GRONINGEN, THE NETHERLANDS – 16 September 2025 – TRACER and Curadel Pharma are pleased to announce that the first patient has been enrolled at a TRACER-managed site in the global TRIPHASE (NCT06101745) clinical trial. The patient, who underwent abdominopelvic surgery at Isala Hospital in Zwolle, received the near-infrared fluorophore ZW800-1 (Nizaracianine Triflutate).
TRIPHASE is an ongoing, multi-centre trial designed to assess the safety and efficacy of ZW800-1 for real-time visualization of the ureters during abdominopelvic surgery. As a small-molecule agent that is rapidly excreted (+10 min after IV administration) via the ureters — the thin-walled tubes connecting the kidneys to the bladder — ZW800-1 aims to enhance intraoperative ureter visualization and function assessment, thereby reducing the operative time and significantly reducing the risk of iatrogenic injury. Such damage to the ureters may remain unnoticed during surgery and may result in serious complications for the patient and elevated healthcare costs.
The TRIPHASE trial is conducted in 8 sites across the U.S. and the Netherlands. TRACER is responsible for the site management and patient inclusion in three Dutch sites: Isala Hospital Zwolle, Martini Hospital Groningen, and the University Medical Centre Groningen (UMCG). Other sites include Erasmus Medical Centre Rotterdam, Leiden University Medical Centre (LUMC), University of Massachusetts Chan Medical School, Stanford University, and Cedars Sinai Medical Center, Los Angeles.
Curadel Surgical Innovations
Curadel Surgical Innovations (known as Curadel Pharma) is a U.S.-based biotechnology company headquartered in Bonita Springs, FL, specializing in the development of a new class of zwitterionic drugs. These compounds are designed to minimize non-specific binding and enable rapid renal clearance, enhancing both safety and precision in medical applications. ZW800-1 is one of the applications of Curadel’s zwitterionic technology, with additional programs in development in the field of MRI and oncology. Learn more at www.curadelpharma.com.
TRACER CRO
TRACER is an imaging-focused Contract Research Organization (CRO) specializing in optical and nuclear molecular imaging in clinical trials. Compounds that already include an imaging component — such as Curadel’s ZW800-1 — can be directly visualized. Other investigational drugs can be labeled specifically for imaging purposes during (pre)clinical development. TRACER collaborates with drug developers to accelerate the evaluation and clinical translation of innovative therapeutics. Learn more at www.tracercro.com.
Further details on TRIPHASE are available on ClinicalTrials.gov under identifier NCT06101745.
