CORMEDIX INC. SUPPORTS CMS POLICY UPDATES REGARDING ACCESS TO INNOVATIVE DRUG PRODUCTS
CORMEDIX INC. SUPPORTS CMS POLICY UPDATES REGARDING ACCESS TO INNOVATIVE DRUG PRODUCTS
November 26, 2024
2024年11月26日
Berkeley Heights, NJ – November 26, 2024 – CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today highlights key policy changes from CMS that benefit hemodialysis patients. Yesterday, the Centers for Medicare & Medicaid Services (CMS) and the Center for Medicare and Medicaid Innovation (CMMI) released important policy updates that will broaden the access of Medicare patients managing End Stage Renal Disease (ESRD) and on dialysis to innovative new therapies.
伯克利高地，新泽西州 – 2024年11月26日 – 康哲药业（纳斯达克：CRMD）是一家专注于开发和商业化针对危及生命疾病及情况的治疗产品的生物制药公司，今天强调了来自康哲药业的关键政策变化，这些变化将惠及透析患者。昨天，医疗保险和医疗补助服务中心（CMS）与医疗保险和医疗补助创新中心（CMMI）发布了重要的政策更新，这将扩大管理终末期肾病（ESRD）和透析患者的医疗保险患者的获取创新新疗法的机会。
Beginning in January 2025, CMMI's Kidney Care Choices (KCC) value-based care model will carve out Transitional Drug Add-on Payment Adjustments (TDAPA payments) from financial calculations such as benchmarks, performance year expenditures and USPCC trend rates, allowing ESRD patients participating in a KCC to have increased access to certain innovative new drugs, including CorMedix drug product DefenCath (taurolidine and heparin). Given that more than 30% of ESRD patients in the US are currently enrolled in a KCC, this change removes a significant barrier to the utilization of innovative therapies by patients in need, and will ensure that financial considerations do not diminish ESRD patients' care choices and access to innovative new drugs
从2025年1月开始，CMMI的肾脏护理选择（KCC）基于价值的护理模式将从财务计算中剔除过渡药物附加支付调整（TDAPA支付），如基准、绩效年度支出和USPCC趋势率，允许参与KCC的ESRD患者增加对某些创新新药的获取，包括康哲药业的药物产品DefenCath（他拉啶和肝素）。鉴于目前超过30%的美国ESRD患者已注册KCC，这一变化消除了患者利用创新疗法的一个重大障碍，并将确保财务考虑不会降低ESRD患者的护理选择和对创新新药的获取。
Joe Todisco, CorMedix CEO, commented, "CorMedix applauds CMS for making a patient-centered policy change that will align provider incentives with patient care and broaden access to innovation. I am appreciative of the industry stakeholders, patient advocacy organizations, and CorMedix team members that worked closely with CMS to enact this change for the benefit of patient access. This important change will better allow providers to more easily protocolize a product like DefenCath across clinics and patient payor segments system-wide."
乔·托迪斯科，康哲药业CEO评论道：“康哲药业赞扬CMS做出以患者为中心的政策变化，这将使提供者的激励措施与患者护理保持一致，并扩大对创新的获取。我感谢与CMS密切合作的行业利益相关者、患者倡导组织和康哲药业团队成员，为促进患者获取而做出的这一改变。这一重要变化将更好地让提供者更容易在整个诊所和患者支付者领域系统化产品如DefenCath。”
About CorMedix
关于cormedix
CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The Company is focused on commercializing its lead product DefenCath (taurolidine and heparin) which was approved by the FDA on November 15, 2023. CorMedix commercially launched DefenCath in inpatient settings in April 2024 and in outpatient settings in July 2024. CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations. For more information visit: .
cormedix是一家生物制药公司，专注于开发和销售预防和治疗危及生命的疾病的治疗产品。该公司专注于商业推广其领先产品DefenCath（他托啉和肝素），该产品于2023年11月15日获得FDA批准。cormedix于2024年4月在住院设置中推出了DefenCath，在2024年7月在门诊设置中推出。cormedix还计划将DefenCath开发为用于其他患者群体的导管锁定解决方案。欲了解更多信息，请访问:
Forward-Looking Statements
前瞻性声明
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are subject to risks and uncertainties. Forward-looking statements are often identified by the use of words such as, but not limited to, "anticipate," "believe," "can," "continue," "could," "estimate," "expect," "intend," "may," "will," "plan," "project," "seek," "should," "target," "will," "would," and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or CorMedix's prospects should be considered forward-looking statements. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix's filings with the SEC, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q, copies of which are available free of charge at the SEC's website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. Investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.
本新闻稿包含《前瞻性陈述》，根据1995年《私人证券诉讼改革法案》，1933年修订版证券法第27A条，以及1934年修订版证券交易法第21E条的规定，这些前瞻性陈述受到风险和不确定性的影响。前瞻性陈述通常通过使用诸如但不限于“预期”，“相信”，“可能”，“继续”，“可能”，“估计”，“期望”，“打算”，“可能”，“将”，“计划”，“项目”，“寻求”，“应该”，“目标”，“将”，“将”及类似表达或旨在识别前瞻性陈述的变化。除了历史事实陈述外，关于管理人员的期望，信念，目标，计划或cormedix前景的所有陈述都应视为前瞻性陈述。读者应当注意，实际结果可能会因为各种重要因素而与预计或估计有所不同。读者被引导阅读cormedix向美国证券交易委员会提交的风险因素披露，包括其年度报告（在Form 10-K上）和季度报告（在Form 10-Q上），拷贝免费提供在美国证券交易委员会网站www.sec.gov上或在cormedix请求时提供。cormedix可能实际上实现不了其前瞻性陈述中描述的目标或计划，并且此类前瞻性陈述仅在本新闻稿发布之日起发生效果。投资者不应对这些声明放置不当的依赖。cormedix不承诺更新这些前瞻性陈述，除非法律另有要求。
Investor Contact:
Dan Ferry
Managing Director
LifeSci Advisors
daniel@lifesciadvisors.com
(617) 430-7576
投资者联系人：
丹·费里，电话：(617) 430-7576
常务董事
LifeSci顾问
daniel@lifesciadvisors.com
(617) 430-7576
