MINNEAPOLIS, May 1, 2012 /PRNewswire/ -- ProUroCare
Medical Inc. (OCTBB: PUMD), provider of proprietary medical imaging
products, announced today it has received clearance from the U.S.
Food & Drug Administration (FDA) for its
ProUroScan™ prostate mechanical imaging (PMI)
system. The approval paves the way for men and their families
to receive high-resolution visual documentations as an aid in
detecting prostate abnormalities that were previously detected by
digital rectal examination (DRE). The ProUroScan system
constructs color 2D and 3D "maps" of the prostate in real-time
that, when in agreement with a DRE finding, can be permanently
stored in electronic records for future analysis and
comparison. ProUroCare's patented tactile elasticity imaging
technology, which uses a handheld pressure-sensing rectal probe and
sophisticated image construction software to produce its prostate
maps, represents a new imaging modality distinct from traditional
ultrasound imaging.
The company plans to introduce the technology in 2012 to a
limited number of top U.S. medical care centers in key major
metropolitan markets. 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.
"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 Medical. "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."
As a standard of care, the American Urological Association (AUA)
currently recommends that beginning at age 40, men receive a DRE
and a prostate specific antigen (PSA) blood test in their yearly
physical, yet data from community-based studies suggest the
positive predictive values of DRE and PSA combined achieve only a
56 percent predictive value. Furthermore, neither test
creates a physical or visual record of the prostate. The
ProUroScan system is being introduced as an adjunctive technology
to a DRE for physicians to use to further clarify and document
abnormalities associated with the prostate gland.
"Having a visual aid of irregularities can be so helpful to
physicians and patients, particularly in the area of prostate care
where decision-making is often difficult," said Dr. Robert Weiss, a urologic oncologist with the
Cancer Institute of New Jersey and
a faculty member at Robert Wood Johnson Medical School who used the
ProUroScan technology as part of its clinical trial process.
"The quality and resolution of the images are excellent, providing
an immensely valuable supplement to the DRE, where physicians must
rely on a gloved finger to feel for changes in the size and shape
of the gland."
The prostate imaging system's FDA 510(k) was first submitted by
ProUroCare's development partner Artann Laboratories, Inc. and
later processed in accordance with the de novo provisions
accounted for in Section 513(f)(2) of the Federal Food, Drug and
Cosmetic Act. The FDA filings were supported by data from a 2009
National Institute of Health and National Cancer
Institute-supported clinical study of patients evaluated at five
leading U.S. medical centers, as well as an earlier study conducted
specifically at the Robert Wood Johnson Medical Center in
New Brunswick, N.J.
About ProUroCare Medical Inc.
ProUroCare Medical Inc. is a publicly traded company engaged in
the business of creating innovative medical imaging products. Based
in Minneapolis, Minn., the
company's stock trades on the OTCBB market.
This news release contains certain "forward-looking"
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. These statements are typically preceded by
words such as "believes," "expects," "anticipates," "intends,"
"will," "may," "should," or similar expressions. These
forward-looking statements are not guarantees of ProUroCare's
future performance and involve a number of risks and uncertainties
that may cause actual results to differ materially from the results
discussed in these statements. Factors that might cause
ProUroCare's results to differ materially from those expressed or
implied by such forward looking statements include, but are not
limited to, the ability of ProUroCare to find adequate financing to
complete the development of its products; the high level of secured
and unsecured debt incurred by ProUroCare; the impact and timing of
actions taken by the FDA and other regulatory agencies with respect
to ProUroCare's products and business; the dependence by ProUroCare
on third parties for the development and manufacture of its
products; and other risks and uncertainties detailed from time to
time in ProUroCare's filings with the Securities and Exchange
Commission including its most recently filed Form 10-K and Form
10-Q. ProUroCare undertakes no duty to update any of these
forward-looking statements.
SOURCE ProUroCare Medical Inc.