Clinical Studies of the NIRS Bladder Monitor System
In 2004, initial insights into this non-invasive technology were facilitated by a trial at UBC of 10 urodynamics patients with a variety of bladder conditions who underwent conventional urodynamic testing and simultaneous NIRS bladder monitoring. The resultant data demonstrated that changes in the oxygenation state of the bladder correlated with stages in voiding. On May 31, 2005, Urodynamix predecessor company MDX Medical Inc. signed an exclusive worldwide license agreement with UBC for the NIRS bladder monitoring technology. In early May 2006, investigators at the UBC Bladder Care Centre completed a study on 60 human subjects using a prototype based on a commercially available brain oxygenation monitoring device. This study was partially funded by Canadian Institutes of Health Research (CIHR). Data is currently awaiting publication. Urodynamix completed the development of its first pre-commercial device in 2006 and received a grant from Canada’s National Research Council Industrial Research Assistance Program (IRAP) to further the development of the technology. In the first quarter of 2007, Urodynamix reported additional clinical data from 63 male and female patients demonstrating that the prototype URO-NIRS Bladder Monitor can non-invasively characterize bladder function in men and women with obstructive lower urinary tract symptoms (LUTS) and urinary incontinence (UI).
A pivotal clinical study was completed at the end of 2007, and additional studies will be supported by Laborie Medical Technologies at high-profile clinical sites in North America and Europe following the launch of the Tetra™ Bladder Monitor System in 2008.
Regulatory Process
The first generation NIRS bladder monitor, the Tetra™ Bladder Monitor System by Laborie Medical Technologies, is an integrated urodynamics (or UDS) accessory device combining Urodynamix's NIRS technology with Laborie's existing UDS* equipment. In the United States, the device is considered a Class 2 medical device and 510(k) marketing clearance has been granted by the U.S. Food adnd Drug Administration (FDA). In Canada, a Canadian Medical Device License has been applied for as a Class II medical device. In the European Union, a CE Mark is being sought as a Class IIa medical device.
The Tetra™ Bladder Monitor System is currently available for commercial sale in the United States through Laborie Medical Technologies. The product was launched at the Annual General Meeting of the American Urology Association (AUA 2008) in Orlando, Florida in May 2008.
* UDS® is
a registered trademark of Laborie Medical Technologies.
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