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.
Given the market potential, the latest usage of the iFuse TORQ TNT system in patients will likely provide a significant impetus to SI-BONE’s business.
SI-BONE’s Notable Developments
In August, SI-BONE reported its second-quarter 2024 results, wherein it registered a solid uptick in its worldwide revenues and U.S. revenues. During the quarter, the company announced favorable five-year results from the SALLY prospective clinical trial, which reaffirmed the significant and sustained reduction in sacroiliac (SI) joint pain, persistent functional improvement and 100% bone integration with iFuse-3D. SIBN also announced early-interim results from the STACI study, which confirm the safety and efficacy of lateral transfixing SI joint fusion using TORQ when performed by interventional spine physicians during the quarter.
In May, SI-BONE announced the first cases completed with the smaller, 9.5 mm diameter, iFuse Bedrock Granite Implant (Granite 9.5).
SIBN’s Share Price Performance
Shares of the company have lost 23.6% in the past year against the industry’s 24.4% rise and the S&P 500's 32.5% growth.
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SI-BONE’s Zacks Rank & Key Picks
Currently, SIBN carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are DaVita Inc. DVA, Baxter International Inc. BAX and Boston Scientific Corporation BSX.
DaVita, carrying a Zacks Rank #2 (Buy) at present, has an estimated long-term growth rate of 17.5%. DVA’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 24.2%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
DaVita’s shares have gained 116.4% compared with the industry’s 38.3% rise in the past year.
Baxter, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 10%. BAX’s earnings surpassed estimates in each of the trailing four quarters, with the average being 3.7%.
Baxter has gained 15% compared with the industry’s 30.7% rise in the past year.
Boston Scientific, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 12.6%. BSX’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 7.2%.
Boston Scientific’s shares have rallied 74.7% compared with the industry’s 30.7% rise in the past year.
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