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SI-BONE, Inc. (NASDAQ: SIBN) is a leading medical device company specializing in the development and commercialization of innovative, minimally invasive surgical implants for the treatment of musculoskeletal disorders, particularly those affecting the sacroiliac (SI) joint. The company's flagship product, the iFuse Implant System®, offers a less invasive alternative to traditional SI joint fusion surgery. This patented system has been used in over 25,000 procedures, providing a significant improvement in patient outcomes.
SI-BONE's portfolio includes a range of patented titanium implants and instruments specifically designed for sacroiliac fusion. Key products include iFuse-3D, iFuse-TORQ, and iFuse Bedrock Granite. These implants are employed in the management of sacroiliac joint dysfunction, adult spinal deformity, degeneration, and pelvic trauma.
The company has achieved several milestones in recent years. Notably, the iFuse Bedrock Granite implant received FDA clearance in May 2022 and was designated a Breakthrough Device due to its significant advantages over existing alternatives. Subsequently, the Centers for Medicare & Medicaid Services (CMS) adopted a New Technology Add-on Payment of up to $9,828 per procedure for this innovative implant.
SI-BONE is managed by an experienced leadership team with backgrounds in top-tier companies like Kyphon, Medtronic, and Inbone. This expertise has driven the company's growth and innovation in the orthopedic field.
In terms of financial performance, SI-BONE has shown robust growth. The company's annual revenue guidance has been increased to $164 million - $166 million, indicating an annual growth rate of approximately 18%-20%. This growth is fueled by the strong reception of new products and established partnerships with major healthcare providers, including compatibility with Medtronic's Solera® rods.
Since its inception in 2009, SI-BONE has supported over 3,000 surgeons in performing more than 80,000 sacropelvic procedures. The company's technologies are backed by a unique body of clinical evidence, including two randomized controlled trials and over 120 peer-reviewed publications.
For more information on SI-BONE and its range of products, visit the official website at www.si-bone.com.
SI-BONE (Nasdaq: SIBN), a medical device company focused on sacropelvic disorders, has announced its participation in the Piper Sandler Healthcare Conference in New York. The company's management will conduct a fireside chat on December 4, 2024, at 11:00 a.m. ET / 8:00 a.m. PT.
Investors can access the conference call through a registration link, and the live audio webcast will be available on the company's website's 'Investors' section. The webcast recording will remain accessible for replay for at least 90 days following the event.
SI-BONE reported Q3 2024 financial results with worldwide revenue of $40.3 million, up 19% year-over-year. U.S. revenue grew 18% to $38.3 million, with gross margin at 79%. The company reduced its net loss by 34% to $6.6 million and improved Adjusted EBITDA loss by 94% to $0.2 million. Notable achievements include reaching over 1,200 U.S. active physicians (15% increase) and commercializing iFuse TORQ TNT. The company updated its 2024 worldwide revenue guidance to $165-166 million and expects to achieve positive Adjusted EBITDA in Q4 2024.
SI-BONE (Nasdaq: SIBN) has received Transitional Pass-Through (TPT) payment status from CMS for its iFuse Bedrock Granite™ system, effective January 1, 2025, for up to three years. This innovative technology, used for pelvic fixation and sacroiliac joint fusion during lumbar spinal fusion procedures, will receive additional payment support without device offset in outpatient settings. The Granite system, which received FDA clearance in May 2022 and Breakthrough Device Designation in November 2021, addresses a market of approximately 130,000 annual lumbar spinal fusion procedures ending at the pelvis in the United States.
SI-BONE, Inc. (Nasdaq: SIBN), a medical device company focused on sacropelvic disorders, has announced that it will release its third quarter 2024 financial results after the market closes on Tuesday, November 12, 2024. Following the release, the company will host a conference call at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time to discuss the results.
Investors interested in participating in the conference call can register using the provided link. Additionally, a live audio webcast will be available on the 'Investors' section of SI-BONE's website. The webcast will be archived and accessible for replay for at least 90 days after the event.
SI-BONE, a medical device company focused on sacropelvic disorders, announced the first-in-patient procedures with their FDA-designated breakthrough device, iFuse TORQ TNT™ Implant System (TNT). This innovative system, which received 510(k) clearance in August 2024, addresses the challenges of pelvic fragility fractures in patients with poor bone quality. The TNT implant features a pelvis-specific design for improved fixation and reduced screw backout risk, and it is the first 3D-printed transiliac-transsacral screw cleared for market use in the U.S. Surgeons praised its streamlined instrumentation and efficient implantation process, which minimizes operating time and enhances patient recovery. SI-BONE’s CEO, Laura Francis, highlighted the system's potential to meet the unmet clinical needs of complex pelvic fractures and expand their leadership in the sacropelvic space.
SI-BONE (Nasdaq: SIBN), a medical device company focused on sacropelvic disorders, has announced its participation in the Morgan Stanley 22nd Annual Global Healthcare Conference in New York. The company's management will host a fireside chat on September 4, 2024, at 10:45 a.m. Eastern Time.
Investors can listen to the conference call by registering through a provided link. The webcast will be available live on the 'Investors' section of SI-BONE's website and will be archived for at least 90 days after the event. This presentation offers an opportunity for investors to gain insights into SI-BONE's operations and future prospects in the medical device industry.
SI-BONE, Inc. (Nasdaq: SIBN) has received FDA 510(k) clearance and Breakthrough Device Designation for its iFuse TORQ TNT™ Implant System (TNT). This next-generation technology is designed for pelvic fragility fracture fixation and sacroiliac joint fusion. The TNT system features a porous threaded implant capable of spanning the posterior pelvis, addressing the specific needs of the sacrum and ilium.
The FDA recognized TNT's potential to provide more effective treatment than the current standard of care, cannulated screws. TNT aims to improve early fixation and reduce screw backout, potentially allowing for earlier patient weight-bearing and mobilization. This innovation is particularly significant for the growing elderly population affected by pelvic fragility fractures.
SI-BONE (Nasdaq: SIBN), a medical device company focused on sacropelvic disorders, has announced its participation in the Canaccord Genuity 44th Annual Growth Conference in Boston. The company's management will host a fireside chat on August 14, 2024, at 3:30 p.m. Eastern Time.
Investors can listen to the conference call by registering through a provided link. The webcast will be available live on the 'Investors' section of SI-BONE's website and will be archived for at least 90 days after the event. This presentation offers an opportunity for investors to gain insights into SI-BONE's growth strategies and market position in the medical device industry.
SI-BONE, Inc. (Nasdaq:SIBN) reported strong Q2 2024 financial results, with worldwide revenue reaching $40.0 million, a 20% increase year-over-year. U.S. revenue grew 21% to $37.8 million. The company improved its net loss by 20% to $8.9 million and reduced its Adjusted EBITDA loss by 43% to $2.7 million. SI-BONE ended the quarter with $151.5 million in cash and equivalents.
Operational highlights include a 23% increase in U.S. active physicians to over 1,150. The company also reported positive 5-year results from the SALLY clinical trial and early interim results from the STACI study. SI-BONE has increased its 2024 revenue guidance to $165-$167 million and expects to achieve positive Adjusted EBITDA in Q4 2024.
SI-BONE, Inc. (Nasdaq: SIBN), a medical device company focused on musculoskeletal disorders of the sacropelvic anatomy, has announced it will release its second quarter 2024 financial results on August 5, 2024, after market close. The company will host a conference call at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time on the same day to discuss the results. Investors can register for the call using the provided link. A live audio webcast will be available on the company's website, and a replay will be accessible for at least 90 days after the event.
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