Proxy Biomedical has launched ProTEX
Proxy Biomedical, a leading global innovator in the design, development, and manufacturing of biomaterial implants, has launched ProTEX Med polypropylene resin, a unique custom synthesized resin, available exclusively for proxy biomedical partners, that helps in downstream textile conversion processes.
ProTEX Med can be provided as a textile component, sub-assembly or finished device. Qualification of the device, for long-term implantation, is undertaken by the device owner themselves, with the assurance that the constituent material is not contra-indicated for long term human implantation.
ProTEX Med is certified to technical specifications and ISO 10993-5 (cytotoxicity), with proven equivalency to currently implanted Polypropylene grades. The material has undergone comprehensive testing and characterization performed in resin, fibre, and mesh forms, to demonstrate physical, chemical, and biocompatibility equivalency. A file registration for ProTEX Med is in place, with a unique FDA Device Master File reference, available to resin users in support of associated product qualification, according to a press release.
Caitriona Conneely, QA & RA manager, Proxy Biomedical said,
“There are serious concerns about companies implanting textiles that are not composed of materials sourced specifically for medical applications; Proxy Biomedical aims to address these concerns with ProTEX Med polypropylene resin.”
“At Proxy Biomedical, we believe strongly in traceability, accountability, quality, consistency and safety of supply chain, from initial precursor substances to final implant production. ProTEX Med reduces the risks associated with a contraindicated resin, overcoming issues related to material regulatory compliance, while ensuring security and continuity of the supply chain”
Proxy Biomedical would also offer a custom synthesization service for partners looking for an exact match to specific polypropylene resin grades used in existing products. This approach addresses material regulatory compliance for existing products, while ensuring long term security of supply.