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Dr. David Delurgio, Director of Electrophysiology Services, Crawford Long of Emory University Hospital, Atlanta, GA, implanted the 1,000th AIGISRx in a 61 year old female who received a replacement bi-ventricular pacemaker. Dr. Delurgio placed the pacemaker into the AIGISRx Anti-bacterial Mesh and positioned the device normally within the surgically created pocket. Once implanted, AIGISRx provides an adjunct to general antibiotic therapy by providing localized antibiotic therapy from the antibiotics minocycline and rifampin.
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"AIGISRx represents a significant advance in possibly protecting our patients from current and emerging infections, representing the majority of organisms implicated in 'pocket infections' following the implantation of pacemakers or cardioverter defibrillators," stated Dr. Delurgio. "The demonstrated benefits of AIGISRx may prove to be cost-effective by potentially preventing serious and life-threatening infections, including those caused by superbugs such as MRSA. AIGISRx Anti-bacterial Mesh protects against this risk by providing localized antibiotics as an adjunct to normal antibiotic therapy," added Dr. Delurgio.
"Achieving this significant milestone is a testament to the demand for a product that has the potential to reduce infections and potential adverse events," said Bill Edelman, CEO of TYRX, Inc. "Because AIGISRx delivers anti-microbial agents directly to the surgically created pocket, we believe that AIGISRx will have a significant impact in reducing the incidence and cost of infections associated with CRMDs, potentially saving taxpayers millions in Medicare/Medicaid costs while reducing morbidity and mortality. We are pleased with the rapid and early adoption by more than 50 hospitals and the 1,100 patients who have received AIGISRx. The anti-bacterial envelope is now being implanted by many of the top teaching hospitals and we expect this trend to continue as hospitals seek to reduce hospital infections in the wake of changing CMS reimbursement rules and growing public pressure to reduce healthcare costs and improve patient care."
The Center for Disease Control and Prevention (CDC) estimates that approximately two million patients contract nosocomial infections annually with 50% being associated with indwelling devices. In testimony before Congress, The Leap Frog Group pointed to the fact that "hospital acquired infections (HAI) add over $15,000 to a patient's hospital bill, amounting to over $30 billion a year wasted on avoidable costs."
In the October, 2008 Federal Registry, CMS stated, "we agree...that surgical site infection following certain cardiac device procedures is a strong HAC (hospital-acquired condition) candidate. The condition is high cost and high volume, triggers a higher-paying MS-DRG, and may be considered reasonably preventable through the application of evidence-based guidelines...we expect to propose surgical site infection following certain cardiac device procedures...as future candidate HACs."
About AIGISRx(TM) CRMD
AIGISRx(TM) CRMD, FDA 510(k) cleared, is a dual-component - resorbable and non-resorbable - anti-bacterial envelope designed to help reduce surgical site infections (SSI) and create a stable environment for implanted CRMD devices. The AIGISRx CRMD technology is constructed of knitted filaments of polypropylene coated with a proprietary bioresorbable polymer that elutes the antimicrobial agents rifampin and minocycline for a minimum of seven days. In in vitro studies, AIGISRx CRMD has demonstrated antimicrobial activity against Methicillin Resistant Staphylococcus aureus (MRSA), Staphylococcus aureus, Staphyloccus capitis, Staphylococcus epidermidis, Acinetobacter baumanii, Enterobacter aerogenes and Proteus mirabilis, which represent a majority of the infections reported in CRMD related endocarditis, including "superbugs" or MRSA.
About TYRX Inc.
TYRX, Inc., an ISO 9001:2000 and ISO 13485:2003 certified medical device manufacturer, commercializes implantable combination drug, including the AIGISRxTM Anti-bacterial Envelope. AIGISRx CRMD contains the antimicrobial agents, rifampin and minocycline, which have been shown to reduce infection by organisms representing a majority of the infections reported in CRMD related endocarditis, including "superbugs" or MRSA. In addition, AIGISRx is intended to securely hold a pacemaker or implantable cardioverter defibrillator (ICD) in order to create a stable environment when implanted in the body. AIGISRx has been implanted in over 1,100 patients nationwide. In February, 2008 TYRX raised $25 million in a venture capital financing led by Clarus Ventures and co-led by Pappas Ventures. TYRX products utilize novel biomaterials, including technology licensed exclusively from Rutgers, The State University of New Jersey. Additionally, TYRX has exclusively licensed from Baylor College of Medicine and The University of Texas M. D. Anderson Cancer Center product patents and associated technologies to address the problem of postsurgical nosocomial infection. TYRX is deploying its capabilities across a broad range of combination implantable medical-pharmaceutical devices. The combination products sector (products incorporating both a drug & a device component) is expected to be the highest growth segment of the medical products industry and TYRX is positioned to be an innovative applications leader in the space.
For more information, please visit www.tyrx.com
CONTACTS Bill Edelman President and CEO TYRX, Inc. 732.246.8676 [email protected] Media Contact: Jennifer Saunders The Ruth Group 646.536.7011 [email protected]
SOURCE TYRX, Inc.
