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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, a medical device company, reported Q3 2022 revenue of $26.4 million, a 19% increase year-over-year. U.S. revenue reached $24.6 million, a 21% increase, while international revenue decreased by 5% to $1.8 million.
Gross margin stood at 84%, down from 89% a year earlier, impacted by pricing and cost factors. Operating expenses rose 9% to $35.8 million, leading to an operating loss of $13.6 million. The company maintains a revenue guidance of $104 million to $105 million for 2022, reflecting a growth rate of 16% to 17%.
SI-BONE, Inc. (Nasdaq: SIBN) announced it will release its third-quarter 2022 financial results on November 7, 2022, post-market close. A conference call will follow at 1:30 PM PT / 4:30 PM ET, allowing investors to engage in a discussion regarding the results. SI-BONE is recognized for its iFuse Implant System aimed at treating sacropelvic disorders, with over 70,000 procedures performed by more than 2,800 surgeons. The company has established a strong reimbursement advantage, supporting its market leadership in minimally invasive surgical solutions.
SI-BONE, Inc. (NASDAQ: SIBN), a leader in surgical solutions for sacropelvic disorders, announced its participation in the Morgan Stanley 20th Annual Global Healthcare Conference. Management will hold a fireside chat on September 14, 2022, at 8:00 a.m. Eastern Time. A live webcast and an archived recording will be available on the company’s website for 90 days post-event. SI-BONE has pioneered the iFuse Implant System since 2009, enabling over 70,000 minimally invasive SI joint fusion procedures, supported by extensive clinical evidence and universal insurance coverage.
SI-BONE, Inc. (Nasdaq:SIBN) reported record worldwide revenue of $25.6 million for Q2 2022, an increase of 15% year-over-year. U.S. revenue of $23.8 million grew 18%, while international revenue fell 8% to $1.8 million. The gross margin was 86%, down from 89% the previous year, attributed to lower average selling prices and rising operational costs. Operating expenses surged 22% to $40.0 million, leading to a net loss of $18.5 million or $0.54 per diluted share. The company anticipates 2022 revenue between $106 million and $108 million.
SI-BONE, Inc. (Nasdaq: SIBN), a leader in surgical solutions for musculoskeletal disorders, announced that CEO Laura Francis and CFO Anshul Maheshwari will present at the Canaccord Genuity 42nd Annual Growth Conference in Boston. The live webcast is scheduled for August 10, 2022, at 9:00 AM ET and will be available for replay on the company's investor relations website for at least 90 days. SI-BONE's iFuse Implant System is used in treating SI joint pain, with over 65,000 procedures performed.
SI-BONE, Inc. (Nasdaq: SIBN), a leader in treating musculoskeletal disorders, will announce its second-quarter 2022 financial results on August 8, 2022, post-market. A live conference call will follow at 1:30 PM PT/4:30 PM ET, accessible by phone or via webcast on their website. The company, known for its iFuse Implant System, has established a robust market presence with over 65,000 procedures performed. Their proprietary reimbursement advantage underscores their market leadership in surgical treatments for sacropelvic issues.
SI-BONE, Inc. (SIBN) announced FDA clearance for the iFuse-TORQ system for pelvic fracture fixation, including acute and non-acute fractures. This approval expands the treatment of pelvic fragility and insufficiency fractures, addressing a market opportunity of approximately $300 million. With 120,000 such fractures occurring annually in the U.S., this innovation is aimed at reducing the complications associated with traditional treatment methods. The iFuse-TORQ is positioned to help remobilize patients suffering from these debilitating injuries.
SI-BONE, Inc. (Nasdaq: SIBN) announced FDA 510(k) premarket clearance for its iFuse Bedrock Granite Implant System. This approval follows its designation as a Breakthrough Device by the FDA and a proposed New Technology Add-on Payment from CMS. The Granite implant aims to improve outcomes in sacroiliac fusion surgery and reduce reoperations. Key endorsements from medical professionals highlight its innovative design addressing existing issues in spinal surgeries. The company is optimistic about Granite's clinical benefits and market potential.
SI-BONE, Inc. (Nasdaq: SIBN) reported first quarter 2022 financial results with worldwide revenue of $22.4 million, a 10% increase from Q1 2021. U.S. revenue rose 9% to $20.4 million, while international revenue surged 24% to $2.1 million. Gross margin was 87%, down from 89% in Q1 2021, impacted by lower average selling prices. Operating expenses rose 22% to $36.3 million, resulting in an operating loss of $16.9 million. The company forecasts $106 million to $108 million total revenue in 2022, reflecting 18% to 20% growth.
SI-BONE, Inc. (Nasdaq: SIBN) announced that the Centers for Medicare and Medicaid Services (CMS) has proposed a New Technology Add-on Payment for the iFuse Bedrock Granite™ implant, intended for sacroiliac fusion. This implant holds FDA Breakthrough Device Designation, indicating its potential for improved treatment over existing options. The planned NTAP aims to enable hospitals to receive additional reimbursement, enhancing patient access to this innovative technology once finalized.
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