SI-Bone stock gains after FDA clears spinal fusion system

Investing.com -- Si-Bone Inc (NASDAQ: SIBN) shares rose 2.8% in after-hours trading Monday following the company's announcement that it received U.S. Food and Drug Administration 510(k) clearance for its iFuse Granite Onyx System.

The clearance marks SI-Bone's first product addressing compromised bone intended for use outside the pelvis, expanding the company's market opportunity beyond its existing pelvic applications.

The technology features a bone-density-specific surface and anatomy-specific thread form designed to allow for rapid osseointegration and reduce micromotion, with the goal of achieving early fixation and reducing screw loosening.

"Loss of fixation due to screw loosening in spinal fusions at the UIV and LIV is an unmet clinical need that has driven the search for a better solution," said Han Jo Kim, Professor and David B. Levine Endowed Chair in Spine Surgery at the Hospital for Special Surgery.

SI-Bone Chief Executive Officer Laura Francis said Onyx is the company's third platform designated as a breakthrough device. The company noted that since 2009, it has supported physicians in performing over 150,000 procedures.

The San Jose, California-based company develops procedural solutions to address clinical challenges associated with compromised bone, with a focus on the spinopelvic anatomy.

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