STOCK TITAN

CorMedix Inc. Receives Innovative Technology Designation From Vizient for DefenCath

Rhea-AI Impact
(Moderate)
Rhea-AI Sentiment
(Neutral)
Tags

CorMedix (Nasdaq: CRMD) announced that DefenCath, its FDA‑approved antimicrobial catheter lock solution, received an Innovative Technology designation from Vizient on Oct. 23, 2025.

DefenCath is approved for a limited population of adult patients on chronic hemodialysis via central venous catheter and in a Phase 3 LOCK IT-100 study showed a 71% reduction in risk of catheter-related bloodstream infections with adverse events comparable to control. CorMedix is conducting a real‑world evidence study in >2,000 patients and expects interim data around year-end. Vizient represents approximately $156 billion in annual purchasing volume.

CorMedix (Nasdaq: CRMD) ha annunciato che DefenCath, la sua soluzione antimicrobica per il rivestimento dei cateteri approvata dalla FDA, ha ricevuto una designazione di Tecnologia Innovativa da Vizient il 23 ottobre 2025.

DefenCath è approvato per una popolazione mirata di pazienti adulti in dialisi renale cronica tramite catetere venoso centrale e nello studio di fase 3 LOCK IT-100 ha mostrato una riduzione del rischio del 71% di infezioni del sangue correlate al catetere, con eventi avversi confrontabili al controllo. CorMedix sta conducendo uno studio di real-world evidence su oltre 2.000 pazienti e prevede dati provvisori verso la fine dell'anno. Vizient rappresenta circa $156 miliardi in volume di acquisti annuo.

CorMedix (Nasdaq: CRMD) anunció que DefenCath, su solución antimicrobiana para bloqueo de catéter aprobada por la FDA, recibió una designación de Tecnología Innovadora por parte de Vizient el 23 de octubre de 2025.

DefenCath está aprobado para una población limitada de pacientes adultos en diálisis renal crónica mediante catéter venoso central y en un estudio de fase 3 LOCK IT-100 mostró una reducción del 71% en el riesgo de infecciones del torrente sanguíneo asociadas al catéter, con eventos adversos comparables al control. CorMedix está realizando un estudio de evidencia en el mundo real en >2,000 pacientes y espera datos interinos hacia fin de año. Vizient representa aproximadamente $156 mil millones en volumen de compras anual.

CorMedix (나스닥: CRMD)는 FDA 승인 항균성 카테터 로크 솔루션인 DefenCath가 2025년 10월 23일 Vizient의 혁신 기술 해당 designation을 받았다고 발표했습니다.

DefenCath는 중심 정맥 카테터를 통한 만성 혈액투석을 받는 성인 환자 일부에 승인되었으며, 3상 LOCK IT-100 연구에서 카테터 관련 혈류감염의 위험을 71% 감소시키는 것으로 나타났고 부작용은 대조군과 비슷했습니다. CorMedix는 2,000명 이상의 실제 세계 증거 연구를 수행 중이며 연말쯤 중간 데이터를 기대합니다. Vizient는 연간 구매 규모가 약 $1560억 달러에 해당합니다.

CorMedix (NASDAQ : CRMD) a annoncé que DefenCath, sa solution de verrouillage de cathéter antimicrobienne approuvée par la FDA, a reçu le label Technologie Innovante de Vizient le 23 octobre 2025.

DefenCath est approuvé pour une population limitée de patients adultes sous dialyse rénale chronique via cathéter veineux central et dans l’étude de phase 3 LOCK IT-100 a montré une réduction du risque de 71% d’infections du sang liées au cathéter, avec des événements indésirables comparables au témoin. CorMedix mène une étude de preuves du monde réel sur plus de 2 000 patients et prévoit des données intermédiaires vers la fin de l’année. Vizient représente environ $156 milliards en volume d’achats annuels.

CorMedix (Nasdaq: CRMD) gab bekannt, dass DefenCath, seine von der FDA zugelassene antimikrobielle Katheter-Locking-Lösung, am 23. Oktober 2025 eine Innovative-Technologie-Bezeichnung von Vizient erhielt.

DefenCath ist für eine begrenzte Patientengruppe erwachsener Patienten, die eine chronische Hämodialyse über einen zentralvenösen Katheter erhalten, zugelassen, und in einer Phase-3-Studie LOCK IT-100 zeigte sich eine 71%-Reduktion des Risikos katheterassoziierter Blutinfektionen mit in der Regel vergleichbaren Nebenwirkungen wie der Kontrolle. CorMedix führt eine Real-World-Evidence-Studie mit über 2.000 Patienten durch und erwartet Zwischenberichte gegen Jahresende. Vizient repräsentiert etwa $156 Milliarden an jährlichem Einkaufsvolumen.

كورمدكس (ناسداك: CRMD) أعلنت أن DefenCath، حلها المعتمد من FDA لغلق القسطرة المضاد للميكروبات، قد حصل على تصنيف تقنية مبتكرة من Vizient في 23 أكتوبر 2025.

DefenCath معتمَد لفئة محدودة من المرضى البالغين في غسيل الكلى المزمن عبر قسطرة وريدية مركزية، وفي دراسة المرحلة 3 LOCK IT-100 أظهرت انخفاضاً بنسبة 71% في خطر الإصابات الدمويّة المرتبطة بالقسطرة، مع أحداث جانبية مقارنة بنظيرها. تقوم CorMedix بإجراء دراسة أدلة واقعية لأكثر من 2,000 مريض وتتوقع بيانات وسيطة نحو نهاية العام. Vizient تمثل حوالي $156 مليار في حجم الشراء السنوي.

CorMedix (纳斯达克: CRMD)宣布其已获批的抗微生物 catheter 锁定溶液 DefenCath 于 2025 年 10 月 23 日获得 Vizient 的创新技术称号

DefenCath 获批用于通过中心静脉导管进行慢性透析的成人患者的有限人群,且在第三阶段 LOCK IT-100 研究中显示出对导管相关血流感染的风险降低 71%,不良事件与对照组相当。CorMedix 正在对超过 2,000 名患者进行真实世界证据研究,预计年末左右公布中期数据。Vizient 的年度采购额约为 $1560 亿

Positive
  • Phase 3 result: 71% reduction in CRBSI risk
  • Vizient designation: Innovative Technology recognition for DefenCath
  • RWE study: ongoing in >2,000 patients with interim data expected around year-end
  • First‑in‑class: only FDA‑approved antimicrobial CLS in the US
Negative
  • Regulatory scope: FDA approval limited to a defined adult chronic hemodialysis CVC population

Insights

Vizient's Innovative Technology designation increases visibility and potential procurement pathways for DefenCath.

DefenCath now holds a peer-recognized designation from Vizient, whose client base represents $156 billion in annual purchasing volume. The product is described as the first and only FDA‑approved antimicrobial catheter lock solution for a limited adult hemodialysis population and showed a 71% risk reduction for catheter-related bloodstream infections in the cited Phase 3 study.

This designation may help drive provider awareness and contracted access among Vizient members. The company also cites an ongoing real‑world evidence study in over 2,000 patients with interim data expected around year-end, which could supply additional clinical and utilization evidence.

Key dependencies and risks include uptake by Vizient members, contracting or formulary decisions, and the substance of the interim real‑world results. Watch for interim data around year-end and any subsequent contracting announcements from Vizient or its members within the next 6–12 months.

BERKELEY HEIGHTS, N.J., Oct. 23, 2025 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced that DefenCath has received an Innovative Technology designation from Vizient®, the largest healthcare performance improvement company in the country. CorMedix exhibited DefenCath at the Vizient Innovative Technology Exchange September 17th in Las Vegas, Nevada.

Each year, healthcare experts serving on Vizient client-led councils review select products and technologies for their potential to enhance clinical care, patient safety, healthcare worker safety or to improve business operations of healthcare organizations. Innovative Technology designations are awarded to previously contracted products to signal healthcare providers the impact of these innovations on patient care and business models of healthcare organizations.

DefenCath is an antimicrobial catheter lock solution (CLS) approved by the FDA to reduce the incidence of catheter-related bloodstream infections (CRBSIs) for the limited population of adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter (CVC). DefenCath is the first and only FDA approved antimicrobial CLS in the US and in the Company’s Phase 3 LOCK IT-100 clinical study, DefenCath demonstrated a 71% reduction in risk of developing a CRBSI and adverse events comparable to control. CorMedix has an ongoing real world evidence study in over 2,000 patients for which it expects to have interim data around year-end.

Joseph Todisco, CEO of CorMedix, commented, “We are proud to have received this important designation from Vizient. DefenCath represents an innovative infection prevention therapy for patients receiving chronic hemodialysis through a central venous catheter. We look forward to working with Vizient to maintain and expand patient access to our product.”

“Congratulations to CorMedix for achieving this peer-designated status,” said Kelly Flaharty, Senior Director Contract Services and Vizient Innovative Technology Program leader. “Our client council deemed DefenCath worthy of this designation for its potential to make a real difference in the healthcare industry.”

Vizient represents a diverse client base that includes academic medical centers, pediatric facilities, community hospitals, integrated health delivery networks and non-acute healthcare providers and represents approximately $156 billion in annual purchasing volume. Through its Innovative Technology Program, Vizient works with client-led councils and task forces to evaluate products for their potential to bring real innovation to healthcare.

About 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. CorMedix is commercializing DefenCath® (taurolidine and heparin) for the prevention of catheter-related bloodstream infections in adult patients undergoing hemodialysis via a central venous catheter. Following its August 2025 acquisition of Melinta Therapeutics LLC, CorMedix is also commercializing a portfolio of anti-infective products, including MINOCIN® (minocycline), REZZAYO® (rezafungin), VABOMERE® (meropenem and vaborbactam), ORBACTIV™ (oritavancin), BAXDELA® (delafloxacin), and KIMYRSA® (oritavancin), as well as TOPROL-XL® (metoprolol succinate).

CorMedix has ongoing clinical studies for DefenCath in Total Parenteral Nutrition and Pediatric patient populations and also intends to develop DefenCath as a catheter lock solution for use in other patient populations. REZZAYO is currently approved for the treatment of candidemia and invasive candidiasis in adults, with an ongoing Phase III study for the prophylaxis of IFD in adult patients undergoing allogeneic BMT. Topline results of the Phase III study for REZZAYO are expected in Q2 2026. For more information visit: www.cormedix.com or www.melinta.com.

Forward-Looking Statements

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, and Section 21E of the Exchange, as amended (the “Exchange Act”), 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 most recent Annual Report on Form 10-K, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix and in the Quarterly Report on Form 10-Q for the quarter ended, on June 30, 2025. 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.

Investor Contact:
Dan Ferry
Managing Director
LifeSci Advisors
daniel@lifesciadvisors.com
(617) 430-7576


FAQ

What does Vizient's Innovative Technology designation mean for CorMedix (CRMD)?

Vizient's designation signals peer recognition and may help increase visibility among healthcare providers and purchasing groups.

What clinical evidence supports DefenCath for CRMD investors?

Phase 3 LOCK IT-100 showed a 71% reduction in catheter‑related bloodstream infection risk with comparable adverse events.

When will CorMedix (CRMD) report interim real‑world data for DefenCath?

The company expects interim real‑world evidence from its >2,000‑patient study around year‑end.

Is DefenCath broadly FDA approved for all dialysis patients?

No; DefenCath is FDA approved for a limited population of adult patients receiving chronic hemodialysis via central venous catheter.

Could Vizient's designation affect DefenCath purchasing by hospitals?

The designation is intended to highlight innovations to Vizient's client base, which may aid adoption discussions with hospitals and networks.

How large is Vizient's purchasing network mentioned in the announcement?

Vizient represents approximately $156 billion in annual purchasing volume across diverse healthcare providers.
Cormedix

NASDAQ:CRMD

CRMD Rankings

CRMD Latest News

CRMD Latest SEC Filings

CRMD Stock Data

909.38M
69.01M
7.56%
46.8%
15.92%
Biotechnology
Pharmaceutical Preparations
Link
United States
BERKELEY HEIGHTS