CPC of America, Inc. Files Patent for Synthetic Sealant for the MedClose(TM) Vascular Closure System (VCS)
LAS VEGAS, May 21 /PRNewswire-FirstCall/ -- CPC of America, Inc. , announced today the filing of its first patent of a synthetic sealant for specific application to the MedClose(TM) VCS. CPC is focused on the development and testing of the MedClose(TM) VCS, which is an internal puncture-closing system for use in percutaneous intravascular diagnostic and interventional procedures. In addition, CPC is focused on the development of its own synthetic sealant product line for various clinical applications not limited to vascular closures devices.
In December 2008, we announced the addition of Olex Hnojewyj, PhD to our team of medical and research advisors and in March 2009, we announced a product development agreement with Dr. Hnojewyj. Today we announce the filing of the first of several intellectual properties for formulations of our synthetic sealant to be used in the MedClose(TM) VCS vascular closure product line, initially with 6-9Fr applications.
The MedClose(TM) VCS device consists of two parts; (1) A delivery system that delivers the sealant to the puncture site, and, (2) the synthetic sealant itself. While we will continue to refine the MedClose(TM) VCS device commercially, we have already reached the point where we are comfortable with its effectiveness as well as its proprietary and competitive advantages. In addition, we are confident about the new direction that the use of synthetic sealants offers with respect to the regulatory approval pathways.
We recently committed to the development of our own proprietary synthetic sealant and we are pleased to announce that we have developed a synthetic compound that is undergoing tests in animals at this time. While the animal testing to date is not conclusive, we are very pleased with the preliminary results. Based on our experience to date, we believe that the development of our proprietary sealant will resolve our outstanding issues with the FDA concerning our application for an investigational device exemption.
We believe that our sealant offers some important advantages over the plasma-based sealant we had intended to utilize in several respects. As a synthetic sealant, our product is free from the risk of blood-borne and other pathogens. Also, testing to date indicates that our sealant is highly adhesive and may ultimately prove to be more adhesive than any other plasma-based sealant presently available. In addition, these tests show that our sealant has excellent adhesive strengths when applied to wet areas and may have greater adhesive strength on wet areas than any other sealant on the market, which could be a tremendous competitive advantage due to the fact that vascular closure sites are normally initially wet due to arterial bleeding from the arteriotomy. Finally, the synthetic sealant appears to perform independently with respect to the level of anti-coagulation present.
About CPC
CPC of America develops therapeutic devices for use in endovascular procedures. CPC's current focus is the completion of development and testing of the MedClose(TM) 6-9Fr vascular closure system, an internal puncture-closing system for use in catheter laboratories and interventional radiological procedures. CPC is also focusing on its own synthetic sealant product line for various applications and not just limited to vascular closure applications of various sizes.
Forward Looking Statements
The statements contained in this press release that are not historical are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), including statements, without limitation, regarding the Company's expectations, beliefs, intentions or strategies regarding the future. Such forward-looking statements relate to, among other things: (1) the Company's continuing development of its MedClose(TM) vascular closure system, (2) the Company's expectations concerning regulatory approvals of the MedClose(TM) system and the commencement of revenue producing operations based on the sale or licensing of the MedClose(TM), (3) the business relationship between the Company and new parties and the expected benefits to the Company from such relationship, and (4) the commencement of manufacturing of the MedClose(TM) system. These statements are qualified by important factors that could cause the Company's actual results to differ materially from those reflected by the forward-looking statements. Such factors include but are not limited to: (1) the Company's ability to finance the continued development and commencement of manufacturing of the MedClose(TM) system, (2) regulatory approvals of the MedClose(TM) system, (3) the general risks and uncertainties inherent in any new business relationship such as the one recently entered into between the Company and its new consultants, and (4) those other risks and factors described from time to time in the Company's reports filed with the Securities and Exchange Commission, including but not limited to the Company's Annual Report on Form 10-K for the year ended December 31, 2008 and subsequently filed Forms 10-Q and Forms 8-K. The Company cautions readers not to place undue reliance on any forward-looking statements. The Company does not undertake, and specifically disclaims any obligation, to update or revise such statements to reflect new circumstances or unanticipated events as they occur
CONTACT: DeDe Sheel, FD Relations and Corporate Communications for CPC of
America, +1-415-293-4412