SARASOTA, Fla., Oct. 18 /PRNewswire/ -- CPC of America, Inc. reports that its subsidiary, Med Enclosure, LLC, has withdrawn the Investigational Device Exemption ("IDE") application submitted July 12, 2005 to the U. S. Food and Drug Administration ("FDA"), Center for Devices and Radiological Health under provisions of the Federal Food, Drug, and Cosmetic Act ("Act"), 21 U.S.C. 360j(g), and 21 C.F.R. Part 812. This submission which had not been reviewed by an Institutional Review Board ("IRB") as required was deemed approved upon expiration of thirty days after FDA receipt unless disapproved in writing by the FDA in accordance with provisions of the Act and regulation, 21 U.S.C. 360j(g)(4). There was no disapproval by the FDA.
Separate and subsequent reviews by independent IRBs of the investigational plan determined that the MedClose(TM) VCS is a nonsignificant/low risk device. The IDE regulations, 21 C.F.R. 812.2(b) do not require FDA approval for investigation of such devices as authorized by IRBs.
At present, the clinical investigation of the non significant/low risk MedClose(TM) VCS device has been approved by two (2) separate Institutional Review Boards ("IRBs") in Canada and the US for the "Randomized, Prospective, Multi-Center Trial of the MedClose(TM) VCS." The Company also has received "Authorization" from the Health Canada, Health Products and Food Branch, Therapeutic Products Directorate approval for patient clinical investigation of the MedClose(TM) VCS device for sealing femoral arterial puncture sites and reducing time to hemostasis and ambulation in patients who have undergone interventional and diagnostic catheterization procedures. The Company upon completion of its "Randomized, Prospective, Multi-Center Trial of the MedClose VCS" expects to submit applications for CE Mark, and FDA Premarket Approval ("PMA") by Q2/2007.
The MedClose(TM) VCS is a proprietary catheter based system that uses existing FDA/CE Mark approved fibrin sealant with appropriate approved existing labeling to rapidly seal arterial puncture sites following diagnostic angiography, interventional cardiology and radiological procedures. MedClose(TM) VCS as stated above is available for human use only in clinical trials and is not presently available for commercial distribution.
MedClose(TM) VCS is the proprietary property of Med Enclosure, LLC, a subsidiary of CPC of America, Inc 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 PMA application for MedClose(TM) 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(TM); 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 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.
CPC of America, Inc.