Simplify Disc receives IDE approval from the FDA for a two-level clinical trial

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Simplify Medical has announced that it has received Investigational Device Exemption (IDE) approval from the Food and Drug Administration (FDA) to initiate a two-level clinical trial comparing its Simplify Disc with anterior cervical discectomy and fusion (ACDF) as a control. This IDE approval grants Simplify the option of expanding its clinical operations.

The goal of the two-level IDE Trial is the clinical success rate of the Simplify Disc compared with ACDF. The trial is a prospective, multi-centre, core lab adjudicated clinical trial evaluating the Simplify Disc at up to 14 clinical sites in the United States and Australia

The company plans to start its previously approved single-level study following the North American Spine Society (NASS) meeting.

Simplify Disc is a cervical disc replacement composed of MRI compatible materials designed to eliminate invasive CT scans, reduce ionising radiation exposure, and provide a metal-free option to patients.  Simplify Disc offers disc heights of 4.1mm for smaller patient anatomy.

David Hovda, CEO of Simplify Medical, says, “We are excited to move forward with the Simplify Disc, which demonstrated promising clinical performance in an OUS clinical trial and commercial settings.”

Simplify has also announced it recently closed an investment by M.H. Carnegie, an Australian private equity/venture capital group. Mark Carnegie, Managing Director, comments, “Motion preservation provides patients with favourable clinical outcomes, and we believe Simplify Disc’s MRI imaging capability can help reduce invasive CT scans and patients’ exposure to ionising radiation.”