Urodynamix, Laborie announce U.S. launch of near IR spectroscopy-based bladder monitor
May 23, 2008 -- Urodynamix Technologies Ltd. (TSX-V:URO, Vancouver, BC, Canada) and Laborie Medical Technologies (Montreal, Que, Canada) announced the U.S. launch of the Tetra Bladder Monitor System, a catheter-free medical device that uses near infrared spectroscopy (NIRS) to aid in the diagnosis of lower urinary tract symptoms (LUTS).
The partners made the announcement as Laborie began introducing Tetra at this week's 103rd American Urological Association (AUA) Annual Meeting.
Tetra is used in conjunction with other non-invasive tests (including uroflowmetry and bladder ultrasound) to assess bladder function and aid in the diagnosis of LUTS. These symptoms are particularly common in men with benign prostatic hyperplasia, or BPH (enlarged prostate), and Tetra provides clinicians with an alternative to more invasive, catheter-based procedures that are currently used to diagnose prostate obstruction and related conditions.
In May 2007, Urodynamix entered into a worldwide licensing agreement with Laborie, global provider of urodynamics equipment and related products, to distribute its URO-NIRS device in acute care settings. Laborie has a global network of direct sales representatives and distributors in 52 countries across North America, South America, Europe, Asia and Oceania.
Lower urinary tract symptoms are common in middle-aged men, with the prevalence of LUTS believed to be as high as 90% in men aged 50 to 80 years old. The term describes a range of urinary symptoms that may be linked with prostate disease or bladder dysfunction.
LUTS are most often associated with an enlarged prostate; however symptoms alone cannot be used to make an accurate diagnosis or ensure appropriate treatment of the underlying disease. In the past, invasive pressure-flow urodynamic studies were the only way to differentiate between symptoms caused by prostatic obstruction and bladder disease.
The Tetra system uses a non-invasive optical sensing technique (near infrared spectroscopy, or NIRS) to aid in the diagnosis of patients with lower urinary tract symptoms without the use of catheters. FDA pivotal trials of Tetra demonstrated 86% sensitivity and 89% specificity for the presence or absence of prostate obstruction compared to a gold-standard diagnosis based on the Abrams-Griffiths nomogram.
Urodynamix Technologies is a medical device company developing and commercializing non-invasive medical technology based on proprietary applications of near-infrared spectroscopy (NIRS). The company is currently focused on products that aid in the diagnosis and treatment of urinary incontinence, lower urinary tract symptoms, prostate cancer, benign prostatic hyperplasia, and traumatic increases in intra-abdominal pressure that cause abdominal compartment syndrome.