Healthcare Industry News: vascular closure
News Release - May 8, 2006
Med Enclosure, LLC - Management Discussion and Analysis of Food and Drug Administration Compliance
SARASOTA, Fla., May 8 (HSMN NewsFeed) -- CPC of America, Inc. (OTC Bulletin Board: CPCFE ) reports that its subsidiary, Med Enclosure, LLC, is developing the MedClose® Class III Medical Device, a proprietary catheter-based delivery system that uses an existing Food and Drug Administration ("FDA") licensed fibrin sealant to rapidly seal arterial puncture sites following angiography and angioplasty. This vascular closure System ("VCS"), known as MedClose-Arterial®, is not presently available for human use. Extensive animal studies were successfully completed in 2002, 2003 and 2004 and provided to the FDA Center for Devices and Radiological Health ("CDRH"). We have successfully manufactured 800 MedClose® devices, including the completion of procedures and processes relating to the sterilization, packaging, manufacturing, engineering, and testing of the MedClose® device. In July 2005, after prior consultation with the primary CDRH reviewer, the required IDE application to clinically investigate the MedClose® device in the U.S. was submitted to the CDRH. A CDRH response identifying some deficiencies was conveyed to the Company in August 2005 and the Company responded in November of 2005. The Company also was advised by the CDRH to submit a request to the FDA Office of Combination Products ("OCP") for an administrative determination as to applicable provisions of law, because the MedClose® device contained the licensed fibrin sealant. The OCP determined that the MedClose® device would be subject to requirements of law applicable to devices but that the Center for Biologics Evaluation and Research ("CBER"), rather than the CDRH, would be the lead agency. The CBER conveyed a conditional IDE approval in March 2006. The Company is appealing the OCP decision and seeking remedies to have IDE responsibility transferred back to the CDRH with whom it has communicated about this device since 2001 as stated above. The Company and its professionals and advisers believe that it has lawful IDE approval from the CDRH, as did previous IDE sponsors. However, it continues to communicate and cooperate with the CBER about its conditional IDE approval while it considers further appeals about the OCP decision. The Company is proceeding with its selection, finalization, procedures, etc. for its clinical sites whether in the U.S. or in Canada or both to fulfill its requirements of either the CBER or CDRH as the Lead Center. The clinical investigation of the MedClose® device, known as the F-A-S-T trial, will be a randomized study involving diagnostic and interventional patients versus manual compression, and is expected to take place at five U.S. and Canadian sites. The results of the clinical investigation will also enable the Company to obtain the CE Mark with the same study data derived from the clinical investigation. The F-A-S-T trial is expected to begin in the second quarter of 2006 or thereabout. Results obtained from the F-A-S-T trial will be used to support a premarket approval application for the MedClose® device projected to be within nine to 12 months after first clinical trial patient. The Company has contracted since November 2001 with Biomed Research, Inc. under a turnkey contract to take the Company's three intellectual property patents and a fourth pending from engineering to a pre market approval process. This agreement enables the Company to effectively manage the process based on projected timelines and budgeted costs thereof to meet its financial goals and objectives and to manage the process thereof. The Company as reported has sufficient funds to complete this agreement and shall upon completion then contract for the manufacture and commercial distribution of such technology to a contracted third party when appropriate to do so. However, if unknown problems or unforeseen circumstances arise that require cash infusion the Company has demonstrated it has the ability to raise such capital either by a Series E Private Placement Memorandum or other forms of applicable capital to fully satisfy any and all working capital requirements in 2007 or 2008 if and when required. MedClose® is the proprietary property of Med Enclosure, LLC, a subsidiary of CPC of America, Inc (OTC Bulletin Board: CPCF ) of Sarasota, Florida.This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to certain risks and uncertainties, and actual circumstances, events or results may differ materially from those projected in such forward-looking statements. Factors that could cause or contribute to differences include, but are not limited to, the risk that the FDA may not approve the IDE application for MedClose® or, if approved, that any such investigation may be unfavorable; that that CPC may be unable to obtain FDA approval for commercial sale of MedClose®; and the risk that CPC may be unable to obtain capital as and when needed. For a discussion of these and other factors, which may cause actual events or results to differ from those projected, please refer to CPC's most recent annual report on Form 10-K/A and quarterly reports on Form 10-Q, as well as other subsequent filings with the Securities and Exchange Commission. CPC of America, Inc. cautions readers not to place undue reliance on any forward-looking statements. CPC does not undertake, and specifically disclaims any obligation, to update or revise such statements to reflect new circumstances or unanticipated events as they occur.
Source: Med Enclosure
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