BioFlex®

BioFlex® was developed at Europierce Worldwide Ltd in the United Kingdom in the late 1990s. More than a year of injection trials, mould development, and formulation testing went into the material before it was considered ready. It was certified to ISO 10993-6 and FDA Class IV before any regulator required it — not to meet a standard, but because it was the right thing to do.

BioFlex® is a medical-grade random copolymer in the PP-R class. It is not TPU. It is not thermoplastic urethane. It is not acrylic, PMMA, nylon, or PVC. It shares none of their toxicological profiles and none of their regulatory problems. The confusion in the market — and in some regulatory frameworks — stems from cheap uncertified copies being sold under the same name, not from any failing of the genuine material.

Patrick Poli is the creator of BioFlex® and Director of Poli International Co., Ltd (formerly Europierce Worldwide Ltd, UK). The full story — including the counterfeit problem, the APP's silence, and why the "post-operative use only" label is a category error — is set out in the article below.

BioFlex® Is Not What the Internet Thinks

A detailed 3,000-word article by Patrick Poli addressing every misconception — the chemistry, the counterfeits, the regulatory category errors, and 25 years of the APP's silence.