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Tenon Medical, Inc.

For the period ended Sep 30, 2025. Filed Nov 13, 2025.

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.

Sep 30, 2025 · Filed Nov 13, 2025

TNON$1.640.0%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 2025-06-30; filed 2025-08-13.

0001213900-25-075652

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

Current report: 10-Q

Period ended 2025-09-30; filed 2025-11-13.

0001213900-25-109961

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 51 previous paragraphs and 51 current paragraphs.

27 unchanged; 21 reworded; 3 added; 3 removed; 0 previous and 0 current paragraphs rearranged.

Tables are not compared: 7 previous and 7 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 (3)

Current report

On November 11, 2025, we announced the pricing of an at-the-market private investment in public equity (the “PIPE”) financing with several accredited investors for total gross proceeds of $2,850,000. Under the terms of securities purchase agreements, dated November 10, 2025 between us and the applicable investors, we will issue an aggregate of 2,217,904 shares of common stock (the “Issued Shares”) and warrants (the “PIPE Warrants”) to purchase 2,217,904 shares of common stock at a combined offering price of $1.285 per share of common stock and warrant to purchase one share of common stock. The PIPE Warrants have a strike price of $1.16 per share, with an expiration date of 3 years from the date of issuance. The Issued Shares and the shares underlying PIPE Warrants will be entitled to customary resale registration rights. The closing of the PIPE is subject to customary closing conditions for financing of this nature. The PIPE is expected to close on November 14, 2025.

Current report

We account for business combinations in accordance with Accounting Standards Codification 805,Business Combinations, which requires that assets acquired and liabilities assumed be recorded at their respective fair values on the date of acquisition. The fair value of the consideration paid is assigned to the underlying net assets of the acquired business based on their respective fair values. Any excess of the purchase price over the estimated fair values of the net assets acquired is recorded to goodwill. Intangible assets acquired are amortized over the expected life of the asset. Fair value determinations and useful life estimates are based on, among other factors, estimates of expected future cash flows, estimates of appropriate discount rates, estimated useful lives of the intangible assets acquired and other factors. Although we believe the assumptions and estimates we have made have been reasonable and appropriate, actual results may vary significantly from estimated results. Our assumptions and estimates are subject to refinement and, as a result, during the measurement period, which may be up to one year from the acquisition date, We record adjustments to the assets acquired and liabilities assumed with the corresponding offset to goodwill.
Removed paragraphs (3)

Previous report

With an entry similar to the SI Joint injection, the surgical approach is direct to the joint. The angle and trajectory of the inferior-posterior approach is designed to point away from critical neural and vascular structures and into the strongest cortical bone. Joined by a patented osteotome bridge, the implant design consists of two hollow fenestrated pontoons with an open framework to facilitate bony in-growth through the SI Joint. One pontoon fixates into the ilium and the other into the sacrum. The osteotome is designed to disrupt the articular portion of the joint to help facilitate a fusion response.

Previous report

Our initial clinical results indicate that the Catamaran System implant is promoting fusion across the joint as evidenced by computerized tomography (CT) scans which is the gold standard widely accepted by the clinical community. We had our national launch of The Catamaran System in October 2022 and are building a sales and marketing infrastructure to market our product and address the greatly underserved market opportunity that exists.

Previous report

We believe that the implant design and procedure we have developed, along with the 2D and 3D protocols for proper implantation will be received well by the clinician community who have been looking for a next generation device.
Reworded paragraphs (21)

Previous wording

Tenon Medical, Inc., a medical device company formed in 2012, has developed a proprietary, U.S. Food and Drug Administration (“FDA”) approved surgical implant-system, which we call The Catamaran™ SI Joint Fusion System (“The Catamaran System”). The Catamaran System offers a novel, less invasive inferior-posterior approach to the sacroiliac joint (“SI Joint”) using a single, robust titanium implant to treat SI Joint dysfunction that often causes severe lower back pain. The system features the Catamaran™ Fixation Device which passes through both the axial and sagittal planes of the ilium and sacrum, transfixing the SI Joint along its longitudinal axis. Published clinical studies have shown that 15% to 30% of all chronic lower back pain is associated with the SI Joint.

Current wording

Tenon Medical, Inc., a medical device company formed in 2012, has developed a proprietary, U.S. Food and Drug Administration (“FDA”) approved surgical implant-system, which we call The Catamaran™ SI Joint Fusion System (“The Catamaran System”). The Catamaran System offers a novel, less invasive inferior-posterior approach to the sacroiliac joint (“SI Joint”) using a single, robust titanium implant to treat SI Joint dysfunction that often causes severe lower back pain. The system features the Catamaran™ Fixation Device which passes through both the axial and sagittal planes of the ilium and sacrum, transfixing the SI Joint along its longitudinal axis. In August 2025, the Company purchased substantially all of the assets of SiVantage, Inc., including the SImmetry SI Joint Fusion System that treats disorders of the SI Joint using a single, robust, titanium implant.

Previous wording

We have incurred net losses since our inception in 2012. As of June 30, 2025, we had an accumulated deficit of approximately $75.1 million. To date, we have financed our operations primarily through public equity offerings, private placements of equity securities, certain debt-related financing arrangements, and sales of our product. We have devoted substantially all of our resources to research and development, regulatory matters and sales and marketing of our product.

Current wording

We have incurred net losses since our inception in 2012. As of September 30, 2025, we had an accumulated deficit of approximately $78.5 million. To date, we have financed our operations primarily through public equity offerings, private placements of equity securities, certain debt-related financing arrangements, and sales of our product. We have devoted substantially all of our resources to research and development, regulatory matters and sales and marketing of our product.

Previous wording

We derive substantially all our revenue from sales of The Catamaran System to a limited number of clinicians. Revenue from sales of The Catamaran System fluctuates based on volume of cases (procedures performed), discounts, rebates, and the number of implants used for a particular patient. Similar to other orthopedic companies, our revenue can also fluctuate from quarter to quarter due to a variety of factors, including reimbursement, changes in independent sales representatives and physician activities.

Current wording

We derive substantially all our revenue from sales of The Catamaran System and, since August 2025, the SImmetry SI Joint Fusion System. Revenue from sales of The Catamaran System and the SImmetry SI Joint Fusion System fluctuates based on volume of cases (procedures performed), discounts, rebates, and the number of implants used for a particular patient. Similar to other orthopedic companies, our revenue can also fluctuate from quarter to quarter due to a variety of factors, including reimbursement, changes in independent sales representatives and physician activities.

Previous wording

We utilize contract manufacturers for production of The Catamaran System implants and Catamaran Tray Sets. Cost of goods sold consists primarily of costs of the components of The Catamaran System implants and instruments, depreciation of Catamaran tray sets, overhead related to operations personnel and facility costs, quality inspection, packaging, scrap and inventory obsolescence, as well as distribution-related expenses such as logistics and shipping costs. We anticipate that certain of our cost of goods sold will increase in absolute dollars as case levels increase.

Current wording

We utilize contract manufacturers for production of The Catamaran System implants, SImmetry implants and the instrument tray sets. Cost of goods sold consists primarily of costs of the components of the implants and instruments, depreciation of instrument tray sets, overhead related to operations personnel and facility costs, quality inspection, packaging, scrap and inventory obsolescence, as well as distribution-related expenses such as logistics and shipping costs. We anticipate that certain of our cost of goods sold will increase in absolute dollars as case levels increase.

Previous wording

Our gross margins have been and will continue to be affected by a variety of factors, including the cost to have our product manufactured for us, pricing pressure from increasing competition, decisions with regard to the level of overhead we choose to maintain, and the factors described above impacting our revenue.

Current wording

Our gross margins have been and will continue to be affected by a variety of factors, including the cost to have our product manufactured for us, pricing pressure from increasing competition, decisions with regard to the level of overhead we choose to maintain, sales volumes to absorb fixed production costs, and the factors described above impacting our revenue.

Previous wording

Sales and marketing expenses primarily consist of salaries, commissions, stock-based compensation expense and travel and entertainment expenses of our sales and market personnel along with commissions paid to our independent distributors. We expect our sales and marketing expenses to increase in absolute dollars with the increased sales of The Catamaran System resulting in higher commissions and salaries, increased clinician and sales representative training, and the cost to complete our clinical study to gain wider clinician adoption of The Catamaran System. Our sales and marketing expenses may fluctuate from period to period due to the timing of sales and marketing activities related to the commercial activity of our product.

Current wording

Sales and marketing expenses primarily consist of salaries, commissions, stock-based compensation expense and travel and entertainment expenses of our sales and market personnel along with commissions paid to our independent distributors. We expect our sales and marketing expenses to increase in absolute dollars with the increased sales resulting in higher commissions and salaries, increased clinician and sales representative training, and the cost to complete our clinical study to gain wider clinician adoption of our products. Our sales and marketing expenses may fluctuate from period to period due to the timing of sales and marketing activities related to the commercial activity of our product.

Previous wording

Our research and development expenses primarily consist of engineering, product development, regulatory expenses, and consulting services, outside prototyping services, outside research activities, materials, and other costs associated with the development and refinement of our product. Research and development expenses also include related personnel and consultants’ compensation and stock-based compensation expense. We expense research and development costs as they are incurred. We expect research and development expense to increase in absolute dollars as we improve The Catamaran System, develop new products, add research and development personnel, and undergo clinical activities that may be required for regulatory clearances of future products.

Current wording

Our research and development expenses primarily consist of engineering, product development, regulatory expenses, and consulting services, outside prototyping services, outside research activities, materials, and other costs associated with the development and refinement of our product. Research and development expenses also include related personnel and consultants’ compensation and stock-based compensation expense. We expense research and development costs as they are incurred. We expect research and development expense to increase in absolute dollars as we improve our existing products, develop new products, add research and development personnel, and undergo clinical activities that may be required for regulatory clearances of future products.

Previous wording

General and administrative expenses primarily consist of salaries, consultants’ compensation, stock-based compensation expense, and other costs for finance, accounting, legal, compliance, and administrative matters. We expect our general and administrative expenses to increase in absolute dollars as we add personnel and information technology infrastructure to support the growth of our business. We also expect to incur additional general and administrative expenses as a result of operating as a public company, including but not limited to: expenses related to compliance with the rules and regulations of the SEC and those of The Nasdaq Stock Market LLC on which our securities are traded; additional insurance expenses; investor relations activities; and other administrative and professional services. While we expect the general and administrative expenses to increase in absolute dollars, we anticipate that it will decrease as a percentage of revenue over time.

Current wording

General and administrative expenses primarily consist of salaries, consultants’ compensation, stock-based compensation expense, and other costs for finance, accounting, legal, compliance, and administrative matters. We expect our general and administrative expenses to increase in absolute dollars as we add personnel and information technology infrastructure to support the growth of our business. We also expect to continue to incur expenses as a result of operating as a public company, including but not limited to: expenses related to compliance with the rules and regulations of the SEC and those of The Nasdaq Stock Market LLC on which our securities are traded; additional insurance expenses; investor relations activities; and other administrative and professional services. We also may incur acquisition-related expenses at the discretion of management and the Board of Directors. While we expect the general and administrative expenses to increase in absolute dollars, we anticipate that it will decrease as a percentage of revenue over time.

Previous wording

Comparison of the Three and Six Months Ended June 30, 2025 and 2024 (in thousands, except percentages)

Current wording

Comparison of the Three and Nine Months Ended September 30, 2025 and 2024 (in thousands, except percentages)

Previous wording

Revenue. The decrease in revenue for the three and six months ended June 30, 2025 as compared to the same periods in 2024 was primarily due to a decrease in the number of surgical procedures in which The Catamaran System was used, while implants per procedure remained relatively constant.

Current wording

*Revenue.*The changes in revenue for the three and nine months ended September 30, 2025 as compared to the same periods in 2024 was primarily due to changes in the number of surgical procedures in which The Catamaran System was used and the addition of sales of the SImmetry SI Joint Fusion System, while implants per procedure remained relatively constant.

Previous wording

Cost of Goods Sold, Gross Profit, and Gross Margin. The change in cost of goods sold for the three and six months ended June 30, 2025 as compared to the same periods in 2024 was due to the absorption of production overhead costs into our standard cost in 2024 and operating leverage created due to lower relative fixed costs.

Current wording

Cost of Goods Sold, Gross Profit, and Gross Margin. The change in cost of goods sold for the three and nine months ended September 30, 2025 as compared to the same periods in 2024 was due to the absorption of production overhead costs into our standard cost in 2024 and operating leverage created due to lower relative fixed costs. The gross margin for the three months ended September 30, 2025 benefitted from increased sales volumes that reduced per unit fixed production costs.

Previous wording

Research and Development Expenses. Research and development expenses for the three months ended June 30, 2025 decreased as compared to 2024 primarily due to decreased professional fees ($58) and stock-based compensation ($150), partially offset by increased payroll and employee expenses ($13). Research and development expenses for the six months ended June 30, 2025 decreased as compared to 2024 primarily due to decreased professional fees ($139) and stock-based compensation ($168), partially offset by increased payroll and employee expenses ($100).

Current wording

Research and Development Expenses. Research and development expenses for the three months ended September 30, 2025 decreased as compared to 2024 primarily due to decreased stock-based compensation ($339) and payroll and employee expenses ($46), partially offset by increased professional fees ($106). Research and development expenses for the nine months ended September 30, 2025 decreased as compared to 2024 primarily due to decreased stock-based compensation ($507) and professional fees ($32), partially offset by increased payroll and employee expenses ($54).

Previous wording

*Sales and Marketing Expenses.*Sales and marketing expenses for the three months ended June 30, 2025 decreased as compared to the same period in 2024 primarily due to decreased commission expenses ($251), payroll and employee expenses ($58), consulting and professional fees ($34), and stock-based compensation ($7). Sales and marketing expenses for the six months ended June 30, 2025 decreased as compared to the same period in 2024 primarily due to decreased commission expenses ($148) and stock-based compensation ($13), partially offset by increases in payroll and employee expenses ($58) and professional fees ($11).

Current wording

Sales and Marketing Expenses. Sales and marketing expenses for the three months ended September 30, 2025 increased as compared to the same period in 2024 primarily due to increased commission expenses ($410) and consulting and professional fees ($38), partially offset by decreases in payroll and employee expenses ($84), and stock-based compensation ($5). Sales and marketing expenses for the nine months ended September 30, 2025 increased as compared to the same period in 2024 primarily due to increased commission expenses ($262) and professional fees ($45), partially offset by decreases in payroll and employee expenses ($27) and stock-based compensation ($18).

Previous wording

General and Administrative Expenses. General and administrative expenses for the three months ended June 30, 2025 decreased as compared to the same period in 2024 primarily due to decreased stock-based compensation ($461), insurance costs ($221) and professional service fees ($26), partially offset by increases in payroll and employee expenses ($31). General and administrative expenses for the six months ended June 30, 2025 decreased as compared to the same period in 2024 primarily due to decreased stock-based compensation ($582), insurance costs ($325) and professional service fees ($70), partially offset by increases in payroll and employee expenses ($86).

Current wording

General and Administrative Expenses. General and administrative expenses for the three months ended September 30, 2025 increased as compared to the same period in 2024 primarily due to acquisition expenses ($779) and increases in professional service fees ($190) and payroll and employee expenses ($135), partially offset by decreased stock-based compensation ($508) and insurance costs ($146). General and administrative expenses for the nine months ended September 30, 2025 decreased as compared to the same period in 2024 primarily due to decreased stock-based compensation ($1,090) and insurance costs ($471), partially offset by acquisition expenses ($779) and increases in employee expenses ($221) and professional service fees ($96).

Previous wording

Gain on investments for the three and six months ended June 30, 2025 increased as compared to the same periods in 2024 due to interest on our increased cash and cash equivalent balances. Interest expense for the six months ended June 30, 2024 related to our convertible debt. Other income (expense), net in 2024 was related to foreign exchange losses on the liquidation of our Swiss subsidiary.

Current wording

Gain on investments for the three and nine months ended September 30, 2025 increased as compared to the same periods in 2024 due to interest on our increased cash and cash equivalent balances. Interest expense for the nine months ended September 30, 2024 related to our convertible debt. Other income (expense), net in 2024 was related to foreign exchange losses on the liquidation of our Swiss subsidiary.

Previous wording

As of June 30, 2025, we had cash and cash equivalents of $7.8 million. Since inception, we have financed our operations through private placements of preferred stock, debt financing arrangements, our initial public offering, additional stock offerings and the sale of our products. As of June 30, 2025, we had no outstanding debt.

Current wording

As of September 30, 2025, we had cash and cash equivalents of $3.4 million. Since inception, we have financed our operations through private placements of preferred stock, debt financing arrangements, our initial public offering, additional stock offerings and the sale of our products. As of September 30, 2025, we had no outstanding debt. As of September 30, 2025, we had an accumulated deficit of $78.5 million, and we expect to incur additional losses in the future. We have not achieved positive cash flow from operations to date.

Previous wording

As of June 30, 2025, we had an accumulated deficit of $75.1 million and we expect to incur additional losses in the future. We have not achieved positive cash flow from operations to date. Based upon our current operating plan, our existing cash and cash equivalents will not be sufficient to fund our operating expenses and working capital requirements through at least the next 12 months from the date these financial statements were filed. We plan to raise the necessary additional capital through one or a combination of public or private equity offerings, debt financings, and collaborations. We continue to face challenges and uncertainties and, as a result, our available capital resources may be consumed more rapidly than currently expected due to (a) the uncertainty of future revenues from The Catamaran System; (b) changes we may make to the business that affect ongoing operating expenses; (c) changes we may make in our business strategy; (d) regulatory 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.

Current wording

Based upon our current operating plan, our existing cash and cash equivalents will not be sufficient to fund our operating expenses and working capital requirements through at least the next 12 months from the date these financial statements were filed. We plan to raise the necessary additional capital through one or a combination of public or private equity offerings, debt financings, and collaborations. We continue to face challenges and uncertainties and, as a result, our available capital resources may be consumed more rapidly than currently expected due to (a) the uncertainty of future revenues; (b) changes we may make to the business that affect ongoing operating expenses; (c) changes we may make in our business strategy; (d) regulatory 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.

Previous wording

The decrease in net cash used in operating activities for the six months ended June 30, 2025 as compared to the six months ended June 30, 2024 was primarily attributable to our decreased net loss ($1,017), adjusted for decreases in non-cash stock-based compensation expenses ($763), in addition to decreased accounts payable ($153) and accrued expenses ($243), partially offset by decreases in accounts receivable ($300).

Current wording

The decrease in net cash used in operating activities for the nine months ended September 30, 2025 as compared to the nine months ended September 30, 2024 was primarily attributable to our decreased net loss ($862), adjusted for decreases in non-cash stock-based compensation expenses ($1,615), in addition to increased inventory levels ($501) and decreased accounts payable ($394), partially offset by increases in accrued expenses ($498).

Previous wording

Cash used in investing activities for the six months ended June 30, 2025 and 2024 consisted of purchases of property and equipment ($192 and $119, respectively).

Current wording

Cash used in investing activities for the nine months ended September 30, 2025 consisted of the cash payment for the SI Acquisition ($750) and purchases of property and equipment ($81). Cash used in investing activities for the nine months ended September 30, 2024 consisted of purchases of property and equipment ($223).

Previous wording

Cash provided by financing activities for the six months ended June 30, 2025 consisted primarily of proceeds from the issuance of common stock from our securities purchase agreements ($4,010) and proceeds from the exercise of warrants under the inducement agreement ($3,057), partially offset by offering costs ($867). Cash provided by financing activities for the six months ended June 30, 2024 consisted primarily of proceeds from the issuance of Series A Convertible Preferred Stock ($2,605) and from the issuance of common stock ($1,990), partially offset by offering costs ($224).

Current wording

Cash provided by financing activities for the nine months ended September 30, 2025 consisted primarily of gross proceeds from the issuance of common stock from our securities purchase agreements ($4,010) and from the exercise of warrants under the inducement agreement ($3,057), net of total cash offering costs ($867). Cash provided by financing activities for the nine months ended September 30, 2024 consisted primarily of gross proceeds from the issuance of common stock and warrants ($4,500), the exercise of warrants under the inducement agreement ($4,647), the issuance of Series A Convertible Preferred Stock ($2,605) and Series B Convertible Preferred Stock ($550) and from issuances of common stock ($2,163), net of total cash offering costs ($1,265).

Previous wording

Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported results of operations during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from three other sources. Actual results could differ from these estimates under different assumptions or conditions. For the six months ended June 30, 2025, there were no significant changes to our existing critical accounting policies from those disclosed in our Annual Report on Form 10-K.

Current wording

Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported results of operations during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from three other sources. Actual results could differ from these estimates under different assumptions or conditions. For the nine months ended September 30, 2025, the only significant change to our existing critical accounting policies from those disclosed in our Annual Report on Form 10-K was related to accounting for business combinations, as described below.