CPC Strengthens Foundation as a Closure Products Company with its Vertically Integrated Product Pipeline

 CPC of America, Inc. (OTC Bulletin Board: CPCF), announced today that its first patent filing of a synthetic sealant for its specific application to the MedClose(TM) Vascular Closure System (VCS) -- previously announced May 21, 2009 -- represents a much broader foundation and basis for its new strategic plan as a Closure Products Company. CPC is presently 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, and announced today it will alsi gueo design and develop new vascular closure applications based upon a broader range of French sizes (i.e., introducer sheath diameters). The MedClose(TM) VCS design has the capabilities to be rapidly adapted to not only focus on its core VCS application for vascular closure following diagnostic or interventional procedures (coronary, carotid, cerebral, peripheral) with 6-9 French (Fr) catheters but also for:

• 4-5Fr for applications such as vascular closure following catheterization procedures in pediatric populations, closure of central line access points for chemo-therapy patients, hemostasis after arteriovenous fistulae access and peripheral arterial and/or venous closure after diagnostic and interventional electrophysiology procedures.
• 10-12Fr for applications such as iliac and abdominal aortic aneurysm (AAA) stent/graft implants.
• 15-20Fr for applications such as existing designs for percutaneous aortic and mitral valve replacement, endovascular stent grafts.

Importantly, the synthetic sealant and its characteristics also have potential future applications such as internal and external bonding and coating of tissue and instruments, (e.g., temporary coatings for burn victims, grafting of artificial skin, adhesion prevention, coatings on polymers, or coatings on implant devices such as stents or grafts), biopsy sealing) with or without drug delivery (e.g., the delivery of glucosamine and chondroitin sulfate into the spine area or other body organs), stem cell or growth factor delivery (e.g., the delivery of stem cells and/or growth factors into the spine area or other body regions), tissue sealants/adhesives to control of bleeding or fluid leakage in body tissue (e.g., lung sealing or hemostasis, tissue, muscle, and bone growth and regeneration) and dermatology (e.g., collagen restoration/replacement, topical application or void-filling by injection to fill wrinkles).

We believe that our sealant offers some important potential advantages over other sealants in several respects. First, as a synthetic sealant, our product is free from the risk of blood-borne and other pathogens. Second, testing to date indicates excellent adhesive strengths when applied to wet areas of tissue which could offer a tremendous competitive advantage due to the fact that vascular closure sites are normally initially wet due to the presence of blood or body fluids. And finally, the synthetic sealant appears to perform independently with respect to the level of anti-coagulation present.

We believe the MedClose(TM) VCS System has the potential to represent multiple product lines in multiple market segments, enhancing the value to such intellectual property. We are no longer one dimensional but believe in the original vision we had with the acquisition in November 1999 of closure technology with broad applications as stated above. We continue to improve the MedClose(TM) VCS by strengthening the platform of regulatory, quality, manufacturing, etc. capabilities for new product development and sustaining engineering.

CPC OF AMERICA INC

Below are edited highlights of CPC's 10-Q/A. 

To date, our activities have included the market analysis and development of our MedClose device and counterpulsation units and the raising of development and working capital. We have developed and prepared for market our counterpulsation units, including a stand-alone unit known as the CPCA 2000. In March 2003, we received FDA clearance to market the CPCA 2000 counterpulsation unit as a Class III medical device. We are also engaged in the business of developing a patented internal puncture closure device and technique known as "MedClose". We have not commenced revenue producing operations...........As previously disclosed in our reports filed with the SEC, in April 2007 we received a warning letter from the FDA which expressed, among other things, that:

· The FDA believed the MedClose device was a significant risk device and not eligible for investigation in the U.S. without an IDE approved by the FDA;

· We had violated IDE regulations governing the proper conduct of clinical studies, including our failure to provide the U.S. reviewing institutional review board's and clinical review site with information they needed to conduct the clinical investigation properly;

· We failed to provide accurate information about the investigations to the FDA and failed to provide to the FDA staff access to the sites pertaining to the MedClose; and

· We provide to the FDA certain information and records concerning our clinical studies.

We disagreed with the claims made by the FDA and filed an appropriate response with the agency. Meanwhile, we suspended human clinical investigations of the MedClose device in the U.S. pending further discussions with the FDA. During the remainder of 2007 and the first part of 2008, we engaged in an ongoing dialogue with the FDA for purposes of addressing its concerns and explaining our positions taken. On May 23, 2008, the FDA advised us by letter that our responses were satisfactory and that no further response to the FDA's warning letter was required. Based on the FDA's letter dated May 23, 2008 and subsequent written correspondence and discussions with the FDA staff, we believe the matter to be closed with no prospect of fine or penalty by the FDA. We also believe that we have addressed substantially all of the FDA's concerns over our human clinical trials and we expect to resume human clinical trials in the United States subject to the FDA's review and approval of our investigative device exemption (IDE) application. We submitted an IDE application to the FDA on November 30, 2007, which, if approved, will facilitate a continuance of the US clinical trials that were suspended by us in November 2006. In December 2007, the FDA responded to our IDE application with a disapproval letter. We have since filed three IDE supplements to address deficiencies cited by the FDA, the third of these was submitted on September 5, 2008. On October 8, 2008, the FDA responded to our third supplemental filing with two cited deficiencies. We are presently preparing a fourth supplemental filing for purposes of addressing the FDA's remaining comments. We estimate that the costs of conducting and completing clinical studies of the MedClose device to be between $178,000 to $430,000. We believe that we have sufficient working capital on hand to complete clinical studies. We intend to analyze our options for moving forward with the commercial exploitation of the MedClose, including licensing or sale of the product and our manufacture, marketing and sale of the product directly. If we pursue the manufacture or marketing of the MedClose product, we will, in all likelihood require significant additional capital. In that event we will endeavor to acquire the necessary working capital from the sale of our securities. However, there can be no assurance we will be able to obtain the required additional working capital on commercially reasonable terms or at all...........However, there are no agreements or understandings with any third parties at this time for our receipt of additional working capital and there can be no guarantee that such funds will be available on commercially reasonable terms, if at all. If we are unable to access additional capital on a timely basis, we will be unable to expand or continue our development of the MedClose device and our operating results will be adversely affected..... Full story HERE

CPC Pursues Development of Proprietary Synthetic Sealants as part of MedClose(TM)

CPC of America, Inc. (OTC Bulletin Board: CPCF.OB), a company focused on the development of therapeutic devices that enhance the quality of patient care in endovascular procedures, announced today that it is actively pursuing the development of proprietary polyethylene glycol (PEG) synthetic sealants as part of its global commercialization strategy for MedClose(TM). MedClose(TM) is an investigational-stage vascular closure system that is intended to seal arterial puncture sites following diagnostic or interventional catheterization procedures.

CPC will develop synthetic PEG sealants as platform technologies for the MedClose(TM) vascular closure system using ultra-pure functionalized, biocompatible and biodegradable polymers. The sealants will have adjustable physical properties, making it possible to 'fine tune' the gel time and strength for varied clinical applications. The proprietary compounds will be sourced from multiple suppliers, providing flexibility and accessibly for global commercialization and cost savings.

"PEG sealants have been found to have notable advantages to other surgical sealants," notes Dr. Olexander Hnojewyj, a medical advisor to CPC who has conducted extensive research and secured multiple patents and patent applications related to vascular closure sealants. Because PEG sealants are purely synthetic, they carry no risk of transmission of viral pathogens or prions. They are also shown to result in less swelling and inflammation than fibrin sealants, are easy to apply, and report consistently good hemostatic results(1).

"With our synthetic sealant strategy and the combined expertise and experience of our medical, technical and research team, we are well positioned to secure global commercialization of the MedClose(TM)," says Rod Shipman, President and CEO of CPC of America. "We anticipate clinical investigation for multiple indications, which may include sealing of femoral arteriotomy closures, biopsies and vertebral bodies following transpedicular interventions. They may also include the sealing of difficult-to-control bleeding sites during surgery - such as cardiac, lung, liver, pancreas, and OB/GYN procedures."

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) vascular closure system, an internal puncture-closing system for use in catheter laboratories.

CPC Adds Key Bench Strengths to Medical and Technical Advisory Team

CPC of America, Inc. (OTCBulletinBoard: CPCF.OB) , a company focused on the development of therapeutic devices that enhance the quality of patient care in endovascular procedures, announced the addition of three medical and technical advisors to its team. Dr. Olexander Hnojewyj, Dr. James L. Rogers and Richard E. Anderson will add strategically important bench strengths to the team's expertise as they work to develop MedClose(TM), an investigational*-stage vascular closure system (VCS) that is intended to seal the femoral arterial puncture site following diagnostic or interventional catheterization procedures. Information on CPC's advisory team can be found at CPC's enhanced corporate Web site, CPCMedDevices.com.

CPC Appoints Medical Product Service GmbH as Authorized European Representative for MedClose

SARASOTA, Fla., Oct. 29 /PRNewswire-FirstCall/ -- CPC of America, Inc.(OTC Bulletin Board: CPCF), a company focused on the development of therapeutic devices for use in endovascular procedures, today announced that it is implementing a European strategy for the development and distribution of its MedClose(TM) investigational-stage medical device. In the roll out of its strategy, CPC announced an agreement with Medical Product Service GmbH (MPS) of Germany to act as authorized European representative for the Company in seeking European regulatory approval for MedClose(TM) Vascular Closure Device(VCD). MedClose(TM) is an extravascular puncture-closure device intended to be used with a biological sealant for diagnostic and interventional cardiovascular procedures. According to published third party research, European VCD market sales for2008 are projected to total approximately $160 million. Industry experts forecast that in Europe, the penetration of VCDs into minimally invasive cardiovascular procedures will experience a 9% compound annual growth rate and drive VCD sales and revenues."The European Union offers significant opportunities to broaden theMedClose(TM) market potential," said Rod Shipman, chairman and chief executive officer of CPC of America. "By aligning ourselves with MPS, we are setting a critical path to market in Europe. Our team will work closely with MPS inbuilding key partnerships and navigating the European regulatory regime and clinical trials. We recognize the need for a safe, reliable closure system that reduces time to hemostasis and allows for faster patient ambulation and,when necessary, wound re-access. With MedClose(TM), we aim to fill that need in the U.S. and Europe."As CPC's authorized representative in Europe, MPS will provide service under the respective CE marking requirements that apply in the European Union.MPS's role will include vigilance reporting, communicating with competent authorities in individual member states, assisting in securing international product registrations, and preparing and completing dossiers for clinical trials and CE markings."MPS knows that physicians operating in catheter laboratories across theEU demand precise instruments that help improve patient safety and outcomes,"said Gehard Fromel, Principal Regulatory Consultant of MPS. "We are eager to collaborate with CPC to bring to market a product that may help the European medical community and their patients."
About Medclose
The MedClose™ VCS is a medical device that is designed to seal femoral arterial puncture sites in patients who have undergone diagnostic or interventional catheterization procedures. It utilizes a proprietary catheter delivery vascular closure system that is designed to enhance manual compression by delivering a biologic sealant which creates an elastic coagulum that is fully resorbed within 10 to 14 days.