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July 05, 2006
Urodynamix reports successful results of NIRS in Prostate Study
For Immediate Release
Vancouver, BC - (July 5, 2006) Urodynamix Technologies Ltd. (TSX.V: URO) announced today it has successfully completed its first major sponsored clinical study of its near infra-red spectroscopy (NIRS) urodynamics technology.
The Prostate Study showed that in 100% of “Positive” patients (n=18) including lower urinary tract symptoms, obstruction, benign prostatic hyperplasia (BPH), and prostate cancer, NIRS accurately measured and identified bladder activities statistically significantly in advance of Uroflow compared to “Normal” subjects (n=15) undergoing the same procedure.
“Based on the data, we believe NIRS will dramatically impact clinical diagnosis in the large prostate population.” Stated Dr. Lynn Stothers, Principal Investigator, Professor and Director of UBC Bladder Care Centre.
This clinical study, supported in part by the Canadian Institutes of Health Research (“CIHR Study”), was conducted by Drs. Lynn Stothers and Andrew Macnab from Feb 01, 2006 to May 30, 2006 at UBC Hospital Bladder Care Centre. In this study, a subset of patients was intentionally recruited for a focused study of prostate disease (“Prostate Study”). A total of 73 subjects were enrolled in the CIHR Study, including 25 “Positive” male subjects (7 were excluded). A total of 21 “Normal” males were enrolled (6 excluded). Subjects underwent simultaneous NIRS and Uroflow procedure.
The Prostate Study showed that the “Positive” subjects recorded bladder activity on average 29.22.seconds +/- 20.34 standard deviation in advance of recorded Uroflow. “Normal” subjects recorded bladder activity on average 8.47 seconds +/- 4.79 standard deviation in advance of recorded Uroflow.
In a statistical diagnosis test, the area under the ROC curve (AUC) was 0.91 (ROC curve or Receiver Operating Characteristics curve is a plot of the true positive rate against the false positive rate for a statistical diagnosis test). The study concluded that NIRS provided quantifiable evidence of the presence or absence of obstruction in this study population. Furthermore, NIRS offered this reliable information in a non-invasive and simple procedure that is not currently available.
In addition, the Prostate Study showed statistically significant differences in measured changes in oxygenated hemoglobin (Hb02), hemoglobin (Hb), and cytochromes (Cyt) for “Positive” versus “Normal”. Absolute changes in concentrations over the voiding period yield AUC of 0.84, 0.81 and 0.77 respectively for HbO2, Hb, and Cyt.
Barry Allen, President and Chief Executive Officer, added, "The strength of this initial data speaks for itself, we are confident that the pending studies with our more advanced prototype will confirm these positive results and provide additional data. We are very excited about the potential for our NIRS technology in the over 21 million men in North America suffering from enlarged prostate, benign hyperplasia and prostate cancer. The Company plans on accelerating the development of this application."
About Prostate Disease
Men are at significant risk for prostate disease. Symptoms of prostate disease include interruption of urinary flow (stopping and starting), inability to urinate, difficulty starting or stopping urination, frequent urination (especially at night), blood in the urine, and pain or burning during urination. As a result of these symptoms, men seek diagnosis and treatment from their General Practitioner and Urologist. A Urologist will perform a series of tests including Prostate Specific Antigen (PSA), digital rectal exam, urodynamics and uroflow, ultrasound and biopsy to aid in the diagnosis.
BPH is non-cancerous and is present in 24% of men age 40 to 49, increasing to 90% of men by the age of 85. Prostate cancer is second most common form of cancer among men and is second only to lung cancer as a cause of cancer related death among men. One in seven men will develop prostate cancer during their lifetime and one in 26 will die of it.
A detailed summary of the Prostate Study results is available by contacting Dr. Luya Li, VP Technology Urodynamix at lli@urodynamix.com. Analysis of additional sub-groups of the CIHR study is currently underway and will be released upon completion.
About Urodynamix Technologies Ltd.
Urodynamix Technologies Ltd. is the world leader in non-invasive measurement of bladder function and urological conditions. Urodynamix is focused on the development and commercialization of breakthrough diagnostic technology for bladder conditions specifically urinary incontinence (UI). Urodynamix is currently developing a family of non-invasive diagnostic and monitoring technologies for the over 200 Million UI sufferers worldwide.
On behalf of the Board,
“Barry Allen”
President & CEO
Urodynamix Technologies Ltd.
Certain information contained in this press release may be forward looking and is subject to unknown risks, which could cause actual results to differ materially from those, set forth or implied herein.Al though the Company believes that the expectations reflected in such forward-looking statements are reasonable; it can give no assurance that such expectations will prove correct.
The TSX Venture Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this release.
For further information, please contact:
Barry Allen
Email: ballen@urodynamix.com |
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