GRENOBLE, France—In a significant leap for prostate cancer care, KOELIS SAS has achieved a key milestone with the completion of patient enrollment in the VIOLETTE trial, which evaluates the innovative OBT-Fusion® technology for the focal ablation of the prostate using microwave needles.

The interim results, published in the prestigious BJUI Compass, will be presented at the 118th French Urology Congress in Paris, which is taking place from November 20-23, 2024.

VIOLETTE Trial Overview

The VIOLETTE trial, a multicentric phase II study, focuses on Targeted Microwave Ablation (TMA™)—a method characterized by its minimally invasive nature and the utilization of advanced imaging technology.

By integrating 3D ultrasound with MRI through KOELIS's proprietary software, the Koelis Trinity® platform allows healthcare providers to create real-time 3D maps of the prostate, enhancing the accuracy of targeting cancerous lesions during the ablation process.

Importance of Targeted Treatments

With prostate cancer being one of the most prevalent cancers affecting men worldwide, reducing the risk of overdiagnosis and overtreatment has become increasingly important.

The introduction of prostate MRI prior to fusion biopsy has significantly improved the visualization and description of cancerous lesions, leading to more tailored treatment approaches.

Patient Enrollment and Key Findings

The VIOLETTE trial enrolled a total of 76 patients across multiple European centers, including Cochin Hospital in Paris, Bordet Cancer Institute in Brussels, Urology Clinic Atlantis in Nantes, and Pellegrin Hospital in Bordeaux.

The final patient was enrolled on September 5, 2024.

Key findings from the interim analysis of the first 37 patients demonstrated impressive results, including: - 70% of the procedures were performed using a transperineal approach. - Patients reported a median pain level of 0/10 on a Visual Analog Scale (VAS) two hours post-procedure. - All patients successfully regained normal urinary function and were discharged on the same day. - Imaging post-ablation showed that 97% of patients exhibited non-vascularized tissue, indicating successful tumor coverage. - A decline in prostate-specific antigen (PSA) levels was noted, suggesting early indications of effective oncological treatment.

Expert Commentary

Prof. Nicolas Barry-Delongchamps, Principal Investigator of the VIOLETTE trial, will share these groundbreaking findings in Paris, highlighting the potential of KOELIS's technology in enhancing the precision and effectiveness of prostate cancer treatments.

He stated, “The completed enrollment of the VIOLETTE trial marks a critical moment in addressing prostate cancer. Our technology not only detects and characterizes tumors but also enables precise treatment planning.”

Looking Ahead

As the global landscape shifts toward more personalized prostate cancer care, KOELIS remains at the forefront of this transformation.

Their technology has been validated by over 400 international clinical publications, affirming its commitment to providing effective and less invasive treatment options for patients.

CEO's Vision

Antoine Leroy, PhD, the founder and CEO of KOELIS, emphasized the importance of precision imaging in revolutionizing prostate cancer care and improving patient outcomes: “Our mission is to become the preferred partner for urologists globally.

The VIOLETTE trial underscores our leading role in advancing focal therapy for prostate cancer.”

Conclusion

As KOELIS prepares to showcase its technological innovations at the French Urology Congress, the medical community is anxiously anticipating how these results will influence future approaches to prostate cancer treatment.

The hope is for widespread implementation of OBT-Fusion® technology, ultimately improving the quality of life for men battling this prevalent disease.