TyRx Pharma, Inc., today announced that it has entered into a material supply agreement with JFC Technologies for TyRx proprietary polymer production requirements. Under the agreement, JFC's contract manufacturing services will provide TyRx's clinical and commercial supplies of polymer. The parties have begun manufacturing development activities in accordance with the agreement.
"JFC's capabilities, expertise and capacity in manufacturing degradable polymers makes them an ideal partner for us, and the establishment of this agreement, following on the heels of our announced collaboration with C.R. Bard, is a key milestone in our development programs," said Bill Edelman, CEO of TyRx.
"We look forward to supporting TyRx's polymer manufacturing," said Jamie Schleck, President of, JFC. "Our collaboration with TyRx exemplifies how JFC partners with its clients from development through commercialization to deliver quality leading-edge polymer products to market."
On January 28th, TyRx announced a strategic alliance with C. R. Bard for the licensing of certain TyRx technologies and proprietary know-how and co-development with a Bard subsidiary utilizing TyRx technology and manufacturing know-how with certain products of a Bard subsidiary.
On December 6th, TyRx was awarded ISO 9001:2000 and ISO 13485:2003 certification in addition to being certified as compliant with the Canadian Medical Devices Directives (CMDCAS), signifying compliance with internationally recognized standards in design, development and manufacturing of medical products.
This notice follows the October 16th announcement that TyRx Pharma, Inc., filed a Premarket Application for PIVIT(TM) CRM, an innovative mesh pouch coated with TyRx's proprietary bioresorbable polymer. These polymers contain the antimicrobial agents rifampin and minocycline, and are designed to enclose a pacemaker or ICD pulse generator when implanted in the body.
PIVIT(TM) CRM acts to provide protection from microbial colonization of the pulse generator during surgical implantation. According to a recent study presented during the Heart Rhythm Society 2006 Scientific Sessions (Boston) the University of Pittsburgh Medical Center noted that the 2003 national incident of infection for pacemakers was estimated to be 5.82% and for ICDs 3.71%.