Grenoble, France, Nov. 19, 2024 (GLOBE NEWSWIRE) — Koelis, SAS, hereinafter “Koelis” or the “Company” (www.koelis.com), a leading and innovative company in the field of treatment of prostate diseases , announced today that it has reached an important milestone demonstrating the value of its Koelis Trinity 3D ultrasound platform as a technology enabling the application of focal prostate therapy. Recruitment for the VIOLETTE Phase II multicenter study on targeted microwave ablation has been finalized, its provisional results are published in the journal BJUI Compass and will be presented at the prestigious annual French Urology Congress which is being held this year. week in Paris.
Recent advances in imaging technology have helped reduce the overdiagnosis and overtreatment of prostate cancer. The use of prostate MRI before so-called “fusion” biopsy guided by MRI/ultrasound fusion imaging has proven its ability to accurately visualize and describe cancerous lesions with a view to more personalized treatment.
Thanks to the Koelis Trinity system®a platform based on a revolutionary technology called Organ-Based Tracking® (or OBT-Fusion) which uses software fusion technology to combine 3D ultrasound and MRI imaging, clinicians can visualize the prostate in real time and create a 3D map while recording the identified lesions.
OBT-Fusion technology® of Koelis also allows treatment needles to be planned and guided to targeted areas with the greatest precision. Among the options at its disposal, Koelis chose to evaluate the use of its own technology by following a minimally invasive approach called Targeted Microwave Ablation (TMA™), as part of a multicenter European Phase II study called VIOLETTE (NCT04582656).
TMA differs from other focal therapy options in that it is a comprehensive strategy, including not only a specific ablation modality, but also, and more importantly, a comprehensive guidance tool to recall the location. of the targeted biopsy and to visualize the tumor visible on MRI.
Koelis software fusion interface based on 3D ultrasound for transperineal guidance in focal prostate cancer therapy
The VIOLETTE clinical study evaluates the effectiveness of focal ablation of prostate cancer using a microwave needle guided into the index lesion by 3D image fusion. The last of 76 patients was successfully recruited on September 5, 2024 at the Clinique Saint-Augustin in Bordeaux, France. Other clinical investigation centers include the Cochin Hospital in Paris, principal investigator, the Jules Bordet Institute in Brussels, the Nantes Atlantis Urological Clinic, the Pellegrin Hospital in Bordeaux and the American Hospital of Paris.
The provisional results were published in BJUI Compass on October 30, 2024. This analysis focused on treatment data, safety, and biological and functional outcomes of the first 37 treated patients.
Here are the main conclusions:
- 70% of procedures were performed transperineally.
- The median pain was 0/10 on the VAS scale two hours after the procedure.
- All patients regained spontaneous urination and were discharged from the hospital the same day.
- The tumor was covered more than 100% by the ablation, and dynamic contrast MRI performed after 7 days showed nonvascularized prostate tissue in 97% of patients.
- A decrease in PSA and PSA density was observed, and it remained stable after one month of follow-up, indicating the first signs of oncological effectiveness.
- No major impact on urinary or sexual function has been reported.
- 58 adverse reactions were reported in 22 patients, including 5 serious ones resolved at the time of analysis.
Professor Nicolas Barry-Delongchamps, Professor of urology at Cochin hospital and principal investigator of the VIOLETTE clinical study, will present the provisional results and the first follow-ups of patients during the 118e French Urology Congress organized in Paris from November 20 to 23, 2024. On this occasion, Koelis plans to exhibit and sponsor an educational session on fusion biopsy and focal therapy (booth B27).
Professor Barry-Delongchamps comments: “ We are delighted to have completed recruitment for the Violette clinical study. 76 patients with a single focus of prostate cancer visible on MRI were meticulously selected. Koelis technology will not only detect and define these tumors, but also accurately plan targeted treatment. Pending definitive oncology results, we believe this new needle-based, image-guided technology is set to become an effective and safe management option for selected patients.”
Prostate cancer remains one of the most common and deadliest cancers in the world for men. While recent advances in imaging have helped improve diagnosis, the Trinity system® from Koelis makes it possible to provide precision care with unprecedented accuracy. Koelis’ technology is supported by more than 400 international clinical publications, which highlight the value of OBT-Fusion® for a more precise and personalized approach in the treatment of prostate cancer.
« The treatment of prostate cancer is changing worldwide. At Koelis, we are convinced that precision imaging can transform the lives of millions of people. As we aim through our efforts to become the preferred partner of urologists around the world, we are proud that the VIOLETTE clinical study demonstrates the leading role of Koelis in focal therapy for prostate cancer. concludes Antoine Leroy, PhD, founder and CEO of Koelis.
About KOELIS
Headquartered in Grenoble, France, Koelis has been a pioneer and leader in MRI-ultrasound image fusion guidance technology since 2006. Featuring proprietary 3D ultrasound and prostate movement tracking software (OBT Fusion®), the Koelis Trinity system® allows for more accurate biopsy diagnosis and provides additional “focal” treatment options for prostate cancer, compared to traditional “radical” treatments of the organ, such as surgical prostatectomy or radiotherapy. The Company’s commitment to minimally invasive treatments for prostate cancer is also illustrated by a multicenter clinical registry (“Violette”, NCT04582656) in Europe, focusing on microwave ablation technology guided by Trinity. Koelis operates offices in Grenoble (France), Princeton (New Jersey, USA), Saarbrücken (Germany) and Singapore, serving more than 50 countries. To find out more about KOELIS, visit: www.koelis.com.
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