SI-BONE Stock

SI-BONE, Inc. operates as a medical device company dedicated to solving musculoskeletal disorders of the sacropelvic anatomy. Leveraging its knowledge of pelvic anatomy and biomechanics, the company has pioneered proprietary minimally invasive surgical implant systems to address sacroiliac joint dysfunction, as well as address unmet clinical needs in pelvic fixation and management of pelvic fractures. The company's products include a series of patented titanium implants and the instruments used to implant them, as well as implantable bone products.

The company markets its products primarily with a direct sales force, as well as a number of third-party sales agents in the United States, and with a combination of a direct sales force, and sales agents and resellers in other countries. As of December 31, 2023, more than 95,000 procedures have been performed using the company's products by over 3,600 physicians in the United States and 38 other countries.

Product and Applications

The company's first-generation iFuse, a machined triangular titanium implant, has a triangular cross section that resists twisting or rotation of the implant. The company's second generation iFuse product, the iFuse-3D implant, launched in 2017, is a patented titanium implant that combines the triangular cross-section of the first generation iFuse implant with a proprietary 3D-printed porous surface and fenestrated design. This design, with its open and porous structure, also allows the implant to self-harvest bone as it is impacted through the ilium. The company holds patents on implants with cross-sections of many non-round shapes, including the triangular shape, as well as the fenestration configuration it uses with its iFuse-3D implants. The company also holds patents for the method of placing the implant across the sacroiliac joint, as well as other parts of the spine and pelvis.

In April 2019, the company received clearance from the United States Food and Drug Administration, or FDA, to promote the use of its iFuse-3D implants for fusion of the sacroiliac joint in conjunction with multi-level spinal fusion procedures to provide further stabilization and immobilization of the sacroiliac joint, which it calls the Bedrock technique. The company CE marked and began marketing iFuse for this indication and surgical technique in the European Union (EU) in 2019. In late-2019, the company introduced iFuse Bone, an implantable bone product manufactured from sterilized recovered cadaveric bone tissue, to meet the demand of some of its surgeon customers to use implantable bone products to support and augment the patient's own bone tissue in orthopedic procedures. In 2020, the company received FDA 510(k) clearance for an expanded indication for its triangular titanium iFuse implants to support its trauma initiative.

In February 2021, the company launched iFuse-TORQ, a line of 3D-printed threaded implants designed for use in pelvic trauma, as well as applications in sacroiliac joint dysfunction and degeneration. Relative to competitive trauma products, iFuse-TORQ is roughly four times as strong in bending and requires 10 times the rotational force, or torque, to insert due to its porosity and other design features. iFuse-TORQ has a larger surface area for bone in-growth and was specifically designed to allow for osteointegration, or incorporation of the bone in the implant's porous surface and structure. In 2022, the FDA provided clearance for an expanded indication for iFuse-TORQ to include acute, non-acute and non-traumatic fractures, as well as for placement across the sacroiliac joint using its Bedrock technique.

In May 2022, the company launched its iFuse Bedrock Granite Implant System. The iFuse Bedrock Granite implant provides sacroiliac fusion and sacropelvic fixation as a foundational element for segmental spinal fusion. The iFuse Bedrock Granite implant has a machined titanium core surrounded by a fusion sleeve that is additively manufactured. The fusion sleeve offers greater surface area for both microporous and macroporous surface features, as well as self-harvesting cutting flutes. In December 2022, the company received FDA clearance for promotion of the compatibility of iFuse Bedrock Granite with a broad class of commercially available rods.

In addition to its implants and instruments, the company provides enabling technologies that are cleared and compatible with Medtronic's surgical navigation systems and Medtronic Mazor surgical robots. The company also markets decortication and graft delivery systems that allow surgeons to remove intra-articular cartilage and deliver flowable bone graft materials to the sacroiliac joint.

Sales and Marketing

The company markets and sells its implants primarily through a direct sales force and third-party sales agents. The company's target customer base includes over 12,000 physicians who perform advanced spinal procedures.

The company's direct sales organization in the United States covered eighteen sales regions as of December 31, 2023. In each region, a number of territory sales managers act as the primary customer contact. The company's territory sales managers have extensive training and experience selling medical devices for spine problems and pain management, generally focusing on emerging technologies and markets. For large and/or high volume territories, the company also employs territory representatives who cover cases. As of December 31, 2023, the company's U.S. sales force consisted of territory sales managers and clinical specialists directly employed by it, and third-party sales agents. As of December 31, 2023, the company's international sales force consisted of sales representatives directly employed by it and third-party sales agents, which together had sales in 38 countries through December 31, 2023. The company intend to continue to grow its specialized sales force to foster relationships with physicians and support revenue growth.

Competition

The company's primary competitors in Europe are Globus Medical, Inc. and SIGNUS Medizintechnik GmbH.

Intellectual Property

The company protects its intellectual property through its pending patent applications and issued patents. As of December 31, 2023, the company had been issued 59 issued U.S. patents and had 34 pending U.S. patent applications, and it owned 18 issued foreign patents and had 22 pending foreign patent applications. The company has focused the majority of its foreign patent efforts in China, Europe, and Japan. The company's U.S. patents on the design of its first generation iFuse implant, including its triangular shape, expire in December 2025. The company's current U.S. patents on iFuse-3D, including the fenestrated design, expire in September 2035. The company's U.S. patents on the triangular cutting tool used to place its implants expire in February 2034, and its current U.S. patents protecting the design of its iFuse Bedrock Granite implants expire in February 2039. The company's foreign patents will expire between August 2025 and September 2035.

As of December 31, 2023, the company had 20 registered trademarks in the United States and have filed for three more. The company has sought protection for at least two of these trademarks in 61 countries including the 27 European member countries of the Madrid Protocol.

Manufacturing and Supply

The company's supplier for iFuse-3D and iFuse-TORQ is rms Company (RMS). The company has an exclusive Manufacture and Supply Agreement with RMS in February 2024 (the Manufacture and Supply Agreement), which supersedes and replaces its prior Manufacturing, Quality and Supply Agreement with RMS. Pursuant to the Manufacture and Supply Agreement, RMS manufactures certain of its implants in accordance with its specifications. RMS is the company's only supplier of iFuse-3D and iFuse-TORQ implants.

The company's iFuse Bedrock Granite implant is manufactured and assembled by third-party suppliers, including RMS. The company's manufacturing operations, and those of its suppliers, comply with regulations mandated by the FDA and the EU.

In the United States, products, the company sells are required to be manufactured in compliance with the FDA's Quality System Regulation, codified at 21 CFR Part 820, which covers the methods used in, and the facilities used for, the design, testing, control, manufacturing, labeling, quality assurance, packaging, storage, and shipping. The company's status in FDA's Establishment Registration and Device Listing is active and it also maintains the Medical Device Manufacturing License issued by the State of California's Department of Public Health Food and Drug Branch. In the EEA, the company is required to comply with Quality Management System (QMS) requirements established in EU medical device legislation. To demonstrate compliance with these requirements, the company obtains and maintains ISO13485:2016 Quality Management System certification for its locations in Santa Clara, California, and Gallarate Italy, issued by DEKRA Certification, B.V.

The company obtains and maintains appropriate CE Certificates of Conformity delivered by its Notified Body, DEKRA, for any medical devices it placed on the EU market in accordance with applicable EU medical device legislation.

The company is required to demonstrate continuing compliance with applicable requirements to maintain these certifications and CE Certificates of Conformity and will continue to be periodically inspected by international regulatory authorities for certification purposes. Further, the company and certain of its suppliers are required to comply with all applicable regulations and current good manufacturing practices. These FDA and EU regulatory requirements cover, among other things, the methods and documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage, and shipping of the company's products.

Regulation

The company's research, development and clinical programs, as well as its manufacturing and marketing operations, are subject to extensive regulation in the United States and other countries. Most notably, all of the company's products sold in the United States are subject to the Federal Food, Drug, and Cosmetic Act (FDCA) as implemented and enforced by the FDA.

There are numerous FDA regulatory requirements governing the clearance or approval and marketing of the company's products. These include product listing and establishment registration, which helps facilitate FDA inspections and other regulatory action; investigational device exemptions to conduct premarket clinical trials, which include extensive monitoring, recordkeeping, and reporting requirements in compliance with good clinical practices (GCP) and with institutional review board (IRB) oversight; Quality System Regulation (QSR), which requires manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the manufacturing process; labeling regulations and FDA prohibitions against the promotion of products for uncleared, unapproved or off-label use or indication; clearance of product modifications that could significantly affect safety or effectiveness or that would constitute a major change in intended use of one of its cleared devices; approval of product modifications that affect the safety or effectiveness of one of its approved devices; medical device reporting regulations, which require that manufacturers comply with FDA requirements to report if their device may have caused or contributed to a death or serious injury, or has malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction of the device or a similar device were to recur; post-approval restrictions or conditions, including post-approval study commitments; post-market surveillance regulations, which apply when necessary to protect the public health or to provide additional safety and effectiveness data for the device; the FDA's recall authority, whereby it can ask, or under certain conditions order, device manufacturers to recall from the market a product that is in violation of governing laws and regulations; regulations pertaining to voluntary recalls; and notices of corrections or removals.

The company has registered its facility with the FDA as a medical device manufacturer.

In November 2008, the company received 510(k) clearance to market its first generation iFuse implant from the FDA. Since 2008, the company has received additional FDA 510(k) clearances for new instruments, additional implant sizes and labeling changes. In the United States, the company's first-generation iFuse implants and its iFuse-3D implants are intended for sacroiliac fusion for the following conditions: sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruptions and degenerative sacroiliitis, which includes conditions where symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than six months; to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion; and acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

In February 2021, the company received 510(k) clearance to market its iFuse-TORQ from the FDA. In June 2022, the company received an additional 510(k) clearance from the FDA to extend the use of iFuse-TORQ to include fragility fractures. This clearance opens a new population that can benefit from sacroiliac joint fusion and fracture fixation using iFuse-TORQ. In September 2022, the company received 510(k) clearance from the FDA for use of iFuse-TORQ using the Bedrock technique. This clearance allows the company to promote the use of a threaded implant (iFuse-TORQ) in a trajectory that is familiar to surgeons through a previous clearance for the same use for iFuse-3D. In the United States, the iFuse TORQ Implant System is indicated for sacroiliac joint fusion for sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis; and augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

In May 2022, the company received 510(k) clearance from the FDA for iFuse Bedrock Granite. The combination of breakthrough designation and FDA clearance allowed the company to obtain a new technology add-on payment (NTAP) from CMS. NTAP provides an additional payment to hospitals for eligible cases that use iFuse Bedrock Granite.

In June 2023, the company received 510(k) clearance from the FDA for iFuse-TORQ placement in the posterolateral or lateral oblique trajectory. The most recent FDA 510(k) premarket clearance was received in January 2024 for the iFuse Bedrock Granite Implant System in a smaller (9.5 mm) diameter with both an expanded indication in pediatric patients, and an expanded application that includes use in the S1 trajectory.

In November 2010, the company obtained a CE Certificate of Conformity from its Notified Body (DEKRA) and affixed a CE mark to its iFuse Implant System in accordance with the MDD to allow commercialization of its triangular iFuse implants in the EEA. In the EEA and Switzerland, iFuse is intended for sacroiliac joint fusion, including use in high and low energy fractures of the pelvic ring. Since 2010, the company has renewed its Certificates, added additional instruments, implant sizes and labeling updates and iFuse-3D, its second generation iFuse implant, to its product offerings in the EEA. The company plans to continue to work with its Notified Body to update its Technical Files and incorporate updates to its products in the EEA in accordance with applicable legislative requirements.

The company maintains approval for iFuse in regions beyond the United States and the EEA, including Australia, New Zealand, and Israel. The laws that may affect the company's ability to operate include:

the federal Anti-Kickback Statute, which prohibits, among other things, knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, lease, order, arrangement for, or recommendation of, items or services for which payment may be made, in whole or in part, under federal healthcare programs, such as the Medicare and Medicaid programs;

the federal civil False Claims Act, which prohibits, among other things, individuals or entities from knowingly presenting, or causing to be presented, false or fraudulent claims for payment of government funds; knowingly making, using, or causing to be made or used, a false record or statement to get a false claim paid or to avoid, decrease, or conceal an obligation to pay money to the federal government;

the federal Health Insurance Portability and Accountability Act of 1996, which imposes criminal and civil liability for, among other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program including private third-party payors, or knowingly and willfully falsifying, concealing, or covering up a material fact or making a materially false, fictitious, or fraudulent statement or representation, or making or using any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry in connection with the delivery of or payment for healthcare benefits, items, or services;

the federal Physician Payment Sunshine Act, implemented by the Centers for Medicare & Medicaid Services (CMS) as the Open Payments program, which requires manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid, or the Children's Health Insurance Program to report annually to the CMS, information related to payments and other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (including physician assistants and nurse practitioners), and teaching hospitals, and requires applicable manufacturers to report annually to CMS ownership and investment interests held by physicians and their immediate family members and payments or other transfers of value to such physician owners; and

analogous state and foreign law equivalents of each of the federal laws, such as anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payor, including commercial insurers and patients; state and foreign laws that require device companies to comply with the industry's voluntary compliance guidelines and the applicable compliance guidance promulgated by the government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state and foreign beneficiary inducement laws, and state and foreign laws that require device manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

The company is, or may become, subject to numerous data privacy and security obligations, including federal, state, local, and foreign laws, regulations, guidance, and industry standards related to data privacy and security. Such obligations may include, without limitation, the European Union's General Data Protection Regulation 2016/679 (EU GDPR), the EU GDPR as it forms part of the United Kingdom (U.K.) law by virtue of section 3 of the European Union (Withdrawal) Act 2018 (UK GDPR), and the ePrivacy Directive. Several states within the United States have enacted or proposed data privacy laws.

The company is also subject to various federal, state and foreign laws that protect the confidentiality of certain patient health information, including patient medical records, and restrict the use and disclosure of patient health information by healthcare providers, such as the Health Insurance Portability and Accountability Act, and its implementing regulations, as amended by Health Information Technology for Economic and Clinical Health Act enacted under the American Recovery and Reinvestment Act 2009 (collectively, HIPAA), in the United States.

History

SI-BONE, Inc. was founded in 2008. The company was incorporated in 2008 in Delaware.