SI-BONE, Inc. Announces FDA Clearance for Expanded Indication of iFuse-TORQ® Implant System

SANTA CLARA, Calif., June 13, 2022 (GLOBE NEWSWIRE) — SI-BONE, Inc. (SIBN), (Nasdaq: SIBN), a Silicon Valley-based medical device company dedicated to solving musculoskeletal disorders of the Sacropelvic Anatomy, today announced FDA clearance for iFuse-TORQ® for pelvic fracture fixation, including acute, non-acute and non-traumatic fractures. Together, these constitute a market opportunity of approximately $300 million.

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

  • 120,000 fragility or sacral insufficiency fractures occur each year in the United States1
  • 78% of patients are treated with bed rest resulting in hospital stays of 14 to 45 days26
  • 27% mortality at 1 year results from complications associated with bed rest5.6

“Many elderly patients with sacral fragility fractures require long periods of immobility while their fracture heals, which often results in complications associated with bed rest,” said Michael Gardner, MD, chief of orthopedic trauma. at Stanford University Hospital. “A paradigm shift is needed. The strength and osseointegration characteristics 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 with pelvic fracture or sacroiliac joint dysfunction,” said Laura Francis, CEO of SI-BONE. “This extension of the pelvic fracture fixation indication follows the launch of iFuse Bedrock Granite and reinforces SI-BONE’s position as a market leader in the sacropelvic space.”

References

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

About SI-BONE, Inc.
SI-BONE is a world technology leader for the surgical treatment of musculoskeletal disorders of the sacropelvic anatomy. Since 2009, when SI-BONE introduced the iFuse implant system for minimally invasive SI joint surgery, over 2,700 surgeons have performed a combined total of over 65,000 joint fusion procedures IF. A unique body of evidence, supporting the iFuse implant system, including two randomized controlled trials and more than 100 peer-reviewed publications, has enabled several government and private insurance payers to establish near universal coverage of the SI joint fusion procedure exclusively when performed with the iFuse Implant System. Backed by this exclusive reimbursement benefit, SI-BONE has actively leveraged its market leadership position in recent years to pursue clinical research and develop and commercialize new surgical treatment solutions for SI-Joint pain, fixation sacropelvic and pelvic and pelvic trauma. For more information or to join our team, visit www.si-bone.com.

For more company or product information, including risks and benefits, please visit www.si-bone.com.

* The newly erased indication statement is:

The iFuse-TORQ Implant System is indicated for:

  • Sacroiliac joint fusion for sacroiliac joint dysfunction including sacroiliac joint rupture and degenerative sacroiliitis
  • Fixation of pelvic fractures, including acute, non-acute and non-traumatic fractures

SI-BONE, iFuse Implant System, iFuse-TORQ, Bedrock and Bedrock Granite are registered trademarks of SI-BONE, Inc. ©2022 SI-BONE, Inc. All rights reserved.

A photo accompanying this ad is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/36baeebe-01cb-430d-bb1e-1d23d65e3e5c

Media Contact:
Joe Powers, Vice President of Marketing
[email protected]

Investor contacts:
Matt Basso
[email protected]

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