Latest news with #VenoValve
Miami Herald
19-05-2025
- Business
- Miami Herald
enVVeno Medical Appoints Jennifer Bright as Chief Financial Officer
IRVINE, CA / ACCESS Newswire / May 19, 2025 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, announced the appointment of Jennifer Bright as Chief Financial Officer, effective today, May 19, 2025. Ms. Bright brings more than 25 years of financial and strategic leadership experience built across several commercial-stage medical device and pharmaceutical companies including Biolase, Spectrum Pharmaceuticals, Apria Healthcare, Smile Brands, and Teleflex Medical, as well as technical accounting and auditing experience at PricewaterhouseCoopers LLP. "Jennifer brings a wealth of commercial experience to the CFO role, which we believe will be instrumental as we transition from a development-stage company to a commercial entity," said Robert Berman, enVVeno Medical's Chief Executive Officer. "In addition to overseeing our financial strategy and operations, Jennifer will play a critical role in strengthening our financial infrastructure, supporting our commercialization efforts for VenoValve, and expanding our relationships with institutional investors and analysts. Her experience navigating growth and change will be a valuable asset as we enter this next phase of the Company's evolution." Ms. Bright is a Certified Public Accountant and received a B.A. degree in Business Administration, Accounting, from the University of Washington. She succeeds Craig Glynn, who will continue to be available to the Company in an advisory capacity. The Company is currently developing two devices for the treatment of deep venous CVI, a potential first-in-class surgical replacement venous valve called the VenoValve®, and a non-surgical replacement venous valve called enVVe®. The Company estimates that there are approximately 2.5 million potential new patients each year in the U.S. that could be candidates for replacement venous valves, including approximately 1.5 million with active venous ulcers. The Company has submitted a pre-market authorization (PMA) application for the VenoValve to the FDA, with a decision anticipated in the second half of 2025. In the third quarter of 2025, the Company expects to file an Investigational Device Exemption (IDE) seeking authorization from the FDA to begin enVVe pivotal trial. About CVISevere, 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 CorporationenVVeno 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 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 Company has submitted a pre-market authorization (PMA) application for the VenoValve to the FDA, with a decision anticipated in the second half of 2025 and is currently performing the final testing necessary to seek approval from the FDA for the enVVe pivotal trial. Cautionary Note on Forward-Looking StatementsThis 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
Miami Herald
13-05-2025
- Health
- Miami Herald
Three-Year VenoValve(R) First-in-Human Trial Data Published in the Annals of Vascular Surgery
IRVINE, CA / ACCESS Newswire / May 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 its manuscript titled, "Three-Year Outcomes of Surgical Implantation of a Novel Bioprosthetic Valve for the Treatment of Deep Venous Reflux1," has been published in the in the peer-reviewed journal, Annals of Vascular Surgery. The VenoValve was surgically implanted in the femoral vein of eleven subjects with active or healed venous ulcers (CEAP classifications C5-C6). Eight subjects completed three years of follow-up, with key findings including: The VenoValve remained safe and effective, achieving target patency and maintaining competence and clinical benefits 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. 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®. 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. INVESTOR CONTACT:Jenene Thomas, JTC Team, LLC NVNO@ 824-0775 MEDIA CONTACT:Glenn Silver, FINN Partners 818-8198 SOURCE: enVVeno Medical Corporation
Associated Press
13-05-2025
- Health
- Associated Press
Three-Year VenoValve(R) First-in-Human Trial Data Published in the Annals of Vascular Surgery
Promising results from the first-in-human study demonstrated that, at three-years post implantation, VenoValve remained safe and effective--achieving a high rate of patency, restoring deep venous competence and maintaining clinical benefitsCompany has submitted PMA application for the VenoValve to the U.S. Food and Drug Administration (FDA) with a decision anticipated in the second half of 2025 IRVINE, CA / ACCESS Newswire / May 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 its manuscript titled, " Three-Year Outcomes of Surgical Implantation of a Novel Bioprosthetic Valve for the Treatment of Deep Venous Reflux 1,' has been published in the in the peer-reviewed journal, Annals of Vascular Surgery. The VenoValve was surgically implanted in the femoral vein of eleven subjects with active or healed venous ulcers (CEAP classifications C5-C6). Eight subjects completed three years of follow-up, with key findings including: 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. 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®. 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. INVESTOR CONTACT: Jenene Thomas, JTC Team, LLC [email protected] (908) 824-0775 MEDIA CONTACT: Glenn Silver, FINN Partners [email protected] (973) 818-8198 SOURCE: enVVeno Medical Corporation press release
Yahoo
13-05-2025
- Business
- Yahoo
Three-Year VenoValve(R) First-in-Human Trial Data Published in the Annals of Vascular Surgery
Promising results from the first-in-human study demonstrated that, at three-years post implantation, VenoValve remained safe and effective--achieving a high rate of patency, restoring deep venous competence and maintaining clinical benefits Company has submitted PMA application for the VenoValve to the U.S. Food and Drug Administration (FDA) with a decision anticipated in the second half of 2025 IRVINE, CA / / May 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 its manuscript titled, "Three-Year Outcomes of Surgical Implantation of a Novel Bioprosthetic Valve for the Treatment of Deep Venous Reflux1," has been published in the in the peer-reviewed journal, Annals of Vascular Surgery. The VenoValve was surgically implanted in the femoral vein of eleven subjects with active or healed venous ulcers (CEAP classifications C5-C6). Eight subjects completed three years of follow-up, with key findings including: Primary patency: 79% (Kaplan-Meier curve) at three years Symptom relief: 7 point improvement Venous Clinical Severity Score; 84% reduction in pain on the Visual Analog Scale (VAS) The VenoValve remained safe and effective, achieving target patency and maintaining competence and clinical benefits 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. 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®. 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. INVESTOR CONTACT:Jenene Thomas, JTC Team, LLC NVNO@ 824-0775 MEDIA CONTACT:Glenn Silver, FINN Partners 818-8198 SOURCE: enVVeno Medical Corporation View the original press release on ACCESS Newswire Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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.
