Spinal Simplicity Announces FDA Clearance of Freedom Decompression System

Spinal Simplicity Announces FDA Clearance of Freedom Decompression System™

The Freedom Decompression System™ (Freedom DS) is a newly FDA-cleared, minimally invasive solution designed to treat lumbar spinal stenosis through targeted decompression.

The system introduces enhanced instrumentation designed to improve procedural control and efficiency, including integrated depth gauges in each of the bone and tissue tools, optimized angle management, and instrumentation designed to remove more tissue with fewer passes.

Freedom DS expands Spinal Simplicity's portfolio, enabling physicians to treat patients with both percutaneous decompression and indirect decompression with stabilization-supporting a more complete, patient-specific approach to care.

"Freedom DS was designed with precision and purpose," said Todd Moseley, CEO of Spinal Simplicity. "Every instrument is thoughtfully engineered to enhance control, helping physicians work more efficiently. Most importantly, this expands our ability to treat the right patient with the right solution, all rooted in our mission to put patients first and help them get their freedom back."

"Advancements in instrumentation matter," said Timothy Deer, MD, Chairman of American Society of Pain and Neuroscience. "The enhanced design of Freedom DS allows for greater procedural efficiency-enabling physicians to accomplish more with less motion. That level of control is critical in minimally invasive spine procedures. More importantly, innovations like this push the entire field forward-and ultimately benefit patients."

The company will initiate a phased limited market release, beginning with a controlled trial phase, with a full commercial launch expected later in 2026.

Media:
Parker Snedden
Vice President of Marketing
[email protected]

Investor Relations
Jonathan Hess
Vice President of Finance & Investor Relations
[email protected]