Journal of Urology Publishes Results of Exact Imaging’s Initial PRI-MUS™ Protocol using High Resolution Micro-Ultrasound
New protocol sets foundation for establishing new standard in targeting prostate biopsies using micro-ultrasound

The paper illustrates the initial finding on PRI-MUS™, the first risk identification protocol developed specifically for micro-ultrasound of the prostate. This new protocol aims to set a new standard to facilitate micro-ultrasound-based visualization and stratification of prostate tissue imaging and to best instruct real-time targeting of suspicious regions using the micro-ultrasound platform. 

“This paper reveals the promising initial results for real-time visualization of suspicious lesions and targeting of biopsies using micro-ultrasound, along with the PRI-MUS protocol,” says Dr. Sangeet Ghai, PRI-MUS Committee Chair and Director of the Biopsy Centre at Princess Margaret Cancer Centre, Toronto, ON. “As we concluded in the paper, the improved performance of this new imaging platform and the protocol in detecting significant disease is consistent with the focus of the field on increasing detection of high risk disease early and on decreasing insignificant diagnoses.”

“Prostate cancer is a diffuse disease and with the significant increase in spatial resolution enabled by our ExactVu technology, we wanted to develop an evidence-based protocol that would allow urologists to identify sonographic features now visible in prostate tissue, to characterize those features in terms of a standardized risk identification protocol, and then to target those areas that appeared suspicious,” says Randy AuCoin, Exact Imaging’s President and CEO. “This led us, along with the clinical leadership of our PRI-MUS Advisory Group, to develop the PRI-MUS protocol for micro-ultrasound based imaging of the prostate. The protocol is completely evidence-based, having been developed based on retrospective studies referencing over 1,000 micro-ultrasound biopsy images and cine-loops and all validated with clinical pathology.“

Exact Imaging is planning on CE approval and then FDA clearance for the ExactVu micro-ultrasound system in the coming months. The company’s Quality Management System has just been assessed and recommended for ISO 13485:2003 certification, a key precursor to CE approval and 510(k) clearance.


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