FDA approves first medical device using Rutgers biomaterialRutgers scientists and TyRx Pharma, Inc., have announced the Food and Drug Administration's clearance of a new medical device for hernia repair that incorporates a biodegradable technology developed at the university. This action signals a paradigm shift in the application of biomaterials from permanent prosthetic replacements toward regenerative medicine, in which materials help the body to repair itself and are then resorbed.
The device consists of a surgical mesh coated with a polymer developed using a Rutgers bioresorbable technology. The polymer gives the surgical mesh improved handling characteristics that facilitate precise placement during the surgical repair and leave less implant material following the resorption of the coating.
Hernias occur when musculature fails and one part of the body protrudes through the resulting gap or opening into another part of the body. And although a hernia can theoretically develop almost anywhere, most are in the groin and abdominal areas.
The partially degradable device has been developed and will be marketed by TyRx Pharma, Inc., a medical device company founded in 1998.
"The company's early research was conducted at the Rutgers-based New Jersey Center for Biomaterials (CBM) in Rutgers' chemistry laboratories," said Joachim Kohn, CBM director and Board of Governors Professor of Chemistry and Chemical Biology at Rutgers, The State University of New Jersey. "This is an example of a close and strong academic-industry interaction that led to a relatively fast entrance of the product into the medical market."
Kohn pointed out that the technology was invented in 1997 and has progressed along a fast and efficient track to FDA approval – a process that usually takes 10 years or more.
The invention was made with initial research support from the National Institutes of Health and demonstrates how a federal agency's funding can reap benefits for the American public. On a local level, the company and the invention from which it grew have already led to economic benefits for New Jersey through the creation of some 30 new jobs.
"There are only a handful of synthetic, degradable polymers that have an FDA approval history – therefore, the approval of the TyRx device employing a new biomaterial represents a major breakthrough for regenerative medicine," Kohn said.
The novel tyrosine-based polyarylates, as they are known chemically, arose from an adaptation of combinatorial chemistry to biomaterials. "Our approach uses two sets of starting materials that are combined with each other in all possible combinations," Kohn said. "In this way, we can create a large variety of related polymers from a small number of initial starting materials."
The result in this case was a library of 112 structurally related materials created in parallel, each one potentially useful in a wide range of medical implant applications. TyRx has licensed this entire library of polyarylates from Rutgers and has now, as a first application, identified one of these polymers for the hernia repair device.
The New Jersey Center for Biomaterials, based at Rutgers, is a cooperative research initiative sponsored by Rutgers, the University of Medicine and Dentistry of New Jersey and New Jersey Institute of Technology.
Established in 1766, Rutgers is America's eighth oldest institution of higher learning and one of the nation's premier public research universities.
TyRx Pharma, Inc. designs, develops and commercializes innovative combination medical devices and drug delivery products using patent protected tyrosine-derived polyarylates.
Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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