SIBN - SI-BONE wins FDA nod to expand availability of iFuse Bedrock spinal implant

• Medical device maker SI-BONE ( NASDAQ: SIBN ) announced Tuesday that the FDA cleared additional indications for its iFuse Bedrock Granite spinal implant allowing its use with a wide range of commercial products.
• iFuse Bedrock Granite is used to immobilize and fuse the sacroiliac (SI) joint and as a supporting structure at the base of a spine fusion construct. The FDA initially cleared it for use with a single manufacturer’s pedicle screw system in May.
• The new clearances allow the company to sell the product for use with a wide range of pedicle screw system rods in the market, SI-BONE ( SIBN ) said.
• “We believe that this expanded clearance will help increase the number of surgeons who treat their patients with this breakthrough device,” Laura Francis, Chief Executive of SI-BONE ( SIBN ) Laura Francis remarked.
• In November, the company set its 2022 revenue guidance below consensus at $104M – $105M.

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