Venous Insufficiency

HANGZHOU, China, March 28, 2025 /PRNewswire/ -- On March 20, Zylox-Tonbridge Medical Technology Co., Ltd. (Stock Code: 2190.HK, hereinafter referred to as "Zylox-Tonbridge" or the "Company") released its 2024 annual results. In 2024, the Company reported revenue of USD 109.4 million, a year-on-year increase of 48.3%, and achieved a net profit exceeding USD 14 million, marking its first full-year profitability. Amid a dynamic market environment, Zylox-Tonbridge benefited from the economies of scale driven by sustained revenue growth, entering a new phase of sustainable profitability. This fully demonstrates the Company's robust capabilities in developing comprehensive product solutions, delivering high-quality products, and operating efficiently. Looking ahead, Zylox-Tonbridge remains committed to its mission of "Innovation for Quality Life", focusing on advancements in medical technology to improve high-quality healthcare and drive the Company's long term growth. Strong Performance in Centralized Procurement and Continued Overseas Expansion In 2024, the Company actively seized opportunities in centralized procurement, securing successful multiple bids by leveraging its robust and high-quality product portfolio. These achievements are expected to accelerate product penetration in hospitals and enhance market competitiveness, laying a solid foundation for sustained growth. In the "3+N" provincial alliance centralized procurement led by Hebei, our SilverSnake Intracranial Support Catheter fully demonstrated its advantages in the A group for its respective category, winning the bid with the highest ranking. During the national-level venous stent procurement, the ZYLOX Penguin Peripheral Venous Stent System became the only domestic bidder to win the first rule of iliac vein indication. In the vascular intervention product procurement led by Hebei Province, our products, including the Kylin Flow Diverter, White Horse Intracranial PTA Balloon Catheter (Rx) and three peripheral balloon products, won bids, each securing a leading position in their respective categories. As centralized procurement policies deepen, the Company has established an extensive distribution network covering over 3,000 hospitals. In 2024, Zylox-Tonbridge allocated dedicated resources across key functions, including R&D, regulatory affairs, and manufacturing, further expanding its overseas footprint. Currently, 20 of the Company's products are commercialized in 24 countries and regions, including Germany, Italy, Argentina, Brazil, and the UAE, spanning Europe, South America, and the Middle East. The Company is conducting post-market clinical trials for the Zenflex™ Peripheral Stent System and ZENFLEX™ Pro Peripheral Drug-Eluting Stent System in overseas markets while actively participating in international academic conferences such as WLNC 2024, LINC 2024, and CIRSE 2024 to enhance brand influence abroad. The Company's overseas revenue reached USD 3.2 million in 2024, with a four-year compound annual growth rate of 87%. Driven by Innovation: Pioneering Cutting-Edge Medical Technologies In 2024, Zylox-Tonbridge launched multiple innovative products, offering patients more comprehensive solutions. The Company is also actively exploring "AI + Healthcare" technologies to empower product innovation and service upgrades. Among its breakthroughs, the launch of ZYLOX Penguin Peripheral Venous Stent System, a product of medical-engineering collaboration, became another milestone in the Company's efforts to address peripheral venous diseases. The Kylin Flow Diverter, independently developed by Zylox-Tonbridge, is China's first fully visible distal closed flow diverter stent. Meanwhile, ZYLOX Unicorn Suture-mediated Closure System, the first domestically manufactured vascular suture product, has broken the market monopoly of imported brands in puncture site closure solutions. The Company's collaboratively developed ZYLOX Pantheris™ Peripheral OCT-Guided Atherectomy Catheter and ZYLOX Tigereye ST™ OCT-Guided Peripheral Vascular Chronic Total Occlusion-crossing Catheter obtained approval from the NMPA to enter the special review procedure for innovative medical devices (innovation channel), which are expected to launch in 2025. Additionally, Zylox-Tonbridge is focusing on next-generation real-time imaging AI diagnostics and analysis technologies to improve precision in vascular interventions and develop personalized treatment solutions. As of the announcement date, the Company has established a pipeline of 66 products. Among these, 47 have received NMPA approval, 8 have obtained EU CE marks, and several others have been approved for sale in countries such as Germany and the UK. Operational Excellence: Entering the Sustainable Profitability Stage With growing revenue, Zylox-Tonbridge's operational efficiency continues to rise. In 2024, the Company reduced its R&D, sales, and administrative expense ratios by 20, 9, and 10 percentage points, respectively, compared to 2023, propelling it into a new phrase of sustainable profitability. At its Hangzhou and Zhuhai manufacturing bases, the Company has invested in automated and digital production lines, optimized lean processes, and strengthened supply chain management to increase the localization rate of core materials, ensuring both product quality and production efficiency. Since fully launching commercialization in late 2020, over 800,000 of the Company's products have been used clinically, earning recognition and trust from medical professionals. Moving forward, Zylox-Tonbridge will uphold its commitment to "Innovation for Quality Life," increasing investments in medical technology to provide global patients with high-quality, affordable medical devices and solutions. The Company aims to ensure that everyone can benefit from advanced medical technologies, contributing to the progress of the healthcare industry. SOURCE ZYLOX-TONBRIDGE WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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

CHAPEL HILL, N.C., March 18, 2025 /PRNewswire/ -- SonoVascular, Inc., a clinical stage medical device company focused on bringing to market its SonoThrombectomy™ System for venous thromboembolism (VTE), a novel treatment solution intended to provide better outcomes for millions of patients suffering from deep vein thrombosis (DVT) and pulmonary embolism (PE), has successfully completed an initial set of eight cases in patients with DVT in its First-In-Human (FIH) study. DVT is a condition that occurs when blood clots form in the deep veins of the leg, restricting blood flow back to the heart and causing pain and swelling. Additionally, if part of the clot breaks off it can travel through the bloodstream to the lungs, causing a PE which can be life threatening. To treat these conditions, the SonoThrombectomy System delivers ultrasound energy and microbubbles directly to the clot through the RESONATOR™ Catheter, inducing microbubble-mediated cavitation, which mechanically breaks down the clot. Additionally, a very low dose of tPA is infused in combination with the microbubbles through the catheter to further improve clot breakdown. The System is designed to treat VTE more safely and effectively, and at a lower cost to the health care system than currently approved therapies. SonoThrombectomy treatment was highly effective in the first eight cases of the FIH study, as all cases achieved a complete (100%) Marder score reduction as assessed by an independent core laboratory. Additionally, significant improvements from baseline in Villalta score, revised Venous Clinical Severity Score, and Numeric Pain Rating Scale scores were observed at 30-day follow-up, and there were no device-related adverse events, major bleeding, or deaths. "We are very encouraged by the initial cases in our FIH clinical study." said Daniel Estay, Founder and Chief Executive Officer of SonoVascular. "Thus far, our investigators have observed complete thrombus resolution, no blood loss, and no evidence of adverse affects on the vein wall or venous valves or other safety concerns. Enrollment in the FIH study is ongoing and planned to be completed by the end of Q2 2025. We are honored that Dr. William Marston presented our initial clinical findings at the 2025 annual meeting of the American Venous Forum on February 19th in Atlanta, Georgia." William Marston, MD, Professor of Surgery at the University of North Carolina at Chapel Hill School of Medicine and Past President of the American Venous Forum, remarked: "The results obtained thus far in SonoVascular's FIH study demonstrate the SonoThrombectomy System has the potential to become a disruptive technology that would effectively overcome the shortcomings of available therapies for the treatment of DVT. As a vascular surgeon and researcher who has treated patients suffering from DVT for over 25 years, I find that despite improvements in our ability to treat these patients, currently available devices still have significant challenges and limitations. In the initial cases, the SonoThrombectomy System has demonstrated its ability to eliminate intravenous clot in a single treatment session with no blood loss and with preservation of venous valves. The System is not limited by the presence of previously implanted filters or stents and is highly steerable for treatment of specific areas of residual thrombus. These initial cases suggest that the SonoThrombectomy System is able to eliminate clot with a gentler approach that does not cause blood loss and preserves vessel and valve integrity. This System has the potential to be a revolutionary technology and address critical limitations with current interventional devices and techniques for treatment of DVT." About Venous Thromboembolism Venous thromboembolism is a condition that occurs when a blood clot forms in a vein. As many as 900,000 VTE events occur each year in the United States.1 VTE includes DVT and PE. DVT occurs when a blood clot forms in a deep vein, usually in the lower leg, thigh or pelvis. The most serious complication of DVT happens when a part of the clot breaks off and travels through the bloodstream to the lungs, causing a blockage called PE. If the clot is large, it can stop blood from reaching the lungs and can be fatal. One-third to one-half of people who have a DVT will have long-term complications caused by damage to the valves in the vein called post-thrombotic syndrome (PTS).2 In some cases, PTS symptoms can be so severe that a person becomes disabled. PE can be life-threatening, with 10-30% of individuals dying within one month of diagnosis.3 About SonoVascular, Inc. SonoVascular is a clinical-stage medical device company that has developed the SonoThrombectomy system. SonoThrombectomy is a novel and highly differentiated ultrasound facilitated, thrombolytic enhanced thrombectomy system for venous and arterial thrombosis that utilizes microbubble-mediated cavitation as a core enabling mechanical mechanism of action to more safely and effectively treat VTE. It is a cathlab-based solution designed to maximize the reduction of clot burden, eliminate blood loss and vessel trauma, and harness the benefit of low dose/duration thrombolytic without bleeding risks. SonoVascular is headquartered in Chapel Hill, NC. For more information, visit . Contact: SonoVascular, Inc. Daniel Estay Founder and Chief Executive Officer [email protected] 1 Gregson J, Kaptoge S, Bolton T, et al. Cardiovascular Risk Factors Associated With Venous Thromboembolism. JAMA Cardiol. 2019;4(2):163–173. doi:10.1001/jamacardio.2018.4537. 2 Wendelboe AM, Campbell J, McCumber M; Bratzler D; Ding K, Beckman M, Reyes N; Raskob G. The Design and Implementation of a New Surveillance System for Venous Thromboembolism using Combined Active and Passive Methods. American Heart Journal. 2015. 3 American Lung Association; SOURCE SonoVascular, Inc. 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