SI-BONE, Inc. Announces FDA Clearance for Expanded Stem

SI-BONE, Inc. Announces FDA Clearance for Expanded Stem

SANTA CLARA, Calif., Dec. 27 10, 2022 (GLOBE NEWSWIRE) — SI-BONE, Inc., (Nasdaq: SIBN), a Silicon Valley-based medical machine firm devoted to fixing musculoskeletal issues of the sacropelvic anatomy, introduced Right now Extra FDA Clearance for iFuse Bedrock Granite®. Newly authorized indications embrace use with all kinds of commercially accessible pedicle screw system rods.

Spinal deformity in adults is a fancy scientific drawback to deal with, with lumbopelvic fixation failure charges reported at 24%.1 Surgeons have adopted completely different methods involving preoperative planning to enhance spinal alignment, biologics, and next-generation pelvic fixation implants to assist enhance surgical outcomes. SI-BONE launched iFuse Bedrock Granite in Might 2022 to handle a few of these points. The implant is usually used each to immobilize and fuse the sacroiliac (SI) joint and to function a base assist on the base of a spinal fusion assemble. The preliminary clearance included a sign to be used with a single producer pedicle screw system. Expanded indications embrace use with a variety of rods generally utilized in multilevel spinal fusion surgical procedures. The expanded indications will permit surgeons to make use of their most popular implant methods and techniques with confidence along side iFuse Bedrock Granite as the idea for his or her assemble.

“Many sufferers with spinal deformity require a radical surgical plan and a wide range of implant options to assist present the perfect outcomes,” stated Robert Eastlack, MD, orthopedic surgeon, Scripps Hospital. “By utilizing iFuse Bedrock Granite as the bottom of my spinal constructs, I present my sufferers with probably the most superior know-how accessible.”

“Since its launch, Granite has grow to be the implant of alternative for surgeons as they incorporate SI joint fusion into their pelvic fixation constructs,” stated Laura Francis, CEO of SI-BONE. “We imagine this expanded authorization will assist improve the variety of surgeons who deal with their sufferers with this revolutionary machine.”

The references

  1. Eastlack RK, et al. Backbone. 2022 Jul 15;47(14):986-994.

SI-BONE, Inc. (NASDAQ: SIBN) is a world know-how chief for the surgical therapy of musculoskeletal issues of the sacropelvic anatomy. Since 2009, when SI-BONE launched the iFuse implant system for minimally invasive SI joint surgical procedure, practically 3,000 surgeons have carried out a mixed whole of greater than 75,000 joint fusion procedures IF. A singular physique of proof, supporting the iFuse implant system, together with two randomized managed trials and greater than 100 peer-reviewed publications, has enabled a number of authorities and personal insurance coverage payers to determine close to common protection of the SI minimally invasive joint fusion, together with many payers who cowl the process solely when carried out with the iFuse implant system. Backed by this unique reimbursement profit, SI-BONE has actively leveraged its market management place over the previous a number of years to advance scientific analysis, and develop and commercialize new surgical therapy options for SI-Joint Ache, sacropelvic and pelvic fixation and pelvic trauma.

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

Ahead-looking statements

Statements on this press launch relating to expectations of future occasions or outcomes, together with SI-BONE’s expectations relating to the continued enlargement of the marketplace for its iFuse Bedrock Granite product, contained on this press launch are statements “prospects”. These forward-looking statements are based mostly on SI-BONE’s present expectations and inherently contain important dangers and uncertainties. These dangers embrace SI-BONE’s skill to broaden the market and person base for iFuse Bedrock Granite, its skill to introduce and market new merchandise and indications, its skill to take care of favorable reimbursement for procedures utilizing its merchandise, its skill to handle dangers to its provide chain, and the longer term affect the COVID-19 pandemic can have on the flexibility and need of sufferers and physicians to endure procedures utilizing the system. iFuse Bedrock Granite implant. Precise outcomes and the timing of occasions might differ materially from these anticipated in these forward-looking statements on account of these and different dangers and uncertainties, a lot of that are described within the firm’s most up-to-date filings on Kind 10-Ok. and Kind 10-Q, and the corporate’s different filings with the Securities and Change Fee (SEC) accessible on the SEC’s web site (, together with underneath “Danger Components”. SI-BONE undertakes no obligation to replace any forward-looking statements and expressly disclaims any obligation or enterprise to publicly launch any updates or revisions to the forward-looking statements contained herein, besides as required by legislation.

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