Latest news with #RobertBerman
Miami Herald
17 hours ago
- Business
- Miami Herald
Positive Interim 2-Year Data from enVVeno Medical's VenoValve Pivotal Study to be Presented Today at the Society for Vascular Surgery (SVS) 2025 Vascular Annual Meeting
Interim two-year follow-up data from 42 subjects in the VenoValve pivotal trial show sustained clinical improvement and continued patient benefit at 24 months compared to baseline 83% of subjects maintained a clinically meaningful benefit with a 3 or more point improvement in Revised Venous Clinical Severity Score (rVCSS) 9.1 point average rVCSS improvement among the clinically meaningful benefit cohort Subjects experienced a median 74% improvement in leg pain Interim follow-up data indicate sustained improvements across all venous-specific quality-of-life (QoL) indicators A decision from the U.S. Food and Drug Administration (FDA) on the VenoValve is anticipated in the second half of 2025 Company to host live webcast with presenting Principal Investigator, today, June 6th at 11:20 AM ET / 10:20 AM CT - Access the Webcast Here IRVINE, CA / ACCESS Newswire / June 6, 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 interim two-year follow-up data on 42 subjects from the 75 person VenoValve U.S. pivotal trial will be presented today by lead enroller Dr. Cassius Iyad Ochoa Chaar, at the Society for Vascular Surgery (SVS) 2025 Vascular Annual Meeting (VAM25) being held June 4-7, 2025 in New Orleans, LA. Additionally, the Company announced it will host a live webcast to discuss these interim results today, Friday, June 6th at 11:20 AM ET / 10:20 AM CT (details below). Key interim two-year follow-up data being presented at VAM25 include: 83.3% of subjects (n=35/42) maintained a clinically meaningful benefit, defined as an improvement of 3 or more points in the revised Venous Clinical Severity Score (rVCSS).9.1 point average rVCSS improvement among the responder cohort.A median 74% improvement in leg pain, as measured by the Visual Analog Scale (VAS).Wound healing outcomes in 17 subjects with 25 ulcers showed that 60% of ulcers healed completely, 24% decreased in size, and 16% increased in outcomes also demonstrated sustained improvements across all venous specific QoL indicators (VEINES-QoL/Sym).Among the subjects (n=30), a 100% valve patency rate. All values were calculated comparing each patient's baseline levels to the reported values at the patient's 24-month visit. The Revised Venous Clinical Severity Score (rVCSS) is a clinically validated scoring system used to track the progression or regression of venous diseases. "These interim two-year follow-up data demonstrate substantial and sustained improvement across all effectiveness endpoints at two years. This is extremely encouraging, especially when you consider that all the patients enrolled in the study had severe CVI and failed all other treatment options," said Robert Berman, enVVeno Medical's Chief Executive Officer. "Despite attempts over many decades, nobody has been able to create an effective treatment for severe CVI caused by malfunctioning valves in the deep veins of the leg. The VenoValve has the potential to change the treatment paradigm for deep venous CVI, both for the millions of patients suffering from severe CVI and the thousands of vascular surgeons who have been waiting for an effective treatment option." Dr. Cassius Iyad Ochoa Chaar, who is the Associate Professor of Surgery, Division of Vascular Surgery and Endovascular Therapy, Yale School of Medicine, will present the abstract titled, "Patients with Deep Venous Reflux Continue to Experience Clinical Improvement 2-year after Implantation of the VenoValve" today at VAM 2025. The VenoValve is a potential first-in-class, surgical replacement venous valve for patients with severe deep venous CVI. The Company estimates that there are approximately 2.5 million potential new patients each year in the U.S. that could be candidates for the VenoValve. The Company has submitted a pre-market authorization (PMA) application for the VenoValve to the U.S. Food and Drug Administration (FDA), with a decision anticipated in the second half of 2025. Webcast Details The Company will host a webcast presentation to discuss the results for investors, analysts and other interested parties today, June 6, 2025, at 11:20 AM ET / 10:20 AM CT. Joining enVVeno management for the event will be Dr. Chaar. The live webcast will be accessible on the Events page of the enVVeno website, and will be archived for 90 days. About CVI Severe, deep venous Chronic Venous Insufficiency (CVI) is a debilitating disease that is most often caused by blood clots (deep vein thromboses or DVTs) in the deep veins of the leg. When valves inside of the veins of the leg fail, blood flows in the wrong direction and pools in the lower leg, causing pressure within the veins of the leg to increase (venous hypertension). Symptoms of severe CVI include leg swelling, pain, edema, and in the most severe cases, recurrent open sores known as venous ulcers. The disease can severely impact everyday functions such as sleeping, bathing, dressing, and walking, and is known to result in high rates of depression and anxiety. There are currently no effective treatments for severe CVI of the deep vein system caused by valvular incompetence. Estimates indicate that CVI costs the U.S. healthcare system in excess of $4 billion each year. About enVVeno Medical Corporation enVVeno Medical (NASDAQ:NVNO) is an Irvine, California-based, late clinical-stage medical device Company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of deep venous disease. The Company's lead product, the VenoValve®, is a first-in-class surgical replacement venous valve being developed for the treatment of deep venous Chronic Venous Insufficiency (CVI). The Company is also developing a non-surgical, transcatheter based replacement venous valve for the treatment of deep venous CVI called enVVe®. Both the VenoValve and enVVe are designed to act as one-way valves, to help assist in propelling blood up the leg, and back to the heart and lungs. The VenoValve is currently being evaluated in the VenoValve U.S. pivotal study and the Company is currently performing the final testing necessary to seek approval for the pivotal trial for enVVe. Cautionary Note on Forward-Looking Statements This press release and any statements of stockholders, directors, employees, representatives and partners of enVVeno Medical Corporation (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 may include, without limitation, statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results and timing (may differ significantly from those set forth or implied in the forward-looking statements. Forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required by applicable law. INVESTOR CONTACT:Jenene Thomas, JTC Team, LLCNVNO@ 824-0775 MEDIA CONTACT:Glenn Silver, FINN 818-8198 SOURCE: enVVeno Medical Corporation
Yahoo
4 days ago
- Business
- Yahoo
Positive Interim 2-Year Data from enVVeno Medical's VenoValve Pivotal Study to be Presented Today at the Society for Vascular Surgery (SVS) 2025 Vascular Annual Meeting
Interim two-year follow-up data from 42 subjects in the VenoValve pivotal trial show sustained clinical improvement and continued patient benefit at 24 months compared to baseline 83% of subjects maintained a clinically meaningful benefit with a 3 or more point improvement in Revised Venous Clinical Severity Score (rVCSS) 9.1 point average rVCSS improvement among the clinically meaningful benefit cohort Subjects experienced a median 74% improvement in leg pain Interim follow-up data indicate sustained improvements across all venous-specific quality-of-life (QoL) indicators A decision from the U.S. Food and Drug Administration (FDA) on the VenoValve is anticipated in the second half of 2025 Company to host live webcast with presenting Principal Investigator, today, June 6th at 11:20 AM ET / 10:20 AM CT - Access the Webcast Here IRVINE, CA / / June 6, 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 interim two-year follow-up data on 42 subjects from the 75 person VenoValve U.S. pivotal trial will be presented today by lead enroller Dr. Cassius Iyad Ochoa Chaar, at the Society for Vascular Surgery (SVS) 2025 Vascular Annual Meeting (VAM25) being held June 4-7, 2025 in New Orleans, LA. Additionally, the Company announced it will host a live webcast to discuss these interim results today, Friday, June 6th at 11:20 AM ET / 10:20 AM CT (details below). Key interim two-year follow-up data being presented at VAM25 include: 83.3% of subjects (n=35/42) maintained a clinically meaningful benefit, defined as an improvement of 3 or more points in the revised Venous Clinical Severity Score (rVCSS). 9.1 point average rVCSS improvement among the responder cohort. A median 74% improvement in leg pain, as measured by the Visual Analog Scale (VAS). Wound healing outcomes in 17 subjects with 25 ulcers showed that 60% of ulcers healed completely, 24% decreased in size, and 16% increased in size. Patient-reported outcomes also demonstrated sustained improvements across all venous specific QoL indicators (VEINES-QoL/Sym). Among the subjects (n=30), a 100% valve patency rate. All values were calculated comparing each patient's baseline levels to the reported values at the patient's 24-month visit. The Revised Venous Clinical Severity Score (rVCSS) is a clinically validated scoring system used to track the progression or regression of venous diseases. "These interim two-year follow-up data demonstrate substantial and sustained improvement across all effectiveness endpoints at two years. This is extremely encouraging, especially when you consider that all the patients enrolled in the study had severe CVI and failed all other treatment options," said Robert Berman, enVVeno Medical's Chief Executive Officer. "Despite attempts over many decades, nobody has been able to create an effective treatment for severe CVI caused by malfunctioning valves in the deep veins of the leg. The VenoValve has the potential to change the treatment paradigm for deep venous CVI, both for the millions of patients suffering from severe CVI and the thousands of vascular surgeons who have been waiting for an effective treatment option." Dr. Cassius Iyad Ochoa Chaar, who is the Associate Professor of Surgery, Division of Vascular Surgery and Endovascular Therapy, Yale School of Medicine, will present the abstract titled, "Patients with Deep Venous Reflux Continue to Experience Clinical Improvement 2-year after Implantation of the VenoValve" today at VAM 2025. The VenoValve is a potential first-in-class, surgical replacement venous valve for patients with severe deep venous CVI. The Company estimates that there are approximately 2.5 million potential new patients each year in the U.S. that could be candidates for the VenoValve. The Company has submitted a pre-market authorization (PMA) application for the VenoValve to the U.S. Food and Drug Administration (FDA), with a decision anticipated in the second half of 2025. Webcast Details The Company will host a webcast presentation to discuss the results for investors, analysts and other interested parties today, June 6, 2025, at 11:20 AM ET / 10:20 AM CT. Joining enVVeno management for the event will be Dr. Chaar. The live webcast will be accessible on the Events page of the enVVeno website, and will be archived for 90 days. About CVI Severe, deep venous Chronic Venous Insufficiency (CVI) is a debilitating disease that is most often caused by blood clots (deep vein thromboses or DVTs) in the deep veins of the leg. When valves inside of the veins of the leg fail, blood flows in the wrong direction and pools in the lower leg, causing pressure within the veins of the leg to increase (venous hypertension). Symptoms of severe CVI include leg swelling, pain, edema, and in the most severe cases, recurrent open sores known as venous ulcers. The disease can severely impact everyday functions such as sleeping, bathing, dressing, and walking, and is known to result in high rates of depression and anxiety. There are currently no effective treatments for severe CVI of the deep vein system caused by valvular incompetence. Estimates indicate that CVI costs the U.S. healthcare system in excess of $4 billion each year. About enVVeno Medical Corporation enVVeno Medical (NASDAQ:NVNO) is an Irvine, California-based, late clinical-stage medical device Company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of deep venous disease. The Company's lead product, the VenoValve®, is a first-in-class surgical replacement venous valve being developed for the treatment of deep venous Chronic Venous Insufficiency (CVI). The Company is also developing a non-surgical, transcatheter based replacement venous valve for the treatment of deep venous CVI called enVVe®. Both the VenoValve and enVVe are designed to act as one-way valves, to help assist in propelling blood up the leg, and back to the heart and lungs. The VenoValve is currently being evaluated in the VenoValve U.S. pivotal study and the Company is currently performing the final testing necessary to seek approval for the pivotal trial for enVVe. Cautionary Note on Forward-Looking Statements This press release and any statements of stockholders, directors, employees, representatives and partners of enVVeno Medical Corporation (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 may include, without limitation, statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results and timing (may differ significantly from those set forth or implied in the forward-looking statements. Forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required by applicable law. INVESTOR CONTACT:Jenene Thomas, JTC Team, LLCNVNO@ 824-0775 MEDIA CONTACT:Glenn Silver, FINN 818-8198 SOURCE: enVVeno Medical Corporation View the original press release on ACCESS Newswire
Indianapolis Star
4 days ago
- Business
- Indianapolis Star
Positive Interim 2-Year Data from enVVeno Medical's VenoValve Pivotal Study to be Presented Today at the Society for Vascular Surgery (SVS) 2025 Vascular Annual Meeting
Interim two-year follow-up data from 42 subjects in the VenoValve pivotal trial show sustained clinical improvement and continued patient benefit at 24 months compared to baseline 83% of subjects maintained a clinically meaningful benefit with a 3 or more point improvement in Revised Venous Clinical Severity Score (rVCSS) 9.1 point average rVCSS improvement among the clinically meaningful benefit cohort Subjects experienced a median 74% improvement in leg pain Interim follow-up data indicate sustained improvements across all venous-specific quality-of-life (QoL) indicators A decision from the U.S. Food and Drug Administration (FDA) on the VenoValve is anticipated in the second half of 2025 Company to host live webcast with presenting Principal Investigator, today, June 6 th at 11:20 AM ET / 10:20 AM CT – Access the Webcast Here IRVINE, CA / ACCESS Newswire / June 6, 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 interim two-year follow-up data on 42 subjects from the 75 person VenoValve U.S. pivotal trial will be presented today by lead enroller Dr. Cassius Iyad Ochoa Chaar, at the Society for Vascular Surgery (SVS) 2025 Vascular Annual Meeting (VAM25) being held June 4-7, 2025 in New Orleans, LA. Additionally, the Company announced it will host a live webcast to discuss these interim results today, Friday, June 6 th at 11:20 AM ET / 10:20 AM CT (details below). Key interim two-year follow-up data being presented at VAM25 include: 83.3% of subjects (n=35/42) maintained a clinically meaningful benefit, defined as an improvement of 3 or more points in the revised Venous Clinical Severity Score (rVCSS). 9.1 point average rVCSS improvement among the responder cohort. A median 74% improvement in leg pain, as measured by the Visual Analog Scale (VAS). Wound healing outcomes in 17 subjects with 25 ulcers showed that 60% of ulcers healed completely, 24% decreased in size, and 16% increased in size. Patient-reported outcomes also demonstrated sustained improvements across all venous specific QoL indicators (VEINES-QoL/Sym). Among the subjects (n=30), a 100% valve patency rate. All values were calculated comparing each patient's baseline levels to the reported values at the patient's 24-month visit. The Revised Venous Clinical Severity Score (rVCSS) is a clinically validated scoring system used to track the progression or regression of venous diseases. 'These interim two-year follow-up data demonstrate substantial and sustained improvement across all effectiveness endpoints at two years. This is extremely encouraging, especially when you consider that all the patients enrolled in the study had severe CVI and failed all other treatment options,' said Robert Berman, enVVeno Medical's Chief Executive Officer. 'Despite attempts over many decades, nobody has been able to create an effective treatment for severe CVI caused by malfunctioning valves in the deep veins of the leg. The VenoValve has the potential to change the treatment paradigm for deep venous CVI, both for the millions of patients suffering from severe CVI and the thousands of vascular surgeons who have been waiting for an effective treatment option.' Dr. Cassius Iyad Ochoa Chaar, who is the Associate Professor of Surgery, Division of Vascular Surgery and Endovascular Therapy, Yale School of Medicine, will present the abstract titled, ' Patients with Deep Venous Reflux Continue to Experience Clinical Improvement 2-year after Implantation of the VenoValve' today at VAM 2025. The VenoValve is a potential first-in-class, surgical replacement venous valve for patients with severe deep venous CVI. The Company estimates that there are approximately 2.5 million potential new patients each year in the U.S. that could be candidates for the VenoValve. The Company has submitted a pre-market authorization (PMA) application for the VenoValve to the U.S. Food and Drug Administration (FDA), with a decision anticipated in the second half of 2025. Webcast Details The Company will host a webcast presentation to discuss the results for investors, analysts and other interested parties today, June 6, 2025, at 11:20 AM ET / 10:20 AM CT. Joining enVVeno management for the event will be Dr. Chaar. The live webcast will be accessible on the Events page of the enVVeno website, and will be archived for 90 days. About CVI Severe, deep venous Chronic Venous Insufficiency (CVI) is a debilitating disease that is most often caused by blood clots (deep vein thromboses or DVTs) in the deep veins of the leg. When valves inside of the veins of the leg fail, blood flows in the wrong direction and pools in the lower leg, causing pressure within the veins of the leg to increase (venous hypertension). Symptoms of severe CVI include leg swelling, pain, edema, and in the most severe cases, recurrent open sores known as venous ulcers. The disease can severely impact everyday functions such as sleeping, bathing, dressing, and walking, and is known to result in high rates of depression and anxiety. There are currently no effective treatments for severe CVI of the deep vein system caused by valvular incompetence. Estimates indicate that CVI costs the U.S. healthcare system in excess of $4 billion each year. About enVVeno Medical Corporation enVVeno Medical (NASDAQ:NVNO) is an Irvine, California-based, late clinical-stage medical device Company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of deep venous disease. The Company's lead product, the VenoValve®, is a first-in-class surgical replacement venous valve being developed for the treatment of deep venous Chronic Venous Insufficiency (CVI). The Company is also developing a non-surgical, transcatheter based replacement venous valve for the treatment of deep venous CVI called enVVe®. Both the VenoValve and enVVe are designed to act as one-way valves, to help assist in propelling blood up the leg, and back to the heart and lungs. The VenoValve is currently being evaluated in the VenoValve U.S. pivotal study and the Company is currently performing the final testing necessary to seek approval for the pivotal trial for enVVe. Cautionary Note on Forward-Looking Statements This press release and any statements of stockholders, directors, employees, representatives and partners of enVVeno Medical Corporation (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 may include, without limitation, statements identified by words such as 'projects,' 'may,' 'will,' 'could,' 'would,' 'should,' 'believes,' 'expects,' 'anticipates,' 'estimates,' 'intends,' 'plans,' 'potential' or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results and timing (may differ significantly from those set forth or implied in the forward-looking statements. Forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required by applicable law. MEDIA CONTACT: Glenn Silver, FINN Partners (973) 818-8198 SOURCE: enVVeno Medical Corporation View the original press release on ACCESS Newswire
Yahoo
18-04-2025
- Business
- Yahoo
That $20 Halloween costume you bought for your kid last year will cost $40 in 2025, warns industry trade group
Retailers are pausing or cancelling orders for Halloween and Christmas decorations. Surcharges from tariffs are causing the action, which could result in a tremendous price spike as the holidays approach. Costumes that sold for $20 last year will likely be double that amount in 2025, industry officials warn. While Donald Trump has hinted a tariff deal with China could be in the works, manufacturers are warning that if the duties remain in place, it could make the end of year holidays a lot less joyful. The Halloween and Costume Association warns tariffs could double the price of costumes. Toy companies, meanwhile, are growing worried about the possible price of toys for Christmas, and Christmas decorations could see price increases along the same lines as Halloween costumes. 'This is an existential moment for our industry,' said Robert Berman, Halloween & Costume Association Board Member and President of Rasta Impasta/Imposta Costumes. 'Halloween isn't like other holidays. If products don't land on time or become too expensive for families, Halloween simply doesn't happen. There is no backup plan.' Sounding an alarm about holidays in the fourth quarter might seem a bit premature, but retailers are already locking in orders for Halloween. Home Depot, last month, launched sales of select spooky decorations, such as its iconic 12-foot skeleton and a 15-foot animated scarecrow. Many of those products, like the costumes kids wear when they go trick or treating come from China. "These are goods that are weeks from shipping — not months," says Berman. And many retailers are cancelling orders or cutting volumes, the industry group says. Thanksgiving is less China dependent, since it's largely a food holiday, but Chinese manufacturers who specialize in Christmas decorations are seeing a slowdown in orders as well. One manufacturer told CNN eight out of 10 U.S. customers have canceled their contracts this year, even after they were offered discounts to help cover the tariffs. Chinese companies are the source of 87% of the Christmas decorations sold in the U.S., making up a $4 billion market. That also included artificial trees, which U.S. retail customers are also pausing orders on. "My peers and I rely on U.S. orders to survive," one business owner in China told Reuters. "This will inevitably affect a lot of people. No one can escape." This story was originally featured on Sign in to access your portfolio
Associated Press
28-02-2025
- Business
- Associated Press
enVVeno Medical Reports Fourth Quarter and Year-End 2024 Financial Results and Progress Towards VenoValve FDA Approval Expected in 2H25
Cash Burn of $5.2 million in Q4 remains in line with projected $4-5 million quarterly range Cash and investments on hand are sufficient to fund operations beyond the anticipated regulatory approval of VenoValve and the initiation of the enVVe pivotal trial PMA application for the VenoValve submitted, with FDA decision expected in the second half of 2025 On track for enVVe IDE application submission by mid-2025, pending GLP study results IRVINE, CA / ACCESS Newswire / February 28, 2025 / enVVeno Medical Corporation (NASDAQ:NVNO) ('enVVeno' or the 'Company'), a company setting new standards of care for the treatment of venous disease, today provided a corporate update and reported financial results for the fourth quarter and year-end of 2024. 'Throughout 2024, we executed on our primary objectives - the successful submission of our PMA application for the VenoValve®, and the advancement of enVVe towards its U.S. pivotal trial, both critical milestones for enVVeno Medical,' commented Robert Berman, CEO of enVVeno Medical. 'We also added two key members to our Executive team in order to begin preparations for the commercialization of the VenoValve and will continue to add to our team following a positive decision from the FDA.' Mr. Berman added, 'We are on the precipice of achieving what no other company has been able to achieve, a viable solution for the millions of patients that suffer from severe deep venous Chronic Venous Insufficiency.' Summary of Financial Results for the Full Year 2024 The Company ended the year with $43.2 million in cash and investments. Based on management's current expectations, this capital has the potential to fund the Company through the anticipated FDA pre-market approval filing for VenoValve, the initiation of commercialization preparations for VenoValve and the commencement of the enVVe pivotal trial. Cash burn for the quarter was $5.2 million, consistent with the Company's projected cash burn rate of approximately $4-5 million per quarter. The Company anticipates that its cash burn rate will increase from current levels of approximately $4 million to $5 million per quarter to $5 million to $7 million per quarter in 2025. The Company reported net losses of $21.8 million and $23.5 million for the years ended December 31, 2024 and 2023, respectively, representing a decrease in net loss of $1.7 million or 7%, resulting from a decrease in operating expenses of $1.5 million, and an increase in other income of $0.2 million. Clinical Program Highlights VenoValve PMA application seeking U.S. Food and Drug Administration (FDA) approval submitted; Decision expected in H2 2025. Interim two-year follow-up data from 34 subjects in the SAVVE U.S. pivotal trial for the VenoValve demonstrated sustained clinical improvement and continued patient benefit, from 12 months to 24 months. 78% of subjects maintained a clinically meaningful benefit of more than 3 points in rVCSS at 24 months, with an average improvement of 8.2 points among the responder cohort. Subjects continued to experience a median 75% reduction in pain at 24 months. Interim follow-up data indicate sustained improvements across all venous specific quality-of-life (QoL) indicators. Reported one-year efficacy and safety data from the SAAVE U.S. pivotal trial at the 51st Annual VEITH Symposium. The data indicated: 85% of the patients enrolled in SAVVE experienced a clinical meaningful benefit from the VenoValve, defined as a three (3) or more point improvement in revised Venous Clinical Severity Score (rVCSS), at one year, compared to baseline. The average rVCSS improvement in the clinically meaningful responder cohort was 7.91 points. Patients in the SAVVE study also experienced a seventy-five percent (75%) median reduction in pain and improvements in quality-of-life indicators. For patients with venous ulcers (CEAP C6 patients), ulcer area was reduced a median average of eighty-seven percent (87%). Over the course of the 1-year period, there was one (1) death (unrelated to the VenoValve), zero (0) pulmonary embolisms, twelve (12) target vein thromboses, ten (10) surgical pocket hematomas, four (4) other bleeds, and seven (7) deep wound infections. Ninety four percent (94%) of the patients that experienced a material safety event also went on to experience a clinically meaningful benefit from the VenoValve. Also, the reported target vein patency rates at thirty (30) days and one (1) year were ninety one percent (91%) and ninety seven percent (97%), respectively. enVVe ®:Non-Surgical Transcatheter Based Replacement Venous Valve Successfully completed final wave for the shorter-term subjects in 6-month pre-clinical GLP study. Completion of GLP study expected in Q1 2025. The GLP study should be the final step necessary before filing the Investigational Device Exemption (IDE) seeking FDA approval to start the enVVe pivotal study. The Company expects to be in a position to file for IDE approval for the enVVe pivotal trial mid-2025. About enVVeno Medical Corporation enVVeno Medical (NASDAQ:NVNO) is an Irvine, California-based, late clinical-stage medical device Company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of venous disease. The Company's lead product, the VenoValve®, is a first-in-class surgical replacement venous valve being developed for the treatment of deep venous Chronic Venous Insufficiency (CVI). The Company is also developing a non-surgical, transcatheter based replacement venous valve for the treatment of deep venous CVI called enVVe®. CVI occurs when valves inside of the veins of the leg become damaged, resulting in the backwards flow of blood (reflux), blood pooling in the lower leg, increased pressure in the veins of the leg (venous hypertension) and in severe cases, venous ulcers that are difficult to heal and become chronic. Both the VenoValve and enVVe are designed to act as one-way valves, to help assist in propelling blood up the leg, and back to the heart and lungs. The VenoValve is currently being evaluated in the SAVVE U.S. pivotal study and the Company is currently performing the final testing necessary to seek approval for the pivotal trial for enVVe. Cautionary Note on Forward-Looking Statements This press release and any statements of stockholders, directors, employees, representatives and partners of enVVeno Medical Corporation (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 may include, without limitation, statements identified by words such as 'projects,' 'may,' 'will,' 'could,' 'would,' 'should,' 'believes,' 'expects,' 'anticipates,' 'estimates,' 'intends,' 'plans,' 'potential' or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results and timing (may differ significantly from those set forth or implied in the forward-looking statements. Forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required by applicable law.
