SARASOTA, Fla., Oct. 25 /PRNewswire-FirstCall/ -- CPC of America, Inc. reports that it's subsidiary, Med Enclosure, LLC; has, as previously reported, in July 2005 submitted an investigational device exemption (IDE) application to the U.S. Food and Drug Administration for the MedClose(TM) Vascular Closure System (MedClose(TM) VCS), a device- biologic combination product. On August, 8, 2005, and contrary to prior FDA assurance that the MedClose(TM) would be regulated as a medical device, the company was asked to submit a "Request for Designation" (RFD) to the FDA's newly formed Office of Combination Products (OCP). The purpose of the RFD process is to determine which Center within the FDA should have lead responsibility for regulating the product, Center for Devices and Radiological Health (CDRH), or Center for Biologics Evaluation and Research (CBER). At the same time the company was also given a list of minor deficiencies resulting from the FDA's review of the IDE, and told that further review was stopped until the lead Center had been determined. On August 17, 2005 the company submitted an RFD to the OCP.
On October 12, 2005 the FDA informed the company that (1) the MedClose(TM) VCS would be regulated under the medical device regulations (IDE-/-PMA), and (2) the lead Center would be CBER. While the company is pleased that the MedClose(TM) VCS will be held to the same regulations as all prior vascular closure devices, it disagrees with the decision that CBER should be assigned lead responsibility for regulating this medical device. Consequently, the company has requested that OCP reconsider its decision, and re-assign CDRH as the lead Center for regulating the MedClose(TM) VCS, just as CDRH has regulated all prior vascular closure devices.
CPC believes that the FDA matters facing the company are purely administrative and in no way reflect on MedClose(TM) design, safety or effectiveness. The company also believes that these administrative issues will be resolved quickly, and regardless of whether CDRH or CBER is assigned lead responsibility for regulating the MedClose(TM) VCS that the IDE authorizing the start of the MedClose(TM) clinical trial will soon be approved.
The MedClose(TM) Vascular Closure System (MedClose(TM) VCS) is a proprietary catheter based system that uses fibrin sealant to rapidly seal arterial puncture sites following angiography and angioplasty. MedClose(TM) VCS is not presently available for human use. The clinical study of MedClose(TM) VCS will be a randomized study involving diagnostic and interventional patients versus manual compression, and will take place at five U.S. sites. The clinical trial is expected to begin in the latter part of Q4 of 2005 or early Q1 2006. Results obtained from the clinical trial will be used to support a premarket approval (PMA) application for the MedClose(TM) VCS.
MedClose(TM) VCS is the proprietary property of Med Enclosure, LLC, a wholly-owned subsidiary of CPC of America, Inc of Sarasota, Florida. Biomed Research, Inc. is a privately held corporation that provides contract product research, development, manufacturing and regulatory advisory services.
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(TM) VCS 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) VCS; 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-KSB and quarterly reports on Form 10-QSB, 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.