March 6, 2012: TYRX Announces New Medicare ICD-9 Code for the AIGISRx Antibacterial Envelope

TYRX®, Inc. announced that the Centers for Medicare and Medicaid Services (CMS), through the ICD-9-CM Coordination and Maintenance Committee, issued a new ICD-9-CM procedure code for hospital reporting of the use of an antimicrobial envelope with insertion of Cardiovascular Implantable Electronic Devices (CIEDs), including pacemakers and implantable defibrillators. This procedure code, 17.81, will allow providers to track the clinical and economic impact of treating patients with a device intended to securely hold an implantable pacemaker or defibrillator in place while delivering site-specific antibiotic prophylaxis to help reduce infection.

"Patients who acquire cardiac device related infections require significant additional treatment that can be very costly. Specifically, patients must be readmitted to the facility for removal of the infected device, receive systemic antibiotic treatment for 10-12 days, and subsequently be reimplanted with a new device. And, treating these infections can range from $28,000 to $58,000, and may often exceed $100,000. As a result, this expense is not always covered by current facility reimbursement. By creating a code to track usage of the antimicrobial envelope when implanted during a CIED procedure, there is a genuine opportunity to help reduce the rate of these infections, positively impact patient care, and lessen the financial impact to the facility and health care system," stated TYRX CEO Robert White.

Mr. White added, "With the CIED infection rate continuing to increase and being very expensive and time consuming to treat, it is critical to make technology available that can help reduce the rate of these infections and help lessen the negative impact on all stakeholders, especially patients."

The ICD-9-CM Coordination and Maintenance Committee of the U.S. Department of Health and Human Services activated this new code which is described below for FY 2012:

• 17.81 – Insertion of antimicrobial envelope o Use of antimicrobial (mesh) (prophylactic antibiotics embedded) envelope with the insertion of cardiovascular implantable electronic devices (CIEDs) Code first primary procedure: Insertion of cardiovascular implantable electronic device(s) [CIED] (00.51, 00.54, 37.94, 37.96, 37.98).

TYRX, Inc. commercializes innovative, implantable combination drug+device products focused on infection control, including the AIGISRx® Antibacterial Envelope, designed to reduce surgical-site infections associated with Cardiovascular Implantable Electronic Devices (CIEDs). AIGISRx products contain antimicrobial agents, rifampin and minocycline, which have been shown to reduce infection by organisms representing a majority of the infections reported in implantable pacemaker and defibrillator related endocarditis, including "superbugs" or MRSA*. Following commercial release, the AIGISRx Envelope has been used in over 25,000 patients nationwide. The company estimates that over 2% of all U.S. implantable pacemaker and defibrillator patients in 2012 will receive an AIGISRx product during their procedure.

TYRX, Inc. is an ISO 13485:2003 certified medical device manufacturer and its products utilize technology licensed exclusively from Rutgers, Baylor College of Medicine, and The University of Texas M. D. Anderson Cancer Center. For more information, please visit http://www.tyrx.com.

* Based upon preclinical in vitro and in vivo data. Data on file at TYRX and published in PACE 2009; 32(7) 898-907