Hyalex Rewarded with FDA Breakthrough Device Designation

Hyalex Orthopaedics, Inc., has recently announced that new concept technology, Hyalex ® Cartilage System, has received the much-awaited Breakthrough Device Designation from the United States Food and Drug Administration (FDA).

The technologically advanced Hyalex Cartilage System is designed to focus on repairing cartilage defects while restoring mobility and functionality. The technology is designed for patients who have suffered knee damage, articular cartilage, and bone-related complications.v has initiated the system’s pre-clinical stage of development, displaying exceptional results so far backed with a world-class team of experts stepping towards their first-in-human clinical trial. Compared to pre-existing conventional cartilage solutions, Hyalex ® Cartilage eliminates the need for multiple surgeries and regeneration.

The new technology system offers a biometric platform designed to conduct a single-step and off-the-shelf method. Additionally, Hyalex ® is a high-strength and low friction low-wear solution to cartilage surgeries. Hyalex Orthopaedics has released sufficient evidence covering the preservation of the cartilage counter-face through the company’s Hyalex ® Cartilage1. It is also protected with more than seventeen patents along with trademarks worldwide.

The FDA-provided Breakthrough device Program is selective and voluntary reserved primarily for certain medical technologies capable of introducing highly effective treatment procedures or diagnosis of some life-threatening conditions also irreversibly enfeebling diseases. The program intends to extend help to patients offering them routine access to such advanced technologies by encouraging the medical device manufacturers through accelerated access to the FDA and gain momentum in the development, assessment, and review processes.