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，新澤西州 – 2024年11月26日 – 康哲藥業（納斯達克：CRMD）是一家專注於開發和商業化針對危及生命疾病及情況的治療產品的生物製藥公司，今天強調了來自康哲藥業的關鍵政策變化，這些變化將惠及透析患者。昨天，醫療保險和醫療補助服務中心（CMS）與醫療保險和醫療補助創新中心（CMMI）發佈了重要的政策更新，這將擴大管理終末期腎病（ESRD）和透析患者的醫療保險患者的獲取創新新療法的機會。
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
從2025年1月開始，CMMI的腎臟護理選擇（KCC）基於價值的護理模式將從財務計算中剔除過渡藥物附加支付調整（TDAPA支付），如基準、績效年度支出和USPCC趨勢率，允許參與KCC的ESRD患者增加對某些創新新藥的獲取，包括康哲藥業的藥物產品DefenCath（他拉啶和肝素）。鑑於目前超過30%的美國ESRD患者已註冊KCC，這一變化消除了患者利用創新療法的一個重大障礙，並將確保財務考慮不會降低ESRD患者的護理選擇和對創新新藥的獲取。
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."
喬·託迪斯科，康哲藥業CEO評論道：「康哲藥業讚揚CMS做出以患者爲中心的政策變化，這將使提供者的激勵措施與患者護理保持一致，並擴大對創新的獲取。我感謝與CMS密切合作的行業利益相關者、患者倡導組織和康哲藥業團隊成員，爲促進患者獲取而做出的這一改變。這一重要變化將更好地讓提供者更容易在整個診所和患者支付者領域系統化產品如DefenCath。」
About CorMedix
關於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是一家生物製藥公司，專注於開發和銷售預防和治療危及生命的疾病的治療產品。該公司專注於商業推廣其領先產品DefenCath（他託啉和肝素），該產品於2023年11月15日獲得FDA批准。cormedix於2024年4月在住院設置中推出了DefenCath，在2024年7月在門診設置中推出。cormedix還計劃將DefenCath開發爲用於其他患者群體的導管鎖定解決方案。欲了解更多信息，請訪問:
Forward-Looking Statements
前瞻性聲明
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.
本新聞稿包含《前瞻性陳述》，根據1995年《私人證券訴訟改革法案》，1933年修訂版證券法第27A條，以及1934年修訂版證券交易法第21E條的規定，這些前瞻性陳述受到風險和不確定性的影響。前瞻性陳述通常通過使用諸如但不限於「預期」，「相信」，「可能」，「繼續」，「可能」，「估計」，「期望」，「打算」，「可能」，「將」，「計劃」，「項目」，「尋求」，「應該」，「目標」，「將」，「將」及類似表達或旨在識別前瞻性陳述的變化。除了歷史事實陳述外，關於管理人員的期望，信念，目標，計劃或cormedix前景的所有陳述都應視爲前瞻性陳述。讀者應當注意，實際結果可能會因爲各種重要因素而與預計或估計有所不同。讀者被引導閱讀cormedix向美國證券交易委員會提交的風險因素披露，包括其年度報告（在Form 10-K上）和季度報告（在Form 10-Q上），拷貝免費提供在美國證券交易委員會網站www.sec.gov上或在cormedix請求時提供。cormedix可能實際上實現不了其前瞻性陳述中描述的目標或計劃，並且此類前瞻性陳述僅在本新聞稿發佈之日起發生效果。投資者不應對這些聲明放置不當的依賴。cormedix不承諾更新這些前瞻性陳述，除非法律另有要求。
Investor Contact:
Dan Ferry
Managing Director
LifeSci Advisors
daniel@lifesciadvisors.com
(617) 430-7576
投資者聯繫人：
丹·費裏，電話：(617) 430-7576
常務董事
LifeSci顧問
daniel@lifesciadvisors.com
(617) 430-7576
譯文內容由第三人軟體翻譯。