
•We have a history of net losses and expect to incur additional losses in the foreseeable future.
•Our audited financial statements for the year ended December 31, 2024 and our unaudited financial statements for the nine months ended September 30, 2025 include a footnote raising substantial doubt about our ability to continue as a “going concern” and we will likely need to raise additional finan…
•Broad adoption of our CapsoCam Colon solution (once cleared) and growing related revenues depend on, among other things, expanding beyond CapsoCam Colon’s initial indicated patient population, increasing the accuracy of our initial CapsoCam Colon solution, and achieving and maintaining a satisfacto…
we may fail to successfully and timely execute related elements of our CapsoCam Colon adoption and revenue growth strategy.
其他信息
相对上期删除的文字 · 来源:10-Q · 2025-11-13
arrangement” or a “non-Rule 10b5-1 trading arrangement”, as each term is defined in Item 408(a) of Regulation S-K.
如何读 10-Q 的风险因素(第 1A 项)
10-Q 的风险因素章节有三种常见形态,本页按其一分类展示:
- 指向(pointer) — 公司仅声明"无重大变化"并指向年度 10-K 的完整风险因素;本季没有自己的风险文本可对比。
- 部分更新(partial) — 公司写明"除下述外无重大变化",只更新部分风险;摘录展示的正是本季新增的内容。
- 全文重述(restated) — 本季重新给出完整风险因素。若上一季只是"指向",则无法逐段对比,本页会将其标为"本季全文重述"。
这只是对文件结构的客观描述,不构成对风险高低的判断。
数据来自 SEC EDGAR 两份申报文件的文本级对比 · 确定性计算(无 AI 生成内容)· 仅供参考 · 非投资建议