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CARLSMED, INC.

For the period ended Jun 30, 2026. Filed Aug 5, 2026.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Jun 30, 2026 · Filed Aug 5, 2026

CARL$14.52-5.2%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2026-03-31; filed 2026-05-05.

0001794546-26-000011

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-06-30; filed 2026-08-05.

0001794546-26-000016

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 134 previous paragraphs and 156 current paragraphs.

96 unchanged; 37 reworded; 20 added; 1 removed; 0 previous and 3 current paragraphs rearranged.

Tables are not compared: 3 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (20)

Current report

In December 2025, we received FDA 510(k) clearance for our corra Cervical Plating System, the first personalized cervical plating system to receive FDA 510(k) clearance. In February 2026, the first procedure using corra was successfully completed at UC San Diego Health, and we expect to commercially launch corra in December 2026.

Current report

In addition, COMPASS data on 207 aprevo patients (100 adult spinal deformity patients and 107 patients with degenerative conditions) having 14-45 month follow-up was presented at the 2026 meeting of the American Association of the Neurological Surgeons/Congress of Neurological Surgeons Section on Disorders of the Spine and Peripheral Nerves. Post-operative alignment, reoperations and Oswestry Disability Index (ODI) scores were reported. Among the 100 deformity patients there were 3 (3%) reoperations between Post-Operative Day 1 (POD1) and 12 months with 2 (2%) additional reoperations between 12-24 months postoperative. Among the 107 patients with degenerative conditions there was 1 revision (0.9%) for adjacent segment disease at 2 months postoperative. ODI improvement was similar for both groups, with 64% achieving minimum clinically important difference. The data demonstrated that aprevo personalized interbody devices designed from an anatomical 3D virtual correction plan provided favorable disability improvement and favorably low reoperation rates during the 14-45 month postoperative period.

Current report

Effective October 2024, aprevo Lumbar's New Technology Add-on Payment (NTAP) expired, and CMS updated its lumbar fusion MS-DRG structure. Inpatient surgical procedures coded to MS-DRGs 427, 448, or 451 that use "custom-made anatomically designed (CMAD) interbody fusion devices" (such as our aprevo Technology Platform) were reassigned to an elevated Major Complication or Comorbidity (MCC)-level MS-DRG payment that results in our hospital customers receiving additional reimbursement compared to lumbar fusion procedures that use stock interbody devices.

Current report

The CMS Fiscal Year 2027 Inpatient Prospective Payment System (FY27 IPPS) Final Rule was released on July 31, 2026, and will be effective October 1, 2026. This final FY27 IPPS rule will replace the current MS-DRG payment framework for inpatient lumbar spine fusions. Effective October 1, 2026, all inpatient lumbar spine fusion procedures utilizing aprevo will be assigned to one of the three new MS-DRG codes: 523, 524, or 525 (Extensive or Complex Spinal Fusion Procedures Except Cervical with MCC, with Complication or Comorbidity (CC), and without CC/MCC, respectively) and will no longer be assigned to the MS-DRG 400 series. CMS removed references to CMAD interbody fusion devices from MS-DRGs 426, 447, and 450 descriptions, clarifying that qualifying personalized lumbar fusion surgeries will only be assigned to new MS-DRGs 523, 524, and 525.

Current report

We believe this updated framework has the potential to support broader aprevo lumbar adoption by (i) reducing hospitals' uncertainty regarding which aprevo procedures will qualify for payment elevation, as this new MS-DRG structure comprehensively includes all aprevo lumbar procedures, and (ii) providing hospitals with more appropriate reimbursement amounts that better reflect their incremental costs to perform personalized lumbar fusion procedures compared to stock interbody device procedures.

Current report

In June 2026, the CMS ICD-10 Coordination and Maintenance Committee published 24 new permanent ICD-10-PCS procedure codes that also will become effective on October 1, 2026. These new permanent codes will replace the ICD-10-PCS "X-series" codes that temporarily described aprevo procedures associated with NTAP. These new ICD-10-PCS codes describe “Interbody Fusion Device, Custom-Made Anatomically and Virtually Designed" (CMAVD) procedures and are used to assign procedures to MS-DRG codes 523, 524, and 525 as part of the FY27 IPPS final rule.

Current report

The addition of the word “virtually” in the ICD-10-PCS procedure codes is consistent with our aprevo Technology Platform’s ability to render an interactive 3D virtual model to realign the spinal anatomy and enhance the preoperative surgical correction planning process. We believe the creation of these permanent procedure codes represents an important milestone, formally recognizing CMAVD attributes within the standard ICD-10-PCS coding system for select procedures, such as those that utilize the aprevo Technology Platform.

Current report

Revenue was $35.1 million and $22.3 million for the six months ended June 30, 2026 and 2025, respectively. The increase of $12.8 million, or 57.4%, was primarily driven by increased volume of aprevo Technology Platform lumbar and cervical surgical procedures in the current six-month period, with our average revenue per procedure substantially constant between these periods.

Current report

Cost of sales was $8.1 million and $5.8 million for the six months ended June 30, 2026 and 2025, respectively. The increase of $2.3 million, or 40.3%, was primarily driven by increased unit sales of the aprevo Technology Platform for both lumbar and cervical procedures, for the six months ended June 30, 2026, as compared to the six months ended June 30, 2025.

Current report

Gross margin was 76.9% for the six months ended June 30, 2026, as compared to 74.1% for the six months ended June 30, 2025 with cost improvements primarily from lower per unit production fees charged by our contract manufacturer in the current period and other efficiencies in our digital production system.

Current report

Sales and marketing expenses were $22.2 million and $14.6 million for the six months ended June 30, 2026 and 2025, respectively. The increase of $7.6 million, or 52.1%, was primarily driven by a $2.9 million increase in personnel-related costs (including increased headcount, sales compensation and bonuses, and stock-based compensation), a $1.8 million increase in commissions to independent sales agents and $1.2 million increase in generic surgical instruments to support increased sales activity, and a $1.7 million increase in various marketing costs.

Current report

General and administrative expenses were $13.8 million and $6.8 million for the six months ended June 30, 2026 and 2025, respectively. The increase of $7.0 million, or 103.3%, was primarily driven by a $3.4 million increase in personnel-related costs to support business growth and compliance and operational requirements as a public company, a $1.6 million increase in professional service and legal fees to support corporate operations, compliance programs, and intellectual property and other ordinary course legal matters, and a $0.8 million increase in the provision for estimated uncollectible customer accounts.

Current report

Interest income was $1.7 million and $0.7 million for the six months ended June 30, 2026 and 2025, respectively. The increase of $1.0 million, or 141.6%, was due to an increase in bank interest earned on our higher daily average cash and cash equivalent balances and increased yields from short-term investments and marketable securities in the current period.

Current report

On May 29, 2026, we entered into a letter agreement with Customers Bank that clarified the treatment of certain cash deposits for ongoing compliance with the Customers Loan Agreement and increased permitted credit card indebtedness and related cash collateral.
Removed paragraphs (1)

Previous report

The Fiscal Year 2027 Inpatient Prospective Payment System (IPPS) proposal was released by CMS on April 10, 2026. The proposal includes updated assignment of lumbar spine fusion procedures utilizing aprevo to three new MS-DRG codes: 523, 524, or 525, rather than current coding in the 400 DRG series. If finalized as proposed, we believe this represents Medicare’s validation of our platform’s clinical and economic value and if implemented, could drive enhanced market adoption with additional reimbursement clarity for our customers. This rule remains preliminary and we anticipate the final rule to be published prior to becoming effective on October 1, 2026.
Reworded paragraphs (37)

Previous wording

The following discussion and analysis provides information that we believe is relevant to an assessment and understanding of our results of operations and financial condition. You should read this discussion and analysis in conjunction with our unaudited financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q and our audited financial statements and the related notes and the discussion under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations” for the year ended December 31, 2025 included in our Annual Report on Form 10-K. Unless the context otherwise requires, references to “Carlsmed,” the “Company,” “we,” “us,” and “our” refer to Carlsmed, Inc., a Delaware corporation. This discussion and other parts of this Quarterly Report on Form 10-Q contain forward-looking statements that involve risks and uncertainties, such as statements regarding our plans, objectives, expectations, intentions, and projections. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the “Risk Factors” section of the Annual Report on Form 10-K. See the section titled “Special Note Regarding Forward-Looking Statements.” Our historical results are not necessarily indicative of the results that may be expected for any period in the future.

Current wording

The following discussion and analysis provides information that we believe is relevant to an assessment and understanding of our results of operations and financial condition. You should read this discussion and analysis in conjunction with our unaudited Condensed Financial Statements and related notes included elsewhere in this Quarterly Report on Form 10-Q and our audited Financial Statements and the related notes and the discussion under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations” for the year ended December 31, 2025 included in our Annual Report on Form 10-K. Unless the context otherwise requires, references to “Carlsmed,” the “Company,” “we,” “us,” and “our” refer to Carlsmed, Inc., a Delaware corporation. This discussion and other parts of this Quarterly Report on Form 10-Q contain forward-looking statements that involve risks and uncertainties, such as statements regarding our plans, objectives, expectations, intentions, and projections. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the “Risk Factors” section of the Annual Report on Form 10-K. See the section titled “Special Note Regarding Forward-Looking Statements.” Our historical results are not necessarily indicative of the results that may be expected for any period in the future.

Previous wording

Our technology is powered by AI-enabled, outcome-based algorithms that provide personalized surgical plans for spine fusion. The surgical kit delivered to customers includes aprevo interbody implants for a custom vertebral fit for each patient’s unique pathology and vertebral bone topography, and single-use surgical instruments. The aprevo Technology Platform supports surgeons in achieving proper spinal alignment as they seek to improve surgical outcomes for patients with degenerative disc disease (“DDD”), including spinal deformity conditions.

Current wording

Our technology is powered by AI-enabled technologies and outcome-based algorithms that provide personalized surgical plans for spine fusion. The surgical kit delivered to customers includes aprevo interbody implants for a custom vertebral fit and personalized alignment to address each patient’s unique needs, and single-use surgical instruments. The aprevo Technology Platform supports surgeons in achieving proper spinal alignment as they seek to improve surgical outcomes for patients with degenerative disc disease (“DDD”), including spinal deformity conditions.

Previous wording

We market the aprevo Technology Platform to surgeons, hospitals and ambulatory surgical centers in the United States through a combination of our direct sales team and independent sales agents. Our direct sales team consists of Area Vice Presidents, Sales Directors, Account Managers, and Strategic and National Account leadership, who are primarily responsible for promoting our platform to surgeons, supporting digital file exchange and other connectivity between our Company and hospitals, and working with customers to secure required approvals for our products. Our direct sales team is also responsible for recruiting independent sales agents who cover each aprevo surgery in the operating room.

Current wording

We market the aprevo Technology Platform to surgeons, hospitals and ambulatory surgical centers in the United States through a combination of our sales team and independent sales agents. Our sales team consists of Area Vice Presidents, Sales Directors, Account Managers, and Strategic and National Account leadership, who are primarily responsible for promoting our platform to surgeons, supporting digital file exchange and other connectivity between our Company and hospitals, and working with hospitals to secure required approvals for our products. Our sales team is also responsible for recruiting independent sales agents who cover each aprevo surgery in the operating room.

Previous wording

Since we began commercializing the aprevo Technology Platform in 2021, we have experienced sequential quarterly and annual revenue growth from its rapid commercial adoption. For the three months ended March 31, 2026 and 2025, we recognized revenue of $16.1 million and $10.2 million, respectively, representing period-over-period growth of 58.2%.

Current wording

Since we began commercializing the aprevo Technology Platform in 2021, we have experienced sequential quarterly and annual revenue growth from its rapid commercial adoption. For the three months ended June 30, 2026 and 2025, we recognized revenue of $18.9 million and $12.1 million, respectively, representing period-over-period growth of 57%. For the six months ended June 30, 2026 and 2025, we recognized revenue of $35.1 million and $22.3 million, respectively, representing period-over-period growth of 57%.

Previous wording

Our business model depends on our ability to timely deliver the aprevo Technology Platform to allow surgeons to maintain surgical schedules for their patients. In November 2024, we launched our enhanced digital production system (“DPS”) that enabled a reduction in our manufacturing time of 10 business days from surgeons' approvals of the digital surgical plans. Beginning in February 2026, this lead time was further reduced to six business days. Our medical devices are manufactured to our specifications by contract manufacturing organizations (“CMOs”) who meet our manufacturer qualification standards.

Current wording

Our business model depends on our ability to timely deliver the aprevo Technology Platform to allow surgeons to maintain surgical schedules for their patients. Our digital production system (“DPS”) enables a short manufacturing lead time of six business days from surgeon approval of the digital surgical plan to aprevo kit delivery to the hospital. We believe that this lead time typically fits well within our customers’ requirements. Our medical devices are manufactured to our specifications by CMOs who meet our manufacturer qualification standards.

Previous wording

Since its full commercial launch in October 2021, the aprevo Technology Platform for spine fusion surgery has been used to treat more than 3,700 patients through March 31, 2026. We estimate there are approximately 4,000 spine surgeons across the United States whose patients could benefit from using our platform. As of March 31, 2026, we had an increase of over 60% of trained surgeon users on the aprevo Technology Platform that have completed one or more aprevo procedures as compared to March 31, 2025.

Current wording

Since its full commercial launch in October 2021, the aprevo Technology Platform for spine fusion surgery has been used to treat more than 4,400 patients through June 30, 2026. We estimate there are approximately 4,000 spine surgeons across the United States whose patients could benefit from using our platform. As of June 30, 2026, we had an increase of over 67% of trained surgeon users on the aprevo Technology Platform who have completed one or more aprevo procedures as compared to June 30, 2025.

Previous wording

We are also committed to building upon our strong foundation of clinical evidence demonstrating the efficacy of our aprevo Technology Platform. Clinical data publications are important tools for surgeon education and patient awareness of the potential significant benefits of our personalized solution as compared to stock implants.

Current wording

We are also committed to building upon our strong foundation of clinical evidence demonstrating the efficacy of our aprevo Technology Platform for DDD and ASD lumbar fusions and anterior cervical discectomy and fusion ("ACDF") cervical fusions. Clinical data publications are important tools for surgeon education and patient awareness of the potential significant benefits of our personalized solution as compared to stock implants.

Previous wording

Procedures using our aprevo Technology Platform are covered by Medicare, Medicare Advantage, and commercial payors. For the three months ended March 31, 2026, we estimate that our hospital customers’ payor mix consisted of approximately 44% for commercial insurance and 56% for both Medicare and Medicare Advantage insurance. Effective October 2024, CMS adopted a new MS-DRG coding system which reassigns MS-DRG codes for certain lumbar spine fusion procedures when “custom-made anatomically designed interbody fusion devices” (such as our aprevo Technology Platform) are utilized. This provides additional reimbursement for our hospital customers, compared to the reimbursement for fusion procedures that use stock implants. We believe this, among other factors, will support our customers' continued demand for use of our technology in lumbar spine fusion surgeries.

Current wording

Procedures using our aprevo Technology Platform are eligible for reimbursement by Medicare, Medicare Advantage, and commercial payors. For the three and six months ended June 30, 2026, we estimate that our hospital customers’ payor mix consisted of approximately 44% commercial insurance and 56% for both Medicare and Medicare Advantage insurance, combined. We believe the clinical benefit of aprevo, which has been shown to significantly reduce long-term reoperations due to mechanical complications, will continue to support demand for our technology in lumbar spine fusion surgeries.

Previous wording

We believe Medicare-aged patients receiving multi-level anterior cervical discectomy and fusion (ACDF) surgeries are uniquely addressed by aprevo cervical. Based on our internal data, a majority of these procedures are performed in an inpatient setting. Effective October 1, 2025, qualifying cervical fusion procedures utilizing aprevo personalized interbody implants for traditional Medicare beneficiaries are eligible for New Technology Add-on Payments ("NTAP") from CMS. The NTAP program provides additional reimbursement to hospitals that use designated new medical technologies in the first few years of market introduction. These new technologies must demonstrate significant clinical improvement in the diagnosis or treatment of Medicare beneficiaries compared to existing alternatives or be designated by the FDA as Breakthrough technology. CMS created unique ICD-10-PCS codes to identify cervical fusion procedures using "custom made anatomically designed interbody fusion devices" such as our aprevo Technology Platform. Reimbursement claims submitted with these unique ICD-10-PCS procedure codes may qualify hospitals for up to an additional $21,125 in NTAP reimbursement for eligible inpatient procedures.

Current wording

We believe Medicare-aged patients receiving multi-level ACDF surgeries are uniquely addressed by aprevo cervical. Based on our internal data, a majority of these procedures are performed in an inpatient setting. Effective October 1, 2025, qualifying cervical fusion procedures utilizing aprevo personalized interbody implants for traditional Medicare beneficiaries are eligible for NTAP from CMS. The NTAP program provides additional reimbursement to hospitals that use designated new medical technologies in the first few years of market introduction. These new technologies must demonstrate significant clinical improvement in the diagnosis or treatment of Medicare beneficiaries compared to existing alternatives or be designated by the FDA as Breakthrough technology. CMS created unique ICD-10-PCS codes to identify cervical fusion procedures using “custom made anatomically designed interbody fusion devices” such as our aprevo Technology Platform. Reimbursement claims submitted with these unique ICD-10-PCS procedure codes may qualify hospitals for up to an additional $21,125 in NTAP reimbursement for eligible inpatient procedures.

Previous wording

aprevo cervical currently has the same payor reimbursement methodology as stock interbody implants for hospital outpatient departments and ambulatory surgery centers. Our requested Transitional Pass-Through (“TPT”) payment for aprevo cervical in outpatient settings was not approved by CMS in its November 2025 Outpatient Prospective Payment System (OPPS) Final Rule, despite our analysis and documentation for its qualification. We will continue to explore opportunities with CMS for various pathways including TPT and New Technology Ambulatory Payment Classification (APC) to appropriately reimburse our customers' costs of providing the aprevo Technology Platform in outpatient cervical fusion procedures.

Current wording

aprevo cervical currently has the same payor reimbursement methodology as stock interbody implants for hospital outpatient departments and ambulatory surgery centers. Our requested Transitional Pass-Through (“TPT”) payment for aprevo cervical in outpatient settings was not approved by CMS in its November 2025 Outpatient Prospective Payment System (OPPS) Final Rule, despite our analysis and documentation for its qualification. We continue to explore opportunities with CMS for various pathways including TPT and New Technology Ambulatory Payment Classification (NT-APC) to appropriately reimburse our customers' costs of providing the aprevo Technology Platform in outpatient cervical fusion procedures.

Previous wording

General and administrative expenses consist primarily of personnel costs (i.e., salaries, bonuses, stock-based compensation expense, and benefits) for executive, legal, finance, corporate information technology and human resources roles. Other significant costs include legal fees relating to intellectual property and corporate matters, consultant and professional fees, insurance, bad debt expenses, and facility-related costs. We recognize general and administrative expenses in the periods in which they are incurred. We anticipate that our general and administrative expenses will increase in the future to support our anticipated business growth as a publicly traded company. These increased costs include accounting, audit, legal, regulatory, tax, insurance, investor relations, and compliance with exchange listing and SEC requirements. While we expect general and administrative expenses to continue to increase in absolute value, we expect that these costs will decrease as a percentage of revenue over time.

Current wording

General and administrative expenses consist primarily of personnel costs (i.e., salaries, bonuses, stock-based compensation expense, and benefits) for executive, legal, finance, corporate information technology and human resources roles. Other significant costs include legal fees relating to intellectual property and corporate matters, consultant and professional fees, insurance, expected credit losses on customer accounts , and facility-related costs. We recognize general and administrative expenses in the periods in which they are incurred. We anticipate that our general and administrative expenses will increase in the future to support our anticipated business growth as a publicly traded company. These increased costs include accounting, audit, legal, facility, regulatory, tax, insurance, investor relations, and compliance with exchange listing and SEC requirements. While we expect general and administrative expenses to continue to increase in absolute value, we expect that these costs will decrease as a percentage of revenue over time.

Previous wording

Interest income is attributable to bank interest on our cash and cash equivalents and interest earned on our short-term investments in certificates of deposit.

Current wording

Interest income is attributable to bank interest on our cash and cash equivalents, interest earned on our short-term investments in certificates of deposit, and interest earned on our marketable securities, including available for sale debt securities.

Previous wording

Prior to the closing of the IPO on July 24, 2025, we had issued warrants for the purchase of our convertible preferred stock in conjunction with the loan and security agreement with Customers Bank (the “Customers Loan Agreement”). On the closing of the IPO, all warrants issued to Customers Bank under the Customers Loan Agreement became exercisable into common stock, with certain warrants continuing to be classified as liabilities. Upon the execution of the Fifth Amendment to the Customers Loan Agreement on October 29, 2025, there were no warrants that remained classified as liabilities as a result of the cancellation of 15,831 shares of common stock that were exercisable contingent on loan draw milestones. We accounted for these liability-classified warrants, initially measured at fair value, in accordance with ASC Topic 480. Changes in fair value of warrant liabilities have been recognized in the statements of operations and comprehensive loss. During the three months ended March 31, 2026, Customers Bank exercised the warrants on a cashless basis, resulting in the issuance of 30,366 shares of common stock. As a result of the exercise, the warrants are no longer outstanding. See Note 2—Summary of Significant Accounting Policiesin the notes to our unaudited condensed financial statements for information regarding the Series B Warrant and the Series C Warrant in connection with the Customers Loan Agreement.

Current wording

Prior to the closing of the IPO on July 24, 2025, we had issued warrants for the purchase of our convertible preferred stock in conjunction with the loan and security agreement with Customers Bank (the “Customers Loan Agreement”). On the closing of the IPO, all warrants issued to Customers Bank under the Customers Loan Agreement became exercisable into common stock, with certain warrants continuing to be classified as liabilities. Upon the execution of the Fifth Amendment to the Customers Loan Agreement on October 29, 2025, there were no warrants that remained classified as liabilities as a result of the cancellation of 15,831 shares of common stock that were exercisable contingent on loan draw milestones.

Previous wording

Comparison of the Three Months Ended March 31, 2026 and 2025

Current wording

Comparison of the Three and Six Months Ended June 30, 2026 and 2025

Previous wording

Revenue was $16.1 million and $10.2 million for the three months ended March 31, 2026 and 2025, respectively. The increase of $5.9 million, or 58.2%, was primarily driven by increased volume of surgical procedures with the aprevo Technology Platform in the current quarter, with our average revenue per procedure substantially constant between these periods.

Current wording

Revenue was $18.9 million and $12.1 million for the three months ended June 30, 2026 and 2025, respectively. The increase of $6.9 million, or 56.7%, was primarily driven by increased volume of aprevo Technology Platform lumbar and cervical surgical procedures in the current quarter, with our average revenue per procedure substantially constant between these periods.

Previous wording

Cost of sales was $3.7 million and $2.6 million for the three months ended March 31, 2026 and 2025, respectively. The increase of $1.1 million, or 44.6%, was primarily driven by increased unit sales of the aprevo Technology Platform for the three months ended March 31, 2026 , as compared to the three months ended March 31, 2025.

Current wording

Cost of sales was $4.4 million and $3.2 million for the three months ended June 30, 2026 and 2025, respectively. The increase of $1.2 million, or 36.8%, was primarily driven by increased unit sales of the aprevo Technology Platform for both lumbar and cervical procedures, for the three months ended June 30, 2026 , as compared to the three months ended June 30, 2025.

Previous wording

Gross margin was 77.1% for the three months ended March 31, 2026, as compared to 74.9% for the three months ended March 31, 2025 with cost improvements per unit primarily due to production fees charged by our contract manufacturer.

Current wording

Gross margin was 76.8% for the three months ended June 30, 2026, as compared to 73.4% for the three months ended June 30, 2025 with cost improvements primarily from lower per unit production fees charged by our contract manufacturer in the current period and other efficiencies in our digital production system.

Previous wording

Research and development expenses were $5.2 million and $3.2 million for the three months ended March 31, 2026 and 2025, respectively. The increase of $2.0 million, or 64.4%, was primarily due to higher personnel costs to support product development and surgical planning AI initiatives.

Current wording

Research and development expenses were $6.0 million and $4.2 million for the three months ended June 30, 2026 and 2025, respectively. The increase of $1.9 million, or 45.2%, was primarily due to higher personnel costs to support product development and surgical planning AI initiatives.

Previous wording

Sales and marketing expenses were $10.3 million and $6.7 million for the three months ended March 31, 2026 and 2025, respectively. The increase of $3.6 million, or 52.8%, was primarily driven by a $1.5 million increase in personnel-related costs (including increased headcount, sales compensation and bonuses, and stock-based compensation), a $0.9 million increase in commissions to independent sales agents as part of sales growth, and a $0.6 million increase in various marketing costs.

Current wording

Sales and marketing expenses were $11.9 million and $7.9 million for the three months ended June 30, 2026 and 2025, respectively. The increase of $4.1 million, or 51.5%, was primarily driven by a $1.5 million increase in personnel-related costs (including increased headcount, sales compensation and bonuses, and stock-based compensation), a $0.9 million increase in commissions to independent sales agents and $0.8 million increase in generic surgical instruments provided to independent sales representatives to support increased case volumes, and a $0.9 million increase in various marketing costs.

Previous wording

General and administrative expenses were $6.2 million and $3.5 million for the three months ended March 31, 2026 and 2025, respectively. The increase of $2.8 million, or 79.6%, was primarily driven by a $1.6 million increase in personnel-related costs to support business growth and compliance and operational requirements as a public company, a $0.4 million increase in provision for credit losses, and a $0.3 million increase in professional service and legal fees for corporate and intellectual property matters.

Current wording

General and administrative expenses were $7.6 million and $3.3 million for the three months ended June 30, 2026 and 2025, respectively. The increase of $4.3 million, or 127.9%, was primarily driven by a $1.8 million increase in personnel-related costs to support business growth and compliance and operational requirements as a public company, a $1.4 million increase in professional service and legal fees to support corporate operations, compliance programs, and intellectual property and other ordinary course legal matters, and a $0.5 million increase in the provision for estimated uncollectible customer accounts.

Previous wording

Interest expense was $0.3 million and $0.4 million as of the three months ended March 31, 2026 and 2025, respectively, as part of our credit facility with $15.6 million principal outstanding.

Current wording

Interest expense was $0.3 million and $0.4 million for the three months ended June 30, 2026 and 2025, respectively, as part of our credit facility with $15.6 million principal outstanding at each date. Interest expense was $0.6 million and $0.7 million for the six months ended June 30, 2026 and 2025, respectively.

Previous wording

Interest income was $0.9 million and $0.4 million for the three months ended March 31, 2026 and 2025, respectively. The increase of $0.5 million, or 134.5%, was due to an increase in bank interest on our higher daily average cash and cash equivalent balances resulting from the proceeds from our IPO in July 2025 and from purchases of short-term investments.

Current wording

Interest income was $0.8 million and $0.3 million for the three months ended June 30, 2026 and 2025, respectively. The increase of $0.5 million, or 149.7%, was due to an increase in bank interest earned on our higher daily average cash and cash equivalent balances resulting from the proceeds from our IPO in July 2025, and from increased yields from purchases of short-term investments and marketable securities in the current period.

Previous wording

There was no change in fair value of warrant liabilities during the three months ended March 31, 2026 compared to a less than $0.1 million increase during the three months ended March 31, 2025, as the Company had no warrant liabilities outstanding during the current period.

Current wording

There was no change in fair value of warrant liabilities during the three months ended June 30, 2026 compared to a $0.2 million increase during the three months ended June 30, 2025, as the Company had no warrant liabilities outstanding during the current period.

Previous wording

We have incurred net losses and negative cash flows from operations since our inception. We have historically financed operations primarily through the net proceeds that we have received from the sale of shares of our convertible preferred stock, borrowings under our debt facilities, and cash generated from the sales of aprevo interbody implants. On July 24, 2025, we completed our IPO and received $93.5 million in net proceeds, after deducting underwriting discounts and commissions and before additional offering expenses of $5.4 million paid by us. As of March 31, 2026, we had $97.1 million of cash, cash equivalents, restricted cash and short-term investments, $15.6 million of principal outstanding under our credit facility, and an accumulated deficit of $109.5 million.

Current wording

We have incurred net losses and negative cash flows from operations since our inception. We have historically financed operations primarily through the net proceeds that we have received from the sale of shares of our convertible preferred stock, borrowings under our debt facilities, and cash generated from the sales of aprevo interbody implants. On July 24, 2025, we completed our IPO and received $93.5 million in net proceeds, after deducting underwriting discounts and commissions and before additional offering expenses of $5.4 million paid by us. As of June 30, 2026, we had $89.3 million of cash, cash equivalents, restricted cash, short-term investments and marketable securities, $15.6 million of principal outstanding under our credit facility, and an accumulated deficit of $120.0 million.

Previous wording

Our losses primarily resulted from the costs incurred in the development and sales and marketing of our products and providing general and administrative support for our operations. We may continue to incur losses and expend significant amounts of cash in the foreseeable future as we continue to scale our business, invest in research and development activities, increase sales and marketing expenses to support commercial expansion, and increase general and administrative expenses associated with operating as a publicly traded company.

Current wording

Our losses have resulted from aggregate revenues that have not yet exceeded our aggregate cost of sales and operating expenses. We may continue to incur losses and expend significant amounts of cash in the foreseeable future as we continue to scale our business, invest in research and development activities, increase sales and marketing expenses to support commercial expansion, and increase general and administrative expenses associated with operating as a publicly traded company.

Previous wording

The maturity date of the Term Loan is October 15, 2030, with an interest-only period through October 15, 2027, followed by principal repayment over 36 months thereafter. Upon achievement of a certain revenue milestone, the interest-only period and repayment terms of the Term Loan may be extended through April 15, 2028 followed by principal repayment over 30 months, and upon achievement of an additional revenue milestone, may be further extended through October 15, 2028, followed by principal repayment over 24 months thereafter. The Non-Formula Revolving Line will mature on October 15, 2028. The applicable per annum interest rate is thegreater of(a) WSJ Prime Rate + 0.25% or (b) 5.25%, which resulted in its 7.0% interest rate as of March 31, 2026.

Current wording

The maturity date of the Term Loan, as amended, is October 15, 2030, with an interest-only period through October 15, 2027, followed by principal repayment over 36 months thereafter. Upon achievement of a certain revenue milestone in June 2026, the interest-only period and repayment terms of the Term Loan were extended through April 15, 2028 followed by principal repayment over 30 months. Upon achievement of an additional revenue milestone, the interest-only period and repayment terms of the Term Loan may be further extended through October 15, 2028, followed by principal repayment over 24 months thereafter. The Non-Formula Revolving Line will mature on October 15, 2028. The applicable per annum interest rate is thegreater of(a) WSJ Prime Rate + 0.25% or (b) 5.25%, which resulted in its 7.0% interest rate as of June 30, 2026.

Previous wording

As of March 31, 2026, $15.6 million of principal was outstanding under the Term Loan that will mature on October 15, 2030 and there were no borrowings outstanding under the Non-Formula Revolving Line. As of March 31, 2026, an aggregate $26.9 million remained available for borrowing under the Term Loan and Non-Formula Revolving Line, net of amounts outstanding. See Note 4—Debtin the accompanying notes to our unaudited condensed financial statements for additional information regarding this credit facility.

Current wording

As of June 30, 2026, $15.6 million of principal was outstanding under the Term Loan that will mature on October 15, 2030 and there were no borrowings outstanding under the Non-Formula Revolving Line. As of June 30, 2026, an aggregate $34.4 million is available for additional borrowing between the Term Loan and Non-Formula Revolving Line (with our achievement of requisite revenue milestone as of June 30, 2026). See Note 4—Debtin the accompanying notes to our unaudited Condensed Financial Statements for additional information regarding this credit facility.

Previous wording

Based on our current operating plan, we believe our existing cash, cash equivalents and short-term investments, the expected cash generated from sales of our aprevo Technology Platform, and amounts currently available for future borrowings under our Customers Loan Agreement will be sufficient to fund our planned operating expenses and capital expenditure requirements for at least the next 12 months. We have based this estimate on assumptions that may prove to be wrong, and we could deplete our capital resources sooner than we expect. Our quarterly and annual financial results may fluctuate as a result of a variety of factors, many of which are outside of our control and, as a result, may not fully reflect the underlying performance of our business. Fluctuation in quarterly and annual results may decrease the value of our common stock.

Current wording

Based on our current operating plan, we believe our existing cash, cash equivalents, short-term investments, and marketable securities, and the expected cash generated from sales of our aprevo Technology Platform, and amounts currently available for future borrowings under our Customers Loan Agreement will be sufficient to fund our planned operating expenses and capital expenditure requirements for at least the next 12 months. We have based this estimate on assumptions that may prove to be wrong, and we could deplete our capital resources sooner than we expect. Our quarterly and annual financial results may fluctuate as a result of a variety of factors, many of which are outside of our control and, as a result, may not fully reflect the underlying performance of our business. Fluctuation in quarterly and annual results may decrease the value of our common stock.

Previous wording

For the three months ended March 31, 2025, net cash used in operating activities was $8.2 million. We received $8.8 million from our customers for sales of the aprevo Technology Platform in the three months ended March 31, 2025 and recognized $10.2 million of revenue based on the timing of aprevo interbody implants use in surgical procedures in this period. Cash payments to vendors during the three months ended March 31, 2025 totaled $9.9 million and payroll-related cash payments totaled $7.0 million.

Current wording

For the six months ended June 30, 2026, net cash used in operating activities was $20.4 million. We received $31.5 million from our customers for sales of the aprevo interbody implants in the six months ended June 30, 2026 and recognized $35.1 million of revenue, based on the period of performed surgical procedures with our devices. Cash payments to vendors during the six months ended June 30, 2026 totaled $30.6 million and payroll-related cash payments totaled $21.3 million.

Previous wording

For the three months ended March 31, 2026, net cash used in operating activities was $13.0 million. We received $14.8 million from our customers for sales of the aprevo Technology Platform in the three months ended March 31, 2026 and recognized $16.1 million of revenue, based on the timing of aprevo interbody implants use in surgical procedures in this period. Cash payments to vendors during the three months ended March 31, 2026 totaled $15.5 million and payroll-related cash payments totaled $12.3 million.

Current wording

For the six months ended June 30, 2025, net cash used in operating activities was $15.2 million. We received $19.0 million from our customers for sales of the aprevo interbody implants in the six months ended June 30, 2025, and recognized $22.3 million of revenue based on the period of performed surgical procedures with our devices. Cash payments to vendors during the six months ended June 30, 2025 totaled $21.2 million and payroll-related cash payments totaled $13.0 million.

Previous wording

For the three months ended March 31, 2026, net cash used in investing activities was $0.2 million and consisted of purchases of property and equipment and capitalized internal use software costs.

Current wording

For the six months ended June 30, 2026, net cash used in investing activities was $19.9 million, consisting primarily of purchases of marketable securities of $18.9 million, purchases of short-term investments of $12.0 million, and purchases of property and equipment and capitalized internal use software costs of $1.0 million. This was partially offset by the maturity and sale of short-term investments of $12.0 million.

Previous wording

For the three months ended March 31, 2025, net cash used in investing activities was $0.1 million and consisted primarily of purchases of property and equipment and capitalized internal use software costs.

Current wording

For the six months ended June 30, 2025, net cash used in investing activities was $0.9 million and consisted primarily of purchases of property and equipment of $0.4 million, capitalized internal use software costs of $0.4 million, and payment of initial direct costs of $0.1 million for our new office operating lease entered into in May 2025.

Previous wording

For the three months ended March 31, 2026, net cash provided by financing activities was $0.4 million, consisting primarily proceeds from the exercise of stock options.

Current wording

For the six months ended June 30, 2026, net cash provided by financing activities was $0.7 million, consisting primarily of proceeds from the exercise of stock options of $0.5 million and proceeds from issuance of common stock under the employee stock purchase plan of $0.2 million.

Previous wording

For the three months ended March 31, 2025, net cash provided by financing activities was $11.7 million, consisting primarily of net proceeds from the issuance of Series C convertible preferred stock of $11.9 million and proceeds from the exercise of stock options of $0.1 million. This was partially offset by payments for related offering costs of $0.4 million.

Current wording

For the six months ended June 30, 2025, net cash provided by financing activities was $9.5 million, consisting primarily of net proceeds from the issuance of Series C convertible preferred stock of $11.9 million and proceeds from the exercise of stock options of $0.2 million. This was partially offset by payments for professional services related to Series C convertible preferred stock and IPO offering costs of $2.6 million.

Previous wording

Total principal outstanding under the Customers Loan Agreement as of March 31, 2026, was $15.6 million under the Term Loan. The Term Loan matures on October 15, 2030, with an interest-only period through October 15, 2027, followed by principal repayment over 36 months thereafter. Upon achievement of certain revenue milestones, the interest-only period and repayment terms may be further extended to an interest-only period through April 15, 2028 followed by principal repayment over 30 months, and upon achievement of an additional milestone, may be further extended through October 15, 2028, followed by principal repayment over 24 months thereafter. The applicable per annum interest rate is thegreater of (a) WSJ Prime Rate + 0.25% or (b) 5.25%.

Current wording

Total principal outstanding under the Customers Loan Agreement as of June 30, 2026, was $15.6 million under the Term Loan. The applicable per annum interest rate is thegreater of (a) WSJ Prime Rate + 0.25% or (b) 5.25%. The Term Loan matures on October 15, 2030 and has an interest-only period that is presently through April 15, 2028, followed by principal repayment over 30 months thereafter. Upon achievement of a certain revenue milestone, the interest-only period may be extended through October 15, 2028 with principal repayment over 24 months to October 15, 2030 maturity.

Previous wording

As of March 31, 2026, contractual obligations for operating lease payments (substantially related to our Carlsbad, California office leases with lease terms to June 30, 2028) totaled $2.1 million and are due over 27 months after March 31, 2026.

Current wording

As of June 30, 2026, contractual obligations for operating lease payments (substantially related to our Carlsbad, California office leases with lease terms to June 30, 2031) totaled $8.0 million and are due over 60 months after June 30, 2026.

Previous wording

We qualify as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, as amended (the “JOBS Act”). As an emerging growth company, we may take advantage of specified reduced disclosure and other requirements that are otherwise applicable generally to public companies. These provisions include:

Current wording

We qualify as an “emerging growth company” as defined in the JOBS Act. As an emerging growth company, we may take advantage of specified reduced disclosure and other requirements that are otherwise applicable generally to public companies. These provisions include:
Rearranged current paragraphs (3)

Current report — wording carried from elsewhere

We accounted for these liability-classified warrants, initially measured at fair value, in accordance with ASC Topic 480. Changes in fair value of warrant liabilities have been recognized in the Condensed Statements of Operations and Comprehensive Loss. During the six months ended June 30, 2026, Customers Bank exercised the warrants on a cashless basis, resulting in the issuance of 30,366 shares of common stock. As a result of the exercise, the warrants are no longer outstanding. See Note 2—Summary of Significant Accounting Policiesin the notes to our unaudited Condensed Financial Statements for information regarding the Series B Warrant and the Series C Warrant in connection with the Customers Loan Agreement.

Current report — wording carried from elsewhere

Research and development expenses were $11.2 million and $7.3 million for the six months ended June 30, 2026 and 2025, respectively. The increase of $3.9 million, or 53.5%, was primarily due to higher personnel costs to support product development and surgical planning AI initiatives.

Current report — wording carried from elsewhere

There was no change in fair value of warrant liabilities during the six months ended June 30, 2026 compared to a $0.3 million increase during the six months ended June 30, 2025, as the Company had no warrant liabilities outstanding during the current period.