enVVeno Medical's (NVNO) submission of the final module for VenoValve’s Premarket Approval (PMA) application to the FDA represents a crucial milestone in addressing unmet needs in the treatment of Chronic Venous Insufficiency (CVI). As a breakthrough-designated device, VenoValve aims to treat severe CVI by restoring proper blood flow and alleviating debilitating symptoms like leg swelling, pain, and venous ulcers.With approximately 2.5 million candidates for the device annually in the U.S., FDA approval cou ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________ to ___________________ Commission file number: 001-38325 enVVeno Medical Corporation (Exact name of registrant as specified in its charter) Delaware 33-09361 ...

产品开发情况 - 公司正在开发两款产品:VenoValve和enVVe,分别为外科手术置换静脉瓣膜和非手术置换静脉瓣膜[53,54,55] - VenoValve已完成首次人体试验,结果显示患者的静脉临床严重程度评分(rVCSS)平均改善6分,疼痛和生活质量也有显著改善[65,66] - 公司已获得FDA的IDE批准,开始进行VenoValve的美国关键性试验SAVVE,目前已完成75例患者入组[68,70] - SAVVE试验初步30天数据显示,8%的患者出现与器械相关的不良事件,主要为深静脉血栓,无死亡和肺栓塞发生[71] - SAVVE试验6个月初步数据显示,97%的患者rVCSS评分有改善,74%患者改善3分以上达到临床显著获益[72] - 公司预计VenoValve将于2024年第四季度有资格向FDA提交上市申请[57] 财务情况 - 公司2024年6月30日的现金和投资为3910万美元[78] - 公司预计现金消耗率将从每季度400万-500万美元的当前水平增加[94] - 公司2024年上半年研发费用同比下降24.4%至590万美元[88] - 公司2024年上半年销售、一般及管理费用同比下降12.1%至510万美元[89] - 公司2024年上半年其他收入同比增加30万美元至100万美元[90] - 公司2024年第二季度研发费用同比下降33.3%至280万美元[83] - 公司2024年第二季度销售、一般及管理费用与去年同期持平为260万美元[84] - 公司2024年第二季度其他收入同比增加25%至50万美元[85] - 公司预计现金储备可维持至少一年的运营[96] - 公司未来资本需求将取决于临床试验的成功、相关产品开发成本以及成功将产品推向市场的能力[94]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to ___________________ Commission file number: 001-38325 enVVeno Medical Corporation (Exact name of registrant as specified in its charter) Delaware 33-0936180 (State or other ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________ to ___________________ Commission file number: 001-38325 enVVeno Medical Corporation (Exact name of registrant as specified in its charter) Delaware 33-0936180 (State ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________ to ___________________ Commission file number: 001-38325 enVVeno Medical Corporation (Exact name of registrant as specified in its charter) Delaware 33-09361 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to ___________________ Commission file number: 001-38325 enVVeno Medical Corporation (Exact name of registrant as specified in its charter) Delaware 33-0936180 (State or other ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to ___________________ Commission file number: 001-38325 enVVeno Medical Corporation (Exact name of registrant as specified in its charter) Delaware 33-0936180 (State or other ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________ to ___________________ Commission file number: 001-38325 enVVeno Medical Corporation (Exact name of registrant as specified in its charter) Delaware 33-0936180 (State ...

| --- | --- | --- | --- | |-------|-------|-------|-------| | | | | | | | | | | Legal Disclaimers This presentation and any statements of stockholders, directors, employees, representatives and partners of enVVeno Medical, Inc. (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements m ...