Site Specific Delivery - Global Impact

Mission

TYRX delivers site-specific therapy by commercializing proprietary, implantable medical-pharmaceutical combination devices for the surgical markets.

About TYRX

Since its inception in 1998, TYRX scientists, engineers and marketers have 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. TYRX is an FDA registered, ISO 13485:2003 certified medical device manufacturer of drug-device combination products utilizing novel polymer technology, including a world-wide license from Rutgers, The State University of New Jersey, covering a broad range of resorbable materials and drug delivery technology. Additionally, TYRX has licensed from Baylor College of Medicine and The University of Texas M. D. Anderson Cancer Center combination drug patents and associated technologies to address the problem of postsurgical infection and fibrosis. TYRX is deploying its capabilities across a broad range of combination medical products.

Market:

The worldwide market for combination products (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 leader in that space. TYRX has gained market clearance for a number of products, and is developing additional product franchises through the application of proprietary technologies in general, cardiovascular, cosmetic and orthopedic surgery. TYRX is targeting the reduction of infection and scar development, common morbidities associated with medical device implants. It is estimated that medical implant related infections and fibrosis add an estimated $3.8 billion to annual US healthcare costs.

Intellectual Property:

TYRX possesses 2 in-licenses providing far reaching fields of use covered by more than 55 US and foreign patents. Rutgers, The State University of New Jersey has granted a license covering a broad family of “best-in class” biodegradable polymers. 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. TyRx owns or licenses an additional 70 patent applications worldwide covering proprietary products targeting cardiovascular, cosmetic surgical applications and other pharmaceutical applications.

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.

Product Development:

Cardiac Rhythm Management Devices (CRMDs): Following its FDA clearance, TYRX launched the AIGISRx™ Anti-bacterial Envelope in June 2008—the first FDA-cleared medical device- product designed to:
• reduce infections associated with implantable pacemakers and/or implantable cardioverter defibrillators (ICDs), as demonstrated in in vitro and in vivo studies and
• stabilize cardiac rhythm management devices (CRMDs)

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 February 28, 2010, TRYX has sold over 7,500 AIGISRx®. Additional information regarding the AIGISRx® Anti-bacterial Envelope may be found at www.AIGISRx.com. TYRX is currently developing a third generation, totally resorbable AIGIS.
Cardiac Surgery: Mediastinitis 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.

General Surgery: TYRX has received FDA clearance for PIVIT™ A/B, a new surgical mesh coated with a proprietary bioresorbable polymer containing the antimicrobial agents of minocycline and rifampin. In 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 PIVIT™ A/B technology.

Cosmetic Surgery: TYRX has completed in vitro and in vivo studies demonstrating the ability of the TyRx technology to reduce the severity of capsular contraction as may be seen in some breast implant recipients via a reduction in bacterial colonization and capsule formation. Capsular contraction is evident in 10 – 17% of all breast augmentations and is the main reason for a re-operation / removal.

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.

Interventional Cardiology: TYRX has developed a proprietary drug-eluting stent (DES) polymer coating that is fully biocompatible.

Financing

In February 2008 TYRX raised $20 million in a venture capital financing led by Clarus Ventures and co-led by Pappas Ventures. Use of proceeds includes product development efforts, support of commercialization & distribution, and production scale-up.

Our Quality Policy

TYRX Inc. will provide our customers with reliable and high-quality 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.