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Devices Urology Regulatory

 News Release - March 9, 2017

Exact Imaging Announces Health Canada Approval and License for its ExactVu(TM) micro-ultrasound system for prostate imaging and biopsy

Sunnybrook Health Sciences Centre with Sunnybrook Research Institute is the first Canadian Customer Site for the ExactVu™ system

TORONTO, March 9, 2017 -- (Healthcare Sales & Marketing Network) - Exact Imaging (www.exactimaging.com), the world's leader in high resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance for the prostate, announced it has received Health Canada approval and the corresponding medical device license (#98667) to sell its ExactVu™ high resolution micro-ultrasound system.

"We are very pleased to received our license and regulatory approval from Health Canada allowing our ExactVu micro-ultrasound system to be commercially available in Canada," says Randy AuCoin, Exact Imaging's President and CEO. "We are especially excited to also announce our first Canadian sale to Dr. Gregory Czarnota and Sunnybrook Health Sciences Centre and Sunnybrook Research Institute in Toronto, ON. Dr. Czarnota's important clinical research in apoptosis is trying to better understand the molecular mechanisms by which diseased cells die and therefore, how therapy can be most effectively applied. We are privileged to have our ExactVu platform being used in Sunnybrook's clinical practice as well as in its innovative research efforts."

"The unmatched resolution of the ExactVu micro-ultrasound system will provide important capabilities to our urologists in helping them actually visualize and distinguish suspicious tissue - and therefore allows us to actually target our prostate biopsies," said Dr. Czarnota, Director of the Odette Cancer Research Program, Sunnybrook Research Institute and Radiation Oncologist at Sunnybrook Health Sciences Centre. "Furthermore, the ExactVu's high resolution imaging also generates rich RF (or radio frequency) data which our research teams can evaluate and correlate with pathology to apply against our models to better understand apoptosis and how cancerous cells respond to therapy. We see very exciting potential in the ExactVu system and look forward to our collaboration with the team at Exact Imaging."

Dr. Czarnota discovered that high-frequency ultrasound could be used to detect apoptosis or cell death. This finding has since been applied to important questions in oncology and organ transplantation. Dr. Czarnota's research group is investigating a number of spectroscopic parameters for characterizing tumors and tumor responses to chemotherapy and radiation therapy at high frequencies and intends to use the ExactVu for such purposes. Specific applications include developing methods to generate color-coded ultrasound parametric maps to aid in assessing tumor responses to therapy. Since these spectroscopic signals are potentially linked to nuclear structure and chromatin structure which differs between normal and neoplastic tissue, there is potential to develop our spectroscopic methods not only into a method to track tumor responses but a potentially important diagnostic tool.

About Exact Imaging

Exact Imaging (www.exactimaging.com) is the world's leader in high-resolution micro-ultrasound systems enabling real-time imaging and guided biopsies in the urological market for prostate cancer. Exact Imaging's ExactVu™ micro-ultrasound platform operates at 29 MHz and enables a whole new level of resolution with the benefits of ease of use, affordability, and being an extension of the current urological workflow. Using the Exact Imaging platform, urologists will now be able to visualize areas of interest in the prostate and specifically target biopsies at those areas in addition to performing systematic biopsy protocols. The ExactVu™ micro-ultrasound system has recently been granted regulatory approval in the European Union (CE Mark), the United States (FDA 510(k) and Canada (Health Canada license).


Source: Exact Imaging

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