AVR 最新10-Q变化
将 AVR 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 · 2026-05-12 与上一份 10-Q · 2025-11-12
| 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 | +29 | −35 | ~10 | 19 |
| 市场风险(第3项) | 文字有新增/删除 | 0 | 0 | ~1 | 0 |
| 控制与程序 | 文字有新增/删除 | +3 | −3 | ~3 | 0 |
| 法律诉讼 | 无段落级文字变化 | 0 | 0 | 0 | 2 |
| 风险因素 | 部分风险因素更新 | 0 | 0 | 0 | 3 |
| 其他信息 | 文字有新增/删除 | 0 | 0 | ~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。
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 · 2026-05-12
We intend to establish the safety and effectiveness of the DurAVR® THV in patients with severe aortic stenosis in our global pivotal study (the “PARADIGM Trial”).
The PARADIGM Trial is a prospective, randomized, controlled multicenter, international study wherein subjects will be randomized to receive either a transcatheter aortic valve replacement (“TAVR”) using the DurAVR® THV or TAVR using a commercially available and approved THV in an “All Comers Randomi…
Recruitment to the PARADIGM Trial commenced in Europe in October 2025, followed by receipt of FDA Investigational Device Exemption (“IDE”) approval for the trial in November 2025. In April 2026, we secured U.S. Medicare reimbursement eligibility for the global pivotal PARADIGM Trial under a Centers …
Recruitment remains ongoing, with planned expansion into additional countries to further accelerate patient enrollment. The PARADIGM Trial is supported by early clinical experience from over 130 patients treated with the DurAVR® THV.
It is anticipated that the design of the PARADIGM Trial will provide the primary clinical evidence on which the FDA could base a decision for Premarket Approval (“PMA”), which is required for commercialization of the DurAVR® THV System in the United States. We anticipate CE Mark approval will progre…
相对上期删除的文字 · 来源:10-Q · 2025-11-12
On December 12, 2024, our Registration Statement relating to our initial public offering (the “IPO”) became effective pursuant to which we issued and sold 14,800,000 shares of our Common Stock at a public offering price of $6.00 per share. On January 14, 2025, TD Cowen, Barclays and Cantor (the unde…
During the third quarter of 2025, we advanced regulatory activities in parts of Europe, with the goal of securing clearance to commence the PARADIGM Trial in those countries. In October 2025, we secured the first European regulatory clearance in Denmark and subsequently enrolled and treated the firs…
The PARADIGM Trial is a prospective, randomized, controlled multicenter, international study wherein subjects will be randomized to receive either a transcatheter aortic valve replacement (“TAVR”) using the DurAVR® THV or TAVR using a commercially available and approved THV in an “All Comers Randomi…
It is anticipated that the design of the PARADIGM Trial will provide the primary clinical evidence on which the FDA could base a decision for the Premarket Approval (“PMA”) that is required for commercialization of the DurAVR® THV System in the United States. We anticipate CE Mark approval will prog…
We continued strengthening our operational infrastructure during the third quarter of 2025, advancing quality management system (“QMS”) buildout to support upcoming clinical activities and future ISO 13485 certification. Key quality procedures and standard operating documents were released to establ…
控制与程序
相对上期新增的文字 · 来源:10-Q · 2026-05-12
In connection with the preparation of our financial statements for the years ended December 31, 2024 and 2023, our management and our independent auditors identified material weaknesses in the design and operating effectiveness of our internal control over financial reporting, which remained unremed…
A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the annual or interim financial statements will not be prevented or detected on a timely basis.
Management has initiated and continues to implement a remediation plan to address the material weaknesses described above. During the year ended December 31, 2025 and through the quarter ended March 31, 2026, we implemented changes to our internal control over financial reporting, including enhancem…
相对上期删除的文字 · 来源:10-Q · 2025-11-12
In connection with the preparation of our financial statements for the years ended December 31, 2024 and 2023, management and our independent auditors identified material weaknesses in the design and operating effectiveness of our internal control over financial reporting, which remained unremediate…
The material weaknesses identified by our management and our independent auditors related to (i) a lack of appropriately designed, implemented and documented procedures and controls, and (ii) deficiencies in the segregation of duties.
To remediate these material weaknesses, management has initiated a remediation plan, which includes formally documenting policies, processes, risks, and controls, and reviewing the design and operating effectiveness of key and non-key controls. Testing of operating effectiveness has commenced. Remed…
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