SANTA CLARA, Calif. - SI-BONE, Inc. (NASDAQ:SIBN), a company specializing in surgical solutions for sacropelvic disorders, announced today that it has received FDA 510(k) clearance for its iFuse TORQ TNT™ Implant System (TNT). The device is engineered to address the specific needs of sacrum and ilium anatomy and bone density, particularly for the treatment of pelvic fragility fractures and sacroiliac joint fusion.
The TNT implant system, which has been designated as a Breakthrough Device by the FDA, features a threaded, porous implant designed for spanning the posterior pelvis. This structure allows the implant to pass through the ilium, sacrum, and into the contralateral ilium. The FDA has recognized TNT's potential to provide more effective treatment for pelvic fragility fractures compared to the current standard of care, which involves cannulated screws.
Dr. Charles Moon, Director of Orthopedic Trauma at Cedars-Sinai, has expressed optimism about the TNT system. He noted the limitations of current smooth stainless steel cannulated screws, which were originally designed for hip fracture fixation and have been repurposed for pelvic fractures. Moon highlighted that the TNT implant system is specifically designed for sacropelvic anatomy and may reduce the rate of screw backout, a common problem that can lead to pain and potential second surgeries, particularly in elderly patients.
Laura Francis, CEO of SI-BONE, emphasized the significance of the FDA's recognition and the company's commitment to addressing the needs of patients suffering from pain related to pelvic fragility fractures. She expressed pride in SI-BONE's role in helping surgeons improve patient mobility with the first anatomy-specific system designed for these biomechanical challenges.
SI-BONE has a history of innovation in the field of minimally invasive surgery for the SI joint since 2009. The company has supported over 3,900 surgeons in more than 100,000 sacropelvic procedures. SI-BONE's technologies are supported by a substantial body of clinical evidence, including randomized controlled trials and peer-reviewed publications.
This news is based on a press release statement from SI-BONE, Inc.
In other recent news, SI-BONE Inc., a medical device company, reported a robust second-quarter financial performance for 2024. The company's worldwide revenue reached a record $40 million, marking a 20% increase from the previous year, with the U.S. market contributing significantly to this growth. SI-BONE also added 220 active physicians and saw a 43% improvement in adjusted EBITDA.
In addition to these achievements, SI-BONE announced plans to launch a new product targeting the pelvic market, which is expected to contribute to long-term revenue growth. The company raised its 2024 worldwide revenue guidance to between $165 million and $167 million, implying 19% to 20% year-over-year growth.
Despite a reported net loss improvement of 20% to $8.9 million and a 7% increase in operating expenses, SI-BONE ended the quarter with a strong cash and marketable securities position of $151 million. The company aims to build a $200 million business by the end of 2024 through strategic sales rep additions and territory expansions. These are the recent developments in SI-BONE's business operations.
InvestingPro Insights
In light of SI-BONE, Inc.'s (NASDAQ:SIBN) recent FDA clearance for its innovative iFuse TORQ TNT™ Implant System, investors may find the company's financial health and market performance to be of particular interest. According to InvestingPro data, SI-BONE holds a market capitalization of approximately $597.06 million. Its revenue has seen a notable uptick, with a growth of 21.15% over the last twelve months as of Q2 2024, highlighting the company’s ability to increase its sales in the competitive medical device market.
However, the company's profitability remains a challenge, as reflected in its negative P/E ratio of -14.18 and an adjusted P/E ratio of -14.62 for the same period. This suggests that SI-BONE has yet to achieve profitability despite its revenue growth. Additionally, the company's operating income margin stands at -30.39%, indicating that it is currently operating at a loss.
From an InvestingPro Tips perspective, it's important to note that analysts have revised their earnings expectations downwards for the upcoming period, and they do not anticipate SI-BONE will be profitable this year. Nevertheless, the company does have certain financial strengths, such as holding more cash than debt on its balance sheet and having liquid assets that exceed short-term obligations. These are positive signs for the company's financial stability and ability to manage its immediate financial commitments. However, SI-BONE does not pay a dividend to shareholders, which may be a consideration for investors seeking income-generating investments.
For those interested in a deeper analysis, InvestingPro offers additional insights on SI-BONE, Inc. There are currently 5 more InvestingPro Tips available, which can be found at: https://www.investing.com/pro/SIBN. These tips could provide further guidance on the company’s stock performance and financial health.
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