−Removed: MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL
−Removed: CONDITION AND RESULTS OF OPERATIONS
−Removed: You should read the following
−Removed: discussion and analysis of our financial condition and results of operations together with our financial statements and the notes to those
−Removed: statements included elsewhere in this Annual Report on Form 10-K.
−Removed: In addition to historical financial information, this discussion
−Removed: and analysis contains forward-looking statements that reflect our plans, estimates and beliefs.
−Removed: You should not place undue reliance on
−Removed: these forward-looking statements, which involve risks and uncertainties.
−Removed: As a result of many factors, including but not limited to those
−Removed: set forth under “Risk Factors,” our actual results may differ materially from those anticipated in these forward-looking
+Added: MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
+Added: should read the following discussion and analysis of our financial condition and results of operations together with our financial statements
+Added: and the notes to those statements included elsewhere in this Annual Report on Form 10-K.
+Added: In addition to historical financial information,
+Added: this discussion and analysis contains forward-looking statements that reflect our plans, estimates and beliefs.
+Added: You should not place
+Added: undue reliance on these forward-looking statements, which involve risks and uncertainties.
+Added: As a result of many factors, including but
+Added: not limited to those set forth under ‘‘Risk Factors,’’ our actual results may differ materially from those anticipated
+Added: in these forward-looking statements.
See “Cautionary Note Regarding Forward-Looking Statements.”
−Removed: Tenon Medical, Inc., a
−Removed: medical device company formed in 2012, has developed a proprietary, U.S.
−Removed: Food and Drug Administration (“FDA”) approved
−Removed: surgical implant-system, which we call The Catamaran™ SI Joint Fusion System (“The Catamaran System”).
−Removed: Catamaran System offers a novel, less invasive inferior-posterior approach to the sacroiliac joint (“SI Joint”) using a
−Removed: single, robust titanium implant to treat SI Joint dysfunction that often causes severe lower back pain.
−Removed: The system features the
−Removed: Catamaran™ Fixation Device which passes through both the axial and sagittal planes of the ilium and sacrum, transfixing the SI
−Removed: Joint along its longitudinal axis.
−Removed: Published clinical studies have shown that 15% to 30% of all chronic lower back pain is
−Removed: associated with the SI Joint.
−Removed: With an entry similar
−Removed: to the SI Joint injection, the surgical approach is direct to the joint.
−Removed: The angle and trajectory of the inferior-posterior approach
−Removed: is designed to point away from critical neural and vascular structures and into the strongest cortical bone.
−Removed: Joined by a patented
−Removed: osteotome bridge, the implant design consists of two hollow fenestrated pontoons with an open framework to facilitate bony in-growth
−Removed: through the SI Joint.
−Removed: One pontoon fixates into the ilium and the other into the sacrum.
−Removed: The osteotome is designed to disrupt the
−Removed: articular portion of the joint to help facilitate a fusion response.
−Removed: Our initial clinical results
−Removed: indicate that the Catamaran System implant is promoting fusion across the joint as evidenced by computerized tomography (CT) scans which
−Removed: is the gold standard widely accepted by the clinical community.
−Removed: We had our national launch of The Catamaran System in October 2022 and
−Removed: are building a sales and marketing infrastructure to market our product and address the greatly underserved market opportunity that exists.
−Removed: We believe that the implant
−Removed: design and procedure we have developed, along with the 2D and 3D protocols for proper implantation will be received well by the clinician
−Removed: community who have been looking for a next generation device.
−Removed: We have incurred net losses
−Removed: since our inception in 2012.
+Added: Medical, Inc.
+Added: (the “Company”) was incorporated in the State of Delaware on June 19, 2012 and was headquartered in San Ramon,
+Added: California until June 2021 when it relocated to Los Gatos, California.
+Added: The Company is a medical device company dedicated to transforming
+Added: care for patients with certain sacro-pelvic disorders.
+Added: The Company currently offers two systems to treat a diseased SI Joint.
+Added: has developed The Catamaran®™ SI Joint Fusion System (“The Catamaran System”) that offers a novel, less invasive
+Added: approach to the SI Joint using a single, robust, titanium implant for treatment of the most common types of SI Joint disorders that cause
+Added: lower back pain.
+Added: The Company received U.S.
+Added: Food and Drug Administration (“FDA”) clearance in 2018 for The Catamaran System
+Added: and is currently focused on the US market.
+Added: Since the national launch of The Catamaran System in October 2022, the Company is focused
+Added: on three commercial opportunities:
+Added: 1) primary SI Joint procedures, 2) revision procedures of failed SI Joint implants and 3) SI Joint
+Added: fusion adjunct to a spine fusion construct.
+Added: August 2025, the Company acquired substantially all of the assets of SiVantage, Inc.
+Added: and SIMPL Medical, LLC, including the SImmetry +®
+Added: SI Joint Fusion System (“The SImmetry + System”) that treats disorders of the SI Joint through minimally invasive
+Added: lateral access solution that incorporates well-established orthopedic fusion principles-including joint decortication, bone graft placement,
+Added: and rigid fixation-with the goal of achieving a true biological fusion across the SI Joint.
+Added: have incurred net losses since our inception in 2012.
As of December 31, 2025, we had an accumulated deficit of approximately $81.3 million.
−Removed: To date, we have financed
−Removed: our operations primarily through public equity offerings, private placements of equity securities, certain debt-related financing arrangements,
−Removed: and sales of our product.
−Removed: We have devoted substantially all of our resources to research and development, regulatory matters and sales
−Removed: and marketing of our product.
−Removed: Reverse Stock Splits
−Removed: On November 2, 2023, we effected
−Removed: a 1-for-10 reverse stock split (the “2023 Reverse Stock Split”) by filing an amendment to our Amended and Restated Certificate
−Removed: of Incorporation, as amended, with the Delaware Secretary of State.
−Removed: The 2023 Reverse Stock Split combined every ten shares of our common
−Removed: stock issued and outstanding immediately prior to effecting the 2023 Reverse Stock Split into one share of common stock.
−Removed: No fractional
−Removed: shares were issued in connection with the 2023 Reverse Stock Split.
−Removed: On September 6, 2024, we
−Removed: effected a 1-for-8 reverse stock split (the “2024 Reverse Stock Split”) by filing an amendment to the our Amended and Restated
−Removed: Certificate of Incorporation, as amended, with the Delaware Secretary of State.
−Removed: The 2024 Reverse Stock Split combined every eight shares
−Removed: of our common stock issued and outstanding immediately prior to effecting the 2024 Reverse Stock Split into one share of common stock.
+Added: To date, we have financed our operations primarily through public equity offerings, private placements of equity securities, certain
+Added: debt-related financing arrangements, and sales of our product.
+Added: We have devoted substantially all of our resources to research and development,
+Added: regulatory matters and sales and marketing of our product.
+Added: September 6, 2024, we effected a 1-for-8 reverse stock split (the “2024 Reverse Stock Split”) by filing an amendment to the
+Added: our Amended and Restated Certificate of Incorporation, as amended, with the Delaware Secretary of State.
+Added: The 2024 Reverse Stock Split
+Added: combined every eight shares of our common stock issued and outstanding immediately prior to effecting the 2024 Reverse Stock Split into
+Added: one share of common stock.
No fractional shares were issued in connection with the 2024 Reverse Stock Split.
All historical share and
−Removed: per share amounts reflected throughout this document have been adjusted to reflect the 2023 Reverse Stock Split and the 2024 Reverse Stock
−Removed: The authorized number of shares and the par value per share of our common stock were not affected by the 2023 Reverse Stock Split
−Removed: or the 2024 Reverse Stock Split.
−Removed: Critical Accounting Policies and Significant Judgments and Estimates
−Removed: Our management’s discussion
−Removed: and analysis of our financial condition and results of operations is based on our audited consolidated financial statements, which have
−Removed: been prepared in accordance with United States generally accepted accounting principles (“U.S.
−Removed: The preparation of
−Removed: these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and
−Removed: the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported results of operations
+Added: per share amounts reflected throughout this document have been adjusted to reflect the 2024 Reverse Stock Split.
+Added: The authorized number
+Added: of shares and the par value per share of our common stock were not affected by the 2024 Reverse Stock Split.
+Added: Accounting Policies and Significant Judgments and Estimates
+Added: management’s discussion and analysis of our financial condition and results of operations is based on our audited financial statements,
+Added: which have been prepared in accordance with United States generally accepted accounting principles (“U.S.
+Added: The preparation
+Added: of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities
+Added: 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.
3 unchanged sentences
Actual results could differ from these estimates under different assumptions or conditions.
−Removed: While our significant accounting policies are described in more detail in the notes to our consolidated financial statements included
−Removed: elsewhere in this Annual Report on Form 10-K, we believe that the accounting policies discussed below are those that are most critical
−Removed: to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s
−Removed: judgments and estimates.
−Removed: For more detail on our critical accounting policies, see Note 2 to our consolidated financial statements.
−Removed: Revenue Recognition
−Removed: Our revenue is derived from
−Removed: the sale of our products to medical groups and hospitals in the United States.
−Removed: Revenue is recognized when control is transferred to the
−Removed: customer, in an amount that reflects the consideration we expect to be entitled to in exchange for the goods or services, using the following
−Removed: five step approach:
−Removed: (1) identify the contract with a customer, (2) identify the performance obligations in the contract, (3) determine
−Removed: the transaction price, (4) allocate the transaction price to the performance obligations in the contract, and (5) recognize revenue when
−Removed: a performance obligation is satisfied.
−Removed: We generate our revenue from
−Removed: the sale of products to hospitals or medical facilities where our products are delivered in advance of a procedure.
−Removed: The performance obligation
−Removed: is the delivery of the products along with the completion of the surgery and therefore, revenue is recognized upon delivery to the customers
−Removed: and completion of the surgery, net of rebates and price discounts.
+Added: While our significant accounting policies are described in more detail in the notes to our financial statements included elsewhere in
+Added: this Annual Report on Form 10-K, we believe that the accounting policies discussed below are those that are most critical to understanding
+Added: our historical and future performance, as these policies relate to the more significant areas involving management’s judgments
+Added: and estimates.
+Added: For more detail on our critical accounting policies, see Note 2 to our financial statements.
+Added: revenue is derived from the sale of our products to medical groups and hospitals in the United States.
+Added: Revenue is recognized when control
+Added: is transferred to the customer, in an amount that reflects the consideration we expect to be entitled to in exchange for the goods or
+Added: services, using the following five step approach:
+Added: (1) identify the contract with a customer, (2) identify the performance obligations
+Added: in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract,
+Added: and (5) recognize revenue when a performance obligation is satisfied.
+Added: generate our revenue from the sale of products to hospitals or medical facilities where our products are delivered in advance of a procedure.
+Added: The performance obligation is the completion of the surgery and therefore, revenue is recognized upon completion of the surgery, net
+Added: of rebates and price discounts.
We account for rebates and price discounts as a reduction to revenue.
−Removed: Sales prices are specified prior to the transfer of control to the customer, via either the customer contract, agreed price list, purchase
−Removed: order, or written communication with the customer.
−Removed: For direct sales to end-user customers, our standard payment terms are generally net
−Removed: We offer our standard warranty
−Removed: to all customers.
+Added: Sales prices are specified prior
+Added: to the transfer of control to the customer, via either the customer contract, agreed price list, purchase order, or written communication
+Added: with the customer.
+Added: For direct sales to end-user customers, our standard payment terms are generally net 30 days.
+Added: offer our standard warranty to all customers.
We do not sell any warranties on a standalone basis.
−Removed: Our warranty provides that our products are free of material defects
−Removed: and conform to specifications, and includes an offer to replace or refund the purchase price of defective products.
−Removed: This assurance does
−Removed: not constitute a service and is not considered a separate performance obligation.
−Removed: We estimate warranty liabilities at the time of revenue
−Removed: recognition and record them as a charge to cost of goods sold.
−Removed: Stock-Based Compensation
−Removed: We account for all stock-based
−Removed: compensation awards using a fair-value method on the grant date and recognize the fair value of each award as an expense over the requisite
−Removed: service period.
−Removed: We recognize compensation
−Removed: costs related to stock-based awards granted to employees, directors, and consultants, including restricted stock units and stock
−Removed: options, based on the estimated fair value of the awards on the date of grant.
−Removed: For restricted stock units, we estimate grant date
−Removed: fair value based on the closing market price on the date of grant.
−Removed: For stock options, we estimate the grant date fair value using the Black-Scholes option-pricing model.
−Removed: The grant date fair value of the stock-based awards is
−Removed: generally recognized on a straight-line basis over the requisite service period, which is generally the vesting period of the
−Removed: respective awards.
−Removed: The Black-Scholes option-pricing
−Removed: model requires the use of subjective assumptions to determine the fair value of stock-based awards.
−Removed: These assumptions include:
−Removed: Expected Term —The
−Removed: expected term represents the period that stock-based awards are expected to be outstanding.
−Removed: The expected term for option grants is determined
−Removed: using the simplified method.
−Removed: The simplified method deems the expected term to be the midpoint between the vesting date and the contractual
−Removed: life of the stock-based awards.
−Removed: Expected Volatility —Since
−Removed: we have only been publicly held since April 2022 and do not have any trading history for our common stock, the expected volatility was
−Removed: estimated based on the average volatility for comparable publicly traded companies over a period equal to the expected term of the stock
−Removed: option grants.
−Removed: The comparable companies were chosen based on their similar size, stage in the life cycle, or area of specialty.
−Removed: Risk-Free Interest Rate —The
−Removed: risk-free interest rate is based on the U.S.
−Removed: Treasury zero coupon issues in effect at the time of grant for periods corresponding with
−Removed: the expected term of option.
−Removed: Expected Dividend —We
−Removed: have never paid dividends on our common stock and have no plans to pay dividends on our common stock.
−Removed: Therefore, we used an expected dividend
−Removed: yield of zero.
−Removed: We account for forfeitures
−Removed: as they occur.
−Removed: Our board of directors intends
−Removed: all options granted to be exercisable at a price per share not less than the per share fair value of our common stock underlying those
−Removed: options on the date of grant.
−Removed: Common Stock Warrants
−Removed: We account for warrants for shares
−Removed: of common stock as equity or liabilities in accordance with the accounting guidance for derivatives.
−Removed: The accounting guidance provides
−Removed: a scope exception from classifying and measuring as a financial liability a contract that would otherwise meet the definition of a derivative
−Removed: if the contract is both (i) indexed to the entity’s own stock and (ii) classified in the stockholders’ deficit section of
−Removed: the consolidated balance sheet.
−Removed: We estimate the fair value of our warrants for shares of common stock by using the Black-Scholes option
−Removed: pricing model.
−Removed: Warrants classified as equity are recorded as additional paid-in capital on the consolidated balance sheet and no further
−Removed: adjustments to their valuation are made after the issuance of the warrants.
−Removed: Financial Operations Overview
−Removed: We derive substantially all
−Removed: our revenue from sales of The Catamaran System to a limited number of clinicians.
−Removed: Revenue from sales of The Catamaran System fluctuates
−Removed: based on volume of cases (procedures performed), discounts, rebates, and the number of implants used for a particular patient.
−Removed: to other orthopedic companies, our revenue can also fluctuate from quarter to quarter due to a variety of factors, including reimbursement,
−Removed: changes in independent sales representatives and physician activities.
−Removed: Cost of Goods Sold, Gross Profit, and Gross Margin
−Removed: We utilize contract manufacturers
−Removed: for production of The Catamaran System implants and Catamaran Tray Sets.
−Removed: Cost of goods sold consists primarily of costs of the components
−Removed: of The Catamaran System implants and instruments, overhead related to operation personnel and facility costs, quality inspection, packaging,
−Removed: scrap and inventory obsolescence, as well as distribution-related expenses such as logistics and shipping costs.
−Removed: We anticipate that certain
−Removed: of our cost of goods sold will increase in absolute dollars as case levels increase.
−Removed: Our gross margins have been
−Removed: and will continue to be affected by a variety of factors, including the cost to have our product manufactured for us, pricing pressure
−Removed: from increasing competition, and the factors described above impacting our revenue.
−Removed: Operating Expenses
−Removed: Our operating expenses consist
−Removed: of sales and marketing, research and development, and general and administrative expenses.
−Removed: Personnel costs are the most significant component
−Removed: of operating expenses and consist of consulting expenses, salaries, sales commissions and other cash and stock-based compensation related
−Removed: We expect operating expenses to increase in absolute dollars as we continue to invest and grow our business.
−Removed: Sales and Marketing Expenses
−Removed: Sales and marketing expenses
−Removed: primarily consist of salaries, commissions, stock-based compensation expense and travel and entertainment expenses of our sales and market
−Removed: personnel along with commissions paid to our independent distributors.
−Removed: We expect our sales and marketing expenses to increase in absolute
−Removed: dollars with the increased sales of The Catamaran System resulting in higher commissions and salaries, increased clinician and sales representative
−Removed: training, and the cost to complete our clinical study to gain wider clinician adoption of The Catamaran System.
−Removed: Our sales and marketing
−Removed: expenses may fluctuate from period to period due to the timing of sales and marketing activities related to the commercial activity of
−Removed: Research and Development Expenses
−Removed: Our research and development
−Removed: expenses primarily consist of engineering, product development, regulatory expenses, and consulting services, outside prototyping services,
−Removed: outside research activities, materials, and other costs associated with the development and refinement of our product.
−Removed: Research and development
−Removed: expenses also include related personnel and consultants’ compensation and stock-based compensation expense.
−Removed: We expense research
−Removed: and development costs as they are incurred.
−Removed: We expect research and development expense to increase in absolute dollars as we improve The
−Removed: Catamaran System, develop new products, add research and development personnel, and undergo clinical activities that may be required for
−Removed: regulatory clearances of future products.
−Removed: General and Administrative Expenses
−Removed: General and administrative
−Removed: expenses primarily consist of salaries, consultants’ compensation, stock-based compensation expense, and other costs for finance,
−Removed: accounting, legal, compliance, and administrative matters.
−Removed: We expect our general and administrative expenses to increase in absolute dollars
−Removed: as we add personnel and information technology infrastructure to support the growth of our business.
−Removed: We also expect to incur additional
−Removed: general and administrative expenses as a result of operating as a public company, including but not limited to:
−Removed: expenses related to compliance
−Removed: with the rules and regulations of the SEC and those of The Nasdaq Stock Market LLC on which our securities are traded;
−Removed: additional insurance
+Added: Our warranty provides that our products
+Added: are free of material defects and conform to specifications, and includes an offer to replace or refund the purchase price of defective
+Added: This assurance does not constitute a service and is not considered a separate performance obligation.
+Added: We estimate warranty
+Added: liabilities at the time of revenue recognition and record them as a charge to cost of goods sold.
+Added: account for all stock-based compensation awards using a fair-value method on the grant date and recognize the fair value of each award
+Added: as an expense over the requisite service period.
+Added: recognize compensation costs related to stock-based awards granted to employees, directors, and consultants, including restricted stock
+Added: units and stock options, based on the estimated fair value of the awards on the date of grant.
+Added: For restricted stock units, we estimate
+Added: grant date fair value based on the closing market price on the date of grant.
+Added: For stock options, we estimate the grant date fair value
+Added: using the Black-Scholes option-pricing model.
+Added: The grant date fair value of the stock-based awards is generally recognized on a straight-line
+Added: basis over the requisite service period, which is generally the vesting period of the respective awards.
+Added: Black-Scholes option-pricing model requires the use of subjective assumptions to determine the fair value of stock-based awards.
+Added: assumptions include:
+Added: Term —The expected term represents the period that stock-based awards are expected to be outstanding.
+Added: The expected term for
+Added: option grants is determined using the simplified method.
+Added: The simplified method deems the expected term to be the midpoint between the
+Added: vesting date and the contractual life of the stock-based awards.
+Added: Volatility —Since we have only been publicly held since April 2022 and did not have any trading history for our common stock
+Added: prior to that date, the expected volatility was estimated based on the average volatility for comparable publicly traded companies over
+Added: a period equal to the expected term of the stock option grants.
+Added: The comparable companies were chosen based on their similar size, stage
+Added: in the life cycle, or area of specialty.
+Added: Interest Rate —The risk-free interest rate is based on the U.S.
+Added: Treasury zero coupon issues in effect at the time of grant for
+Added: periods corresponding with the expected term of option.
+Added: Dividend —We have never paid dividends on our common stock and have no plans to pay dividends on our common stock.
+Added: we used an expected dividend yield of zero.
+Added: account for forfeitures as they occur.
+Added: board of directors intends all options granted to be exercisable at a price per share not less than the per share fair value of our common
+Added: stock underlying those options on the date of grant.
+Added: Stock Warrants
+Added: account for warrants for shares of common stock as equity or liabilities in accordance with the accounting guidance for derivatives.
+Added: The accounting guidance provides a scope exception from classifying and measuring as a financial liability a contract that would otherwise
+Added: meet the definition of a derivative if the contract is both (i) indexed to the entity’s own stock and (ii) classified in the stockholders’
+Added: deficit section of the balance sheet.
+Added: We estimate the fair value of our warrants for shares of common stock by using the Black-Scholes
+Added: option pricing model.
+Added: Warrants classified as equity are recorded as additional paid-in capital on the balance sheet and no further adjustments
+Added: to their valuation are made after the issuance of the warrants.
+Added: account for business combinations in accordance with Accounting Standards Codification (“ASC”) 805, Business Combinations ,
+Added: which requires that assets acquired and liabilities assumed be recorded at their respective fair values on the date of acquisition.
+Added: fair value of the consideration paid is assigned to the underlying net assets of the acquired business based on their respective fair
+Added: Any excess of the purchase price over the estimated fair values of the net assets acquired is recorded to goodwill.
+Added: assets acquired are amortized over the expected life of the asset.
+Added: Fair value determinations and useful life estimates are based on,
+Added: among other factors, estimates of expected future cash flows, estimates of appropriate discount rates, estimated useful lives of the
+Added: intangible assets acquired and other factors.
+Added: Although we believe the assumptions and estimates made have been reasonable and appropriate,
+Added: actual results may vary significantly from estimated results.
+Added: Our assumptions and estimates are subject to refinement and, as a result,
+Added: during the measurement period, which may be up to one year from the acquisition date, we record adjustments to the assets acquired and
+Added: liabilities assumed with the corresponding offset to goodwill.
+Added: Operations Overview
+Added: derive substantially all our revenue from sales of The Catamaran System and The SImmetry + System to a limited number of clinicians.
+Added: Revenue from sales of The Catamaran System and The SImmetry + System fluctuates based on volume of cases (procedures performed),
+Added: discounts, rebates, and the number of implants used for a particular patient.
+Added: Similar to other orthopedic companies, our revenue can
+Added: also fluctuate from quarter to quarter due to a variety of factors, including reimbursement, changes in independent sales representatives
+Added: and physician activities.
+Added: Goods Sold, Gross Profit, and Gross Margin
+Added: utilize contract manufacturers for production of The Catamaran System and The SImmetry + System implants and tray sets.
+Added: of goods sold consists primarily of costs of the components of The Catamaran System and The SImmetry + System implants and
+Added: instruments, overhead related to operations personnel and facility costs, quality inspection, packaging, scrap and inventory obsolescence,
+Added: as well as distribution-related expenses such as logistics and shipping costs.
+Added: We anticipate that certain of our cost of goods sold will
+Added: increase in absolute dollars as case levels increase.
+Added: gross margins have been and will continue to be affected by a variety of factors, including the cost to have our products manufactured
+Added: for us, pricing pressure from increasing competition, and the factors described above impacting our revenue.
+Added: operating expenses consist of sales and marketing, research and development, and general and administrative expenses.
+Added: Personnel costs
+Added: are the most significant component of operating expenses and consist of consulting expenses, salaries, sales commissions and other cash
+Added: and stock-based compensation related expenses.
+Added: We expect operating expenses to increase in absolute dollars as we continue to invest
+Added: and grow our business.
+Added: and Marketing Expenses
+Added: and marketing expenses primarily consist of salaries, commissions, stock-based compensation expense and travel and entertainment expenses
+Added: of our sales and market personnel along with commissions paid to our independent distributors.
+Added: We expect our sales and marketing expenses
+Added: to increase in absolute dollars with the increased sales of The Catamaran System and The SImmetry + System resulting in higher
+Added: commissions and salaries, increased clinician and sales representative training, and the cost to complete our clinical study to gain
+Added: wider clinician adoption of The Catamaran System.
+Added: Our sales and marketing expenses may fluctuate from period to period due to the timing
+Added: of sales and marketing activities related to the commercial activity of our product.
+Added: and Development Expenses
+Added: research and development expenses primarily consist of engineering, product development, regulatory expenses, and consulting services,
+Added: outside prototyping services, outside research activities, materials, and other costs associated with the development and refinement
+Added: of our product.
+Added: Research and development expenses also include related personnel and consultants’ compensation and stock-based
+Added: compensation expense.
+Added: We expense research and development costs as they are incurred.
+Added: We expect research and development expense to increase
+Added: in absolute dollars as we improve The Catamaran System and The SImmetry + System, develop new products, add research and development
+Added: personnel, and undergo clinical activities that may be required for regulatory clearances of future products.
+Added: and Administrative Expenses
+Added: and administrative expenses primarily consist of salaries, consultants’ compensation, stock-based compensation expense, and other
+Added: costs for finance, accounting, legal, compliance, and administrative matters.
+Added: We expect our general and administrative expenses to increase
+Added: in absolute dollars as we add personnel and information technology infrastructure to support the growth of our business.
+Added: We also expect
+Added: to incur additional general and administrative expenses as a result of operating as a public company, including but not limited to:
+Added: related to compliance with the rules and regulations of the SEC and those of The Nasdaq Stock Market LLC on which our securities are
+Added: additional insurance expenses;
investor relations activities;
and other administrative and professional services.
−Removed: While we expect the general and administrative
−Removed: expenses to increase in absolute dollars, we anticipate that it will decrease as a percentage of revenue over time.
−Removed: Gain (Loss) on Investments
−Removed: Gain (loss) on investments
−Removed: consists of interest income and realized gains and losses from the sale of our investments in money market and corporate debt securities.
−Removed: Interest Expense
−Removed: Interest expense is related
−Removed: to borrowings and includes deemed interest derived from the beneficial conversion prices of notes payable.
−Removed: Other Income (Expense), Net
−Removed: Other income and expenses
−Removed: have not been significant to date.
−Removed: Results of Operations (in thousands, except percentages)
−Removed: Consolidated Statements of Operations Data in Dollars:
−Removed: Cost of goods sold
+Added: While we expect
+Added: the general and administrative expenses to increase in absolute dollars, we anticipate that it will decrease as a percentage of revenue
+Added: on Investments
+Added: (loss) on investments consists of interest income and realized gains and losses from the sale of our investments in money market and
+Added: corporate debt securities.
+Added: expense is related to borrowings and includes deemed interest derived from the beneficial conversion prices of notes payable.
+Added: Income (Expense), Net
+Added: income and expenses have not been significant to date.
+Added: of Operations (in thousands, except percentages)
+Added: Ended December 31,
+Added: of Operations Data in Dollars:
+Added: of goods sold
+Added: and development
+Added: and marketing
+Added: and administrative
operating expenses
−Removed: Research and development
−Removed: Sales and marketing
−Removed: General and administrative
−Removed: Total operating expenses
−Removed: Loss from operations
−Removed: Interest and other income (expense), net:
−Removed: Gain on investments
−Removed: Interest expense
−Removed: Other expense
−Removed: Consolidated Statements of Operations Data as a Percent of Revenue:
+Added: from operations
+Added: and other income (expense), net:
+Added: on investments
+Added: Ended December 31,
+Added: of Operations Data as a Percent of Revenue:
Cost of goods sold
2 unchanged sentences
Sales and marketing
−Removed: General and administrative
−Removed: Total operating expenses
+Added: and administrative
+Added: operating expenses
Loss from operations
2 unchanged sentences
Interest expense
−Removed: Other expense
−Removed: Comparison of the years ended December 31, 2024 and 2023 (in
−Removed: thousands, except percentages)
−Removed: Revenue, Cost of Goods Sold, Gross Profit, and Gross Margin
−Removed: Years Ended December 31,
+Added: of the years ended December 31, 2025 and 2024 (in thousands, except percentages)
+Added: Cost of Goods Sold, Gross Profit, and Gross Margin
+Added: Ended December 31,
Cost of goods sold
Gross profit percentage
−Removed: The increase in revenue for
−Removed: the year ended December 31, 2024 as compared to 2023 was primarily due to an increase in revenue per surgical procedure on a 0% change
−Removed: in the number of surgical procedures in which The Catamaran System was used.
−Removed: Cost of Goods Sold, Gross Profit, and Gross
−Removed: The change in cost of goods sold for the year ended December 31, 2024 as compared to 2023 was due to the absorption of
−Removed: production overhead costs into our standard cost and operating leverage created due to lower relative fixed costs.
−Removed: Operating Expenses
−Removed: Years Ended December 31,
+Added: increase in revenue for the year ended December 31, 2025 as compared to 2024 was primarily due to an increase in the number of surgical
+Added: procedures and the addition of revenue related to The SImmetry + System.
+Added: of Goods Sold, Gross Profit, and Gross Margin.
+Added: The change in cost of goods sold for the year ended December 31, 2025 as compared
+Added: to 2024 was due to the absorption of production overhead costs into our standard cost and operating leverage created due to lower relative
+Added: fixed costs and increased revenue volume.
+Added: Ended December 31,
Research and development
1 unchanged sentence
General and administrative
−Removed: Total operating expenses
−Removed: Research and Development Expenses.
−Removed: and development expenses for the year ended December 31, 2024 decreased as compared to 2023 primarily due to decreased professional fees
−Removed: ($528), stock-based compensation ($73) and payroll expenses ($39) as we move our focus from research to sustaining our Catamaran portfolio.
−Removed: Sales and Marketing Expenses.
−Removed: and marketing expenses for the year ended December 31, 2024 decreased as compared to 2023 primarily due to SpineSource transition fees
−Removed: in 2023 ($932), decreased payroll and employee expenses ($499), and consulting and professional fees ($178), partially offset by increased
−Removed: commission expense ($21) due to restructuring of our sales operations.
−Removed: General and Administrative Expenses .
−Removed: and administrative expenses for the year ended December 31, 2024 increased as compared to 2023 primarily due to increased insurance costs
−Removed: ($331), legal and professional service fees ($289), payroll and employee expenses ($146), and bad debt expense ($41), partially offset
−Removed: by decreases in stock-based compensation ($147) due to continued operating expenses.
−Removed: Gain on Investments, Interest Expense
−Removed: and Other Expense, Net
−Removed: Years Ended December 31,
−Removed: Gain on investments
−Removed: Interest expense
−Removed: Other expense, net
−Removed: Total operating expenses
−Removed: Gain on Investments.
+Added: operating expenses
+Added: and Development Expenses.
+Added: Research and development expenses for the year ended December 31, 2025 decreased as compared to 2024
+Added: primarily due to decreased stock-based compensation ($772) and payroll expenses ($1), partially offset by increased professional fees
+Added: and Marketing Expenses.
+Added: Sales and marketing expenses for the year ended December 31, 2025 increased as compared to 2024 primarily
+Added: due to increased commission expense ($544) related to our increased revenue and increased payroll and employee expenses ($174) and consulting
+Added: and professional fees ($174), partially offset by decreased stock-based compensation ($13).
+Added: and Administrative Expenses .
+Added: General and administrative expenses for the year ended December 31, 2025 decreased as compared to 2024
+Added: primarily due to decreased stock-based compensation ($1,367), insurance costs ($614) and professional service fees ($87), partially offset
+Added: by acquisition expenses ($778) and increases in employee expenses ($321) and other fees and expenses ($206).
+Added: on Investments, Interest Expense and Other Expense, Net
+Added: Ended December 31,
Gain on investments
−Removed: for the year ended December 31, 2024 increased as compared to 2023 due to interest on our higher amounts of investments in money market
−Removed: and corporate debt securities.
Interest expense
−Removed: Interest expense for
−Removed: the year ended December 31, 2024 increased as compared to 2023 primarily due to the convertible debt.
Other expense, net
−Removed: Other expense, net
−Removed: for the year ended December 31, 2024 was related to foreign exchange losses on the liquidation of our Swiss subsidiary.
−Removed: Liquidity and Capital Resources
−Removed: As of December 31, 2024, we had cash and cash
−Removed: equivalents of $6.5 million.
−Removed: Since inception, we have financed our operations through private placements of preferred stock, debt
−Removed: financing arrangements, our initial public offering, additional stock offerings and the sale of our products.
−Removed: As of December 31, 2024,
−Removed: we had no outstanding debt.
−Removed: In March 2025, we raised net proceeds of $2.7 million from the exercise of warrants under an inducement agreement.
−Removed: Under the inducement agreement, the holder of the existing warrants to purchase an aggregate of 2,445,700 agreed to exercise the warrants
−Removed: at a reduced exercise price of $1.25 per share in consideration for our agreement to issue new unregistered five-year warrants to purchase
−Removed: up to an aggregate of 2,445,700 shares of common stock at an exercise price of $1.25 per share and new unregistered three-year warrants
−Removed: to purchase up to an aggregate of 1,222,850 shares of common stock at an exercise price of $1.25 per share.
−Removed: On March 25, 2025, we entered into a securities
−Removed: purchase agreement for the issuance of 733,500 shares of our common stock (or common stock equivalents in lieu thereof) in a registered
−Removed: direct offering at a purchase price of $2.00 per share.
−Removed: In a concurrent private placement, we also agreed to issue to the same investor
−Removed: warrants to purchase up to 733,500 shares of our common stock at an exercise price of $2.00 per share, which will be exercisable immediately,
−Removed: and will expire five years following the date of issuance.
−Removed: Pursuant to the agreements, we received proceeds, net of financial advisor
−Removed: fees and other transaction expenses, of $1,234.
−Removed: Also on March 25, 2025, we entered into a securities
−Removed: purchase agreement for the issuance of 1,271,500 shares of our common stock (or common stock equivalents in lieu thereof) in a registered
−Removed: direct offering at a purchase price of $2.00 per share.
−Removed: In a concurrent private placement, we also agreed to issue to the same investor
−Removed: warrants to purchase up to 1,271,500 shares of our common stock at an exercise price of $2.00 per share, which will be exercisable immediately,
−Removed: and will expire five years following the date of issuance.
−Removed: Pursuant to the agreements, we received proceeds, net of financial advisor
−Removed: fees and other transaction expenses, of $2,290.
−Removed: As of December 31, 2024, we had an accumulated
−Removed: deficit of $68.7 million and we expect to incur additional losses in the future.
−Removed: We have not achieved positive cash flow from operations
−Removed: Based upon our current operating plan, our existing cash and cash equivalents will not be sufficient to fund our operating expenses
−Removed: and working capital requirements through at least the next 12 months from the date these consolidated financial statements were available
−Removed: to be released.
−Removed: We plan to raise the necessary additional capital through one or a combination of public or private equity offerings,
−Removed: debt financings, and collaborations.
−Removed: We continue to face challenges and uncertainties and, as a result, our available capital resources
−Removed: may be consumed more rapidly than currently expected due to (a) the uncertainty of future revenues from The Catamaran System;
−Removed: we may make to the business that affect ongoing operating expenses;
−Removed: (c) changes we may make in our business strategy;
−Removed: (d) regulatory developments
−Removed: affecting our existing products;
−Removed: (e) changes we may make in our research and development spending plans;
−Removed: and (f) other items affecting
−Removed: our forecasted level of expenditures and use of cash resources.
−Removed: As we attempt to raise additional capital to fund
−Removed: our operations, funding may not be available to us on acceptable terms, or at all.
−Removed: If we are unable to obtain adequate financing when
−Removed: needed, we may have to delay, reduce the scope of or suspend one or more of our sales and marketing efforts, research and development
−Removed: activities, or other operations.
−Removed: We may seek to raise any necessary additional capital through a combination of public or private equity
−Removed: offerings, debt financings, and collaborations.
−Removed: If we do raise additional capital through public or private equity offerings, the ownership
−Removed: interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences
−Removed: that adversely affect our stockholders’ rights.
−Removed: If we raise additional capital through debt financing, we may be subject to covenants
−Removed: limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring
−Removed: If we are unable to raise capital, we will need to delay, reduce, or terminate planned activities to reduce costs.
−Removed: will likely harm our ability to execute our business plans.
−Removed: Due to the uncertainty in our ability to raise capital, management believes
−Removed: that there is substantial doubt in our ability to continue as a going concern for the next twelve months from the issuance of these consolidated
−Removed: financial statements.
−Removed: Cash Flows (in thousands, except percentages)
−Removed: The following table sets forth the primary sources
−Removed: and uses of cash for each of the periods presented below:
−Removed: Years Ended December 31,
−Removed: Net cash (used in) provided by:
−Removed: Operating activities
−Removed: Investing activities
−Removed: Financing activities
−Removed: Effect of foreign currency translation on cash flow
−Removed: Net increase in cash and cash equivalents
−Removed: The decrease in net cash used in operating activities
−Removed: for the year ended December 31, 2024 as compared to 2023 was primarily attributable to our decreased net loss ($1,908) and decreased prepaid
−Removed: expenses ($484) and increased depreciation and amortization ($209), partially offset increases in accounts receivable ($96) and decreases
−Removed: in non-cash stock-based compensation expenses ($300).
−Removed: Cash used in investing activities for the year
−Removed: ended December 31, 2024 related to purchases of property and equipment ($186).
−Removed: Cash provided by investing activities for the year ended
−Removed: December 31, 2023 consisted primarily of the net sales of short-term investments ($6,503) to fund operations, partially offset by purchases
−Removed: of property and equipment ($361) as we acquired the components for our surgical tray sets.
−Removed: Cash provided by financing activities for the
−Removed: year ended December 31, 2024 consisted primarily of net proceeds from the issuance of common stock and warrants ($3,846), the exercise
−Removed: of warrants under the inducement agreement ($4,306), the issuance of Series A Convertible Preferred Stock ($2,567) and Series B Convertible
−Removed: Preferred Stock ($489) and from issuances of common stock ($2,105).
+Added: operating expenses
+Added: on Investments.
+Added: Gain on investments for the year ended December 31, 2025 increased as compared to 2024 due to interest on our higher
+Added: amounts of investments in money market and corporate debt securities.
+Added: Interest expense for the year ended December 31, 2024 related to convertible debt, whose outstanding principal and interest
+Added: were converted to common stock in 2024.
+Added: Expense, Net .
+Added: Other expense, net for the year ended December 31, 2024 was related to foreign exchange losses on the liquidation of
+Added: our Swiss subsidiary.
+Added: and Capital Resources
+Added: of December 31, 2025, we had cash and cash equivalents of $3.8 million.
+Added: Since inception, we have financed our operations through
+Added: private placements of preferred stock, debt financing arrangements, our initial public offering, additional stock offerings and the sale
+Added: of our products.
+Added: As of December 31, 2025, we had no outstanding debt.
+Added: As of December 31, 2025, we had an accumulated deficit of $81.3 million
+Added: and we expect to incur additional losses in the future.
+Added: We have not achieved positive cash flow from operations to date.
+Added: On March 11, 2026, we entered into securities purchase agreements with
+Added: certain accredited investors pursuant to which the Company issued and sold in a private placement 20% original issue discount senior convertible
+Added: promissory notes in an aggregate principal amount of approximately $5.2 million for aggregate gross proceeds of approximately $4.3 million
+Added: (the “Convertible Promissory Notes”).
+Added: The Convertible Promissory Notes have a maturity date of September 11, 2026, which at
+Added: the option of the Company can be extended to December 11, 2026.
+Added: Following the 6-month anniversary of the issuance date, the Convertible
+Added: Promissory Notes will be convertible any time at the option of the holder into shares of our common stock at a conversion price per share
+Added: equal to the greater of 80% of the VWAP for the three trading days immediately prior to the date of conversion and $0.1567, subject to
+Added: adjustment for stock splits and pro rata distributions as provided in the Convertible Promissory Notes.
+Added: If the maturity date of the Convertible
+Added: Promissory Notes is extended their outstanding principal amount will be increased by 5%.
+Added: Any prepayment of the Convertible Promissory
+Added: Notes will be paid at 102.5% of the principal amount being prepaid.
+Added: In addition, we are required to prepay the Convertible Promissory
+Added: Notes from 15% of the net proceeds we may receive from future securities financing transactions less certain amounts attributable to the
+Added: original issue discount.
+Added: upon our current operating plan, our existing cash and cash equivalents will not be sufficient to fund our operating expenses and working
+Added: capital requirements through at least the next 12 months from the date these financial statements were filed.
+Added: We plan to raise the necessary
+Added: additional capital through one or a combination of public or private equity offerings, debt financings, and collaborations.
+Added: to face challenges and uncertainties and, as a result, our available capital resources may be consumed more rapidly than currently expected
+Added: due to (a) the uncertainty of future revenues;
+Added: (b) changes we may make to the business that affect ongoing operating expenses;
+Added: we may make in our business strategy;
+Added: (d) regulatory developments affecting our existing products;
+Added: (e) changes we may make in our research
+Added: and development spending plans;
+Added: and (f) other items affecting our forecasted level of expenditures and use of cash resources.
+Added: we attempt to raise additional capital to fund our operations, funding may not be available to us on acceptable terms, or at all.
+Added: we are unable to obtain adequate financing when needed, we may have to delay, reduce the scope of or suspend one or more of our sales
+Added: and marketing efforts, research and development activities, or other operations.
+Added: We may seek to raise any necessary additional capital
+Added: through a combination of public or private equity offerings, debt financings, and collaborations.
+Added: If we do raise additional capital through
+Added: public or private equity offerings, the ownership interest of our existing stockholders will be diluted, and the terms of these securities
+Added: may include liquidation or other preferences that adversely affect our stockholders’ rights.
+Added: If we raise additional capital through
+Added: debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional
+Added: debt, making capital expenditures, or declaring dividends.
+Added: If we are unable to raise capital, we will need to delay, reduce, or terminate
+Added: planned activities to reduce costs.
+Added: Doing so will likely harm our ability to execute our business plans.
+Added: Due to the uncertainty in our
+Added: ability to raise capital, management believes that there is substantial doubt in our ability to continue as a going concern for the next
+Added: twelve months from the issuance of these financial statements.
+Added: (in thousands, except percentages)
+Added: following table sets forth the primary sources and uses of cash for each of the periods presented below:
+Added: Ended December 31,
+Added: cash (used in) provided by:
+Added: of foreign currency translation on cash flow
+Added: change in cash and cash equivalents
+Added: increase in net cash used in operating activities for the year ended December 31, 2025 as compared to 2024 was primarily attributable
+Added: to decreases in stock-based compensation ($2,154) and increased accounts receivable ($465) and prepaid expenses ($218), partially offset
+Added: by a decrease in net loss ($1,117) and increases in accrued expenses ($819) and accounts payable ($550).
+Added: used in investing activities for the year ended December 31, 2025 consisted of the cash payment for the SI Acquisition ($750) and purchases
+Added: of property and equipment ($273).
+Added: Cash used in investing activities for the year ended December 31, 2024 related to purchases of property
+Added: and equipment ($186).
+Added: provided by financing activities for the year ended December 31, 2025 consisted of gross proceeds from the issuance of common stock from
+Added: our securities purchase agreements ($4,010), the exercise of warrants under the inducement agreement ($3,057) and the issuance of common
+Added: stock and warrants ($2,850), net of total cash offering costs ($928).
Cash provided by financing activities for the year ended December
−Removed: 31, 2023 consisted of the net proceeds received from our offerings of stock in 2023 ($5,303) in addition to proceeds from the issuance
−Removed: of the Convertible Notes ($1,250).
−Removed: Off-Balance Sheet Arrangements
−Removed: As of December 31, 2024 and 2023, we did not have
−Removed: any relationships with unconsolidated organizations or financial partnerships, such as structured finance or special purpose entities
−Removed: that would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow
−Removed: or limited purposes.
−Removed: QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET
−Removed: The Company is a smaller reporting company as
−Removed: defined by Rule 12b-2 of the Exchange Act and is not required to provide the information required under this item.
+Added: 31, 2024 consisted of gross proceeds from the issuance of common stock and warrants ($4,500), the exercise of warrants under the inducement
+Added: agreement ($4,648), the issuance of Series A Convertible Preferred Stock ($2,605) and Series B Convertible Preferred Stock ($550) and
+Added: from issuances of common stock ($2,106) and the exercise of warrants ($812), net of total cash offering costs ($1,096).
+Added: Off-Balance Sheet
+Added: of December 31, 2025 and 2024, we did not have any relationships with organizations or financial partnerships, such as structured finance
+Added: or special purpose entities that would have been established for the purpose of facilitating off-balance sheet arrangements
+Added: or other contractually narrow or limited purposes.
+Added: QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
+Added: Company is a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and is not required to provide the information required
+Added: under this item.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.