KOELIS Unveils First Interim Results of VIOLETTE: Key Insights and Innovations

KOELIS Unveils First Interim Results of VIOLETTE: Key Insights and Innovations

November 20, 2024 Catherine Williams - Chief Editor Health

Koelis Announces Milestone in Prostate Care
GRENOBLE, France, Nov. 20, 2024 — Koelis, SAS, a leader in prostate care, achieved a major milestone with its Koelis Trinity 3D Ultrasound Platform. The VIOLETTE multicentric phase II trial on Targeted Microwave Ablation (TMA) has completed enrollment and published interim results in BJUI Compass. These results will be shared at the annual French Urology meeting in Paris.

Advancements in Prostate Imaging

Recent imaging technology improvements have helped lower overdiagnosis and overtreatment of prostate cancer. Prostate MRI before MRI/ultrasound fusion biopsy has improved the accuracy of identifying cancerous lesions, enabling personalized treatment.

Koelis Trinity Technology

The Koelis Trinity® fusion imaging system uses Organ-Based Tracking® (OBT-Fusion) technology. This combines 3D ultrasound and MRI imaging to allow real-time visualization of the prostate and mapping of lesions. OBT-Fusion also aids in planning precise needle treatments. Koelis is examining this technology through the VIOLETTE trial (NCT04582656) focused on TMA.

VIOLETTE Trial Overview

The VIOLETTE trial studies microwave needle ablation of prostate cancer using 3D image fusion. The final patient was enrolled at Clinique Saint-Augustin in Bordeaux on September 5, 2024. Other sites include Cochin Hospital in Paris, Bordet Cancer Institute in Brussels, Urology Clinic Atlantis in Nantes, and Pellegrin Hospital in Bordeaux.

Interim Results Highlights

Interim results, analyzed in October 2024 from 37 treated patients, include:

  • 70% of procedures were transperineal.
  • Median pain level was 0/10 two hours post-procedure.
  • All patients regained the ability to urinate without assistance and went home the same day.
  • Ablation covered over 100% of the tumor; 97% of patients showed non-vascularized tissue on MRI after one week.
  • A decrease in PSA levels was noted, signaling early oncological efficacy.
  • No significant urinary or sexual function impacts were observed.
  • 58 adverse events were reported in 22 patients, with 5 being severe but resolved.

Expert Commentary

Prof. Barry-Delongchamps stated, “Completing enrollment in the VIOLETTE trial is a delight. This technology accurately detects and characterizes tumors, enabling targeted treatments.”

Company Vision

Antoine Leroy, PhD, Founder and CEO of Koelis, added, “Prostate care is transforming. Precision imaging can change many lives. The VIOLETTE trial highlights Koelis’ role in advancing focal therapy for prostate cancer.”

About Koelis

Koelis, founded in 2006, is based in Grenoble, France. The company focuses on MRI-US fusion technology to improve biopsy accuracy and offers alternatives to total organ treatments for prostate cancer. Koelis operates in over 50 countries.

For Media Inquiries

Contact:
Thomas Martins Pinheiro
Communication Manager
Phone: +33 (0)7 88 31 16 48
Email: Thomas.martins-pinheiro@koelis.com