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

SANTA CLARA, Calif., June 13, 2022 (GLOBE NEWSWIRE) — SI-BONE, Inc. (SIBN), (Nasdaq: SIBN), a Silicon Valley-based medical gadget firm devoted to fixing musculoskeletal issues of the sacropelvic anatomy, at this time introduced an FDA clearance for iFuse-TORQ^® for pelvic fracture fixation, together with acute, non-acute and non-traumatic fractures.* Fractures coated on this clearance embrace pelvic fragility fractures (fractures associated to low-energy traumatic occasions) and pelvic insufficiency fractures. Collectively, these represent an roughly $300 million market alternative.

Sacral fragility and insufficiency fractures are frequent and sometimes devastating for sufferers and healthcare programs, the place:

• 120,000 sacral fragility or insufficiency fractures happen yearly within the US¹
• 78% of sufferers are handled with bedrest resulting in 14- to 45-day hospital stays^2–6
• 27% 1-year mortality outcomes from bedrest-associated issues^5,6

“Many aged sufferers with sacral fragility fractures require lengthy durations of immobility whereas their fracture heals, typically resulting in issues related to bedrest,” stated Michael Gardner, MD, Chief of Orthopedic Trauma at Stanford College Hospital. “A paradigm shift is required. The power and osseointegrative options of iFuse-TORQ make it probably the most enticing implant available on the market to remobilize these osteoporotic sufferers.”

“Since its launch in 2021, iFuse-TORQ has been used to deal with many sufferers affected by a pelvic fracture or sacroiliac joint dysfunction,” stated Laura Francis, CEO of SI-BONE. “This pelvic fracture fixation indication enlargement comes on the coattails of the iFuse Bedrock Granite launch and expands SI-BONE’s place because the market chief within the sacropelvic area.”

References

1. Burge R, et al. J Bone Miner Res. 2007 Mar; 22(3):465-75.
2. Per Medicare ICD-10 Code Search contains sufferers >65 y/o by Watson Coverage Evaluation. June 2020.
3. Alnaib et al J Orthop Traumatol. 2012 Jun; 13(2): 97–103
4. Breuil V, et al. Joint Bone Backbone. 2008;75:585–8.
5. Taillandier J, et al. Joint Bone Backbone. 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 worldwide technological chief for surgical therapy of musculoskeletal issues of the sacropelvic anatomy. Since 2009, when SI-BONE launched the iFuse Implant System for minimally invasive surgical procedure of the SI joint, greater than 2,700 surgeons have carried out a mixed complete of greater than 65,000 SI joint fusion procedures. A novel physique of proof, supporting the iFuse Implant System, together with two randomized managed trials and over 100 peer reviewed publications, has enabled a number of authorities and personal insurance coverage payors to determine near-universal protection of the SI joint fusion process completely when carried out with the iFuse Implant System. Supported by this proprietary reimbursement benefit, SI-BONE has actively leveraged its market management place in recent times to additional scientific analysis and evolve and commercialize novel surgical therapy options for SI-Joint ache, sacropelvic and pelvic fixation, and pelvic trauma. For extra data or to hitch our staff, please go to us at www.si-bone.com.

For added data on the corporate or the merchandise together with dangers and advantages, please go to www.si-bone.com.

* The newly cleared indication assertion is:

The iFuse-TORQ Implant System is indicated for:

• Fusion of the sacroiliac joint for sacroiliac joint dysfunction together with sacroiliac joint disruption and degenerative sacroiliitis
• Fracture fixation of the pelvis, together with acute, non-acute and non-traumatic fractures

SI-BONE, iFuse Implant System, iFuse-TORQ, Bedrock, and Bedrock Granite are registered logos of SI-BONE, Inc. ©2022 SI-BONE, Inc. All Rights Reserved.

A photograph accompanying this announcement is on the market at https://www.globenewswire.com/NewsRoom/AttachmentNg/36baeebe-01cb-430d-bb1e-1d23d65e3e5c

Media Contact:
Joe Powers, Vice President of Advertising and marketing
jpowers@si-bone.com

Investor Contact:
Matt Bacso
buyers@si-bone.com