Wednesday, April 15, 2009


Below are edited highlights of CPC's 10-Q/A. 
To date, our activities have included the market analysis and development of our MedClose device and counterpulsation units and the raising of development and working capital. We have developed and prepared for market our counterpulsation units, including a stand-alone unit known as the CPCA 2000. In March 2003, we received FDA clearance to market the CPCA 2000 counterpulsation unit as a Class III medical device. We are also engaged in the business of developing a patented internal puncture closure device and technique known as "MedClose". We have not commenced revenue producing operations...........As previously disclosed in our reports filed with the SEC, in April 2007 we received a warning letter from the FDA which expressed, among other things, that:
· The FDA believed the MedClose device was a significant risk device and not eligible for investigation in the U.S. without an IDE approved by the FDA;
· We had violated IDE regulations governing the proper conduct of clinical studies, including our failure to provide the U.S. reviewing institutional review board's and clinical review site with information they needed to conduct the clinical investigation properly;
· We failed to provide accurate information about the investigations to the FDA and failed to provide to the FDA staff access to the sites pertaining to the MedClose; and
· We provide to the FDA certain information and records concerning our clinical studies.
We disagreed with the claims made by the FDA and filed an appropriate response with the agency. Meanwhile, we suspended human clinical investigations of the MedClose device in the U.S. pending further discussions with the FDA. During the remainder of 2007 and the first part of 2008, we engaged in an ongoing dialogue with the FDA for purposes of addressing its concerns and explaining our positions taken. On May 23, 2008, the FDA advised us by letter that our responses were satisfactory and that no further response to the FDA's warning letter was required. Based on the FDA's letter dated May 23, 2008 and subsequent written correspondence and discussions with the FDA staff, we believe the matter to be closed with no prospect of fine or penalty by the FDA. We also believe that we have addressed substantially all of the FDA's concerns over our human clinical trials and we expect to resume human clinical trials in the United States subject to the FDA's review and approval of our investigative device exemption (IDE) application. We submitted an IDE application to the FDA on November 30, 2007, which, if approved, will facilitate a continuance of the US clinical trials that were suspended by us in November 2006. In December 2007, the FDA responded to our IDE application with a disapproval letter. We have since filed three IDE supplements to address deficiencies cited by the FDA, the third of these was submitted on September 5, 2008. On October 8, 2008, the FDA responded to our third supplemental filing with two cited deficiencies. We are presently preparing a fourth supplemental filing for purposes of addressing the FDA's remaining comments. We estimate that the costs of conducting and completing clinical studies of the MedClose device to be between $178,000 to $430,000. We believe that we have sufficient working capital on hand to complete clinical studies. We intend to analyze our options for moving forward with the commercial exploitation of the MedClose, including licensing or sale of the product and our manufacture, marketing and sale of the product directly. If we pursue the manufacture or marketing of the MedClose product, we will, in all likelihood require significant additional capital. In that event we will endeavor to acquire the necessary working capital from the sale of our securities. However, there can be no assurance we will be able to obtain the required additional working capital on commercially reasonable terms or at all...........However, there are no agreements or understandings with any third parties at this time for our receipt of additional working capital and there can be no guarantee that such funds will be available on commercially reasonable terms, if at all. If we are unable to access additional capital on a timely basis, we will be unable to expand or continue our development of the MedClose device and our operating results will be adversely affected..... Full story HERE

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