Urodynamix Expands NIRS intra-abdominal pressure study

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Urodynamix Technologies Ltd. receives notification from Health Canada allowing the company to expand its clinical trial ('NIRS IAP Study') at the Foothills Medical Centre in Calgary. Under the approved protocol the company may enroll up to 70 intensive care unit ('ICU') patients and will monitor subjects continuously for up to seven days.

Based on the success of the company's initial NIRS IAP clinical trial, the company and the investigators sought approval to increase the monitoring period from 24 hours to up to seven days in order to test the device in an environment that more accurately reflects the clinical ICU setting. According to data on inpatient admissions processed for the Centers for Medicare and Medicaid Services, patients at short-term acute care hospitals who require admission to an ICU have an average length of stay of eight days. However, elevated intra-abdominal pressure ('IAP') is associated with severe organ dysfunction during the ICU stay, and a recent study showed significantly longer average ICU stays of up to 28 days among abdominal compartment syndrome ('ACS') patients who suffer multiple organ dysfunction due to sustained elevated IAP.

The goal of the NIRS IAP Study is to evaluate the company's prototype near-infrared spectroscopy ('NIRS') device for continuous monitoring of changes in IAP in critical care ICU patients compared to intermittent catheter-based IAP measurements. Untreated ACS is fatal and recent studies have confirmed the importance of early intervention and treatment in these patients.