Navigation Links
ProUroCare Medical Receives FDA Clearance for ProUroScan Elasticity Imaging System

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.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. ProUroCare Medical Elects Larry W. Getlin as New Director
2. UPDATE - ProUroCare Announces $3 Million Financing Agreement
3. ProUroCare Medical Inc. Announces Completion of Warrant Replacement Offering
4. ProUroCare Medical Announces Offering of Replacement Warrants in Exchange for Early Exercise of Outstanding Warrants
5. ProUroCare Medical Secures $885,000 in Financing
6. ProUroCare to Showcase Investigational Portable Platform for Its Prostate Imaging Device at AUA 2010
7. ProUroCare Medical Announces Filing of Request to Classify the Prostate Mechanical Imager ("PMI") as a Class II Device
8. ProUroCare Medical Elects Two New Directors
9. ProUroCare Medical Completes Multiple Site Clinical Study for Imaging Prostate Abnormalities
10. ProUroCare Medical Completes Clinical Trial at Second Study Site Using Digital Prostate Imaging Technology
11. ProUroCare Medical Inc. Announces Pricing of Equity Offering
Post Your Comments:
(Date:11/30/2015)... Nov. 30, 2015 Oramed Pharmaceuticals Inc. (NASDAQ: ... the development of oral drug delivery systems, announced today ... at up to $50,000,000 with Hefei Tianhui Incubator of Technologies Co., Ltd. ... capsule, ORMD-0801, in China , ... . The agreements were signed at the Israel ...
(Date:11/30/2015)... 30, 2015 Cumberland Pharmaceuticals (CPIX), today announced that ... on December 3, 2015. TIME: 3:15p.m. ET ... ET LINK: --> DATE: ... --> --> ... are invited to ask the company questions in real-time - ...
(Date:11/30/2015)... Nuance Communications, Inc. (NASDAQ: NUAN ) and ... today jointly announced a new integrated set of clinical ... College of Radiology,s (ACR) Imaging 3.0™ tools to enable ... current and emerging value-based payment models . ... clinical decision support, radiology reporting and image sharing technology ...
Breaking Medicine Technology:
(Date:11/30/2015)... ... , ... Scott Newman MD, FACS of New York’s Advanced ... in the New York City area to utilize the new, non-invasive SculpSure™ Laser ... treatment for fat loss in the abdomen, flanks, and other areas that is ...
(Date:11/30/2015)... (PRWEB) , ... November 30, 2015 , ... GKhair & ... of the San Juan Beauty Show held on November 8th and 9th at the ... by media personalities, hair artists, renowned beauticians and top of the line fashion journalists. ...
(Date:11/30/2015)... (PRWEB) , ... November 30, ... ... ), a leading provider of enterprise Time and Attendance/Workforce Management cloud-based ... in the Microsoft Partner Program with competencies in the Application Development, demonstrating ...
(Date:11/30/2015)... , ... November 30, 2015 ... ... Inc. are pleased to announce their strategic partnership at the Radiological Society ... Transcription Service, Inc., and Winscribe, global providers of cutting-edge dictation and speech-enabled ...
(Date:11/30/2015)... ... November 30, 2015 , ... ... dealer. Joining more than 30 HealthPostures’ dealers located throughout the United States, is ... the number of corporate, industrial, manufacturing and government workers and organizational leaders that ...
Breaking Medicine News(10 mins):