SIBN Stock Up After First-In-Patient Use of FDA Breakthrough Device
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SI-BONE, Inc. SIBN announced first-in-patient procedures with the FDA-designated breakthrough device, iFuse TORQ TNT Implant System (TNT), on Thursday. TNT received the FDA’s 510(k) clearance and was awarded Breakthrough Device Designation by the FDA in August 2024.
Per SI-BONE, TNT, which has been designed to address the anatomic and biomechanical challenges of pelvic fragility fractures (particularly in patients with poor bone quality), is expected to offer a significant advancement over traditional cannulated screws.
The latest successful usage of TNT in patients is expected to significantly boost SI-BONE’s sacropelvic treatment business and solidify its foothold in the niche space.
Likely Trend of SIBN Stock Following the News
Following the announcement on Oct. 10, shares of the company moved nearly 0.5% north to $13.13 till last trading.
Historically, the company has achieved a few regulatory milestones. We expect market sentiment on the stock to continue to remain positive around this announcement, too.
SI-BONE currently has a market capitalization of $547.4 million. It has a current ratio of 9.2, higher than the industry’s 2.5. In the last reported quarter, SIBN delivered an earnings surprise of 15.4%.
Significance of the Usage of SI-BONE’s TNT
Per SI-BONE, TNT is the first 3D-printed transiliac-transsacral screw cleared for market use in the United States. It features a pelvis-specific design to improve initial fixation and reduce the risk of screw backout.
Per an expert familiar with the usage of TNT, the streamlined instrumentation and implant design provided excellent fixation. Additionally, it enabled quick and precise implantation. The expert believes that this efficiency is critical while treating patients having fragile bones, as it reduces operating time, minimizes risks and leads to faster recovery.
SI-BONE’s management believes that the successful completion of these initial procedures using the iFuse TORQ TNT system marks a significant step forward in addressing the unmet clinical needs of complex pelvic fragility fractures. Management expects that by providing a solution that improves both surgical efficiency and patient recovery, SIBN will be able to expand its foothold in the sacropelvic space.
Industry Prospects in Favor of SIBN
Per a report by Dataintelo, the global pelvis fixation system market was valued at $1.2 billion in 2023 and is anticipated to reach $2.1 billion by 2032 at a CAGR of 6.2%. Factors like the rising incidences of pelvic fractures and the growing elderly population susceptible to falls and degenerative bone diseases are likely to drive the market.