SI-Bone Shares Rise After FDA Clears Spinal Fusion System for Expanded Use

SI-Bone Inc. (NASDAQ:SIBN) shares gained in after-hours trading Monday after the medical device company announced it received U.S. Food and Drug Administration clearance for a new spinal fusion system. The regulatory green light for its iFuse Granite Onyx System expands the company's market reach beyond its traditional pelvic applications.

FDA Clearance Expands Market

SI-Bone announced on Monday it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its iFuse Granite Onyx System. This clearance marks a significant milestone for the San Jose-based company, as it is the first product it has developed for use in compromised bone outside of the pelvis.

The approval allows SI-Bone to enter a broader segment of the spinal surgery market, moving beyond its established focus on the spinopelvic anatomy.

System Targets Common Complication

The Onyx system is engineered to address a frequent complication in spinal surgery: the loosening of screws at the upper and lower instrumented vertebrae of fusion constructs. According to the company, this issue can occur in as many as 27% of spinal fusion procedures, with higher revision rates among patients with low bone density.

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"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, in a statement provided by the company. The device features a specialized surface and thread form intended to promote rapid osseointegration and reduce micromotion.

Market Reaction and Context

Investors reacted positively to the news, with shares of SI-Bone rising 2.8% in after-hours trading on Monday. The clearance adds a new product to the company's portfolio, which has supported physicians in performing over 150,000 procedures since 2009.

Chief Executive Officer Laura Francis highlighted that Onyx is the company's third platform to be designated as a breakthrough device by the FDA, underscoring its focus on innovative procedural solutions.