Soft Tissue Injuries

CHARLOTTESVILLE, Va., Oct. 10, 2024 /PRNewswire/ -- RIVANNA®, developers of imaging-based medical solutions, has announced the launch of the first multi-site study employing the Accuro® XV musculoskeletal imaging system. This milestone follows a $30.5 million funding option executed in 2023 by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Over 20 million patients present to emergency departments (ED) annually with suspected distal extremity trauma, and an estimated 90% to 99% receive X-ray imaging, according to The Journal of Emergency Medicine. However, it is reported that in the lower leg, the incidence of fractures ranges between 8% to 19%, and in the distal arm, the incidence is between 25% to 57%, according to The Journal of Trauma and Acute Care Surgery and The American Journal of Emergency Medicine. A bedside triage device like Accuro XV may significantly reduce the utilization of radiological resources for low-acuity injury triage. This feasibility study, enrolling 200 participants, aims to acquire fracture images with Accuro XV to evaluate device safety, ability to integrate within ED workflow and the system's ability to render automated diagnostic ultrasound images. Accuro XV integrates ultrasound-based bone and 3D soft-tissue imaging technology with AI-enabled software and is designed to enable rapid automated detection and volumetric assessment of skeletal fractures and soft tissue injuries without harmful radiation exposure. Additionally, Accuro XV aims to address limitations in EDs such as identifying soft tissue injuries during the acute phase, ensuring accurate treatment decisions and prompt discharge of those not needing further intervention. "Since October 2021, we have quickly progressed from design to proof of concept in clinical sites, thanks to our collaboration with BARDA," said Delphine Le Roux, PhD, PMP, Director of Program Management. "Study data will expedite the development of Accuro XV for comprehensive point-of-care musculoskeletal diagnostics and validate product design with ED physician end-users." UVA Health worked with RIVANNA at the study's inception, providing study start-up and optimization before expanding to The University of Texas Southwestern Medical Center, where faculty treat patients at Parkland Memorial Hospital, one of the nation's busiest EDs with 240,000 visits annually. "We are working to transform technological opportunities into applications that may improve treatment for low-acuity patients and reduce wait times," said Chris Thom, MD, RDMS, Associate Professor of Emergency Medicine at the University of Virginia School of Medicine. This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50121C00035. About BARDA. About RIVANNA RIVANNA® is a commercial-stage medical device innovator and manufacturer in Charlottesville, VA. RIVANNA's mission is to develop and commercialize world-first imaging-based medical technologies that elevate global standards of care. RIVANNA is privately held and operates an FDA-registered and ISO 13485:2016-certified manufacturing facility. Learn more: RIVANNA. SOURCE RIVANNA WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

HADDONFIELD, N.J., Sept. 16, 2024 /PRNewswire/ -- Linnaeus Therapeutics, Inc. (Linnaeus), a privately held clinical-stage biopharmaceutical company focused on the development and commercialization of novel small-molecule oncology therapeutics, today announced the presentation of clinical data at the 2024 ESMO Annual Meeting from its dose-expansion cohort of LNS8801 as a monotherapy in patients with metastatic cutaneous melanoma who could not tolerate immunotherapy due to prior immune-related adverse events. The poster is entitled "Efficacy of LNS8801 in melanoma patients with prior immune-related adverse events from immune-checkpoint inhibitors" (Abstract 1137P). LNS8801 given alone was tolerable without unanticipated toxicities and demonstrated encouraging antitumor activity in patients with metastatic cutaneous melanoma who had prior severe immune-related adverse events on immune checkpoint inhibitor therapies. LNS8801 monotherapy treatment resulted in a disease control rate of 100% in biomarker-positive patients, with a preliminary progression-free survival of over 6 months. This includes a patient that has been on treatment for over 4.5 years with resolution of all soft-tissue lesions and no evidence of active disease in the residual bone-associated target lesion or elsewhere. "We are extremely pleased to showcase these data at ESMO," commented Patrick Mooney, MD, CEO of Linnaeus. "The data from this study demonstrate that LNS8801 is extremely safe and well tolerated and shows very promising signs of efficacy. Given that patients with prior irAEs are often prevented from receiving further immunotherapy, these patients represent a large unmet need. We look forward to generating more data in this patient population and in unresectable treatment refractory melanoma." Linnaeus anticipates initiating a randomized controlled clinical trial in unresectable, treatment-refractory cutaneous melanoma in Q4 of this year. This study will randomize 135 biomarker-positive patients to receive LNS8801 monotherapy; LNS8801 and pembrolizumab; or physician's choice therapy. The study will assess median progression-free survival and overall survival among the groups. About LNS8801 LNS8801 is an orally bioavailable and highly specific and potent agonist of GPER whose activity is dependent on the expression of GPER. GPER activation by LNS8801 rapidly and durably depletes c-Myc protein levels. In preclinical cancer models, LNS8801 displays potent antitumor activities across a wide range of tumor types, rapidly shrinking tumors and inducing immune memory. In the ongoing clinical study in humans, LNS8801 monotherapy has been safe and well tolerated. Additionally, LNS8801 has demonstrated target engagement, c-Myc protein depletion, and clinical benefit in patients with advanced cancers, and a predictive biomarker has been identified. About Metastatic Cutaneous Melanoma Although there has been progress in the treatment of metastatic cutaneous melanoma, most patients will progress on standard of care therapies and need further treatment. According to the American Cancer Society, almost 8,000 patients die each year in the United States, highlighting the need for safe and effective therapies in the treatment-refractory setting. About Linnaeus Linnaeus Therapeutics, Inc. is a privately held clinical-stage biopharmaceutical company focused on the development and commercialization of novel small molecule oncology therapeutics that target G protein-coupled receptors. The company was formed and launched in partnership with the UPstart incubator at the University of Pennsylvania's Penn Center for Innovation (PCI). SOURCE Linnaeus Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

精彩内容 近日，随着A股医药企业上半年业绩披露完毕，奇正藏药、云南白药、羚锐制药3家中成药贴膏剂龙头企业的业绩也浮出水面，均取得亮眼的成绩。其中，奇正藏药贴膏剂收入稳健增长，独家大单品2023年在中国三大终端六大市场的销售额突破20亿元，4款新药在路上；羚锐制药营收实现“14连涨”，净利润连续多年双位数增长，猛攻外用化药530亿市场。 中成药贴膏剂百亿市场！奇正、云南白药、羚锐盘踞前三 中成药贴膏剂是一种传统经典的中药外用疗法，也是一种现代透皮给药制剂。相比于口服药物，中成药贴膏剂具有无肝脏首过效应、避免胃肠道破坏、毒副作用小、药效持久、使用方便等优点。 近年来，人口老龄化加速、慢病年轻化以及消费升级驱动中成药贴膏剂市场的增长。米内网数据显示，2023年中国三大终端六大市场（统计范围详见本文末）中成药贴膏剂销售额超过130亿元，同比增长6.5%，市场规模创近年来新高。 近年来中国三大终端六大市场中成药贴膏剂销售情况（单位：万元）来源：米内网格局数据库 在一级集团竞争格局中，奇正集团、云南白药、羚锐制药稳居前三，近年来市场份额均在10%以上。其中，奇正集团、羚锐制药近年来持续正增长，2023年奇正集团顶替云南白药，拿下“一哥”宝座。 近年来中国三大终端六大市场中成药贴膏剂TOP3集团市场份额情况来源：米内网格局数据库 近日，随着A股医药企业2024上半年业绩披露完毕，上述3家中成药贴膏剂龙头企业的业绩也浮出水面，均取得亮眼的成绩。 2024上半年，奇正藏药营业收入10.10亿元（+21.70%），归母净利润3.26亿元（+4.30%）；羚锐制药营业收入19.06亿元（+12.07%），归母净利润4.13亿元（+30.3%）；云南白药营业收入204.55亿元（+0.72%），归母净利润31.89亿元（+12.76%）。 奇正藏药：贴膏剂收入稳健增长，4款新药在路上 奇正藏药主营业务为藏药的研发、生产及销售，目前拥有以25个独家品种为核心的141个药品批准文号，包括以消痛贴膏（独家）、青鹏软膏、白脉软膏（独家）、铁棒锤止痛膏（独家）等为主的外用系列产品，以及红花如意丸（独家）、如意珍宝片（独家）等口服藏药产品及其他经典中药产品，涵盖骨骼肌肉、神经系统、妇科、儿科、呼吸系统等多个治疗领域。 2024上半年，奇正藏药经营业绩稳步增长，报告期内实现营业收入10.1亿元，同比增长21.7%；归母净利润3.26亿元，同比增长4.3%。从分产品收入看，贴膏剂收入约7.14亿元，同比增长28.37%，占总营收比重超过70%；软膏剂收入约1.33亿元，同比增长20.49%；其他剂型收入约1.52亿元，同比略有下滑...... 贴膏剂为奇正藏药主要收入来源，拥有消痛贴膏、铁棒锤止痛膏、伤湿止痛膏等多个品种。近年来公司的贴膏剂收入持续增加，由2016年的7.4亿元增长至2023年的14.23亿元，2024年有望再创新高。 近年来奇正藏药贴膏剂收入情况（单位：亿元）来源：公司公告 消痛贴膏为奇正藏药核心产品，已被纳入国家医保乙类、国家基药目录。该产品具有活血化瘀、消肿止痛的功效，用于急慢性扭挫伤、跌打瘀痛、骨质增生、风湿及类风湿疼痛、落枕、肩周炎、腰肌劳损和陈旧性伤痛。针对老龄化趋势，奇正藏药聚焦重点医院，多科室多疾病拓展，深耕骨科，联动康复科、老干科、疼痛科及全科等重点科室，不断增加消痛贴膏在等级及基层的医院覆盖，同时做大线上渠道，B2C、O2O渠道销售显著增长。 米内网数据显示，近年来消痛贴膏在中国三大终端六大市场的销售额逐年上涨，2023年突破20亿元，同比增长9.4%。在中成药贴膏剂产品排名中，近年来消痛贴膏稳居首位，市场份额由2019年的约14%提升至2023年的约16%。 近年来中国三大终端六大市场消痛贴膏销售情况（单位：万元）来源：米内网格局数据库 近年来，奇正藏药持续加大研发投入，推进藏药新药研发、经典藏药二次开发、质量标准提升、资源可持续发展等。2023年公司研发投入接近1亿元，同比增长14.86%；2024上半年以9.86%的同比增速继续增长。 在研新药中，催汤颗粒在开展III期临床，用于治疗普通感冒及流行性感冒；消痛气雾剂、正乳贴均处于II期临床，分别用于急性腰扭伤/急性软组织损伤、乳腺增长病；化药1.1类新药乙烷硒啉分散片在开展I期临床，用于治疗恶性实体瘤。此外，白脉软膏用于糖尿病周围神经病变的新适应症于近日获批临床。 奇正藏药在开展临床的新药来源：米内网中国临床试验数据库 羚锐制药：营收“14连涨”，猛攻530亿市场 羚锐制药主营业务为中成药及化药制剂的研发、生产和销售，拥有橡胶膏剂、贴剂、片剂、胶囊剂、乳膏剂等10余种剂型百余种产品，涉及骨科、心脑血管、儿科、癌性疼痛等治疗领域，核心产品包括通络祛痛膏（独家）、活血消痛酊（独家）、壮骨麝香止痛膏、培元通脑胶囊（独家）、丹鹿通督片（独家）、参芪降糖胶囊、芬太尼透皮贴剂等。 2024上半年，羚锐制药经营业绩稳步增长，报告期内实现营业收入19.06亿元，同比增长12.07%；归母净利润4.13亿元，同比增长30.3%。尽管公司半年报未披露分产品收入情况，但其贴剂产品2023年收入20.5亿元，占总营收比例高达61.83%。 近年来，羚锐制药表现可圈可点，2011年至2024上半年营业收入实现“14连涨”；2018年至2024上半年，公司归母净利润始终保持两位数增长，这在整个A股医药市场也是比较少见的。 近年来羚锐制药业绩情况（单位：亿元）来源：公司公告 目前羚锐制药在销的中成药贴膏剂有12种。米内网数据显示，近年来在中国零售药店终端（城市实体药店+网上药店）中成药贴膏剂品牌TOP20中，羚锐制药均有5个品牌上榜，是上榜品牌数最多的企业，其中通络祛痛膏稳居第二。 通络祛痛膏为国家医保乙类、国家基药品种，具有活血通络、散寒除湿、消肿止痛等功效，用于腰部、膝部骨性关节炎属瘀血停滞，寒湿阻络证。近年来，该产品在中国三大终端六大市场的销售额逐年上涨，2023年突破10亿元，同比增长28.94%。 近年来中国三大终端六大市场通络祛痛膏销售情况（单位：万元）来源：米内网格局数据库 为了向更多元、更成熟的制药企业迈进，羚锐制药也在积极布局外用化药制剂、口服制剂等。其中，盐酸洛美沙星乳膏、芬太尼透皮贴剂、吲哚美辛贴片等产品陆续上市，不断丰富公司产品种类，开拓新增量。此外，公司的莫匹罗星软膏以仿制4类报产在审，氟比洛芬凝胶贴膏以仿制4类报临床且在审，盐酸多奈哌齐透皮贴片、格拉司琼透皮贴片等处于I期临床。 米内网数据显示，近年来中国三大终端六大市场外用化药（不含生物药）销售额逐年上涨，2023年超过530亿元，同比增长13.81%。从细分剂型看，软膏剂、眼用制剂、贴膏剂依次位列前三。 近年来中国三大终端六大市场外用化药（不含生物药）销售情况（单位：万元）来源：米内网格局数据库 注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。 本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦