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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, Inc. announced that UnitedHealthcare will exclusively cover its iFuse triangular implants for minimally invasive SI joint fusion procedures, effective October 1, 2021. This change highlights a shift from covering all devices to a specific preference for iFuse implants, supported by over 100 peer-reviewed publications and more than 60,000 iFuse procedures performed. With coverage from UnitedHealthcare, which has over 45 million members, and other major insurers, the policy aims to enhance patient access to effective treatment for degenerative SI joint disease.
SI-BONE, a medical device firm listed on Nasdaq under the symbol SIBN, announced its participation in two upcoming investor conferences. The 19th Annual Morgan Stanley Global Healthcare Conference will feature a fireside chat on September 14, 2021, at 12:30 p.m. ET. Additionally, SI-BONE will present at the Cantor Virtual Global Healthcare Conference on September 27, 2021, at 4:00 p.m. ET. Interested parties can access live and archived webcasts via the company’s website.
SI-BONE specializes in surgical treatments for musculoskeletal disorders and is known for its iFuse Implant System.
SI-BONE reported record second quarter 2021 revenue of $22.2 million, a 58% increase year-over-year. U.S. revenue was $20.2 million, up 53% from 2020. Gross margin improved to 89%, compared to 85% in 2020. Operating expenses rose 49% to $32.8 million, resulting in an operating loss of $13.0 million. Net loss was $14.0 million, or $0.42 per diluted share. The company maintains 2021 revenue guidance of $92 million to $94 million, reflecting 25% to 28% growth.
SI-BONE, Inc. (Nasdaq: SIBN) announced that Anthem, America's 2nd largest health insurer, will cover minimally invasive SI joint fusion exclusively with the iFuse Implant System. This new policy, effective from July 30, 2021, provides virtually universal coverage for chronic sacroiliac joint pain, contingent on specific criteria. Anthem has adopted clinical guidelines from AIM Specialty Health, aligning coverage with current medical practices and supporting the iFuse system backed by multiple clinical trials. This marks a significant step for patient access and positions SI-BONE favorably within the competitive health insurance landscape.
SI-BONE, Inc. (Nasdaq: SIBN), a leader in musculoskeletal disorder solutions, announced its participation in the Canaccord Genuity 41st Annual Growth Conference on August 11 at 3:30 p.m. ET. This event will showcase SI-BONE's innovations, particularly the iFuse Implant System, designed for minimally invasive surgeries targeting SI joint pain, a contributor to chronic low back pain affecting up to 30% of patients. More than 55,000 SI joint fusion procedures have been performed using this technology. Live access to the presentation will be available on the company’s website.
SI-BONE, a leader in musculoskeletal disorder treatments, will report its second quarter 2021 financial results on August 2, 2021, after market close. A conference call will follow at 1:30 p.m. PT, which investors can join by calling (866) 470-1968. The company's iFuse Implant System has been pivotal in treating SI joint issues, supported by extensive clinical evidence. More than 55,000 procedures have been conducted by over 2,300 surgeons. SI-BONE aims to leverage its market position for further commercial device development.
SI-BONE, Inc. (Nasdaq: SIBN) announced on July 14, 2021, that Centene Corporation has implemented a positive coverage policy for the iFuse Implant System, a treatment for chronic sacroiliac joint pain. This policy recognizes minimally invasive SI joint fusion as a medically necessary procedure when specific criteria are met, enhancing patient access. Centene serves over 25 million members and aims to improve treatment availability for low-income individuals. The policy reflects extensive clinical evidence supporting the safety and effectiveness of the iFuse system.
SI-BONE, Inc. (Nasdaq: SIBN) has released promising 24-month results from the SALLY study, showcasing the efficacy of the iFuse-3D™ Implant System in treating sacroiliac joint pain. The study reported a significant decline in opioid use from 59% to 18% and consistent improvements in patient function and quality of life. This follows earlier studies endorsing the iFuse implant's safety and effectiveness. The iFuse-3D implant, designed for enhanced bone integration, is expected to further bolster the company's market position in the medical device sector.
SI-BONE, Inc. (SIBN) has launched the SI-BONE SImulator™, a revolutionary training simulation system for surgeons. This innovative platform is designed to enhance the learning of SI-BONE sacropelvic procedures, including iFuse procedures, using radiation-free technology. The SImulator can be utilized in various settings without traditional imaging equipment, making it accessible and portable. The collaboration with Medability has resulted in a versatile training tool that supports both group and individual training sessions and focuses on patient-specific anatomies.
SI-BONE, Inc. (Nasdaq: SIBN) announced national reimbursement for the iFuse-3D Implant System™ by the French Health Ministry, effective June 1, 2021, for five years. This follows a positive opinion from the Haute Autorité de Santé recognizing the implant's therapeutic benefits for sacroiliac joint dysfunction. The implant is the first 3D-printed titanium solution for SI joint fusion, designed for effective bony integration. With reimbursement confirmed, patient access in France improves, allowing surgeons to leverage this technology for various pelvic and spinal conditions.
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