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CORMEDIX INC. ANNOUNCES OUTPATIENT AVAILABILITY OF DEFENCATH

CORMEDIX INC. ANNOUNCES OUTPATIENT AVAILABILITY OF DEFENCATH

CORMEDIX公司宣布DEFENCATH现可门诊使用。
CorMedix ·  07/03 00:00
July 3, 2024
2024年7月3日

Berkeley Heights, NJ – July 3, 2024CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing therapeutic products for life-threatening diseases and conditions, today announced that it has commenced commercialization of DefenCath (taurolidine and heparin) to outpatient dialysis centers and vascular access clinics where patients receive outpatient dialysis and catheter placement services. The outpatient launch coincides with the effective date of July 1st for outpatient reimbursement of DefenCath as directed by the Center for Medicare & Medicaid Services (CMS).

新泽西州伯克利海茨 - 2024年7月3日 - 康哲药业股份有限公司(Nasdaq: CRMD)是一家专注于开发治疗严重疾病和条件的治疗产品的生物制药公司,今天宣布已开始将DefenCath(曲拉啶和肝素)推向门诊透析中心和血管通路诊所,患者在那里接受门诊透析和导管放置服务。门诊推出与7月1日作为门诊补偿的有效日期(由医疗保险与医疗服务中心(CMS)指导)同时举行。

CorMedix received NDA approval of DefenCath under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) on November 15, 2023, and began commercialization of the product in the inpatient setting on April 15, 2024. This week CorMedix began shipping orders for DefenCath to dialysis operators under previously announced commercial agreements, and anticipates additional customer agreements and orders in the upcoming weeks.

康哲药业已于2023年11月15日在有限人群病原体和真菌药物途径(LPAD)下获得DefenCath的新药批准,并于2024年4月15日开始在住院设置中商业化该产品。本周,康哲药业开始向透析操作员发货DefenCath,根据先前宣布的商业协议,并预计在未来几周内签订更多的客户协议和订单。

"I am very excited to have now commenced outpatient distribution of DefenCath, an important milestone for CorMedix and for patients, who will now have access to the first and only FDA approved antimicrobial catheter lock solution," says CorMedix CEO, Joseph Todisco. "I am impressed with how efficiently our customers are rolling out the launch of DefenCath thus far, and I am looking forward to expanding access in the upcoming months as we solidify additional customer contracts."

“我非常高兴现在已经开始门诊分销DefenCath,这是康哲药业和患者的一个重要里程碑,患者现在将能够访问第一款并且唯一一种获得FDA批准的抗菌留置导管溶液,”康哲药业首席执行官Joseph Todisco说。“我对客户这么高效地推出DefenCath的推广如此印象深刻,我期待在未来几个月扩大访问并巩固更多的客户合同。”

DefenCath (taurolidine and heparin)

DefenCath(曲拉啶和肝素)

IMPORTANT SAFETY INFORMATION

重要的安全信息

These highlights do not include all the information needed to use DefenCath safely and effectively. See full prescribing information for DefenCath.

这些要点不包括使用DefenCath的全面信息。有关DefenCath的完整处方信息,请参见处方说明。

LIMITED POPULATION: DefenCath is indicated to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC). This drug is indicated for use in a limited and specific population of patients.

有限人群:DefenCath适用于通过中心静脉导管(CVC)接受慢性血液透析(HD)的肾功能衰竭成人患者,用于减少导管相关的血流感染(CRBSI)。此药物适用于患者的有限和特定人群。

DefenCath is contraindicated and has warnings and precautions in patients with:

DefenCath在以下患者中为禁忌症并有警告和注意事项:

  • Known heparin-induced thrombocytopenia (HIT).
  • 已知肝素诱导的血小板减少症(HIT)。
  • Known hypersensitivity to any drug products in DefenCath, including taurolidine, heparin or the citrate excipient or pork products.
  • 已知对DefenCath中的任何药物产品(包括曲拉啶,肝素或柠檬酸盐赋形剂或猪肉产生过敏反应。

If exposure to either of the above occurs, discontinue use of DefenCath and institute appropriate supportive measures.

如发生以上任何一种情况,请停止使用DefenCath并采取适当的支持措施。

To report any safety concerns including suspected adverse reactions, contact CorMedix Inc. at 1-888-424-6345 or FDA at 1-800-FDA-1088 or visit .

如有任何安全问题,包括疑似不良反应,请联系康哲药业公司(1-888-424-6345)或FDA(1-800-FDA-1088)或访问。

Please see the full Prescribing Information.

请参阅完整的处方信息。

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, which was approved by the FDA on November 15, 2023. CorMedix commercially launched DefenCath in inpatient settings in April 2024 and began outpatient commercialization on July 1st following the effectiveness of outpatient reimbursement from CMS. CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations. For more information visit: .

康哲药业股份有限公司是一家专注于开发和商业化用于预防和治疗严重疾病和条件的治疗产品的生物制药公司。该公司专注于商业化其主导产品DefenCath,该产品已于2023年11月15日获得FDA批准。康哲药业于2024年4月在住院环境中推出DefenCath,并于7月1日开始门诊商业化(随着CMS的门诊补偿的有效性)进展。康哲药业还打算将DefenCath开发为其他患者群体使用的导管锁定方案。有关更多信息,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.

本新闻稿包含根据1995年私人证券诉讼改革法第27A条、1933年证券法修正案第21E条以及1934年证券交易法修正案第21E条进行的"前瞻性陈述",该陈述受到风险和不确定性的影响。前瞻性陈述经常通过使用诸如“预计”、“相信”、“可以”、“继续”、“可能”、“将”、“计划”、“项目”、“寻求”、“应该”、“目标”、“会”、“将要”等表达或旨在表达前瞻性陈述的类似表达或变化来识别。所有关于管理层的期望、信念、目标、计划或cormedix前景的声明,都应被视为前瞻性陈述。读者应注意,实际结果可能因多种重要因素而与预测或估计不同,读者被指示在美国证券交易委员会(SEC)的网站www.sec.gov免费获取cormedix提交的文件,包括其年度报告10-K和季度报告10-Q以及对cormedix的要求。CorMedix可能无法实现描述在其前瞻性陈述中的目标或计划,此类前瞻性陈述仅根据本新闻稿的发布日期而发表。投资者不应过度依赖这些声明。cormedix不承担任何义务,并无意更新这些前瞻性陈述,除非法律要求。


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
董事总经理
LifeSci Advisors
daniel@lifesciadvisors.com
(617) 430-7576

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