INNOVATIVE ELASTICITY IMAGING TECHNOLOGY FOR MAPPING THE PROSTATE

We are a publicly-held company that develops and markets prostate imaging systems. Our first product, developed in collaboration with Artann Laboratories Inc. working under grants from the National Institute of Health (NIH), is an innovative prostate imaging system known as the ProUroScan^TM system. The ProUroScan incorporates our new proprietary elasticity imaging technology to create and electronically store a “map” of the prostate. The system provides information for patients who are considering their prostate biopsy, transrectal ultrasound or radical prostatectomy options following a positive digital rectal exam for men (DRE).

Our approach to imaging is based on the fact that most abnormal tissue in otherwise homogenous organ tissue is less elastic than normal tissue. The ProUroScan’s unique technology uses measurements of relative tissue elasticity as detected by mechanical sensors and interpreted by mathematical algorithms to create images, rather than using transrectal ultrasound or other alternatives. Using the system’s specially designed rectal probe, physicians can quickly and cost-effectively visualize the prostate gland and document specific areas of concern. The real-time map can be saved as a permanent electronic record and compared to maps created in successive evaluations.

Elasticity Imaging for a Prostate Biopsy

The ProUroScan imaging system is currently in the final stages of a multi-site FDA clinical study. The objective of the study is to provide sufficient documentation of the system’s effectiveness in mapping the prostate and identifying abnormalities detected by digital rectal exams for men to support an FDA 510(k) application for U.S. market clearance.

The ProUroScan clinical study is focused on patients with unfavorable DREs, consistent with our proposed 510(k) labeling claim. According to the results published in a 2008 article in Urology, a ProUroScan map of the prostate gland has been successfully created for more than 80 percent of individuals who have been imaged. Potential benefits of the technology have been analyzed and confirmed in eight separate peer-reviewed articles, ranging from journals such as Urology, IEEE Transactions in Medical Imaging, The Journal of Urology, Nature Clinical Practice Urology and the International Journal of Medical Informatics.To view our latest news updates, click here.

Not available for Sale in the United States.
CAUTION – Investigational device. Limited by Federal law to investigational use.
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