SIBN 10-K & 10-Q changes, risk factors and insider trading

We have incurred net losses since our inception in 2008. For the years ended December 31, 2025, 2024, 2023, and 20222023 we had net losses of $30.9$18.9 million, $43.3$30.9 million, and $61.3$43.3 million, respectively. As of December 31, 2024,2025, we had an accumulated deficit of $431.4$450.3 million. We have financed our operations primarily through the net proceeds of our public offerings of our common stock, private placements of equity securities, certain debt-related financing arrangements, and from sales of our products. We have devoted substantially all of our resources to research and development of our products, sales and marketing activities, investments in training and educating surgeonsphysicians and other healthcare providers, and clinical and regulatory matters for our products. There can be no assurances that we will be able to generate sufficient revenue from our existing products or from any of our product candidates in development, and to transition to profitability and generate consistent positive cash flows. We expect that our operating expenses will continue to increase as we continue to develop, enhance, and commercialize our existing and new products and grow our commercial infrastructure. As a result, we may continue to incur operating losses for some time and may never achieve profitability. Furthermore, even if we do achieve profitability, we may not be able to sustain or increase profitability on an ongoing basis. If we do not achieve profitability, it will be more difficult for us to finance our business and accomplish our strategic objectives.

Our expected future capital requirements depend on many factors including expanding our physician base, the expansion of our sales force including through hybrid sales agencies, investment in implants and instruments, the timing and extent of spending on the development of our technology to increase our product offerings, and potential investment in additional product and service offerings through the acquisition of other businesses. We may need additional funding for our operations, but additional funds may not be available to us on acceptable terms on a timely basis, if at all. We may seek funds through borrowings or through additional rounds of financing, including private or public equity or debt offerings. If we raise additional funds by issuing equity securities, our stockholders may experience dilution. Any future debt financing into which we enter may impose upon us additional covenants that restrict our operations, including limitations on our ability to incur liens or additional debt, pay dividends, repurchase our common stock, make certain investments, and engage in certain merger, consolidation or asset sale transactions. Any future debt financing or additional equity that we raise may contain terms that are not favorable to us or our stockholders. Furthermore, we cannot be certain that additional funding will be available on acceptable terms, if at all. The capital markets have deteriorated substantially since the beginning of 2022, especially with respect to securities issued by small- and mid-cap companies in the medical device sector. Equity and debt capital have become substantially more expensiveexpensive, unpredictable, and difficult to raise on attractive terms. If we are unable to raise additional capital or generate sufficient cash from operations to adequately fund our operations, we will need to curtail planned activities to reduce costs, which will likely harm our ability to execute on our business plan and continue operations.

Maintaining and growing sales of our products depends on the availability of adequate coverage and reimbursement from third-party payors,payers, including government programs such as Medicare and Medicaid, Veterans Administration benefits, private insurance plans, and managed care programs. Hospitals, physicians, and other healthcare providers that purchase or use medical devices generally rely on third-party payorspayers to pay for all or part of the costs and fees associated with the procedures performed with these devices. When a procedure using our implants is performed, the reimbursement process depends on the site of service. For procedures performed in a hospital or ambulatory surgical center, both the physicians and the healthcare facility submit claims for reimbursement to the healthcare payor.payer. When the procedure is performed in an office-based lab, a single claim covers both physician services and facilityoverhead costs.costs including supplies and implants.

The AMA develops and maintains CPT codes that are used by third-party payors to determine the amount of reimbursement that a healthcare provider and facility will receive for a particular service. As of January 1, 2025,2026, the Medicare physician fee reimbursement for minimally invasive sacroiliac joint fixation or fusion with our laterally placed transfixingtransarticular iFuse implants, described as CPT Code 27279, is $790.$762. As of January 1, 2025,2026, Medicare physician fee for procedures using intra-articular, non-transfixingnon-piercing implants, including our iFuse INTRA X bone allograft products, is $465$441 when performed in the facility setting, and $11,805$13,834 when performed in the physician office (e.g., office-based lab) setting. Minimally invasive surgical sacroiliac joint fixation or fusion performed with a transfixingtransarticular or intra-articular piercing device is currently not eligible for payment in the office-based lab site-of-servicesite of service and there is therefore no corresponding value for office-based reimbursement for CPT Code 27279.

Even to the extent our products and procedures using our products are currently covered and reimbursed by third-party private and public payors,payers, adverse changes in coding, coverage and reimbursement policies that affect our products, discounts, and number of implants used may also drive our prices and revenue down and harm our ability to market and sell our products.

While all Medicare Administrative Contractors ("MAC") and a predominant number of private payers are regularly reimbursing for minimally invasive surgical sacroiliac joint fixation or fusion utilizing laterally placed transfixing devicesreported under CPT Code 27279, a small number of private payorspayers still have policies that treat the procedure as experimental or investigational and do not regularly reimburse for the procedure. We expect at least some of these payers to also cover newer sacroiliac joint procedures utilizing intra-articular devices that pierce cortical walls of the ilium and sacrum bones, and are reported under CPT Code 27279.

In contrast, the reimbursement environment for the procedure described by CPT Code 27278 (placement of intra-articularintra-articular, non-piercing device or allograft implant without the placement of a transfixing device) is less consistent. In 2024, three Medicare Administrative Contractors finalized Local Coverage Determinations precluding coverage for CPT Code 27278. The coverage decisions of the remaining Medicare Administrative Contractors remain uncertain. We believe this reimbursement environment has impacted demand for our iFuse INTRA X products.

Commercial payorspayers generally set their physician fee reimbursement with reference to Medicare reimbursement rates. Many have yet to set coverage decisions for CPT Code 27278, and may decide not to cover these procedures until more evidence is developed. There is a small number of commercial payers with positive coverage policies for CPT Code 27278 procedures, and many may allow coverage on a case-by-case basis.

We may be unable to sell our products on a profitable basis if third-party payorspayers deny coverage, or if reimbursement levels are insufficient to support use of our products by healthcare facilities or to compensate physicians for their time spent diagnosing patients and performing procedures using our products. Even if favorable coverage and reimbursement status is attained for procedures using our implants, less favorable coverage policies and reimbursement rates may be implemented in the future.

Future action by the Centers for Medicare and Medicaid Services ("CMS"), its MACs, or commercial third-party payorspayers may reduce the availability of payments to physicians, outpatient surgery centers, and/or hospitals for procedures using our products. Volatility in the payment rates that physicians and hospitals receive from CMS may have a material impact on their willingness to perform procedures including our products, as well as place additional pressure on pricing of our implants. CMS policies on incremental or differentiated reimbursement for eligible products and procedures may also change. Our request that CMS consider MS-DRG reassignment for FY 2027 of certain inpatient hospital-based procedures involving the iFuse Bedrock Granite are paid adequately may affect hospitals’ future willingness to continue adopting high-cost implants in favor of less expensive alternatives. In addition, our reliance on incremental reimbursement eligibility-based programs for high-cost, innovative technologies, such as NTAP and TPT, may come under added scrutiny during review, or may be subject to future changes in policy as between the FDA and CMS.

Minimally invasive surgical sacroiliac joint fusion procedures are primarily separated into two main types: procedures where devices placed either via transarticular or intra-articular approach fixate within the joint by means of “piercing” the dense outer cortical walls of the ilium and sacrum bones, and those procedures where devices transfixor theallograft joint,implants anduse neweronly procedures usingan intra-articular (in-line)approach devices thatand do not transfixpierce cortical walls of both the joint.ilium and sacrum bones. The transfixingcortical piercing transarticular and intra-articular procedures are described by CPT Code 27279.27279, which was updated by the AMA CPT Editorial Panel effective for procedures as of January 1, 2026. The non-transfixingnon-piercing intra-articular procedures are described by CPT Code 27278, which was adopted by the AMA CPT Editorial Panel oneffective for procedures as of January 1, 2024.

We believe that the favorable coverage and reimbursement profile of CPT Code 27279 as compared to CPT Code 27278 is a result of third-party payers’ review and assessment of peer-reviewed clinical literature supporting its use. Most procedures available to U.S. patients have a clear coding interpretation, reported as either CPT Code 27279 or 27278. AmbiguityAdditionally, exists,recent however,clarity overby the AMA CPT Editorial Panel regarding the proper categorization of some sacroiliac joint devices which use an intra-articular (in-line) approach, but also have integrated fixation design features which “pierce” ilium and sacrum bones on either side of the implant.implant Thewill AMAsupport ispayers' currently receiving proposals to change some code definitions, including for CPT code 27278review and CPTconsideration code 27279, to allow for newerof sacroiliac joint procedures via the CPT Editorial process, which would impact the reporting of procedures effective January 1, 2026. These changes could impact the code definitions of either or both of these codes.procedures.

If procedures requiring lower work effort supported by lower-quality clinical evidence, and/or having less favorable patient outcomesoutcomes, are reported via CPT Code 27279 insteadwith ofgreater CPT Code 27278frequency as a result of future changes to the code definitions, it may contribute to a loss of value for CPT Code 27279. This dynamic could also prompt reevaluations of third-party payers’ coverage policies, which could ultimately decrease demand for our products and negatively impact our business and prospects. Additionally, if physicians and facilities are confused about the proper coding for our products or our competitors’ products, physicians may choose competitors’ products or choose not to perform sacroiliac joint procedures altogether, which would adversely affect demand for our products.

Recent political, economic, and regulatory influences are subjecting the healthcare industry to fundamental changes that can impact coverage and reimbursement from third-party payors. We expect that the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2011,2011 (collectively the "ACA"), as currently enacted or as it may be amended in the future, and other healthcare reform measures that may be adopted in the future, could have a material adverse effect on our industry generally and on our ability to maintain or increase sales of our existing products. InSince addition,its enactment, there have been amendments and judicial, Congressional and executive branch challenges to certain aspects of the ACA. For example, on AugustJuly 16,4, 2022, President Biden signed2025, the InflationOne ReductionBig Beautiful Bill Act of(the 2022 (“IRAOBBBA”), was signed into law, which narrowed access to ACA marketplace exchange enrollment and declined to extend the ACA enhanced advanced premium tax credits that expired at the end of 2025, which, among other things,provisions extendsin enhancedthe subsidieslaw, are anticipated to reduce the number of Americans with health insurance. The OBBBA also is expected to reduce Medicaid spending and enrollment by implementing work requirements for individualssome purchasingbeneficiaries, healthcapping insurancestate-directed coveragepayments, reducing federal funding, and limiting provider taxes used to fund the program. Congress is considering proposed legislation intended to further reduce healthcare costs with alternatives to replace the expired ACA subsidies. We expect that additional U.S. federal healthcare reform measures will be adopted in ACAthe marketplacesfuture, throughany planof yearwhich 2025.could The IRA also eliminateslimit the “donutamounts hole” underthat the MedicareU.S. Partfederal Dgovernment programwill beginningpay for healthcare products and services, which could result in 2025reduced bydemand significantlyfor loweringour the beneficiary maximum out-of-pocket cost and creating a new manufacturer discount program. Further, CMS budget neutrality requirements may impose cuts to the Medicare physician fee schedule, which may be mitigated by acts of Congressproducts or otheradditional changespricing to regulations.pressures. Other federal laws, known as budget sequestration, further reduce Medicare’s payments to providers by 2%, which, due to subsequent legislative amendments, will stay in effect through 2032. These reductions may reduce reimbursement for procedures performed using our products, which could potentially negatively impact our revenue, and may reduce providers’ revenues or profits, which could affect their ability to purchase new technologies. Both the federal and state governments in the United States and foreign governments continue to propose and pass new legislation and regulations designed to contain or reduce the cost of healthcare. Such legislation and regulations may result in decreased reimbursement for medical devices,devices or procedures in which may further exacerbate industry-wide pressure to reduce the prices charged for medical devices.devices are used. This could harm our ability to market our products and generate sales, which could adversely affect our business, results of operations and financial condition.

We anticipate that more outpatient eligible procedures will be performed in ASCs and OBLs to control costs and expand patient access to medical procedures. This shift accelerated during the COVID-19 pandemic, and we expect it to continue because ASCs and OBLs are generally a more economically favorable site of service, and physicians performing the procedures and their practices sometimes have ownership interests in the ASC and generally own the OBL.OBL outright. Because reimbursement for procedures in an ASC or OBL is typically less than the reimbursement in an in-patient setting and due to physicians’ economic interest in ASCs and OBLs, we typically experience more pressure on the pricing of our products by ASCs and OBLs than by hospitals, and the average price for which we sell our products to ASCs and OBLs can be less than the average prices we charge to hospitals. In addition, some physicians may choose to use fewer implants per case due to their interest in the profitability of the ASC or OBL. An accelerated shift of procedures using our products to ASCs and OBLs could adversely impact the average selling prices of our products and/or the number of implants we are able to sell, and our revenues could suffer as a result.

In 2024, CMS announced a TPT payment status for the use of the iFuse Bedrock Granite implant system in hospital outpatient and ASC settings of care, for procedures effective January 1, 2025. TPT allows the hospital outpatient departments and ASCs supporting the case to “pass through” the costs of the iFuse Bedrock Granite technology to the Medicare program, to encourage innovation and early access of new technologies for Medicare beneficiaries. We anticipate this may reduce pricing pressure on our Granite family of implants in the outpatient sites of care, particularly where the Medicare population is heavier. However, we have less experience with our Granite implants being used in outpatient procedures and it remains to be seen whether surgeons will perform more of these procedures in the outpatient setting in the future.

We have historically been highly dependent on revenue from the salesales of a single family ofsimilar products focused on procedures, the goal of which is to stabilize and fuse the sacroiliac joint. Continued reliance on a single familysales of similar products and single family of procedures could negatively affect our results of operations and financial condition.

The majority of our revenue comes from the sale of iFuse, iFuse-3D,iFuse 3D, iFuse TORQ, and iFuse Bedrock Granite implants, and related tools and instruments. Therefore, we are dependent on widespread market adoption of the iFuse family ofour products, and we will continue to be dependent on the success of this single product family for the foreseeable future. There can be no assurance that our solutions will maintain a substantial degree of market acceptance among physicians, patients or healthcare providers. Our failure to successfully grow the market for our solutions and increase our share within that market or any other event impeding our ability to sell iFuse, could adversely affect our results of operations, financial condition and continuing operations.

We generally use a small number of suppliers for our instruments and currently rely on RMS for iFuse-3DiFuse 3D and iFuse TORQ implants and for several of the components, including the assembly and packaging, of our iFuse Bedrock Granite implants. Our dependence on such a limited number of suppliers exposes us to risks, including, among other things:

A majority of our products are manufactured and sold inside of the United States, which increases our exposure to domestic inflation and fuel price increases. Inflationary pressures may result in increased fuel, raw materials and other costs which, if they continue for a prolonged period, may adversely affect our results of operations. We continue to actively monitor the impact of various macroeconomic trends, such as tariffs, changes to international trade agreements, labor costs, interest rates, inflation rates, and geopolitical instability within the United States and abroad. The implementation of more restrictive trade policies, including the imposition of further tariffs in connection with the new presidential administration in the United States and retaliatory tariffs in response thereto, or the renegotiation of existing trade agreements with the United States or countries where we source supplies, could have a material adverse effect on our business, results of operations and financial condition. For example, much of the titanium used in our implants is sourced from Canada and any disruption to trade with Canada caused by tariffs could increase the cost or disrupt the supply of our implants, which could materially harm our business, financial condition and results of operation. Our efforts to mitigate supply chain weaknesses may not be successful or may have unfavorable effects. For example, efforts to purchase raw materials in advance for product manufacturing may result in increased storage costs or excess supply. If our costs rise due to significant inflationary pressures, tariffs, or supply chain disruptions, we may not be able to fully offset such higher costs through price increases. In addition, delays in obtaining materials, components or instruments from our suppliers could delay product launches or result in lost opportunities to sell our products due to their availability. Increased costs and decreased product availability due to supply chain issues could adversely impact our revenue and/or gross margin, and could thereby harm our business, financial condition, and results of operation.operations.

Our suppliers purchase many of the materials and components used in the manufacture of our products from third-party suppliers. Certain of these materials and components can only be obtained from a single source or a limited number of sources due to quality considerations, expertise, costs or constraints resulting from regulatory requirements. In certain cases, our suppliers may not be able to establish additional or replacement suppliers for such materials or components or outsourced activities in a timely or cost-effective manner. A reduction or interruption in the supply of materials or components used in manufacturing our products, such as due to one or more suppliers experiencing reductions in operations and/or worker absences due to health epidemics, an inability to timely develop and validate alternative sources if required, or a significant increase in the price of such materials or components, such as that caused by inflationtariffs and risingretaliatory countermeasures, inflation or interest rates,rates fluctuations, could adversely affect our business, financial condition and results of operations. For example, certain of our products require titanium, which is sourced from third-party suppliers. While the titanium required for such products is not directly sourced from Russia, the current geopolitical events involving Russia and Ukraine are negatively impacting the wider titanium supply chain. These geopolitical events and related factors and results, including related sanctions, may negatively impact the ability of our suppliers’ third-party supply sources to timely supply titanium to our suppliers and may increase or result in additional costs to us. The imposition of tariffs on titanium sourced from Canada or elsewhere could further exacerbate these challenges and increase the cost of our implants.

The products we currently market in the United States have either received premarket clearance under Section 510(k) of the United States FDCA, or are exempt from premarket review. Those marketed in the EEA have been the subject of a CE Certificate of Conformity.Conformity, where applicable, and have been CE marked. The 510(k) clearance process of the FDA requires us to document that our product is “substantially equivalent” to another 510(k)-cleared product. The 510(k) process is shorter and typically requires the submission of less supporting documentation than other FDA approval processes, such as a PMA, and does not usually require pre-clinical or clinical studies. As a result, each of our products has been launched prior to gathering substantial prospective clinical trial evidence, and our post-market clinical studies may lack the size and scope of randomized controlled clinical trials required to support approval of a PMA. For these reasons, physicians may be slow to adopt our more recent products including iFuse TORQ, iFUseiFuse Bedrock GraniteGranite, iFuse TORQ TNT, and iFuse INTRA,INTRA/INTRA X, each of which are supported by smaller bodies of clinical evidence than iFuse and iFuse-3D,iFuse 3D, third-party payors may be slow to provide coverage for novel procedures and techniques using these products, and we may be subject to greater regulatory and product liability risks. Further, future patient studies or clinical experience may indicate that treatment with any of our products does not improve patient outcomes. Such results would slow the adoption of our products by physicians, significantly reduce our ability to achieve expected sales, and could prevent us from achieving profitability.

If clinical experience with our iFuse Bedrock techniqueimplants or ourinstruments iFuse Bedrock Granite, iFuse TORQ, or iFuse INTRA products dodoes not result in positive outcomes for patients, or if clinical trialsstudies involving theour useimplant of iFuse Bedrock, iFuse Bedrock Granite, iFuse INTRA and/or iFuse TORQsystems fail to show meaningful patient benefit, sales of our iFuse, iFuse-3D, iFuse TORQ and/or iFuse Bedrock Granite implantsproducts could be adversely impacted.

As we launch new products, expand physician call points, and increase our marketing efforts with respect to existing products, we will need to expand the reach of our marketing and sales networks. Our future success will depend largely on our ability to continue to hire, train, retain and motivate skilled direct sales representatives and third-party sales agents and resellers with significant technical knowledge in various areas, such as spine and pelvic health and treatment. New sales representatives and agents require training and take time to achieve full productivity. If we fail to train new sales representatives and third-party sales agents adequately, or if we experience high turnover in our sales force in the future, we cannot be certain that new sales representatives and third-party sales agents will become as productive as may be necessary to maintain or increase our sales. If a direct sales representative or third-party sales agent or reseller departs and is retained by one of our competitors, we may be unable to prevent them from helping competitors solicit business from our existing customers, which could further adversely affect our sales. The launch of new products or entrance into new markets could distract our sales representatives from existing customers and markets and redirect resources from existing to novel markets. Furthermore, any such change affects our ability to hire, contract with and retain members of our direct sales force and third-party sales agents and resellers. Because of the intense competition for their services, we may be unable to recruit or retain additional qualified third-party sales agents and resellers or to hire additional direct sales representatives to work with us. Furthermore, we may not be able to enter into agreements with them on favorable or commercially reasonable terms, if at all. Failure to hire or retain qualified direct sales representatives or third-party sales agents and resellers would prevent us from expanding our business and generating sales. If our direct sales representatives or third-party sales agents fail to adequately promote, market and sell our products or decide to leave or cease to do business with us, our sales could significantly decrease.

Our business is highly reliant on a base of skilled employees, including those serving in engineering, information technology, operational, strategic marketing and sales functions. Many of these employees have developed specialized skills which are valuable within the medical device and life sciences industry, and, in some cases, in a broader variety of industries. Competition for skilled employees remains significant. If we experience turnover among our employees at a higher rate than expected, managing our labor force could become difficult and more costly, adversely impacting our results of operation.operations. Sustained pressure in these labor markets could also cause prevailing wages to rise, which could adversely impact our business, results of operationoperations and financial condition.

• sales of the product may decrease significantly, and we may not achieve the anticipated market share;

• regulatory authorities or our Notified Body may require changes to the labeling of our product. This may include the addition of labeling statements, specific warnings, and contraindications and issuing field alerts to physicians and patients;

• we may be required to change instructions regarding the way the product is implanted or conduct additional clinical trials;

• we may be subject to limitations on how we may promote the product;

• regulatory authorities may require us to temporarily or permanently take our approved product off the market or to conduct other field safety corrective actions;

• our Notified Body may suspend, amend, or withdraw our CE Certificate of Conformity or refuse or delay any ongoing applications relating to the issuance or renewal of CE Certificates of Conformity;

• we may be required to modify our product;

• we may be subject to litigation fines or product liability claims; and

• our reputation may suffer.

• supply chain disruptions, including those caused by material and labor supply shortagesshortages, tariffs and retaliatory countermeasures, and prolonged inflation;

• managing production yields;

We market our 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 in other countries. As of December 31, 2024,2025, more than 115,000140,000 procedures have been performed by over 4,300 physicians in the United States and 38 other countries since we introduced iFuse in 2009.

As of December 31, 2024,2025, our U.S. sales force consisted of 89 territory sales managers and 83 clinical support specialists directly employed by us and 320 third-party sales agents, compared to 87 territory sales managers and 71 clinical support specialists directly employed by us and 252 third-party sales agents, compared to 82 territory sales managers and 69 clinical support specialists directly employed by us and 175 third-party sales agentagents as of December 31, 2023.2024. As of December 31, 2024,2025, our international sales force consisted of 911 sales representatives directly employed by us and 3128 third-party sales agents and resellers, compared to 149 sales representatives directly employed by us and 31 third-party sales agents and resellers as of December 31, 2023.2024.

For fiscal year ended December 31, 2024,2025, over 25 percent33% of our procedures for sacroiliac joint dysfunction were performed at ASCs and OBLs. With the steady increase in the numbers of minimally invasive procedures, including sacroiliac joint fusion procedures, being performed at ASCs, we continue to actively engage with these facilities to educate their management groups on our clinical evidence, exclusive commercial payor coverage and focus on driving improved education and pathways between pain physicians and surgeons.

Engaging and educating physician and other healthcare professionals about the clinical merits and patient benefits of our solutions will beis important to growgrowing physician adoption.adoption and utilization of our solutions. Our medical affairs team works closely with our sales team to increase physician engagement and activation. Physician activity includes both the number of physicians performing our procedures as well as the number of procedures performed per physician. In addition to training new physicians,physicians and working with our existing physician customers to grow their use of our products, we have several initiatives to re-engage inactive physicians.

Our revenue from sales of implants fluctuatefluctuates based on volume of cases (procedures performed), discounts, mix of international and U.S. sales, different implant pricing and the number of implants used for a particular patient. Similar to other orthopedic companies, our case volume can vary from quarter to quarter due to a variety of factors including reimbursement, sales force changes, physician activities, product launches, and seasonality. In addition, our revenue is impacted by changes in average selling price as we respond to the competitive landscape and price differences at different medical facilities, such as hospitals, ASCs and OBLs. Further, revenue results can differ based upon the mix of business between U.S. and international sales mix of our products used, and the sales channel through which each procedure is supported. Our revenue from international sales is impacted by fluctuations in foreign currency exchange rates between the U.S. dollar (our reporting currency) and the local currency.

Interest expense is primarily related to borrowings, amortization of debt issuance costs, and accretion of final fees on the First-Citizens ThirdFourth Amended Loan Agreement.

Gross Profit and Gross Margin. Gross profit increased $22.7$27.8 million for the year ended December 31, 20242025 compared to the year ended December 31, 20232024 driven by higher revenue. Gross margin was 79%79.6% and 79.0% for the years ended December 31, 20242025 and December 31, 2023.2024 respectively. Gross margin wasincreased consistentfrom withthe prior year due to higherchanges totalin costsproduct relatedmix, to iFuse TORQ and iFuse Bedrock Granite implants including royalties,partially offset by ahigher decrease in depreciation costsroyalties and inventory reserves.

Sales and Marketing Expenses. The increase in sales and marketing expenses for the year ended December 31, 20242025 as compared to the year ended December 31, 20232024 was primarily due to a $6.4$10.0 million increase in commissions and employee related costs driven by higher revenues, an increase of $1.1 million in physician training and engagement expenses, and an increase in travel expenses of $0.4 million, partially offset by a $1.1$3.1 million decrease in certaintravel, advertisingtraining and marketingstock-based activities and consulting.compensation.

Research and Development Expenses. The increase in research and development expenses for the year ended December 31, 20242025 as compared to the year ended December 31, 20232024 was primarily due to a $0.9$0.4 million increase in employee related costs and stock-based compensation due to higher headcountcompensation, and a $0.6$0.4 million increase in product development costs.

General and Administrative Expenses. The increase in general and administrative expenses for the year ended December 31, 20242025 as compared to the year ended December 31, 20232024 was primarily due to a $1.8$6.5 million increase in employee related costs andcosts, stock-based compensation, and a $0.9 million increase in consulting, accounting, audit, and legal expenses.

Interest Income. The increasedecrease in interest income for the year ended December 31, 20242025 as compared to the year ended December 31, 20232024 was mainly due to higherlower interest earned on our investments in marketable securities, primarily as a result of higherlower interest rates earned on higher cash and investment balances.rates.

Interest Expense. The decrease in interest expense for the year ended December 31, 20242025 as compared to the year ended December 31, 20232024 was primarily due to lower interest rates associated with the First-Citizens ThirdFourth Amended Loan Agreement.

Our outstanding debt is related to a Loan and Security Agreement (the “Original Loan Agreement”) dated August 12, 2021 (the “Effective Date”), entered into by us and Silicon Valley Bank, a California corporation (“SVB”). Pursuant to the Original Loan Agreement, SVBwe provided us withborrowed a term loan in the aggregate principal amount of $35.0 million (the “Original Term Loan”).

On January 6, 2023, we entered into a First Amendment to Loan and Security Agreement with SVB to amend our Original Loan Agreement (the “First Amendment”, and together with the Original Loan Agreement, collectively the “Amended Loan Agreement”). Upon entry into the Amended Loan Agreement, we borrowed $36.0 million pursuant to a new term loan in the aggregate principal amount of $36.0 million (the “First Amendment Term Loan”), which was substantially used to repay in full the $35.0 million Original Term Loan outstanding under the Original Loan Agreement, and we also obtained a secured a revolving credit facility in an aggregate principal amount of up to $15.0 million (the “Revolving Line"). The First Amendment also provided for a final payment fee payable to SVB of 2% of the original principal amount of the First Amendment Term Loan due upon the earlier of the First Amendment Term Loan Maturity Date, termination of the Amended Loan Agreement, acceleration by the Lender following an event of default, or prepayment of the First Amendment Term Loan.

On January 25, 2024, we entered into a Second Amendment to Loan and Security Agreement with Silicon Valley Bank, a division of First-Citizens Bank & Trust Company, as successor in interest to SVB (“First-Citizens”) whichto further amendedamend our Amended Loan Agreement (the “Second Amendment” and together with the Amended Loan Agreement, collectively, the “Second Amended Loan Agreement”). The Second Amendment revised certain provisions related to financial covenants and the periods in which such covenants applied.

On November 8, 2024, we entered into a Third Amendment to Loan and Security Agreement with First-Citizens to further amend our Second Amended Loan Agreement (the “Third Amendment” and together with the Second Amended Loan Agreement, collectively, the “Third Amended Loan Agreement”),. relativeUpon toentry into the Third Amended Loan Agreement, we borrowed a new term loan in the original aggregate principal amount of $36.0 million extended by First-Citizens to the Company (the “Third Amendment Term Loan”), which was substantially used to refinance and repay in full the then-outstanding $36.0 million existing First Amendment Term Loan. We also paid a certain final payment fee due relativerelated to such prior First Amendment Term Loan. The Third Amendment set the maturity date for the Third Amendment Term Loan to September 1, 2029 (the "Third Amendment Term Loan Maturity Date"), and set the first principal repayment due date relativefor to the Third Amendment Term Loan to October 1, 2027;2027, providedwhich thatdate will, upon the achievement of the Performance Milestone (as defined in the Third Amendment), the first principal payment shall become due onbe October 1, 2028. Interest on the outstanding principal balance of the Third Amendment Term Loan is payable monthly at a floating rate per annum equal to the greater of 4.25% and the WSJ prime rate minus 0.5%. The Company may elect to prepay the Third Amendment Term Loan in whole prior to the Third Amendment Term Loan Maturity Date, subject to a prepayment fee equal to 1.5% of the original principal amount of the Third Amendment Term Loan if the loan is prepaid within 18 months following the closing of the Third Amendment. The Third Amendment further revised certain provisions related to financial covenants and the periods in which such covenants apply, and First-Citizens and the Company also agreed to terminate the Revolving Line and an uncommitted accordion term loan provision.

We market our 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 in other countries. As of MarchJune 31,30, 2026, nearlyover 150,000 procedures have been performed using our technologies since initial commercialization.

We monitor certain key performance indicators that we believe provide us and our investors indications of conditions that may affect results of our operations. Our revenue growth rate andrate, commercial progress isand profitability are impacted by, among other things, our key performance indicators, including our ability to expand access to solutions, increase physician penetration, launch new products, address human capital needs and gain operational efficiencies.

We believe we are the industry leader in pioneering anatomy-specific solutions that are grounded in our biomechanical design expertise and backed by strong clinical evidence. Our product development strategy focuses on addressing unmet clinical needs while leveraging our existing platform technologies, enabling us to expand surgeonphysician adoption and increase procedure volumes over time. As pioneers of minimally invasive treatment for sacroiliac joint dysfunction and degeneration, we developed a deep competency in addressing the challenges of low-density bone in the sacrum. Over the years, we have expanded our platform of solutions to address spinopelvic fixation and pelvic trauma. Our focus on innovation has resulted in three of our platform technologies being designated as breakthrough devices by the FDA.

We continue to invest in research and development initiatives to bring new and differentiated solutions to the market. Robust clinical evidence is central to drive adoption and favorable reimbursement, and we remain focused on continuing to set the industry standard in delivering evidence-based care through best-in-class clinical trials that demonstrate the efficacy, safety, and economic benefit of our solutions. During the threesix months ended MarchJune 31,30, 2026, we spent $4.2$9.4 million on research and development, equating to 8.0%8.7% of our revenue. During the threesix months ended MarchJune 31,30, 2025, we spent $4.5$8.8 million on research and development, equating to 9.6%9.2% of our revenue.

Our commercial growth is driven by expansion of our sales organization, increased surgical capacity, and broader site-of-service adoption. As of MarchJune 31,30, 2026, our U.S. commercial organization includedcomprised 89of more than 175 sales team members, including territory sales managers,managers 80and clinical support specialists, and 336more than 350 third-party sales agents,agents. comparedAs toof 85June 30, 2025, our U.S. commercial organization comprised of more than 160 sales team members, including territory sales managers,managers 78and clinical support specialists, and 278295 third-party sales agents as of March 31, 2025.agents.

As of MarchJune 31,30, 2026, our international commercial organization included 10 direct sales representatives and 2831 third-party sales agents and resellers, compared to 10 direct sales representatives and 29 third-partythird- party sales agents and resellers as of MarchJune 31,30, 2025.

Our expanded platform allows us to serve our physicians across all sites of care. Over 33%35 percent of U.S. sacroiliac joint procedures were performed in ambulatory surgical center (“ASC”) and office-based lab (“OBL”) settings during the quarter.

Each year, weWe conduct instructor-led trainings designed to build people leadership capabilities and train managers on delivering actionable feedback. We have also adopted a goal for each of our managers to have regular check-ins with employees to discuss their personal goals and career plans in furtherance of our commitment to career and professional development.

We are focused on increasing our territory sales managers’ and sales representatives’ capacity, efficiency and productivity. We may do this by adding more clinical support specialists and third-party sales agents as part of hybrid arrangements for case coverage, and by consigning instrument trays and implants at selective sites of service. As of MarchJune 31,30, 2026, our trailing twelve month average revenue per territory sales manager has increased to approximately $2.2 million from $2.0$2.1 million as of MarchJune 31,30, 2025.

Our revenue from sales of implants fluctuates based on volume of cases (procedures performed), discounts, mix of international and U.S. sales, different implant pricing and the number of implants used for a particular patient. Similar to other orthopedic companies, our case volume can vary from quarter to quarter due to a variety of factors including reimbursement, sales force changes, physician activities, product launches, and seasonality. In addition, our revenue is impacted by changes in average selling price as we respond to the competitive landscape and price differences at different medical facilities, such as hospitals, ASCs and OBLs. Further, revenueRevenue results can differalso vary based upon the mix of business between U.S. and international sales mix of our products used, and the sales channel through which each procedure is supported. Our revenue from international sales is impacted by fluctuations in foreign currency exchange rates between the U.S. dollar (our reporting currency) and the local currency.

Comparison of the Three Months Ended MarchJune 31,30, 2026 and 2025

Revenue. The increase in revenue for the three months ended MarchJune 31,30, 2026 as compared to the three months ended MarchJune 31,30, 2025 was primarily driven by highera $6.8 million increase in U.S. revenue due to 14.9% increase in procedure volumes, supported by expanded adoption of our product portfolio, increased sales channel coverage, and continued growth in ASC and OBL settings.

Gross Profit and Gross Margin. Gross profit increased $4.2$5.7 million for the three months ended MarchJune 31,30, 2026 as compared to the three months ended MarchJune 31,30, 2025, mainly driven by higher revenue. The gross margin remainedwas stable79.5% year-over-year,for reflectingthe lowerthree months ended June 30, 2026 compared to a gross margin of 79.8% for the three months ended June 30, 2025 due to changes in product costs partially offset by higher royalty expenses.mix.

Sales and Marketing Expenses. The increase in sales and marketing expenses for the three months ended MarchJune 31,30, 2026 as compared to the three months ended MarchJune 31,30, 2025 was primarily due to a $0.8$2.5 million increase in commissions and employeepersonnel related costscost driven by higher revenues and increase in headcount, and a $1.6$1.1 million increase inrelated to travel, training and marketing activities, partially offset by a decrease of $0.3$0.4 million related to stock-based compensation.

Research and Development Expenses. The decreaseincrease in research and development expenses for the three months ended MarchJune 31,30, 2026 as compared to the three months ended MarchJune 31,30, 2025 was primarily due to timinga and$0.9 stagemillion of product development across projects, as we continue to investincrease in recently launched products, next generation product development,development andactivities, clinical and regulatory initiatives.

General and Administrative Expenses. The increasedecrease in general and administrative expenses for the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025 was primarily due to a $0.3 million increasedecrease in personnel costs and stock-based compensation,compensation partially offset byand a $0.3 million decrease in professional service costs.

Interest Income. The decrease in interest income for the three months ended MarchJune 31,30, 2026 as compared to the three months ended MarchJune 31,30, 2025 was primarily due to lower interest rate earned on our investments in marketable securities, primarily as a result of lower interest rates.

Interest Expense. The decrease in interest expense for the three months ended MarchJune 31,30, 2026 as compared to the three months ended MarchJune 31,30, 2025 was primarily due to lower interest rates associated with the First-Citizens Fourth Amended Loan Agreement.

Other Income (Expense), Net. The change in other income (expense), net for the three months ended MarchJune 31,30, 2026 as compared to the three months ended MarchJune 31,30, 2025 was primarily due to foreign currency fluctuations.

As of MarchJune 31,30, 2026, we had cash and marketable securities of $144.7$145.9 million as compared to $147.8 million as of December 31, 2025. We have financed our operations primarily through the sale of our common stock in our public offerings and debt financing arrangements. As of both MarchJune 31,30, 2026 and December 31, 2025, we had $35.6 million in outstanding debt.

As of MarchJune 31,30, 2026, we had an accumulated deficit of $454.6$458.7 million as compared to $450.3 million as of December 31, 2025. During the threesix months ended MarchJune 31,30, 2026, we incurred a net loss of $4.3$8.4 million. During the years ended December 31, 2025 and 2024, we incurred a net loss of $18.9 million and $30.9 million, respectively, and expect to incur additional losses in the future. We have not achieved positive cash flow from operations for the six months ended June 30, 2026.

Based upon our current operating plan,plan and improved cash flow from operations, we believe that our existing cash and marketable securities will enable us to fund our operating expenses and capital expenditure requirements over the next 12 months from the filing of this Form 10-Q. However, the financial impact of a potential economic downturn or capital market disruptions pose risks andto uncertainties in our future available capital resources. We may face challenges and uncertainties and, as a result, may need to raise additional capital as our available capital resources may be consumed more rapidly than currently expected due to, but not limited to (a) decreases in sales of our products and the uncertainty of future revenues from new products; (b) changes we may make to the business that affect ongoing operating expenses; (c) changes we may make in our business strategy; (d) regulatory and reimbursement developments affecting our existing products; (e) changes we may make in our research and development spending plans; and (f) other items affecting our forecasted level of expenditures and use of cash resources. In addition, as we seek to deploy new product offerings, the need for additional capital to fund the purchase of inventories of implants and instrument trays may become more acute and may limit the number of revenue opportunities that we pursue. Each new product family introduced typically requires the purchase of consumable implant inventory as well as investment in a fleet of instrument trays required to support procedures nationwide.

On November 8, 2024, we entered into a Third Amendment to Loan and Security Agreement with First-Citizens to further amend our Second Amended Loan Agreement (the “"Third Amendment”" and together with the Second Amended Loan Agreement, collectively, the “"Third Amended Loan Agreement”"). Upon entry into the Third Amended Loan Agreement, we borrowed a new term loan in the aggregate principal amount of $36.0 million (the “Third Amendment Term Loan”), which was substantially used to refinance and repay in full the then-outstanding $36.0 million First Amendment Term Loan. We also paid a certain final payment fee due related to such prior First Amendment Term Loan. The Third Amendment set the maturity date for the Third Amendment Term Loan to September 1, 2029 (the "Third Amendment Term Loan Maturity Date"), and set the first principal repayment due date for to the Third Amendment Term Loan to October 1, 2027, which date will, upon the achievement of the Performance Milestone (as defined in the Third Amendment), bebecome October 1, 2028. Interest on the outstanding principal balance of the Third Amendment Term Loan is payable monthly at a floating rate per annum equal to the greater of 4.25% and the WSJ prime rate minus 0.5%. The Company may elect to prepay the Third Amendment Term Loan in whole prior to the Third Amendment Term Loan Maturity Date, subject to a prepayment fee equal to 1.5% of the original principal amount of the Third Amendment Term Loan if the loan is prepaid within 18 months following the closing of the Third Amendment. The Third Amendment revised certain provisions related to financial covenants and the periods in which such covenants apply, and First-Citizens and the Company also agreed to terminate the Revolving Line and an uncommitted accordion term loan provision.

Our material cash requirements include various contractual and other obligations consisting of long-term debt obligations with First-Citizens, purchase obligations with some of our suppliers and have not changed materially since the Form 10-K filed with the SEC on February 24, 2026. In February 2026, we entered into an operating lease for an office building in San Jose, California. As of MarchJune 31,30, 2026, expected timing of those payments are as follows:

(2)Represents the future interest obligations on our First-Citizens Fourth Amended Loan Agreement estimated using an interest rate of 6.25% as of MarchJune 31,30, 2026.

During the threesix months ended MarchJune 31,30, 2026, net cash used in operating activities was $2.4$1.6 million, consisting of a net loss of $4.3$8.4 million and an increase in net operating assets of $5.9$8.5 million, partially offset by non-cash charges of $7.9$15.4 million. During the threesix months ended MarchJune 31,30, 2025, net cash used in operating activities was $4.9$4.7 million, consisting of a net loss of $6.5$12.7 million and an increase in net operating assets of $6.2$8.7 million, partially offset by non-cash charges of $7.8$16.6 million.

Significant changes in net operating assets during the threesix months ended MarchJune 31,30, 2026 included higher inventory levels to support new product introductions, higher accounts receivable due to timing of sales and cash collections, and lower accrued liabilities and higher accounts payable balance due to the timing of payments. Non-cash charges consisted primarily of stock-based compensation and depreciation.

Net cash used in investing activities in the threesix months ended MarchJune 31,30, 2026 was $6.2$9.0 million as compared to cash provided by investing activities of $10.6$1.2 million in the threesix months ended MarchJune 31,30, 2025. Net cash used in investing activities for the threesix months ended MarchJune 31,30, 2026 consisted of purchasesa $6.3 million cash outflow from purchase of our marketable securities net of maturities of $5.2 million,maturities, and $2.6 million purchases of property and equipment of $1.1 million primarily related to individual components in instrument trayssets to support revenue growth.growth and leasehold improvement assets for our new corporate office. Net cash provided by investing activities for the threesix months ended MarchJune 31,30, 2025 consisted of a $5.3 million cash inflow from maturities of our marketable securities net of purchases of $12.7 million,purchases, and $4.2 million purchases of property and equipment of $2.1 million primarily related to individual components in instrument trayssets to support revenue growth.

Cash provided by financing activities in the threesix months ended MarchJune 31,30, 2026 and 2025 resultedwas $1.7 million and $2.3 million, respectively, resulting from the issuance of common stock under our stock-based incentive compensation plans.