ProUroCare Medical (OTC:PUMD) won the FDA’s okay for its flagship ProUroScan system, a diagnostic imaging device for detecting irregularities in the prostate.
The Minneapolis, Minn.-based company plans this year to launch ProUroScan at "a limited number of top U.S. medical centers in key metropolitan markets," according to a press release.
The device employs a rectal probe that produces an "elasticity image" of the prostate, analyzing tissue movement and displacement for excessive stiffness that may be a sign of trouble.
The system then creates 2D and 3D real-time "maps" of the prostate, using color coding to highlight areas of softness or rigidity. The results can be logged in a patient’s permanent health records for future comparison.
"This is a major milestone for the company, for physicians looking for more assurance and documentation in their evaluations and for men eager for more information to assess and make decisions about their prostate health," CEO Rick Carlson said in prepared remarks. "A color image can go a long way in documenting a person’s prostate condition, and this development puts us one step closer to supplementing other screening measures with a helpful, high quality visual aid that can be referred and compared to over time."
ProUroScan would be used in complement with other existing prostate screening methods, looking for signs of abnormality detected by a digital rectal examination, but may replace other traditional tests such as the prostate specific antigen test.
"Although PSA and DRE provide some positive predictive value, neither of these tests creates a physical or visual record documenting abnormalities in the prostate," according to the ProUroCare website. "The low predictive ability of the DRE and PSA tests to gauge the presence of cancer over-inflates the number of referrals for invasive biopsy than are necessary to confirm that a patient has cancer."
Preventing unneeded biopsies is just 1 way that the ProUroCare system may help cut costs in prostate screening. Patient screening with the ProUroScan is expected to cost $250-$350 per procedure, a far cry from the $2,000 price tag for a prostate biopsy, Minnesota’s ABC 6 news reported.
Prostate cancer is the most common cause of cancer among men over the age of 50, and the 2nd most common cause of cancer death for the group. About 241,000 men were diagnosed with prostate cancer in 2011, and more than 33,000 died from the disease, according to ProUroCare.
PUMD shares spiked 50% from a close of 80¢ apiece as of market close on April 24 to $1.20 after announcement of the win on May 1. Shares had settled down to around $1.10 as of about 11:45 a.m. today.
