Moderated webcast with Robert Berman, Chief Executive Officer of enVVeno Medical on Wednesday, December 3rd at 4:00 PM ET IRVINE, CA / ACCESS Newswire / November 26, 2025 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno Medical" or the "Company"), today announced that Robert Berman, Chief Executive Officer of enVVeno Medical will participate in a Live Virtual Investor CEO Connect segment on Wednesday, December 3, 2025 at 4:00 PM ET. As part of the event, Mr. ...

Group 1: RLX Technology Inc - RLX Technology Inc reported quarterly earnings of 3 cents per share on sales of $158.600 million [1] - Shares of RLX Technology rose 6% to $2.47 in pre-market trading following the earnings report [1] Group 2: Other Stocks in Pre-Market Trading - Cidara Therapeutics, Inc. surged 92% to $203.50 after a Schedule 13D Amendment revealed beneficial ownership of 3.37 million shares [4] - Binah Capital Group, Inc. gained 52.2% to $2.17 after posting stronger-than-expected third-quarter results [4] - Expion360 Inc. rose 42.4% to $1.81 following its third-quarter results [4] - Aspire Biopharma Holdings, Inc. surged 31.2% to $0.1380 in pre-market trading [4] - Invivyd, Inc. gained 28.8% to $2.28 after reporting better-than-expected third-quarter financial results [4] - Milestone Scientific Inc. surged 26.3% to $0.4801 after reporting better-than-expected third-quarter sales [4] - Lazydays Holdings, Inc. gained 23.3% to $1.85 after a previous surge [4] - Omeros Corp gained 12.5% to $7.08 following a narrower-than-expected quarterly loss [4] - Nouveau Monde Graphite Inc rose 10% to $3.25 after a decline the previous day [4] Group 3: Declining Stocks in Pre-Market Trading - TSS Inc tumbled 40.2% to $9.10 after reporting a year-over-year decrease in third-quarter results [4] - enVVeno Medical Corp declined 35.8% to $0.42 after an unfavorable FDA appeal decision [4] - Nuvve Holding Corp fell 29.3% to $0.34 after announcing third-quarter results [4] - ESS Tech Inc shares dipped 24.2% to $3.22 after reporting weak quarterly sales [4] - Direct Digital Holdings Inc fell 18.8% to $0.23 after a significant gain the previous day [4] - StubHub Holdings Inc fell 18.8% to $15.28 after worse-than-expected third-quarter EPS results [4] - Mangoceuticals Inc dipped 17.7% to $0.98 after a decline the previous day [4] - Red Cat Holdings Inc dipped 15.1% to $6.57 after worse-than-expected financial results and a lowered FY25 sales guidance [4] - WhiteFiber Inc fell 13.4% to $17.21 after reporting worse-than-expected financial results [4] - Sobr Safe Inc fell 12.4% to $2.21 after a decline the previous day [4]

IRVINE, CA / ACCESS Newswire / November 13, 2025 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today announced that it has received an unfavorable decision from the U.S. Food & Drug Administration ("FDA") in response to its supervisory appeal of the not-approvable letter it received on August 19, 2025 in response to its Premarket Approval (PMA) application for VenoValve®, a surgical replacement veno ...

Core Insights - The company has sufficient cash and investments to fund current operations through Q2 2027, excluding VenoValve commercialization and the enVVe IDE study [1] - The cash burn for Q3 2025 was $4.2 million, which aligns with the projected quarterly range [1] - The company is engaged in an ongoing appeal with the FDA regarding the VenoValve PMA decision, with feedback anticipated by the end of 2025 [1] Financial Summary - The company ended Q3 2025 with $31.0 million in cash and investments [1]

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, 2025 OR (Address of principal executive offices) ☐ 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 ...

Watch the "What This Means" video here IRVINE, CA / ACCESS Newswire / September 26, 2025 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today announced that Robert Berman, Chief Executive Officer of enVVeno Medical participated in a Virtual Investor "What This Means" segment. As part of the segment, Mr. ...

IRVINE, CA / ACCESS Newswire / September 15, 2025 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today announced that it will file a request for supervisory appeal of the not-approvable letter from the Center for Devices and Radiological Health (CDRH) of the U.S. Food & Drug Administration (FDA) received on August 19, 2025, in response to its Premarket Approval (PMA) application for the VenoValve®, a ...

Key Takeaways NVNO stock sank 76.1% after the FDA issued a not-approvable letter for VenoValve.The FDA flagged insufficient NVNO's SAVVE study data and raised surgical safety concerns.NVNO eyes an IDE filing for its non-surgical enVVe valve as the next pipeline step.Shares of enVVeno Medical (NVNO) have crashed 76.1% since Aug. 19. The significant decline was due to the FDA’s not-approvable letter in response to its Premarket Approval (“PMA”) application for Veno Valve.The company submitted the PMA applicat ...

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, 2025 OR ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 For the transition period from to ___________________ Commission file number: 001-38325 enVVeno Medical Corporation (Exact name of registrant as specified in its charter) (State or other jurisdiction of inco ...

Financial Performance - The company reported net losses of $4.5 million for Q1 2025, a decrease of 10% from $5.0 million in Q1 2024[56]. - Other income decreased by $0.1 million or 25% to $0.4 million for the three months ended March 31, 2025, compared to $0.5 million for the same period in 2024[60]. - The company incurred losses from operations of $5.0 million and used $4.0 million in operating activities for the three months ended March 31, 2025, an increase of $0.4 million from $3.6 million in the same quarter of 2024[61]. - The increase in cash usage is primarily due to product research and development activities, including clinical studies for VenoValve and enVVe[62]. - The company does not currently generate revenue and does not expect significant revenue until successful commercialization of product candidates after FDA approval[63]. Research and Development - Research and development expenses decreased by $0.5 million or 19% to $2.6 million in Q1 2025, primarily due to lower costs related to the VenoValve pivotal study[58]. - The VenoValve pivotal study reached full enrollment on September 1, 2023, and is currently in the post-enrollment follow-up period[47]. - The company expects to file for IDE approval for the enVVe pivotal study in Q3 2025[54]. - The VenoValve has shown an 85% clinical meaningful benefit at one year, with an average improvement of 7.91 points in the revised Venous Clinical Severity Score (rVCSS)[50]. - The VenoValve is estimated to be eligible for FDA approval in the second half of 2025[51]. - The increase in cash usage is primarily due to product research and development activities, including clinical studies for VenoValve and enVVe[62]. Financial Position and Capital Requirements - The company finished 2024 with approximately $43.2 million in cash and investments, with an expected increase in cash burn rate to $4 million to $5 million per quarter[55]. - Future capital requirements will depend on the success of clinical studies and product development costs, with an anticipated cash burn rate increasing to $5 million per quarter[65]. - The company has sufficient capital resources to meet obligations for at least one year after March 31, 2025, based on current cash and working capital[66]. - The company expects a modest increase in property and equipment purchases as it continues clinical studies and plans for commercialization of VenoValve[64]. Market Context - The total direct medical costs from venous ulcer sufferers in the U.S. exceed $3 billion annually[45]. - Approximately 20 million people in the U.S. are estimated to suffer from severe deep venous CVI (C4 to C6 disease) with reflux[45].