Site Specific Delivery - Global Impact Our MissionTYRX delivers site-specific therapy by commercializing proprietary, implantable medical-pharmaceutical combination devices for the surgical markets. Our Focus Since its inception in 1998, TYRX scientists, engineers and marketers are focused on a singular goal — creating unique, cost-effective solutions that address surgical-site infections (SSIs) and inflammatory tissue-reaction associated with implanted medical devices. It is estimated that surgery related infections and fibrosis add an estimated $3.7 billion to annual US health care costs. Our Technology TYRX has world-wide license to proprietary, bioresorbable polymers that can be tailored to the appropriate mechanical strength, rate of therapeutic agent release and rate of biological resorption. In the situation where localized, rather than systemic, antibiotic delivery is desired, TYRX has exclusive license in specific fields for the use of the clinically proven combination of minocycline and rifampin antibiotics. Please visit Our Technology web page for additional information regarding TYRX’s proprietary technology. Our Results In June 2008, TYRX launched the AIGISRx Anti-Bacterial Envelope—the first FDA-cleared combination drug+device product designed to stabilize cardiac rhythm management devices (CRMDs), and; reduce infections associated with implantable pacemakers and/or implantable cardioverter defibrillators (ICDs), as demonstrated in in vitro and in vivo studies. CRM products are currently implanted at the rate of 500,000 units per year in the US and post-surgical infections are estimated to have a $700M annual economic impact. As of July 2009, TRYX has sold over 3,800 AIGISRx. Additional information regarding the AIGISRx Anti-Bacterial Envelope may be found at AIGISRx . TYRX is currently developing a third generation, totally resorbable AIGISRx.
Cardiac SurgeryMediastinitis is a dangerous and expensive to treat infection of the sternum, which may occur after a Coronary Artery Bypass Graft (CABG) or other open chest procedure. TYRX has developed an antibiotic eluting bone paste that has the potential to reduce or eliminate this high morbidity/high mortality post-surgical complication. TYRX expects to begin in vivo studies during 2009.
Interventional Cardiology TYRX has developed a proprietary drug-eluting stent (DES) polymer coating that does not cause inflammation, and is fully biocompatible, during resorption. TYRX is presently exploring collaboration with the major players in the field of drug eluting stents.
General SurgeryIn July 2006, TYRX received FDA clearance for PIVIT AB, a new surgical hernia mesh coated with a proprietary bioresorbable polymer containing the antimicrobial agents of minocycline and rifampin. In January 2007, TYRX entered a licensing/co-development agreement and strategic alliance with C.R. Bard for the development and marketing of unique hernia repair products incorporating TYRX’s PIVIT AB technology for the prevention of scarring and infection.
Cosmetic Surgery TYRX has completed extensive and studies confirming its ability to reduce the severity of capsular contraction in breast implant recipients via a reduction in bacterial colonization and capsule formation. Capsular contraction is evident in 10 – 15% of all breast augmentations and is the main reason for a re-operation / removal. TYRX anticipates beginning its human clinical studies during 2010. Orthopedic Implants TYRX’s proprietary bioresorbable polymer containing the antimicrobial agents of minocycline and rifampin may be used to coat orthopedic implants with the intent of reducing the potential for infection. TYRX expects to enter clinical studies with an orthopedic partner during 2010. Back to Top Intellectual PropertyTYRX possesses 2 in-licenses providing far reaching fields of use covered by 20 issued patents. Rutgers, The State University of New Jersey has granted a license covering a broad family of “best-in class” biodegradable polymers (16 patents). Baylor College of Medicine and MD Anderson Cancer Center has granted a broad license covering clinically proven combination antibiotics for use with implant medical devices (4 patents). And, TYRX has filed 7 patent applications covering proprietary products targeting cardiovascular and cosmetic surgical applications. Back to Top
Quality PolicyTYRX Inc. will provide our customers with high-quality and reliability in our science and products that consistently meet or exceed their expectations through a commitment to continuous improvement of the Quality System. As a company engaged in producing medical devices, we are committed to the principles of ISO 13485:2003, FDA’s Quality System Regulations and all applicable statutory and regulatory requirements. TYRX Executive Summary
TYRX Executive Summary
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