PET developer Naviscan of San Diego recently completed enrollment for a 400-patient randomized prospective trial, which the company is sponsoring with the U.S. National Institutes of Health (NIH).
The study will attempt to quantify the sensitivity and specificity of positron emission mammography (PEM) against breast MRI, as well as delve into any influence PEM may have on the management of patients' surgery and treatment.
Naviscan also recently received clearance from the U.S. Food and Drug Administration (FDA) for its surgical navigation software. The company plans to conduct the beta review of the software in the coming months and anticipates production and shipments to begin in the second quarter of 2009.
The clinical trial and software clearance come as Naviscan grows the installation base for its PEM Flex Solo II organ-specific PEM scanner. "We are about a year and a half into our production capacity and we are approaching 30 systems installed," said chairman and CEO Paul Mirabella.
Despite the economic recession gripping the U.S., Mirabella said there has been no slowdown in orders for the Naviscan system. "What I have seen is a bit of a slowdown in how fast customers are spending the money and taking delivery," he added. "It is hard to call it a slowdown, because we don't have big numbers, but I would say the pace at which people are taking delivery and booking sales is a little slower than our orders right now."
Related Reading
PEM may reduce false-positive reports, December 3, 2008
Road to RSNA, Molecular Imaging, Naviscan, October 28, 2008
Naviscan nets NYC customer, August 13, 2008
Naviscan touts PEM trial data, June 17, 2008
Naviscan completes NY installation, May 21, 2008
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