CPC of America, Inc. has filed 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," the company states.
"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."
