Health Canada Grants Focal Healthcare Class II Medical Device License for Targeted Prostate Biopsy Device, Fusion Bx

TORONTO, ON – April 24, 2017

Focal Healthcare Inc. has been granted a Class II Health Canada Medical Device License for its targeted prostate biopsy device, Fusion Bx. Fusion Bx uses MRI/Ultrasound fusion to provide urologists with 3D image-guidance, allowing biopsies to be taken directly from suspicious cancer regions in the prostate for improved prostate cancer diagnosis. Health Canada’s license of Fusion Bx further expands Focal Healthcare’s geographic reach and impact on the field of urological care. Both of Focal Healthcare’s products – Fusion Bx and Fusion MR Viewer – are now being actively sold in Canada and the United States.

“We are very pleased to have been granted this license from Health Canada for Fusion Bx,” said Chicuong La, President and CEO of Focal Healthcare. “With this milestone, we are closer to realizing our vision of improving prostate cancer care worldwide.”

The routine method for prostate cancer diagnosis in Canada today is a systematic biopsy. During a systematic biopsy, urologists use ultrasound imaging to take random samples from throughout the prostate with the hope that a sample intersects any existing cancerous lesion or tumour. With the availability of Fusion Bx, Canadian clinicians can access a new innovative technology known as MRI/Ultrasound fusion. Clinical studies have shown that prostate biopsies performed using fusion technology find 30% more high-risk cancer than traditional biopsy. This improved diagnostic power results from taking advantage of the ability to see prostate lesions (tumours) on MRI. These images are ‘fused’ to ultrasound during the biopsy procedure, allowing doctors to directly sample suspected cancer regions.

Fusion Bx was developed with input from Focal Healthcare’s esteemed clinical advisors, including Dr. Daniel Margolis at Weill Cornell Medicine (New York), Dr. Laurence Klotz at Sunnybrook Health Sciences Centre (Toronto), Dr. Winston Barzell at Florida State University (Sarasota), and Dr. Michael McGuire at NorthShore University Health System (Chicago). Dr. Laurence Klotz is a professor in the Department of Surgery at the University of Toronto and has been named to the Order of Canada for his contributions to the treatment of prostate care. “Focal Healthcare developed Fusion Bx as the practical solution to perform MRI-targeted biopsies in urology practices,” said Dr. Klotz. “I believe their ability to simplify this new standard of care for prostate cancer diagnosis will lead to greater access for patients.”

With this Health Canada license, Focal Healthcare hopes to make fusion biopsy a procedure that is accessible to all Canadian patients. “Prostate-targeted biopsy is quickly becoming the standard of care for prostate cancer diagnosis around the world,” said Lauren Killip, Vice President Business Development at Focal Healthcare. “Focal Healthcare’s Fusion Bx device is well-positioned to meet growing demand from the Canadian urology community and give Canadian patients access to better prostate cancer care and improved outcomes.”


About Focal Healthcare Inc.

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 diagnosis and management in clinics and hospitals of all sizes.

Contact Information:

Lauren Killip

VP, Business Development

[email protected]