Focal Healthcare’s Fusion Bx 2.0 Targeted Prostate Biopsy Solution Receives CE Mark

Fusion Bx™ 2.0 MRI/Ultrasound fusion technology to provide targeted prostate biopsies across Europe

TORONTO, CANADA – Focal Healthcare, an innovator of image-guided prostate cancer technology, announced it has received CE Mark for its Fusion Bx 2.0 prostate fusion biopsy solution. By combining information from multiparametric MRI (mpMRI) with a semi-robotic arm and user-friendly interface, the Fusion Bx 2.0 will give urologists across Europe the ability to perform targeted transrectal and transperineal prostate biopsies.

Earlier this year, both the European Association of Urology (EAU) and the National Institute for Health and Care Excellence (NICE) released updated guidelines that recommend the use of mpMRI prior to biopsy, followed by a targeted biopsy when the MRI is positive. This diagnostic pathway reduces the number of biopsies while increasing the likelihood of finding significant cancers. These recommendations highlight the important role played by MRI/Ultrasound fusion technology and the need for an accurate and accessible device such as the Fusion Bx 2.0.

“We are excited to receive the CE Mark as it greatly expands the market for our Fusion Bx,” said Chicuong La, CEO of Focal Healthcare. “The results from last year’s PRECISION trial has changed the way in which prostate cancer is being diagnosed in Europe. Now urologists throughout the EU will have access to our Fusion Bx – providing them with a targeted biopsy system that is accurate, and simple to learn and use. This will make it easier for clinics and hospitals of all sizes to adopt the new guidelines.”

Focal Healthcare’s Fusion Bx 2.0 provides urologists with the ability to perform both transrectal and transperineal biopsies using a simple and intuitive interface. Fusion Bx 2.0 features:

  • A semi-robotic arm that keeps the probe steady to ensure consistent pressure on the prostate, limiting movement and deformation, thereby leading to increased accuracy
  • A 3D model that allows the urologist to visualize the prostate and MRI targets in real-time to guide the biopsy needle to the regions of interest
  • Automatic motion compensation which adjusts for patient movement to maintain image registration, allowing procedures to continue uninterrupted
  • A step-by-step guided workflow combined with semi-automatic segmentation that enables urologists to perform procedures in less time and with minimal training

Fusion Bx 2.0 will be available to European physicians through distribution. Fusion Bx 2.0 is also cleared for sale in Canada, USA and Taiwan. For more information, contact Focal Healthcare at sales@focalhealthcare.com.

About Focal Healthcare Inc.

Focal Healthcare is a Canadian-based medical device company committed to improving the lives of prostate cancer patients and their families through technical innovation. By developing imaging tools that emphasize accuracy, efficiency and accessibility, Focal Healthcare strives to advance prostate cancer diagnosis and management in clinics and hospitals of all sizes. Focal Healthcare designs and manufactures all its products at its headquarters in Toronto, Canada.