Chronic venous insufficiency

Results from Part 1 of a two-part Phase 2 clinical trial demonstrate the efficacy and safety of a novel subcutaneous biologic for chronic venous leg ulcersRESEARCH TRIANGLE PARK, N.C., March 26, 2025 (GLOBE NEWSWIRE) -- Merakris Therapeutics announced the publication of positive clinical trial results from the first part of its ongoing Phase 2, multicenter trial. This study evaluates its biological drug, MTX-001 (Dermacyte Liquid), a cell-free amniotic fluid (cfAF) for chronic, non-healing venous leg ulcers (VLUs). Interim results from part one of the study published in the International Wound Journal, highlights the investigational new drug’s potential as a first-in-class biologic therapy in nine patients completing study treatment with lower extremity venous wounds refractory to healing using standard-of-care-based approaches. Key Findings: Wound Duration Prior to Treatment: Prior to injection therapy, the patients’ VLUs persisted for a median duration of 7 months despite correcting the underlying venous reflux and standard-of-care interventions.Pain Reduction: Mean pain scores were significantly reduced by the study end.Total Wound Closure: 66.7% of patients achieved complete wound closure by the one-month post-trial follow-up.Wound Area Reduction: The average percent reduction of ulcer area was 83.7% in patients that completed the 12-week treatment duration.Long-Term Chronic Wounds Treated: The average duration of ulcers before study enrollment was 73 weeks, emphasizing the challenge of treating these cases with standard care alone. “These results are highly encouraging, particularly given the long-standing, non-healing nature of the wounds treated in this study and support the growing body of evidence demonstrating efficacy and safety of this novel subcutaneous biologic for chronic venous leg ulcers,” said Chris Broderick, Merakris’ CEO. “MTX-001 represents an innovative therapeutic approach to significantly improving outcomes for patients suffering from chronic, recalcitrant venous leg ulcers, and if approved, could be a cost-effective therapy.” Addressing a Critical Unmet Need in Venous Wound Care Chronic venous insufficiency (CVI) affects millions of Americans, with up to 3% of adults in the United States developing severe venous leg ulcers (VLUs). While 60% of VLUs typically heal within 12 weeks, recurrence rates remain alarmingly high — 30% within one year and up to 70% within two years. Advancing Innovation in Wound Healing The primary objectives of the first part of this ongoing Phase 2 trial were to evaluate the safety and tolerability of MTX-001 while gaining insights into dosing frequency and efficacy metrics such as: Complete wound closureReduction of wound sizePain relief (VAS score)Improved quality of life (HR-QoL) “To our knowledge, this is the first multi-patient clinical trial evaluating cfAF therapy for chronic, non-healing VLUs,” added Chris Broderick. “The data suggest that MTX-001 is safe, well-tolerated, and effective in patients who have undergone correction of underlying venous reflux disease. These findings support its potential role in reducing clinical burden, improving healing rates, and enhancing patient quality of life.” Next Steps: Enrollment Open for Phase 2 Part 2 Merakris has opened patient enrollment for Part 2 of this Phase 2 clinical trial (NCT04647240) to further assess the efficacy and safety of MTX-001. For more information on the venous leg ulcer study or Merakris’ expanded access drug program, please contact the medical affairs team at medaffairs@merakris.com. About Merakris Therapeutics Merakris Therapeutics is a leading innovator in regenerative medicine focused on developing and commercializing biologically derived products for wound healing and other complex conditions. Leveraging advanced biologic manufacturing capabilities and a robust research pipeline, Merakris is committed to improving patient outcomes and advancing the science of regenerative therapies. Merakris Forward Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of Merakris’ products, or regarding potential future revenues from any such product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Merakris’ management believes that any forward-looking statements in this press release are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Merakris, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and advisors and on the global economy as a whole. Investigational drug tradename (Dermacyte Liquid or Dermacyte Amniotic Wound Care Liquid) has not been approved by FDA. PR Contact:Garth MillerNova Marketing Solutionsgarth.miller@novamktsolutions.com919-923-3505

YOKNEAM, Israel, Jan. 13, 2025 /PRNewswire/ -- ElastiMed Ltd. a leading innovator in wearable medical devices for treating and managing lymphatic and venous diseases, is proud to announce the appointment of Dr. Steve Elias as a member of its Medical Advisory Board, effective immediately. Continue Reading Steve Elias MD FACS FAVLS DABVLM, Director, Center for Vein Disease, Englewood Health Network Dr. Elias brings years of experience and expertise to ElastiMed's Medical Advisory Board. With a distinguished career as board certified in Venous and Lymphatic Medicine and general surgery, Dr. Elias has garnered wide recognition for his commitment to patient care and medical innovation. His deep understanding of vascular health and his passion for improving patient outcomes make him an invaluable addition to the ElastiMed team. "We are delighted to welcome Dr. Elias to our Medical Board," said Mr. Omer Zelka, CEO and Founder of ElastiMed. "His extensive experience in vascular surgery and his dedication to advancing healthcare align perfectly with ElastiMed's mission to empower patients through innovative wearable technology." Dr. Steve Elias is a distinguished figure in the field of vascular surgery. Among his roles, Dr. Elias serves on the executive committee of the American Venous Forum (AVF), as a past board director of the American Vein & Lymphatic Society (AVLS). He is co-founder of the online video magazine, Venous Edge, and the Expert Venous Management meeting. His support of compression therapy as a crucial treatment modality for various patient populations is well known. He emphasizes its efficacy in improving circulation, reducing swelling, and alleviating symptoms in patients with Lymphedema and additional conditions like chronic venous insufficiency, varicose veins, and venous ulcers. Through his research, publications, and clinical practice, Dr. Elias continues to educate both patients and healthcare professionals about the importance of compression therapy in enhancing vascular health and quality of life. As a respected leader in the medical community, Dr. Elias has contributed significantly to research and clinical practice in venous disease. His clinical insights and expertise will play a vital role in guiding ElastiMed's product development and ensuring the highest standards of medical excellence. "I am honored to join ElastiMed's Medical Board and contribute to the advancement of wearable compression technology," said Dr. Elias. "ElastiMed's commitment to innovation and patient-centered care resonates with my own professional values, and I look forward to collaborating with the team to drive meaningful impact in healthcare." Dr. Elias's appointment underscores ElastiMed's ongoing commitment to assembling a world-class team of medical experts dedicated to advancing healthcare through technology. About ElastiMed: ElastiMed's wearable medical devices are designed to treat and manage lymphatic and venous diseases. With a focus on innovation and technology, ElastiMed designs, and cutting-edge solutions empower patients and healthcare providers alike. ElastiMed is dedicated to improving patient's outcomes, addressing health equity challenges and enhancing healthcare delivery at home. For more information about Elastimed and its innovative products, please visit Contact details: Omer Zelka, CEO ElastiMed [email protected] Photo: SOURCE ElastiMed Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Successful Completion of All Planned Implants in GLP StudyenVVe Delivery System Demonstrates Consistent PerformanceCompany Maintains Timeline for IDE Application Submission by Mid-2025, Pending GLP Study Results IRVINE, CA / ACCESSWIRE / December 16, 2024 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today announced the successful completion of the final wave of implants for shorter-term subjects in its six-month pre-clinical GLP study for enVVe, its transcatheter-delivered replacement venous valve. The successful completion of all planned implants in the GLP study, including both long-term and short-term subjects, completes a critical phase of the study. The follow-up period, which began with the first wave of implants, is ongoing as scheduled. Pending successful completion of the GLP study, the Company anticipates submitting its IDE application to the FDA in mid-2025. The submission, if approved, would allow the Company to initiate the pivotal clinical trial for enVVe."With the successful completion of all planned implants in the enVVe GLP study, we have achieved the last of our milestones for 2024," said Robert Berman, enVVeno Medical's Chief Executive Officer. "Our enhanced enVVe crimping and delivery system has performed very well throughout the study and is ready for the pivotal trial. We will continue to monitor the performance of the enVVe valves throughout the remainder of the study and with successful data and pathology, should be in a position to file the IDE on schedule in mid 2025. We remain focused on our goal of becoming the established leader in both the surgical and non-surgical replacement venous valve markets for patients with severe deep venous 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.The Company's lead product is the VenoValve,® a potential first-in-class, surgical replacement venous valve for patients with severe deep venous CVI. In November, the Company submitted a PMA application with the U.S. Food and Drug Administration seeking approval to market and sell the VenoValve in the U.S. 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 is also developing enVVe®, a next-generation, transcatheter based replacement venous valve, that could appeal to an even larger market in terms of both patients and physicians.Beginning early next year, the Company will begin to implement its strategy to transition from a development stage to a commercial entity for the VenoValve, while completing the necessary non-clinical and GLP testing for enVVe in preparation for its IDE application.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 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 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, LLC[email protected](908) 824-0775SOURCE: enVVeno Medical Corporation