Si-Bone (SIBN) FY2025 10-K Risk Factors: 8 New, 16 Dropped

What the changes say

Medicare reimbursement rates for CPT Code 27279 and 27278 drive adoption risks for iFuse products.
Patent expirations starting in August 2028 threaten exclusivity for iFuse and newer implant lines.
Compliance burdens grow with new state consumer health data laws and strict European MDR transitional provisions.

What changed since the prior 10-K

New

NewRisks Related to Our Business and Our Industry
the comparative benefits of our products that are intended for use in those procedures, sales of our implants could decline or fail to grow, which could adversely affect our business, results of operations and financial condition
Medicare set the 2026 physician fee for CPT Code 27279 at $762, while non-piercing implants under CPT Code 27278 range from $441 in facilities to $13,834 in office-based labs.
NewRisks Related to Our Business and Our Industry
We have historically been highly dependent on revenue from the sales of similar products focused on procedures, the goal of which is to stabilize and fuse the sacroiliac joint. Continued reliance on sales of similar products could negatively affect our results of operations and financial condition
Revenue depends heavily on the iFuse, iFuse 3D, iFuse TORQ, and iFuse Bedrock Granite implant families and single-source suppliers.
NewRisks Related to Our Business and Our Industry
If clinical experience with our implants or instruments does not result in positive outcomes for patients, or if clinical studies involving our implant systems fail to show meaningful patient benefit, sales of our products could be adversely impacted
Clinical studies targeting chronic SI joint dysfunction, sacral fractures, multilevel spine fusion, and pelvic fixation must show meaningful patient benefits.
NewRisks Related to Our Legal and Regulatory Environment
CCPA, also exempt some data processed in the context of clinical trials, these developments further complicate compliance efforts, and increase legal risk and compliance costs for us, the third parties with whom we work, and our customers
State laws like Washington's My Health My Data Act regulate consumer health data privacy and create a private right of action.
NewRisks Related to Our Legal and Regulatory Environment
groups. Some European regulators have ordered certain companies to suspend or permanently cease certain transfers out of Europe for allegedly violating the GDPR’s cross-border data transfer limitations
Europe's NIS2 directive imposes fines up to 10 million Euros or 2% of worldwide revenue for cybersecurity non-compliance.
NewRisks Related to Our Intellectual Property
We rely primarily on patent, copyright, trademark and trade secret laws, as well as confidentiality and nondisclosure agreements and other methods, to protect our proprietary technologies and know-how
U.S. patents for the original iFuse triangular shape expire by August 2028, while iFuse TORQ patents extend to February 2041.
NewRisks Related to Our Intellectual Property
As of December 31, 2025, we have 24 registered trademarks in the United States and have three pending trademark applications in the United States. We have registrations for 24 of these trademarks in 58 countries including the 27 European Union member countries
The company holds 24 U.S. registered trademarks and 24 foreign registrations across 58 countries.
NewRisks Related to Ownership of Our Common Stock
intellectual property to other parties, engaging in mergers or acquisitions, paying dividends or making other distributions, incurring indebtedness, transacting with affiliates, and entering into certain investments, in each case subject to certain exceptions
Covenants in the Amended Loan Agreement restrict debt incurrence, asset sales, and dividends, risking acceleration upon default.

Dropped

DroppedRisks Related to Our Business and Our Industry
include a sacroiliac joint evaluation as part of their diagnosis and, as a result, those patients may continue to receive unnecessary surgical procedures or only non-surgical treatment
DroppedRisks Related to Our Business and Our Industry
(e.g., office-based lab) setting. Minimally invasive sacroiliac fusion performed with a transfixing device is not eligible for payment in the office-based lab site-of-service and there is therefore no corresponding value for office-based reimbursement for CPT Code 27279
DroppedRisks Related to Our Business and Our Industry
competitors’ products or choose not to perform sacroiliac joint procedures altogether, which would adversely affect demand for our products
Physicians hesitant to change practices due to lack of experience or liability.
DroppedRisks Related to Our Business and Our Industry
control and assurance. For example, from time to time, we have experienced certain delays and may experience delays from our suppliers in the future
Certain transfixing devices ineligible for office-based lab reimbursement under CPT Code 27279.
DroppedRisks Related to Our Business and Our Industry
to generate revenue would be impaired, market acceptance of our products could be adversely affected, and customers may instead purchase or use our competitors’ products. Additionally, we could be forced to seek alternative sources of supply
DroppedRisks Related to Our Business and Our Industry
estimates and projections overestimate the size of this market or these benefits and cost savings, our sales growth may be adversely affected
Uncertainty in coverage and reimbursement rates impacting product demand.
DroppedRisks Related to Our Business and Our Industry
activities. Also, the failure to comply with applicable legal and regulatory obligations could result in the disruption of our distribution and sales activities
DroppedRisks Related to Our Business and Our Industry
our reputation, business, results of operations, and financial condition. In addition, the cost and operational consequences of implementing further data protection or data restoration measures could be significant
DroppedRisks Related to Our Legal and Regulatory Environment
unable to fulfil these obligations, or our Notified Body may consider that we have not adequately demonstrated compliance with our related obligations to merit a CE Certificate of Conformity on the basis of the Medical Device Regulation
DroppedRisks Related to Our Legal and Regulatory Environment
federal Physician Payment Sunshine Act, each of which is described in detail in "Item 1. Business - Healthcare Fraud and Abuse” and “-Data Privacy and Security Laws”
DroppedRisks Related to Our Legal and Regulatory Environment
or state regulatory authorities might challenge our current or future activities under these laws. Additionally, we cannot predict the impact of any changes in these laws, whether or not retroactive
Reliance on RMS for iFuse-3D, iFuse TORQ, and iFuse Bedrock Granite components.
DroppedRisks Related to Our Legal and Regulatory Environment
imposition of integrity obligations and agency oversight, damage to our reputation, and loss of goodwill, any of which could harm our operations, financial performance, and business. Moreover, despite our efforts, our personnel or third parties with whom we work may fail to comply with such obligations
Supply agreements lacking minimum purchase obligations for both parties.
DroppedRisks Related to Our Legal and Regulatory Environment
vary among countries and may involve requirements for substantial additional testing, and the time required to obtain approval may differ from country to country and from that required to obtain FDA clearance or approval or to obtain CE Certificates of Conformity
DroppedRisks Related to Our Legal and Regulatory Environment
insurance policy, these policies typically have substantial retentions or deductibles that we are responsible for. Product liability claims in excess of applicable insurance coverage could have a material adverse effect on our business, results of operations, and financial condition
DroppedRisks Related to Our Intellectual Property
As of December 31, 2024, we have 22 registered trademarks in the United States and have filed for three more. We have sought protection for at least fourteen of these trademarks in 60 countries including the 27 European member countries of the Madrid Protocol
DroppedRisks Related to Ownership of Our Common Stock
our ability to access our cash and cash equivalents could adversely impact our ability to meet our operating expenses, result in breaches of our contractual obligations or result in violations of federal or state wage and hour laws, any of which could have material adverse impacts on our operations and liquidity

Reworded

100% rewrittenRisks Related to Our Intellectual Property
If we or our licensors fail to adequately protect or enforce our intellectual property rights or secure rights to patents of others, the value of our intellectual property rights would diminish and our ability to successfully commercialize our products may be impaired
Updated patent portfolio figures as of December 31, 2025, showing 49 U.S. and 23 foreign issued patents, removing late 2025 expiration details.
91% rewrittenRisks Related to Our Legal and Regulatory Environment
Any delay in, or failure to receive or maintain, clearance or approval for our products under development could prevent us from generating revenue from these products or achieving profitability
Added that European Medical Device Regulation transitional provisions are subject to strict conditions.
89% rewrittenRisks Related to Our Legal and Regulatory Environment
We may fail to obtain or maintain foreign regulatory approvals to market our products in other countries
Clarified that international approvals may require substantial additional testing and vary from FDA clearance or CE certificates.
78% rewrittenRisks Related to Our Business and Our Industry
We may not be able to demonstrate to physicians that our products are attractive alternatives to our competitors’ products and that our procedures are attractive alternatives to existing surgical and non-surgical treatments for their respective indications
Removed specific historical context about physicians lacking adequate surgical procedures prior to iFuse introduction.
Was: We may not be able to convince physicians that our products are attractive alternatives to our competitors’ products and that our procedures are attractive alternatives to existing surgical and non-surgical treatments for their respective indications
69% rewrittenRisks Related to Our Business and Our Industry
Healthcare reforms may have a material adverse effect on our operations
Retained healthcare reform and cost containment risk text without substantive operational changes.
68% rewrittenRisks Related to Our Business and Our Industry
Physicians and payors may not find the clinical evidence supporting our more recent products to be compelling, which could limit our sales and revenue, and on-going and future research may prove our products to be less safe and effective than currently thought
Added that European EEA products have been CE marked where applicable.
63% rewrittenRisks Related to Our Business and Our Industry
Uncertainty in the coverage and reimbursement environment may decrease demand for our products and adversely affect our business
Updated CPT code definitions to specify piercing versus non-piercing intra-articular and transarticular procedures effective January 1, 2026.
56% rewrittenRisks Related to Our Business and Our Industry
We are required to maintain adequate levels of inventory, the failure of which could consume our resources and reduce our cash flows
Retained inventory obsolescence and surgical set backup component risks without textual changes.
55% rewrittenRisks Related to Our Business and Our Industry
Our results of operations could suffer if we are unable to manage our international business effectively
51% rewrittenRisks Related to Our Business and Our Industry
development involves a high degree of risk and there can be no assurance that our new product development efforts will result in any commercially successful products
51% rewrittenRisks Related to Our Business and Our Industry
We have incurred significant operating losses since inception, we may continue to incur operating losses in the future, and we may not be able to achieve or sustain future profitability
50% rewrittenRisks Related to Ownership of Our Common Stock
Our loan and security agreement contains covenants that may restrict our business and financing activities
50% rewrittenRisks Related to Ownership of Our Common Stock
Our ability to access credit on favorable terms, if necessary, for the funding of our operations and capital projects may be limited due to changes in credit markets
47% rewrittenRisks Related to Our Legal and Regulatory Environment
We depend on a number of third parties in relation to the provision of our services, a number of which process personal data on our behalf. These third party service providers may breach their contractual or legal obligations, which could negatively affect our business and/or our reputation
42% rewrittenRisks Related to Our Business and Our Industry
Practice trends, market dynamics, and other factors, have caused, and may continue to cause, procedures to shift from the hospital environment to ambulatory surgical centers ("ASCs") or office-based labs ("OBLs") where pressure on the prices of our products is generally more acute
34% rewrittenRisks Related to Our Legal and Regulatory Environment
Certain of the products we market are derived from human tissue and are or could be subject to additional regulations and requirements
Was: Certain of our products are derived from human tissue and are or could be subject to additional regulations and requirements
31% rewrittenRisks Related to Our Business and Our Industry
We operate in a very competitive business environment and if we are unable to compete successfully against our existing or potential competitors, our sales and operating results may be adversely affected
30% rewrittenRisks Related to Our Legal and Regulatory Environment
We may incur product liability losses, and insurance coverage may be inadequate or unavailable to cover these losses
27% rewrittenRisks Related to Our Legal and Regulatory Environment
The results of our clinical trials may not support our product candidate claims or may result in the occurrence of adverse events
25% rewrittenRisks Related to Ownership of Our Common Stock
We may be unable to utilize our federal and state net operating loss carryforwards to reduce our income taxes
23% rewrittenRisks Related to Ownership of Our Common Stock
Adverse developments affecting the banking industry or the broader financial services industry, such as actual events or concerns involving liquidity, defaults or non-performance, could adversely affect our operations and liquidity
21% rewrittenRisks Related to Our Business and Our Industry
We have incorporated and continue to work to further incorporate artificial intelligence into our operations. Implementation of artificial intelligence and machine learning technologies may result in legal and regulatory risks, reputational harm, or other adverse consequences to our business

All 62 risk factors

Headings as the filing states them, in filing order.

Risks Related to Our Business and Our Industry

01We operate in a very competitive business environment and if we are unable to compete successfully against our existing or potential competitors, our sales and operating results may be adversely affected31% rewritten
02We have incurred significant operating losses since inception, we may continue to incur operating losses in the future, and we may not be able to achieve or sustain future profitability51% rewritten
03the comparative benefits of our products that are intended for use in those procedures, sales of our implants could decline or fail to grow, which could adversely affect our business, results of operations and financial conditionNew
04Uncertainty in the coverage and reimbursement environment may decrease demand for our products and adversely affect our business63% rewritten
05Healthcare reforms may have a material adverse effect on our operations69% rewritten
06Pricing pressure from our competitors, healthcare provider consolidation, the presence of physician-owned distributorships, and payor consolidation may impact our ability to sell our product at prices necessary to support our current business strategies
07Practice trends, market dynamics, and other factors, have caused, and may continue to cause, procedures to shift from the hospital environment to ambulatory surgical centers ("ASCs") or office-based labs ("OBLs") where pressure on the prices of our products is generally more acute42% rewritten
08We have historically been highly dependent on revenue from the sales of similar products focused on procedures, the goal of which is to stabilize and fuse the sacroiliac joint. Continued reliance on sales of similar products could negatively affect our results of operations and financial conditionNew
09Prolonged inflation and supply chain disruptions could result in delayed product launches, lost revenue, higher costs and decreased profit margins
10Disruptions in the supply of the materials and components used in manufacturing our products or the sterilization of our products by third-party suppliers could adversely affect our business, financial condition and results of operations
11Physicians and payors may not find the clinical evidence supporting our more recent products to be compelling, which could limit our sales and revenue, and on-going and future research may prove our products to be less safe and effective than currently thought68% rewritten
12We may not be able to demonstrate to physicians that our products are attractive alternatives to our competitors’ products and that our procedures are attractive alternatives to existing surgical and non-surgical treatments for their respective indications78% rewritten
13If clinical experience with our implants or instruments does not result in positive outcomes for patients, or if clinical studies involving our implant systems fail to show meaningful patient benefit, sales of our products could be adversely impactedNew
14If we are unable to maintain our network of direct sales representatives, third-party sales agents, and resellers, we may not be able to generate anticipated sales
15Our business could suffer if we lose the services of key members of our senior management, key advisors or personnel
16If use of our products results in adverse events, this may require them to be taken off the market, require them to include safety warnings or otherwise limit their sales
17Various factors outside our direct control may adversely affect manufacturing, sterilization, and distribution of our products
18If we are not able to manage growth successfully, it could adversely affect our business, financial condition, and results of operations
19Unfavorable media reports or other negative publicity concerning both alleged improper methods of tissue recovery from donors and disease transmission from donated tissue could limit widespread acceptance of some of the products we market
20Natural disasters and man-made business disruptions such as war and terrorism could seriously harm our future revenue and financial condition and increase our costs and expenses
21We may encounter problems or delays in the assembly of our products or fail to meet certain regulatory requirements which could result in an adverse effect on our business and financial results
22If we do not enhance and broaden our product offerings through our research and development efforts, we may be unable to compete effectively
23We are required to maintain adequate levels of inventory, the failure of which could consume our resources and reduce our cash flows56% rewritten
24Our results of operations could suffer if we are unable to manage our international business effectively55% rewritten
25These risks may limit or disrupt our expansion, restrict the movement of funds or result in the deprivation of contractual rights or the taking of property by nationalization or expropriation without fair compensation
26In the future our products may become obsolete, which would negatively affect operations and financial condition
27development involves a high degree of risk and there can be no assurance that our new product development efforts will result in any commercially successful products51% rewritten
28We have incorporated and continue to work to further incorporate artificial intelligence into our operations. Implementation of artificial intelligence and machine learning technologies may result in legal and regulatory risks, reputational harm, or other adverse consequences to our business21% rewritten
29We may seek to grow our business through acquisitions of or investments in new or complementary businesses, products or technologies, and the failure to manage acquisitions or investments, or the failure to integrate them with our existing business, could have a material adverse effect on us
30We may enter into collaborations, in-licensing arrangements, joint ventures, strategic alliances, or partnerships with third-parties that may not result in the development of commercially viable products or the generation of significant future revenue
31Epidemic diseases, or the perception of their effects, may continue to adversely affect our business, financial condition, results of operations, or cash flows

Risks Related to Our Legal and Regulatory Environment

32We, our suppliers, and our third-party manufacturers are subject to extensive governmental regulation both in the United States. and abroad, and failure to comply with applicable requirements could cause our business to suffer
33Before we can market or sell a new regulated medical device or make a significant modification to an existing product in the United States, with limited exceptions, we must obtain either clearance under Section 510(k) of the FDCA for Class II devices or approval of a PMA application from the FDA for a Class III device
34Any delay in, or failure to receive or maintain, clearance or approval for our products under development could prevent us from generating revenue from these products or achieving profitability91% rewritten
35CCPA, also exempt some data processed in the context of clinical trials, these developments further complicate compliance efforts, and increase legal risk and compliance costs for us, the third parties with whom we work, and our customersNew
36groups. Some European regulators have ordered certain companies to suspend or permanently cease certain transfers out of Europe for allegedly violating the GDPR’s cross-border data transfer limitationsNew
37We depend on a number of third parties in relation to the provision of our services, a number of which process personal data on our behalf. These third party service providers may breach their contractual or legal obligations, which could negatively affect our business and/or our reputation47% rewritten
38We are subject to risks associated with our non-U.S. operations
39Our employees, independent contractors, consultants, manufacturers, and third-party sales agents and resellers may engage in misconduct or other improper activities, relating to regulatory standards and requirements
40We may be subject to enforcement action, including fines, penalties or injunctions, if we are determined to be engaging in the off-label promotion of our products
41We are required to report certain malfunctions, deaths, and serious injuries associated with our products, which can result in voluntary corrective actions or agency enforcement actions
42Modifications to our products may require new 510(k) clearances or premarket approvals and new conformity assessment by our Notified Body, or may require us to cease marketing or recall the modified products until clearances, approvals, or CE Certificates of Conformity are obtained
43There is no guarantee that the FDA will grant 510(k) clearance or premarket approval of our future products or that our Notified Body will issue the required CE Certificate of Conformity, and failure to obtain necessary clearances or approvals for our future products would adversely affect our business prospects
44We may fail to obtain or maintain foreign regulatory approvals to market our products in other countries89% rewritten
45The results of our clinical trials may not support our product candidate claims or may result in the occurrence of adverse events27% rewritten
46We may incur product liability losses, and insurance coverage may be inadequate or unavailable to cover these losses30% rewritten
47We are subject to environmental laws and regulations that can impose significant costs and expose us to potential financial liabilities
48Certain of the products we market are derived from human tissue and are or could be subject to additional regulations and requirements34% rewritten

Risks Related to Our Intellectual Property

49If we or our licensors fail to adequately protect or enforce our intellectual property rights or secure rights to patents of others, the value of our intellectual property rights would diminish and our ability to successfully commercialize our products may be impaired100% rewritten
50We rely primarily on patent, copyright, trademark and trade secret laws, as well as confidentiality and nondisclosure agreements and other methods, to protect our proprietary technologies and know-howNew
51As of December 31, 2025, we have 24 registered trademarks in the United States and have three pending trademark applications in the United States. We have registrations for 24 of these trademarks in 58 countries including the 27 European Union member countriesNew
52We may be subject to damages resulting from claims that we, our employees, or our third-party sales agents or resellers have wrongfully used or disclosed alleged trade secrets of our competitors or are in breach of non-competition or non-solicitation agreements with our competitors
53The medical device industry is characterized by patent litigation and we could become subject to litigation that could be costly, result in the diversion of management’s time and efforts, require us to pay damages, and/or prevent us from developing or marketing our existing or future products

Risks Related to Ownership of Our Common Stock

54The price of our common stock may be volatile, and the value of an investment in our common stock could decline
55Our sales volumes and our operating results may fluctuate over the course of the year, which could affect the price of our common stock
56We may be unable to utilize our federal and state net operating loss carryforwards to reduce our income taxes25% rewritten
57Our charter documents and Delaware law could discourage takeover attempts and lead to management entrenchment
58A Delaware corporation may opt out of this provision by express provision in its original certificate of incorporation or by amendment to its certificate of incorporation or bylaws approved by its stockholders. However, we have not opted out of, and do not currently intend to opt out of, this provision
59Adverse developments affecting the banking industry or the broader financial services industry, such as actual events or concerns involving liquidity, defaults or non-performance, could adversely affect our operations and liquidity23% rewritten
60Our loan and security agreement contains covenants that may restrict our business and financing activities50% rewritten
61intellectual property to other parties, engaging in mergers or acquisitions, paying dividends or making other distributions, incurring indebtedness, transacting with affiliates, and entering into certain investments, in each case subject to certain exceptionsNew
62Our ability to access credit on favorable terms, if necessary, for the funding of our operations and capital projects may be limited due to changes in credit markets50% rewritten

Other Si-Bone 10-Ks

FY2024 10-K risk factors
70 risks
SI-BONE faces ongoing operating losses with an accumulated deficit of $431.4 million as of December 31, 2024. The company relies heavily on third-party suppliers like RMS for key implants and faces intense pricing and reimbursement pressures. Operations are subject to stringent FDA regulations and the adoption risks of the iFuse family of implants.
Filed Feb 25, 2025

About this page

The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.