SOURCE: Proxy Biomedical

Proxy Biomedical

April 14, 2015 10:30 ET

Proxy Biomedical Introduces Custom Synthesized ProTEX Med™ Medical Grade Polypropylene (PP) Resin

Proprietary, FDA Device Master File Referenced Resin Ensures Continuity of Material Supply for Medical Implants

GALWAY, IRELAND--(Marketwired - Apr 14, 2015) - Proxy Biomedical, a leading global innovator in the design, development and manufacturing of biomaterials, today announced the release of ProTEX Med™ Polypropylene Resin, a unique custom synthesized resin, available exclusively for Proxy Biomedical partners, leveraging 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, fiber 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.

"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," said Caitriona Conneely, QA & RA manager, Proxy Biomedical. "At Proxy Biomedical, we believe strongly in traceability, accountability, quality, consistency and safety of supply chain, from initial precursor substances to final materials 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 has extensive expertise in homopolymers and compounds of both resorbable and non-resorbable materials, along with their respective characteristics, including mechanical performance, degradation profile and biocompatibility. Proxy Biomedical can also offer a custom synthesization service for partners looking for an exact match to specific polypropylene resin grades used in existing products. The service includes comprehensive testing and characterization, to demonstrate physical, chemical and biocompatibility equivalency, in resin, fiber and processed textile forms. This approach addresses material regulatory compliance for existing products, while ensuring long term security of supply.

Proxy Biomedical representatives will be available for briefings at the 1st World Conference on Abdominal Wall Hernia Surgery taking place April 25-29, 2015 in Milan, Italy. Contact stephen.duffy@proxybiomedical.com to schedule a briefing.

About Proxy Biomedical Limited

Proxy Biomedical Ltd is an Irish based company that specializes in biomaterial solutions for medical implantable products, with a proven track record in innovative design and quality-assured manufacturing. The company offers a full-service solution, from the design and development of key components, to finished devices for world leading tier-one medical device companies who seek a trusted partner to help realize their product development needs. Proxy Biomedical Ltd. is quality assured to ISO 13485:2012 and FDA standards, including certification for the provision of Design Services. For more information, visit http://proxybiomedical.com/.

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