Our Technology Bioresorbable Polymers
TYRX utilizes a completely novel and proprietary family of bioresorbable polymers to create drug eluting products. These polymers have fostered the design and commercialization of a wide variety of drug-eluting products, from coated medical devices to sustained release injectable formulations. All of these polymers are created from naturally occurring substances and degrade in the presence of water. TYRX was the first and remains the only company to have achieved FDA clearance for a dual-drug eluting product that contains a novel resorbable material. The TYRX technology provides assets for both the product designer as well as the patient: - Easily manipulated for a wide variety of end-use applications from microspheres and gels to coatings and partially load bearing plastics
- Multiple hydrogen bonding sites that promote long-term drug elution and little or no "burst" effect
- Degrade in a relatively linear fashion and have much less acidity associated with them than traditional "suture" materials such as poly(lactide) and glycolide. As a result, they are much less likely to promote inflammation and scarring.
TYRX was initially founded on the premise that more effective implantable devices could result from the creation of better bioresorbable materials. The company created that vision via a broad license from Rutgers, the State University of New Jersey to technology invented in the laboratory of Joachim Kohn, PhD. The Company currently holds in excess of 16 patents that permit the design, synthesis, and use of thousands of unique resorbable polymers. TYRX's unique family of tyrosine-based resorbable polymers can be tailored or "tuned" to: - Elute single or multiple drugs;
- Elute drugs at a controllable rate and time;
- Resorb at a predetermined rate, and;
- Possess a wide variety of mechanical properties.
TYRX's tyrosine-based resorbable polymers are designed to degrade to natural metabolites or substances with known safety history: - Resorb benignly in vivo;
- Elicit minimal inflammatory response, and;
- Have been employed in FDA cleared implantable medical devices.
Intellectual Property: TYRX holds world-wide licenses to more than 16 issued and pending patents covering this technology. Back to Top
Antibiotics
TYRX’s AIGISRx, a commercially available antibacterial envelope for use with Cardiac Rhythm Management Devices (CRMD), (see AIGISRx ), and PIVITAB™, a new surgical hernia mesh licensed to C.R. Bard, both elute the powerful antibiotic combination of minocycline and rifampin. 
There is a strong clinical rationale behind the combination of minocycline and rifampin selected for the AIGISRx, PIVIT ABT, and future TYRX anti-bacterial products. Minocycline and rifampin have been shown to provide a broad spectrum of activity against a wide range of antibiotic-sensitive and antibiotic-resistant bacteria, including methicillin- and vancomycin resistant strains.
In addition, the results from five randomized clinical trials have demonstrated that minocycline and rifampin coatings reduce medical device implant infections.
In vitro testing6,7 with central venous catheters has demonstrated that the combination of minocycline and rifampin is safe, effective, and:
- Superior to a combination of chlorhexidine and silver sulfadiazine;
- Superior to vancomycin, clindamycin, novobiocin and minocycline alone, and;
- Equivalent to ceftazidime or amphotericin B against gram negative bacilli and Candida albicans.
Additionally, in in vitro studies, AIGISRx has demonstrated antimicrobial activity against Methicillin Resistant Staphylococcus aureus (MRSA), Staphylococcus aureus, Staphylococcus epidermidis, Acinetobacter baumanii, Enterobacter aerogenes, and Proteus mirabilis, which represent a majority of the infections reported in CRMD-related infections, (see AIGISRx Clinical Data ).
Intellectual Property: TYRX holds a broad license to patents covering the clinically proven combination antibiotics for use with implantable medical devices by Baylor College of Medicine and MD Anderson Cancer Center. Back to Top
Polypropylene Mesh
TYRX’s AIGISRx Anti-Bacterial CRMD envelope and PIVIT AB™, a new surgical hernia mesh licensed to C.R. Bard, are both constructed of a light-filament, knitted, polypropylene surgical mesh. Discovered more than 50 years ago,polypropylene is a biocompatible, flexible, thermoplastic polymer resistant to acids, stress and cracking. These qualities make it ideal for withstanding the chemical environment and internal stresses found within the human body, and is classified as GRAS (Generally Recognized As Safe) by the FDA.
Polypropylene has an extensive history as a medical device implant and is most often used as a non-absorbable synthetic suture material, and has been used in thousands of hernia repair mesh procedures.
Polypropylene should not be confused with polyester, (e.g., Dacron), which has been used in the past for CRMD pouches (i.e. Parsonnet™ pouch), sutures and hernia patches.
Clinical studies have shown:
- Polypropylene does not cause the intense chronic inflammation and subsequent fibrotic tissue in growth of polyester.8,9
- Polypropylene, when used in a hernia repair setting, has fewer infections than multi-filament polyester (0% vs. 16%, p<0.05).9
In addition, TYRX’s AIGISRx polypropylene mesh is intentionally woven in a fashion that the pores are larger compared to the weave of historical polyester products.
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| AIGISRx polypropylene envelope | |
| Parsonnet™ polyester pouch | | A retrospective analysis of hernia clinical trials indicates that the use of more open pore weave meshes may result in less scar tissue formation around the implant.10
In a 365 day, in vivo rabbit model3, tissue response to the AIGISRx polypropylene mesh was compared to the commonly used negative control of polyethylene filaments. - Mean Reaction Zone (diameter of the area of tissue reaction, e.g., inflammation, fibrosis, etc.)measures were consistently lower for the polypropylene mesh than the polyethylene control at all time points, and;
- Polypropylene mesh showed an in growth of “normal” tissue (defined as tissue with similar morphology to that surrounding the implant site, i.e., loose connective tissue, occasional cellular elements, capillaries, etc.),while the polyethylene control was surrounded by a band of fibrous,scar-like tissue.11
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- Hanna et al, J Clin Oncol 2004 22(15), 3163.
- Leon, et al, Intensive Care Medicine 2004 30(10), 1891.
- Zabramski et al, J Neurosurg 2003 98(4), 725.
- Chatzinikoloau et al, Amer J Med 2003 115(5), 352.
- Radd et al, Ann Intern Med 1997 128(4), 267.
- Darouiche et al, N Engl J Med 1999 340(1), 1.
- Raad et al, Antimicrobial Agents Chemother 1995 39(11),2397.
- Parsonnet V et al, Pacing and Clinical Electrophysiology 1994 17(12), 2274.
- Marois Y et al, Artificial Organs 2000 24(7), 533.
- Weyhe et al, World J Surg 2007 31(1), 234.
- Data on file at TYRX.
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