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CORMEDIX INC. ANNOUNCES OUTPATIENT AVAILABILITY OF DEFENCATH

CORMEDIX INC. ANNOUNCES OUTPATIENT AVAILABILITY OF DEFENCATH

CORMEDIX公司宣佈DEFENCATH現可門診使用。
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).

新澤西州伯克利海茨 - 2024年7月3日 - 康哲藥業股份有限公司(Nasdaq: CRMD)是一家專注於開發治療嚴重疾病和條件的治療產品的生物製藥公司,今天宣佈已開始將DefenCath(曲拉啶和肝素)推向門診透析中心和血管通路診所,患者在那裏接受門診透析和導管放置服務。門診推出與7月1日作爲門診補償的有效日期(由醫療保險與醫療服務中心(CMS)指導)同時舉行。

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.

康哲藥業已於2023年11月15日在有限人群病原體和真菌藥物途徑(LPAD)下獲得DefenCath的新藥批准,並於2024年4月15日開始在住院設置中商業化該產品。本週,康哲藥業開始向透析操作員發貨DefenCath,根據先前宣佈的商業協議,並預計在未來幾周內簽訂更多的客戶協議和訂單。

"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."

“我非常高興現在已經開始門診分銷DefenCath,這是康哲藥業和患者的一個重要里程碑,患者現在將能夠訪問第一款並且唯一一種獲得FDA批准的抗菌留置導管溶液,”康哲藥業首席執行官Joseph Todisco說。“我對客戶這麼高效地推出DefenCath的推廣如此印象深刻,我期待在未來幾個月擴大訪問並鞏固更多的客戶合同。”

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.

這些要點不包括使用DefenCath的全面信息。有關DefenCath的完整處方信息,請參見處方說明。

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適用於通過中心靜脈導管(CVC)接受慢性血液透析(HD)的腎功能衰竭成人患者,用於減少導管相關的血流感染(CRBSI)。此藥物適用於患者的有限和特定人群。

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

DefenCath在以下患者中爲禁忌症並有警告和注意事項:

  • Known heparin-induced thrombocytopenia (HIT).
  • 已知肝素誘導的血小板減少症(HIT)。
  • Known hypersensitivity to any drug products in DefenCath, including taurolidine, heparin or the citrate excipient or pork products.
  • 已知對DefenCath中的任何藥物產品(包括曲拉啶,肝素或檸檬酸鹽賦形劑或豬肉產生過敏反應。

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

如發生以上任何一種情況,請停止使用DefenCath並採取適當的支持措施。

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 .

如有任何安全問題,包括疑似不良反應,請聯繫康哲藥業公司(1-888-424-6345)或FDA(1-800-FDA-1088)或訪問。

Please see the full Prescribing Information.

請參閱完整的處方信息。

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, 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: .

康哲藥業股份有限公司是一家專注於開發和商業化用於預防和治療嚴重疾病和條件的治療產品的生物製藥公司。該公司專注於商業化其主導產品DefenCath,該產品已於2023年11月15日獲得FDA批准。康哲藥業於2024年4月在住院環境中推出DefenCath,並於7月1日開始門診商業化(隨着CMS的門診補償的有效性)進展。康哲藥業還打算將DefenCath開發爲其他患者群體使用的導管鎖定方案。有關更多信息,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.

本新聞稿包含根據1995年私人證券訴訟改革法第27A條、1933年證券法修正案第21E條以及1934年證券交易法修正案第21E條進行的"前瞻性陳述",該陳述受到風險和不確定性的影響。前瞻性陳述經常通過使用諸如“預計”、“相信”、“可以”、“繼續”、“可能”、“將”、“計劃”、“項目”、“尋求”、“應該”、“目標”、“會”、“將要”等表達或旨在表達前瞻性陳述的類似表達或變化來識別。所有關於管理層的期望、信念、目標、計劃或cormedix前景的聲明,都應被視爲前瞻性陳述。讀者應注意,實際結果可能因多種重要因素而與預測或估計不同,讀者被指示在美國證券交易委員會(SEC)的網站www.sec.gov免費獲取cormedix提交的文件,包括其年度報告10-K和季度報告10-Q以及對cormedix的要求。CorMedix可能無法實現描述在其前瞻性陳述中的目標或計劃,此類前瞻性陳述僅根據本新聞稿的發佈日期而發表。投資者不應過度依賴這些聲明。cormedix不承擔任何義務,並無意更新這些前瞻性陳述,除非法律要求。


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
董事總經理
LifeSci Advisors
daniel@lifesciadvisors.com
(617) 430-7576

声明:本內容僅用作提供資訊及教育之目的,不構成對任何特定投資或投資策略的推薦或認可。 更多信息
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