EDEN PRAIRIE, Minn.--(BUSINESS WIRE)--ProUroCare Medical Inc. (OTCBB: PUMD - News) (OTCBB: PUMDU) (OTCBB: PUMDW - News) announced today that on March 29, 2010 a letter was received from the FDA regarding the pending 510(k) premarket application for the Company’s ProUroScan prostate imaging system. The letter indicated that the FDA could not complete its review because they believed an appropriate predicate device had not been identified. The FDA specifically noted the lack of a comparable predicate device for use as an aid in visualizing and documenting abnormalities of the prostate detected by digital rectal examination. The Company intends to discuss this letter and its findings with the FDA as soon possible and also plans to explain why it believes there is a suitable predicate.
If the ProUroScan system is not found to be substantially equivalent because a suitable predicate cannot be identified, the FDA may indicate that the product may be appropriate for a “de novo” or “risk-based” classification. This path is intended to allow low-risk devices to be marketed under a 510(k) when there is no adequate predicate. Information supporting the de novo application would then be combined with the previously submitted 510(k) application and re-submitted to the FDA for review.
ProUroCare CEO, Rick Carlson stated, “We remain optimistic about the regulatory status of the system, and believe the FDA will recognize the ProUroScan as a low-risk device that can be cleared under either the 510(k) application or the de novo process. We will provide additional information after we receive further clarification of the regulatory path with the FDA.”
About ProUroCare Medical Inc.
ProUroCare Medical Inc. is a publicly traded company engaged in the business of creating innovative medical imaging products and technologies. The company’s current focus is the ProUroScan prostate imaging system, which is used to map abnormalities of the prostate detected by DRE. Based in Minneapolis, Minnesota, ProUroCare is traded on the OTCBB.
Safe Harbor Statement
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 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.
Contact:
ProUroCare Medical Inc. Rick Carlson, 952-476-9093 Chief Executive Officer rcarlson@prourocare.com or Halliburton Investor Relations Jeff Elliott, 972-458-8000 jelliott@halliburtonir.com
