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July 8, 2021

FDA grants breakthrough device status to Hyalex’s cartilage system

A biomimetic materials platform, HYALEX Cartilage can act as a reduced friction and low wear solution for cartilage defects. 

The US Food and Drug Administration (FDA) has granted breakthrough device designation to Hyalex Orthopaedics’ cartilage system for repairing cartilage defects.

The HYALEX Cartilage System can also be used to restore function in patients who lost knee articular cartilage and bone and need a surgical procedure.

At present, the system is in the pre-clinical development stage with encouraging results so far.

Hyalex Orthopaedics CEO Mira Sahney said: “Obtaining this designation will be an invaluable opportunity for our team to work closely with the FDA and expedite bringing the HYALEX Cartilage System to the millions of patients who face limited treatment options for knee pain caused by cartilage lesions.”

As compared to cartilage solutions needing several procedures and regeneration, HYALEX Cartilage is a biomimetic materials platform that potentially offers a one-step, off-the-shelf, increased strength, reduced friction and low wear solution.

Earlier, Hyalex published data that demonstrated the system’s ability to preserve the cartilage counter-face in animal models.

With approximately 17 patents and trademarks globally, HYALEX Cartilage is not yet available for clinical purposes.

University of California San Francisco orthopaedic surgery professor and chair Dr Thomas Vail said: “The HYALEX Cartilage System is exciting because its biomimetic material properties create the potential to replace a damaged joint surface, and thereby interrupt the progression of cartilage degeneration.

“This is a paradigm-changing technology that can be applied across orthopaedics.”

The FDA breakthrough device programme aids in expediting the development, analysis and review processes of select medical technologies to allow timely access to patients.

A privately-held medical device company in the US, Hyalex focuses on creating synthetic cartilage technology and implant solutions for diseased as well as damaged joints.

In March 2019, Hyalex raised a total of $33m in Series A funding to advance its synthetic cartilage technology platform into the clinic.

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