TORONTO, ON-- (July 28, 2016) Exact Imaging (www.exactimaging.com), the world’s leader in high resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance of the prostate, today announced that the Journal of Urology has published the initial results supporting the development of their PRI-MUS™ (prostate risk identification using micro-ultrasound) protocol. The Journal of Urology, the official journal of the American Urological Association, just published the paper, “Assessing Cancer Risk on Novel 29 MHz Micro-Ultrasound Images of the Prostate: Creation of the Micro-Ultrasound Protocol for Prostate Risk Identification,“ in the August 2016 issue. The peer-reviewed paper is now available online at www.jurology.com/article/S0022-5347(16)00027-6/abstract.
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.“
Along with Dr. Sangeet Ghai, the Chair of the PRI-MUS Clinical Advisory Board, the other members of the Board who helped develop and validate the protocol, are Dr. Christian Pavlovich, Johns Hopkins University, Brady Urological Institute, Baltimore, MD; Dr. Gregg R. Eure, Urology of Virginia, Virginia Beach, VA; Dr. Vincent Fradet, CHU de Quebec - Université Laval - L'Hôtel-Dieu de Québec, Quebec, QC; and Dr. Eric Hyndman, Prostate Cancer Calgary, Calgary, AB.
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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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. Operating up to 29 MHz, the ExactVu™ micro-ultrasound platform enables a whole new level of resolution and 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, trans-rectal, ultrasound biopsy protocols. ExactVu™ micro-ultrasound system has CE marking (Certificate #649960) for sale in the European Union. The product is not yet commercially available in the US and Canada.
