SI-BONE Receives FDA Nod for Its TNT Implant System

SI-BONE, Inc. SIBN has recently received FDA 510(k) clearance for its iFuse TORQ TNT implant system ("TNT"). The TNT implant system is the first anatomy-specific system designed to meet the biomechanical challenges presented by pelvic fragility fractures.

FDA has determined that TNT has the potential to provide more effective treatment of pelvic fragility fractures than the current standard of care, such as cannulated screws. The latest development highlights SI-BONE's capability to develop a platform of unique solutions that target large unmet clinical needs.

About the TNT Implant System

The TNT implant system is designed for the specific anatomical and bone mineral density needs of the sacrum and ilium. TNT comes with a porous threaded implant with lengths capable of spanning the posterior pelvis, passing through the ipsilateral ilium, sacrum and into the contralateral ilium. It includes a system specially designed for sacropelvic anatomy to reduce the rate of screw backout.

TNT improves early fixation and reduces the rate of screw backout, which may allow for early patient weight-bearing and mobilization. It will serve as the next-generation technology for pelvic fragility fracture fixation and sacroiliac joint fusion.

TNT was awarded the Breakthrough Device Designation earlier by the FDA.

Industry Prospects

Per a Grand View Research report, the global sacroiliac joint fusion market size was valued at $721.2 million in 2023 and is anticipated to witness a CAGR of 19.8% from 2024 to 2030. Primary factors driving the market growth include the increasing prevalence of pain in the lower back, buttocks, groin and lower extremities, technological advancements and rising incidence of sacroiliitis or sacroiliac joint dysfunction.

Furthermore, the market growth is supported by developments in minimally invasive surgical techniques, insurance coverage improvements and major companies' proactive efforts.

Looking at the market potential, SI-BONE's latest progress for its TNT system is well-timed.

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Other Recent Developments

In May 2024, SI-BONE expanded its iFuse Bedrock Granite implant system portfolio with the launch of Granite 9.5, followed by FDA 510(k) premarket clearance in January. Granite 9.5 is suitable for patients with smaller anatomy and allows easier placement of stacked implants in the sacroalar-iliac trajectory.

Price Performance of SIBN

Shares of SIBN have lost 21.2% in the year-to-date period against the industry's 9.4% growth.

Zacks Rank and Other Key Picks

SI-BONE currently carries a Zacks Rank #2 (Buy).

Some other top-ranked stocks in the broader medical space are Intuitive Surgical ISRG, TransMedics Group TMDX and Quest Diagnostics DGX. While Intuitive Surgical and TransMedics sport a Zacks Rank #1 (Strong Buy) each, Quest Diagnostics currently carries a Zacks Rank of 2.

Intuitive Surgical's shares have surged 61.3% in the past year. Estimates for the company's earnings have remained constant at $6.67 per share for 2024 in the past 30 days.

ISRG's earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 8.97%. In the last reported quarter, it posted an earnings surprise of 16.34%.

Estimates for TransMedics' 2024 earnings per share have moved up 48.1% to $1.20 in the past 30 days. Shares of the company have gained 187.6% in the past year compared with the industry's 12.4% growth.

TMDX's earnings surpassed estimates in each of the trailing four quarters, the average surprise being 287.50%. In the last reported quarter, it delivered an earnings surprise of 66.67%.

Estimates for Quest Diagnostics' 2024 EPS have increased 0.2% to $8.89 in the past 30 days. In the past year, shares of DGX have risen 15.9% compared with the industry's 22.4% growth.

In the last reported quarter, DGX delivered an earnings surprise of 1.73%. The company has a trailing four-quarter average earnings surprise of 3.31%.

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