Toronto, ON – January 29, 2016 – Focal Healthcare Inc.TM, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for their targeted prostate biopsy device, Fusion Bx TM. With the availability of Fusion Bx, clinicians are no longer limited to the traditional systematic biopsy approach for diagnosis, but can instead accurately take targeted biopsies directly from suspicious cancer regions within the prostate using MRI-ultrasound “fusion” technology.
MRI has the ability to see tumors in the prostate that ultrasound alone cannot. Thus, by fusing previously-acquired MR images to live ultrasound, clinicians can target suspicious tumors when taking biopsy samples. Fusion biopsy has been shown to detect high-grade cancer in 30% more men compared to traditional systematic biopsy . In addition, by accurately determining the location and extent of the cancer, this procedure allows clinicians to confidently monitor cancer progression over time and prescribe the appropriate course of treatment to patients with varying grades of cancer.
With this clearance, Focal Healthcare plans to make this procedure accessible to all patients. “Focal Healthcare was founded to bring state of the art procedures into clinics of all sizes. Fusion Bx was developed with both the patient and doctor in mind and we are excited that this clearance will help us provide patients with broad access to this valuable procedure”, said Chicuong La, CEO of Focal Healthcare.
Focal Healthcare’s accurate and intuitive device has been developed in close collaboration with clinicians including Dr. Winston Barzell, Florida State University (Sarasota), Dr. Daniel Margolis, David Geffen School of Medicine at UCLA (Los Angeles), and Dr. Michael McGuire, NorthShore University Health System (Chicago). Dr. Barzell, a former attending surgeon at Memorial Sloan Kettering Cancer Center, holds 19 patents for his innovations in prostate therapy. He is currently conducting a clinical trial with Fusion Bx at 21st Century Oncology in Sarasota, Florida.
“In contrast to systematic “blind” biopsies, targeted fusion biopsies reliably identify clinically significant cancers, while reducing the random detection of insignificant cancers that are frequently at risk of over-treatment. Fusion Bx is an exciting, innovative technology that will provide busy clinicians access to a state-of-the-art, user-friendly fusion biopsy system which can be seamlessly introduced to the routine urology office workflow” –Dr. Winston Barzell
Fusion Bx is FDA 510k cleared for use by physicians for enhanced visualization of ultrasound imaging of the prostate in clinic and hospital settings. It provides 2D and 3D image visualization including review, manipulation, and analysis tools.
About Focal Healthcare
Focal Healthcare is a Toronto-based medical device company committed to improving the lives of prostate cancer patients and their families through technical innovation. By developing imaging tools that are accurate, efficient, and accessible, Focal Healthcare aims to advance prostate cancer management in clinics of all sizes.
Reference: Siddiqui MM, et al. JAMA. 2015 Jan 27;313(4):390-7. doi: 10.1001/jama.2014.17942.