SI-BONE Inc. (SIBN) Announces FDA Clearance for Expanded Indication of the iFuse-TORQ® Implant System

SI-BONE, Inc. (SIBN), (Nasdaq: SIBN), a Silicon Valley-based medical device company dedicated to solving musculoskeletal disorders of the sacropelvic anatomy, today announced an FDA clearance for iFuse-TORQ® for pelvic fracture fixation, including acute, non-acute and non-traumatic fractures.* Fractures covered in this clearance include pelvic fragility fractures (fractures related to low-energy traumatic events) and pelvic insufficiency fractures. Together, these constitute an approximately $300 million market opportunity.

Sacral fragility and insufficiency fractures are common and often devastating for patients and healthcare systems, where:

• 120,000 sacral fragility or insufficiency fractures occur annually in the US1
• 78% of patients are treated with bedrest leading to 14- to 45-day hospital stays2-6
• 27% 1-year mortality results from bedrest-associated complications5,6

“Many elderly patients with sacral fragility fractures require long periods of immobility while their fracture heals, often leading to complications associated with bedrest,” said Michael Gardner, MD, Chief of Orthopedic Trauma at Stanford University Hospital. “A paradigm shift is required. The strength and osseointegrative features of iFuse-TORQ make it the most attractive implant on the market to remobilize these osteoporotic patients.”

“Since its launch in 2021, iFuse-TORQ has been used to treat many patients suffering from a pelvic fracture or sacroiliac joint dysfunction,” said Laura Francis, CEO of SI-BONE. “This pelvic fracture fixation indication expansion comes on the coattails of the iFuse Bedrock Granite launch and expands SI-BONE’s position as the market leader in the sacropelvic space.”

References

1. Burge R, et al. J Bone Miner Res. 2007 Mar; 22(3):465-75.
2. Per Medicare ICD-10 Code Search includes patients >65 y/o by Watson Policy Analysis. June 2020.
3. Alnaib et al J Orthop Traumatol. 2012 Jun; 13(2): 97–103
4. Breuil V, et al. Joint Bone Spine. 2008;75:585–8.
5. Taillandier J, et al. Joint Bone Spine. 2003;70 (4):287–289.
6. Morris R, et al. Postgrad Med J. 2000;76 (900):646.

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