Triangle Pharmaceuticals, Inc.

编者按：本文来自赛柏蓝内容矩阵账号-赛柏蓝器械，作者阿廖沙 秦酒；赛柏蓝转载，编辑凯西 支付端逻辑改写，药械货款结算驶入新阶段。 01 医保结算清算工作启动 回款“三角债”加速破除 据国家医保局官网消息，2024年7月15日-18日，国家医保局党组成员、副局长施子海带队赴福建、浙江实地考察医疗机构和医药企业，与有关方面座谈了解集采中选药品耗材货款结算情况。 施子海指出，集采中选药品耗材的及时结款，对于改善医药采购环境、稳定生产配送企业预期、保障集采药品耗材供应具有积极作用。各地要高度重视，结合本地情况，引导医疗机构规范采购行为、切实履行及时回款责任。要充分发挥国家医保信息平台的信息化、一体化优势，积极探索、及时总结推广有效的货款结算模式，持续提升结算效率。  近日，DRG/DIP2.0方案正式出台，要求各统筹地区组织开展月结算工作，进一步提升结算效率，原则上费用结算时间自申报截止次日起不超过30个工作日。此外，今年9月底前，各地要对2023年以前按照协议约定应付未付的医保基金(含居民医保大病保险等)开展全面清理。 伴随高效医保结算体系搭建，以及全面清账工作推进，医疗机构资金压力将得到缓解，相关上下游账期均有望迎来改善。 医疗器械营销专家王强认为，部分地区的医保与医院结算的周期比较长，医保基金结算清算效率提升后，医保局和医院的结款周期会大大缩短，肯定会加快供应商回款进度，但依据地方医保基金结余情况不同，应该会全国分步骤落地。经济较发达的地方可能先执行，经济相对落后的地区延后执行。 预付金管理制度也在一定程度上推进药械回款进度。 2.0方案中提到，支持有条件的地区进一步完善预付金管理办法，通过预付部分医保资金的方式帮助定点医疗机构缓解资金压力。 根据最新方案，医保基金预付将向符合相应条件的医院倾斜，其中就包括与医保有长期合作、管理规范、信用良好以及在医保政策落地等方面表现较好的指标。 近期，国家十四部门发布《关于印发2024年纠正医药购销领域和医疗服务中不正之风工作要点的通知》，明确将回款结算列为聚焦的关键环节之一。此外，多地已将“药械结算回款率”作为对医疗机构的考核指标。 可见，药械回款情况能够影响医疗机构的管理、信用评判。在预付金倾斜的利益驱动下，药械回款周期有望进一步缩短。 02 线上结算推进 回款周期缩短 充足的资金系加速药械回款的重要基础，而结算模式的优化升级能再度提高其效率。 近日，国家医保局连发多文，介绍山东、福建、内蒙古、江西、广西等地推行医保直接结算举措后的相应成果。 图源：国家医保局 2023年福建省累计直接结算企业药品货款275.95亿元，结算率达99.96%；结算集采医用耗材货款34.92亿元，结算率达98.55%，覆盖全省所有定点公立医疗机构，回款周期控制在23个工作日内，惠及504家药械供应企业。 截至今年5月，江西省通过医保基金与集采中选医药企业直接结算，已累计为3041家配送企业直接结算药品耗材货款149.77亿元，其中，今年1-5月为2628家配送企业直接结算35.53亿元，货款结算周期从6个月缩减为30天左右。 医保信息平台的搭建为医保直接结算提供了支持。 以广西为例，今年8月起各医疗机构通过国家医疗保障信息平台药品和耗材招标管理子系统采购的集采药品、医用耗材货款，纳入统一线上结算范围，流程如下： 赛柏蓝器械制图 王强表示，地方回款效率和线上结算平台的建设力度也有关系。部分省份的线上结算平台还未搭建成熟，就无法完成线上对账和线上提款，医保无法与企业直接结算。随着各地线上结算平台不断投入使用，回款周期也会随之缩短。 “医保-医院”环节的结算模式也在持续优化，在近日国家医保局召开的新闻发布会上，国家医保局医保中心副主任王国栋介绍： 今年2月，国家医保局印发《关于在医疗保障服务领域推动“高效办成一件事”的通知》，将“及时与定点医疗机构结算合规医疗费用”作为12个重点事项之一，并在《2024年度“高效办成一件事” 经办工作指南》中，将其细化为结算申报、智能审核、及时拨付、鼓励预付4个环节。通过调取国家医保信息平台数据、调研督导调度等方式，每月跟进掌握地方结算情况，加快医保基金及时拨付。 依托智能工具助力，官方对医保基金数据的把控将更为精准，进而有针对性地监督医保结算与拨付情况。 对于药械企业而言，过长的回款周期意味着沉重的成本负担。“三角债”问题的破除可谓是医药商业的夙愿。 END 内容沟通：郑瑶（13810174402） 医药代理商产品交流群 扫描下方二维码加入 医药代表交流群 扫描下方二维码加入 左下角「关注账号」，右下角「在看」，防止失联

IRVINE, Calif., Oct. 17, 2023 /PRNewswire/ -- VESICA HEALTH, INC., a multi-omics, liquid biopsy company transforming the management of hematuria patients and improving the early detection of bladder cancer, today announced the appointment of three accomplished industry veterans with proven executive leadership, strategic and commercial experience to its Board of Directors. Continue Reading "It is with great pleasure that we announce the appointment of Dr. Jan Groen, Mark McDonough, and Joe Sollee to our Board of Directors. Their extensive experience in genomics and molecular pathology spans across research and development, operations, finance, human resources, reimbursement, and corporate governance," commented Christopher Thibodeau, Chief Executive Officer of Vesica Health. "We are confident that the Board's collective strategic, operational, and commercial expertise will provide valuable insights and contributions to the organization, supporting management's efforts to maximize value for both patients and shareholders alike." Vesica is poised to immediately reap the benefits of its extensive clinical validation studies Tweet this "With a well-differentiated, scalable solution addressing a multi-billion-dollar market opportunity, I am thrilled to support Vesica's management team on its commercialization strategy," stated Mark McDonough. "Based on my experience, Vesica has a singular opportunity to not only take market share but drive widespread clinical adoption of its AssureDx test." "Vesica is uniquely positioned with an impressive portfolio of intellectual property issued both domestically and internationally," commented Joe Sollee. "The AssureDx test is equally well-suited to Vesica's laboratory services model, as well as IVD kits, thereby enabling the company to address its total available market directly and in combination with key strategic partners." "Vesica is poised to immediately reap the benefits of its extensive clinical validation studies and take market share with its AssureDx test, which promises to significantly enhance the quality of life for patients with hematuria and bladder cancer," stated Dr. Jan Groen. "Speaking on behalf of my fellow Board members, we are excited to be joining Vesica's Board at this important time for the company. We are eager to work alongside the management team to ensure that Vesica is well-positioned for successful commercialization." The Board of Directors will advise the company's management team on strategic, operational, and commercial objectives. Provided below are brief summaries of the Board's credentials: Dr. Jan Groen, Chair of the Board Dr. Groen is the Chairman & CEO of Intravacc (The Netherlands) a contract development & manufacturing organization for the development of innovative human vaccines. His career spans many years in biotechnology, formerly as CEO at MDxHealth (MDXH), where he established the company as a market-leading molecular diagnostic uro-oncology company in the U.S. and EU. Earlier, as the President and COO of Agendia, responsible for the diagnostic operations in the U.S. and EU, he led the introduction of the first FDA-cleared breast cancer recurrence assay in the U.S. He served as VP of Research & Development at Focus Diagnostics, a subsidiary of Quest Diagnostics in California, and co-founded ViroClinics B.V. and DxOrange B.V. He has held numerous scientific leadership positions at the Erasmus Medical Center, RIVM (National Institute of Public Health, NL) and Akzo-Nobel. Previously, Dr, Groen served on the Board of IBL-International (DE) and MyCartis (BE), presently serves as Chairman of the Board at Cergentis (NL), and currently as Independent Director at Novigenix (CH), and Chairman of the Board member Angle Plc. (UK). Mark McDonough, Independent Director Mr. McDonough is the CEO and Board member of ChromaCode, Inc, a genomics multiplexing company that leverages their High-Definition PCR (HDPCR™) platform to enable comprehensive, fast, less expensive testing solutions. Previously, he served as CEO of PierianDx where he raised ~$48M to fund the company's growth initiatives and successfully completed an exit to Summa Equity which resulted in the formation of Velsera. Mr. McDonough served as President, CEO, and Board member for Immunis.AI, a privately held pre-commercial liquid biopsy platform company, and at CombiMatrix, a publicly traded company and leader in high-complexity reproductive health testing. At CombiMatrix, he successfully led the company's turnaround growth and ultimately orchestrated its sale in November 2017. Earlier, he served in various leadership roles at high-growth diagnostic companies including US LABS (acquired by LabCorp) and Ventana Medical Systems (acquired by Roche). Mr. McDonough is a proud former Naval Officer having served as a Navigator and Communications Officer on the USS FLETCHER (DD 992). Joe Sollee, Independent Director Mr. Sollee is the Executive Vice President of Corporate Development and General Counsel at MDxHealth and has more than 20 years of experience in the healthcare industry, including senior management roles in both private and publicly listed pharmaceuticals, health information technology, and molecular diagnostics companies. He has served as chief legal counsel to MDxHealth since its inception in 2003. Prior to MDxHealth, he led the Life Sciences Practice Group at the law firm of Kennedy Covington (now K&L Gates) and held senior legal and management positions at TherapyEdge and Triangle Pharmaceuticals. In addition, he has practiced as a corporate attorney in the Washington D.C. legal firm Swidler & Berlin and as an investment banker at Smith Barney in New York. Mr. Sollee received a Juris Doctorate in Law and a master's degree in international law from Duke University, a BA degree from Harvard University, and has been awarded New York, Washington D.C. and North Carolina legal bar certifications. About AssureDx™ Vesica Health's patented, noninvasive, urine-based AssureDx test helps physicians accurately triage hematuria patients, distinguishing those at increased risk for bladder cancer, who may benefit from immediate referral to urology and clinical evaluation, from those at very low risk for bladder cancer, who may safely avoid invasive procedures and secondary cancer risk from harmful CT scans. AssureDx biomarkers and technology have been extensively reported in 20 peer-reviewed and published studies on over 5,878 patients, including three sequential, prospective clinical validation studies, delivering robust clinical performance with a 0.96 AUC (area under the receiver operating characteristic curve), 99% Negative Predictive Value (NPV), 96% Sensitivity and 83% Specificity for the detection of bladder cancer in hematuria patients. AssureDx also provides urologists with a noninvasive method to monitor bladder cancer patients at increased risk of recurrence after initial treatment, thereby improving patient management and outcomes. About Vesica Health, Inc. Vesica Health's mission is to transform the management of hematuria patients and improve the early detection of bladder cancer. Each year it is estimated that upwards of 17M (1-in-5) adults will present with hematuria, the primary symptom of bladder cancer, yet despite guideline recommendations only ~12% of patients are referred to urology for clinical evaluation. As a consequence, ~20% of bladder cancers are missed each year, leading to later-stage disease at diagnosis and higher mortality. Vesica has translated 20 years of advanced multi-omics research in bladder cancer into a well-validated, commercial-ready precision diagnostic test to improve the evaluation of hematuria, early detection of disease, and recurrence monitoring. For more information, please visit . For more information: Vesica Health Corporate Communications [email protected] This company announcement contains forward-looking statements and estimates with respect to the anticipated future performance of Vesica Health and the market in which it operates. Such statements and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable but may not prove to be correct. Actual events are difficult to predict, may depend upon factors that are beyond the company's control, and may turn out to be materially different. Vesica Health expressly disclaims any obligation to update any such forward-looking statements in this announcement to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based unless required by law or regulation. This company announcement does not constitute an offer or invitation for the sale or purchase of securities or assets of Vesica Health in any jurisdiction. No securities of Vesica Health may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. securities laws. NOTE: The Vesica Health wordmarks and logos, including Vesica Health, and AssureDx are trademarks or registered trademarks of Vesica Health, Inc. All other trademarks and service marks are the property of their respective owners. SOURCE Vesica Health

Bruce McCreedy Ph.D. joins the Executive Leadership Team as Chief Scientific Officer, as the company continues to grow its US-based operations Brings three decades of experience in drug development, including gene-edited cell therapy products Responsible for steering ONK’s pre-clinical, optimally engineered NK cell therapy candidates through final IND-enabling studies and into the clinic Scientific founder and former CSO Professor Michael O’Dwyer remains as an advisor to the company and board director GALWAY, Ireland and SAN DIEGO, Dec. 06, 2022 (GLOBE NEWSWIRE) -- ONK Therapeutics, an innovative company dedicated to developing optimally engineered natural killer (NK) cell therapies to cure patients with cancer, today announced the appointment of Bruce McCreedy Ph.D. as Chief Scientific Officer (CSO). A member of the company’s Executive Leadership Team, he will be based in the USA. Dr. McCreedy is a renowned immunologist and cell and gene therapy expert, who brings over three decades of experience in drug development, including differentiated gene-edited, cell therapy products. He has been responsible for leading research organizations through the design and execution of highly successful drug development programs including currently marketed products. He joins ONK Therapeutics from Myeloid Therapeutics, Inc., where as CSO his responsibilities included all IND-enabling pre-clinical studies. Prior to this he served as SVP Cell Therapy and Immuno-Oncology Research at Nasdaq-listed Precision Biosciences, Inc., where he directed all R&D activities to create multiple, novel off-the-shelf allogeneic cell therapies for the treatment of cancer, and advanced three products into Phase I/II clinical studies in only five years. Previous industry positions held by Dr. McCreedy include Executive Vice President and Chief Development Officer for Neximmune, Inc., President and CEO of Fulcrum Pharma Developments, Inc. and Vice President of Clinical Virology and Diagnostics for Triangle Pharmaceuticals, Inc. (now Gilead Sciences). His earlier career involved roles at divisions of Roche and Organon. He received his Ph.D. in microbiology and immunology from the School of Medicine of Wake Forest University, North Carolina. Dr. McCreedy succeeds ONK’s former CSO and scientific founder Professor Michael O’Dwyer, who is making a planned return to the role of full-time Professor of Hematology, responsible for clinical and translational research in blood cancers at the University of Galway, Ireland, where he has maintained a part-time role whilst CSO at ONK Therapeutics. Professor O’Dwyer remains as a board director of the company and as a scientific advisor providing ongoing expert counsel as ONK continues to grow and progress. Welcoming Dr. McCreedy to the team, CEO of ONK Therapeutics, Chris Nowers said, “Bruce’s deep R&D leadership experience will be invaluable as ONK executes on its growth ambitions, advancing its portfolio of optimized NK cell therapies through IND and into human clinical trials. I look forward to working with Bruce as he further builds the momentum and expansion of our R&D teams in the USA and Ireland.” He continued, “As a founder of the company we would like to thank Michael for the very significant input that he has made as we have built the company. His central contribution to our optimally engineered NK cell therapy platform has been invaluable, and we are pleased that the company will have the opportunity to draw on Michael’s extensive experience, as he returns to his full-time academic research role.” ONK Therapeutics has used its $21.5 million series A financing, raised in December 2021, to make substantial progress in delivering against its ambition to establish a global leadership position within the off-the-shelf NK cell therapy area. ONK’s optimally engineered NK cell therapy platform designed to improve the metabolic health, persistence and anti-tumor effect has been strengthened through a number of licensing agreements. These include world-leading CRISPR/Cas9 gene editing and LNP delivery technologies from Intellia Therapeutics that will enable the company to take full advantage of its suite of proprietary edits, including the CISH knockout technology licensed globally from WEHI (Walter and Eliza Hall Institute of Medical Research), Melbourne, Australia. The company has also continued to progress its manufacturing plan as it drives towards GMP manufacturing and clinical trial supply. Concurrently ONK is strategically building out its corporate structure and diligently expanding its transatlantic team. Bruce McCreedy Ph.D., CSO of ONK Therapeutics said, “I am excited to be joining ONK Therapeutics at a pivotal time in its development as it navigates its path towards clinical trials. I have been impressed by ONK’s innovative approach to developing optimally engineered NK cell therapies which I believe have the potential to make a significant contribution to the growing arsenal of cell-based therapies to treat and even to cure cancer, offering new hope for patients.” About ONK Therapeutics – ONK Therapeutics is an innovative cell therapy company dedicated to developing the next generation of optimally engineered, off-the-shelf, natural killer (NK) cell therapies. With a growing pre-clinical pipeline targeting both hematological malignancies and solid tumors, ONK is advancing multiple cell therapy candidates towards the clinic, including its lead program, ONKT102, an optimized affinity CD38 CAR-NK product, intended for the treatment of patients with relapsed/ refractory multiple myeloma. Read about the pipeline here. The company’s optimally engineered NK cell therapy platform utilizes a suite of proprietary gene edits and cell modification strategies to optimize NK cell metabolic health, persistence and anti-tumor effect of NK cells, while reducing the potential for their exhaustion in the tumor microenvironment. These include CISH knockout (KO); the expression of high affinity, membrane bound, TNF-related apoptosis-inducing ligand variants (TRAILv) targeting DR5 or DR4; and the deletion of inhibitory receptors, including extracellular proteins for example CD96, and Siglec-7. Read about the platform here. ONK Therapeutics is headquartered in the med-tech hub of Galway, Ireland, with a wholly-owned USA subsidiary, ONK Therapeutics, Inc. based at JLabs @ San Diego. Shareholders include Acorn Bioventures, Cormorant Asset Management, ALSHC (principally Seamus Mulligan), and Enterprise Ireland. Follow us on Twitter@ONKTherapeutics and LinkedIn. International Sue Charles, Charles Consultants - +44 7968 726585 sue@charles-consultants.com Ireland Ray Gordon, Gordon MRM - +353 87 2417373 ray@gordonmrm.ie