Less than a week after making a regulatory submission for a $1 million capital raise, prostate health company ProUroCare Medical, based in Eden Prairie, Minnesota, announced that it has secured market clearance for its diagnostic device.
ProUroCare has developed an elasticity imaging technology that can be used to document abnormalities of the prostate. The technology would serve as an adjunct to a digital rectal image, the current standard by which prostate health is determined. The ProUroScan system constructs color 2-D and 3-D “maps” of the prostate in real time that can confirm a DRE finding and be permanently stored in electronic records for future analysis and comparison, according to a news release.
The announcement marks a victory for the firm that has labored to get U.S. market clearance.
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An application for a 510(k) clearance was filed back in November 2009. In March 2010, ProUroCare said that a letter from the U.S. Food and Drug Administration said that the agency had not finished reviewing the application because a predicate device could not be identified. A 510(k) application for a new product has to demonstrate substantial equivalence to another product already on the market, which is known as a predicate.
Thereafter, in May 2010, a de novo application was filed with the FDA. A de novo application asks for market clearance for low-risk devices that have no predicate device on the market. Tuesday’s announcement comes two years after the de novo application was filed.
“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,” said Rick Carlson, CEO of ProUroCare, in a news release.
Meanwhile, it appears as if the company is looking for either a corporate distribution partner or an outright acquisition.
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“With assistance from Minneapolis investment firm Cherry Tree & Associates LLC, ProUroCare has been actively seeking a strategic corporate partner with a strong sales and in-service support presence in the urologic market to fully commercialize its technology,” the news release said.
