[Part I. Financial Information](index=3&type=section&id=Part%20I.%20Financial%20Information) This section presents SINTX Technologies' unaudited condensed consolidated financial statements, management's discussion, market risk disclosures, and controls for Q2 2025 [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) This section presents unaudited condensed consolidated financial statements, including balance sheets, operations, equity, cash flows, and detailed notes [Condensed Consolidated Balance Sheets (unaudited)](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20(unaudited)) The balance sheets present the company's financial position as of June 30, 2025, and December 31, 2024, showing slight decreases in assets and liabilities, and a minor equity increase Balance Sheet Summary (in thousands) | Balance Sheet Item (in thousands) | June 30, 2025 | December 31, 2024 | Change | | :-------------------------------- | :------------ | :---------------- | :----- | | Total assets | $9,195 | $9,413 | $(218) | | Total liabilities | $5,207 | $5,519 | $(312) | | Total stockholders' equity | $3,988 | $3,894 | $94 | [Condensed Consolidated Statements of Operations (unaudited)](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20(unaudited)) The statements of operations show increased net losses for Q2 and H1 2025, driven by significant revenue declines and changes in other income/expenses Statements of Operations Summary (in thousands) | Operating Metric (in thousands) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | Change (YoY) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change (YoY) | | :------------------------------ | :--------------------------- | :--------------------------- | :----------- | :--------------------------- | :--------------------------- | :----------- | | Total revenue | $151 | $859 | $(708) (-82%) | $520 | $1,546 | $(1,026) (-66%) | | Gross profit | $57 | $635 | $(578) (-91%) | $180 | $1,099 | $(919) (-84%) | | Loss from operations | $(2,665) | $(2,710) | $45 (-2%) | $(5,048) | $(5,907) | $859 (-15%) | | Net loss | $(2,318) | $(2,204) | $(114) (5%) | $(4,610) | $(3,090) | $(1,520) (49%) | | Basic Net loss per share | $(0.91) | $(3.49) | $2.58 | $(2.14) | $(8.61) | $6.47 | [Condensed Consolidated Statements of Stockholders' Equity (unaudited)](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity%20(unaudited)) The statements detail changes in stockholders' equity, including common stock issuances, stock-based compensation, and net losses, resulting in a slight equity increase from December 31, 2024, to June 30, 2025 Stockholders' Equity Summary (in thousands) | Stockholders' Equity Item (in thousands) | As of Dec 31, 2024 | As of Jun 30, 2025 | Change | | :--------------------------------------- | :----------------- | :----------------- | :----- | | Common Stock Amount | $13 | $26 | $13 | | Additional Paid-In Capital | $285,619 | $290,443 | $4,824 | | Accumulated Deficit | $(281,738) | $(286,348) | $(4,610) | | Total Stockholders' Equity | $3,894 | $3,988 | $94 | - Common stock shares outstanding increased from **1,342,853** as of December 31, 2024, to **2,591,171** as of June 30, 2025, reflecting significant equity issuance activities[14](index=14&type=chunk) [Condensed Consolidated Statements of Cash Flows (unaudited)](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20(unaudited)) Cash flow statements show decreased cash used in operating activities, positive investing cash flow, and reduced financing cash flow for the six months ended June 30, 2025 Cash Flow Summary (in thousands) | Cash Flow Activity (in thousands) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change (YoY) | | :-------------------------------- | :--------------------------- | :--------------------------- | :----------- | | Net cash used in operating activities | $(3,710) | $(4,948) | $1,238 |\n| Net cash provided by (used in) investing activities | $289 | $(173) | $462 |\n| Net cash provided by financing activities | $4,143 | $6,338 | $(2,195) |\n| Net increase in cash and cash equivalents | $722 | $1,217 | $(495) |\n| Cash and cash equivalents at end of period | $4,320 | $4,557 | $(237) | [Notes to Condensed Consolidated Financial Statements (unaudited)](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) These notes provide detailed disclosures on accounting policies, significant events, and financial instrument valuations, offering context to the condensed consolidated financial statements [1. Organization and Summary of Significant Accounting Policies](index=9&type=section&id=1.%20Organization%20and%20Summary%20of%20Significant%20Accounting%20Policies) SINTX Technologies, an advanced ceramics company, focuses on silicon nitride for medical and agribiotech applications, with unaudited financials noting going concern uncertainty - SINTX Technologies specializes in silicon nitride (Si₃N₄) for medical devices (musculoskeletal, antipathogenic) and agribiotech applications, with products implanted in humans since **2008**[18](index=18&type=chunk)[19](index=19&type=chunk) - The company's Salt Lake City facility is **FDA registered**, **cGMP**, **ANVISA RDC 665 compliant**, and **ISO 9001:2015**, **ISO 13485:2016**, and **ASD9100D certified**[22](index=22&type=chunk) - Management concluded substantial doubt exists about the Company's ability to continue as a going concern for **12 months** from issuance due to net losses and accumulated deficit[28](index=28&type=chunk)[29](index=29&type=chunk)[38](index=38&type=chunk) - SINTX is strategically repositioning to focus on the biomedical sector, transitioning from industrial applications to develop and commercialize innovative silicon nitride medical devices[33](index=33&type=chunk)[34](index=34&type=chunk) - The company implemented a workforce reduction and ceased efforts to make the armor plant operational in August 2024, incurring a **$4.6 million impairment charge** related to the armor plant in **2024**[35](index=35&type=chunk)[36](index=36&type=chunk) [2. Disposition of TA&T](index=12&type=section&id=2.%20Disposition%20of%20TA%26T) On February 19, 2025, SINTX sold its subsidiary TA&T to Tethon Corporation, which assumed TA&T's liabilities, a transaction not qualifying for discontinued operations - SINTX sold its subsidiary TA&T to Tethon Corporation on **February 19, 2025**, in exchange for Tethon assuming TA&T's outstanding liabilities[37](index=37&type=chunk)[42](index=42&type=chunk) TA&T Assets and Liabilities Transferred (in thousands) | TA&T Assets and Liabilities Transferred (in thousands) | February 19, 2025 | | :--------------------------------------------------- | :---------------- | | Total assets sold | $743 | | Total liabilities assumed | $(719) | [3. Basic and Diluted Net Income (Loss) per Common Share](index=14&type=section&id=3.%20Basic%20and%20Diluted%20Net%20Income%20(Loss)%20per%20Common%20Share) Basic and diluted net loss per common share calculations are presented, excluding antidilutive securities from diluted EPS for the periods Net Loss Per Share (Basic and Diluted) | Net Loss Per Share (Basic and Diluted) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :------------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Basic Net Loss | $(0.91) | $(3.49) | $(2.14) | $(8.61) | | Diluted Net Loss | $(0.91) | $(3.61) | $(2.14) | $(13.62) | - Approximately **2.1 million** and **0.1 million** potentially dilutive securities were excluded from diluted loss per share calculations as of June 30, 2025, and 2024, respectively, because they were antidilutive[45](index=45&type=chunk) [4. Inventories](index=15&type=section&id=4.%20Inventories) Inventories decreased from **$967 thousand** at December 31, 2024, to **$805 thousand** at June 30, 2025, with approximately half current and half long-term Inventory Breakdown (in thousands) | Inventory Category (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Raw materials | $516 | $629 | | WIP | $162 | $182 | | Finished goods | $127 | $156 | | Total Inventories | $805 | $967 | - As of June 30, 2025, inventories were split approximately **$0.4 million current** and **$0.4 million long-term**[48](index=48&type=chunk) [5. Fair Value Measurements](index=15&type=section&id=5.%20Fair%20Value%20Measurements) Derivative liabilities, primarily common stock warrants, are measured at fair value using Level 3 inputs via Monte Carlo Simulation, decreasing from **$(208) thousand** to **$(160) thousand** from December 2024 to June 2025 - Common stock warrants are classified as derivative liabilities and re-measured to fair value at each reporting period using the **Monte Carlo Simulation valuation model**[49](index=49&type=chunk)[52](index=52&type=chunk) Derivative Liabilities (in thousands) | Derivative Liabilities (in thousands) | December 31, 2024 | June 30, 2025 | Change | | :------------------------------------ | :---------------- | :------------ | :----- | | Common stock warrants | $(208) | $(160) | $48 | Valuation Assumptions | Valuation Assumption | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :------------ | :---------------- | | Weighted-average risk-free interest rate | 3.66-3.92% | 4.12-4.35% | | Weighted-average expected life (years) | 0.09-3.59 | 0.10-4.09 | | Weighted-average expected volatility | 140.00-165.00% | 140.00-210.00% | [6. Accrued and Other Current Liabilities](index=17&type=section&id=6.%20Accrued%20and%20Other%20Current%20Liabilities) Accrued liabilities decreased from **$986 thousand** to **$585 thousand** due to reduced payroll and payables, while other current liabilities increased to **$750 thousand** for Sinaptic Surgical acquisition stock issuance Accrued Liabilities (in thousands) | Accrued Liabilities (in thousands) | June 30, 2025 | December 31, 2024 | Change | | :--------------------------------- | :------------ | :---------------- | :----- | | Payroll and related expense | $215 | $400 | $(185) | | Accrued payables | $10 | $178 | $(168) | | Other | $360 | $408 | $(48) | | Total Accrued Liabilities | $585 | $986 | $(401) | - Other current liabilities increased to **$750 thousand** as of June 30, 2025, primarily due to a deposit for stock issuance related to the acquisition of Sinaptic Surgical[55](index=55&type=chunk) [7. Debt](index=18&type=section&id=7.%20Debt) The Company entered two new insurance premium finance arrangements in March and May 2025, with outstanding balances of **$88 thousand** and **$21 thousand** as of June 30, 2025, and a prior arrangement was fully paid in Q1 2025 - New premium finance arrangements were entered in **March 2025** (D&O insurance, **$145 thousand** financed at **7.45% APR**, **$88 thousand** outstanding) and **May 2025** (general liability, **$21 thousand** financed at **11.15% APR**, **$21 thousand** outstanding)[57](index=57&type=chunk)[58](index=58&type=chunk) - A **June 2024** premium finance arrangement for commercial liability insurance (**$117 thousand** financed at **8.75% APR**) was fully paid in **Q1 2025**[56](index=56&type=chunk) [8. Equity](index=18&type=section&id=8.%20Equity) SINTX completed a **$5.0 million** private placement in February 2025, issuing common stock and warrants, and conducted public offerings in April, March, and February 2024, raising approximately **$1.5 million**, **$1.3 million**, and **$4 million**, with the ATM Agreement suspended - On **February 20, 2025**, the Company closed a private placement for **$5.0 million** gross proceeds, issuing **1,171,189 common shares**, **278,098 pre-funded warrants**, and **1,449,287 common warrants**[59](index=59&type=chunk) - Public offerings in **April 2024** (**$1.5 million** gross proceeds for **358,000 shares**) and **March 2024** (**$1.3 million** gross proceeds for **142,000 shares**) were completed[60](index=60&type=chunk)[62](index=62&type=chunk) - A public offering in **February 2024** raised approximately **$4 million**, involving common units, pre-funded warrant units, Class E warrants, and Class F warrants[63](index=63&type=chunk) - The ATM Agreement was suspended in **March 2024** and had no capacity for further sales as of **June 30, 2025**[64](index=64&type=chunk) [9. Stock-Based Compensation](index=20&type=section&id=9.%20Stock-Based%20Compensation) As of June 30, 2025, **90,032** stock options were outstanding with a weighted-average exercise price of **$20.85** and **9.7 years** remaining life, and **$478 thousand** unrecognized stock-based compensation to be recognized over **1.7 years** Stock Option Activity | Stock Option Activity | As of Dec 31, 2024 | Granted | Expired | As of Jun 30, 2025 | | :-------------------- | :----------------- | :------ | :------ | :----------------- | | Options | 35 | 90,000 | (3) | 90,032 | | Weighted Average Exercise Price | $18,872 | $3.00 | $19,267 | $20.85 | - Unrecognized stock-based compensation for stock grants amounted to **$478 thousand**, with a weighted-average remaining recognition period of **1.7 years** as of **June 30, 2025**[66](index=66&type=chunk) [10. Commitments and Contingencies](index=20&type=section&id=10.%20Commitments%20and%20Contingencies) The Company has agreements with executive officers for payments and accelerated stock vesting upon a change in control and is subject to ordinary course legal proceedings, which management believes will not have a material adverse effect - Executive officers have agreements for payments and accelerated stock vesting upon a change in control[67](index=67&type=chunk) - Management believes any liability from ordinary course legal proceedings will not materially adversely affect the Company's financial position, operating results, or cash flows[68](index=68&type=chunk) [11. Leases](index=22&type=section&id=11.%20Leases) SINTX leases office, warehouse, and manufacturing space under operating leases, with **$2.6 million** in right-of-use assets and **$3.4 million** in liabilities as of June 30, 2025, and TA&T lease facilities were transferred upon disposition - SINTX leases **30,764 square feet** of space under an operating lease expiring in **October 2031**, with a **five-year extension option**[71](index=71&type=chunk) - Operating lease right-of-use assets were approximately **$2.6 million** and operating lease liability was approximately **$3.4 million** as of **June 30, 2025**[75](index=75&type=chunk) Operating Lease Future Minimum Payments (in thousands) | Operating Lease Future Minimum Payments (in thousands) | Amount | | :----------------------------------------------------- | :----- | | 2025 (Remainder) | $326 | | 2026 | $668 | | 2027 | $688 | | 2028 | $709 | | 2029 | $730 | | Thereafter | $1,395 | | Total future minimum lease payments | $4,516 | | Present value of lease liability | $3,420 | [12. Related Party Transactions](index=22&type=section&id=12.%20Related%20Party%20Transactions) During Q2 2025, the Company entered a Research Collaboration Agreement with a majority-owned shareholder company, paying **$500,000** to fund it, with **$163,000** remaining prepaid as of June 30, 2025 - SINTX paid **$500,000** to fund a Research Collaboration Agreement with a company majority-owned by a shareholder, with **$163,000** remaining prepaid as of **June 30, 2025**[77](index=77&type=chunk) [13. Subsequent Events](index=22&type=section&id=13.%20Subsequent%20Events) On **July 1, 2025**, SINTX acquired Sinaptic Surgical, LLC assets and liabilities, issuing warrants for **325,000 common shares** at **$6.30** exercisable upon milestones, and Sinaptic Surgical purchased **216,450 common shares** in a private placement - On **July 1, 2025**, SINTX acquired assets and assumed liabilities of Sinaptic Surgical, LLC, issuing warrants to purchase **325,000 common shares** (exercise price **$6.30**, exercisable upon milestones)[78](index=78&type=chunk) - Sinaptic Surgical purchased **216,450 common shares** at **$3.465 per share** in a private placement[79](index=79&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section analyzes SINTX Technologies' financial condition and results, highlighting the strategic shift to biomedical applications, revenue declines, and ongoing liquidity challenges [Overview](index=24&type=section&id=Overview) SINTX Technologies is an advanced ceramics company specializing in silicon nitride for medical and agribiotech applications, focusing on biomedical solutions and recently submitting a 510(k) for osteotomy wedges - SINTX is an advanced ceramics company focused on developing and commercializing silicon nitride materials for medical and agribiotech applications, with products implanted in humans since **2008**[81](index=81&type=chunk) - The company submitted a **510(k) premarket notification** for novel silicon nitride osteotomy wedges in **July 2025**, entering the foot and ankle reconstruction market[82](index=82&type=chunk) - SINTX silicon nitride is noted for its **biocompatibility**, **bone affinity**, **antibacterial properties**, and ability to inactivate pathogens like **SARS-CoV-2**[83](index=83&type=chunk)[84](index=84&type=chunk) [Components of our Results of Operations](index=25&type=section&id=Components%20of%20our%20Results%20of%20Operations) This section outlines SINTX's key financial components, including product and grant revenue, cost of revenue, gross profit, and operating expenses like R&D, G&A, sales & marketing, and grant & contract expenses - Product revenue is derived from manufacturing and selling products like coatings, materials, and components for aerospace and medical devices, and toll processing services[87](index=87&type=chunk) - Grant and contract revenue comes from awards by governmental agencies[88](index=88&type=chunk) - Research and development costs, expensed as incurred, include engineering, product development, clinical trials, and regulatory activities, expected to increase with new medical device development[91](index=91&type=chunk)[92](index=92&type=chunk) [RESULTS OF OPERATIONS](index=26&type=section&id=RESULTS%20OF%20OPERATIONS) SINTX experienced significant revenue declines for product and grant/contract revenue in Q2 and H1 2025 due to strategic repositioning towards proprietary biomedical devices, leading to decreased gross profit and increased net loss Operating Results Summary (in thousands) | Operating Metric (in thousands) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | Change (YoY) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change (YoY) | | :------------------------------ | :--------------------------- | :--------------------------- | :----------- | :--------------------------- | :--------------------------- | :----------- | | Product revenue | $100 | $378 | $(278) (-74%) | $391 | $687 | $(296) (-43%) | | Grant and contract revenue | $51 | $481 | $(430) (-89%) | $129 | $859 | $(730) (-85%) | | Total revenue | $151 | $859 | $(708) (-82%) | $520 | $1,546 | $(1,026) (-66%) | | Gross profit | $57 | $635 | $(578) (-91%) | $180 | $1,099 | $(919) (-84%) | | Net loss | $(2,318) | $(2,204) | $(114) (5%) | $(4,610) | $(3,090) | $(1,520) (49%) | - The decrease in total revenue is primarily due to the Company's strategic repositioning away from non-core, low-margin OEM technical manufacturing contracts towards proprietary silicon nitride-based biomedical devices[97](index=97&type=chunk)[98](index=98&type=chunk) [Liquidity and capital resources](index=28&type=section&id=Liquidity%20and%20capital%20resources) SINTX faces significant liquidity challenges with ongoing net losses and accumulated deficit, leading to substantial doubt about its going concern ability, requiring substantial future capital and active pursuit of potentially dilutive financing - The Company incurred net losses of **$4.6 million** and **$3.1 million** for the six months ended June 30, 2025, and 2024, respectively, and had accumulated deficits of **$286 million** and **$282 million**[110](index=110&type=chunk) - Management concluded substantial doubt exists about the Company's ability to continue as a going concern for **12 months** from the date of issuance[109](index=109&type=chunk)[119](index=119&type=chunk) - SINTX is actively seeking additional equity and/or debt financing to fund operations, R&D, and commercialization, acknowledging potential dilution for current stockholders[111](index=111&type=chunk)[112](index=112&type=chunk) [Cash Flows](index=29&type=section&id=Cash%20Flows) For the six months ended June 30, 2025, net cash used in operating activities decreased, net cash from investing activities turned positive, and net cash from financing activities decreased year-over-year Cash Flow Summary (in thousands) | Cash Flow Activity (in thousands) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change (YoY) | | :-------------------------------- | :--------------------------- | :--------------------------- | :----------- | | Net cash used in operating activities | $(3,710) | $(4,948) | $1,238 | | Net cash provided by (used in) investing activities | $289 | $(173) | $462 | | Net cash provided by financing activities | $4,143 | $6,338 | $(2,195) | | Net increase in cash | $722 | $1,217 | $(495) | - Net cash used in operating activities decreased by **$1.2 million** to **$3.7 million** for H1 2025, driven by a **$1.5 million** decrease in net loss and **$2.9 million** in non-cash adjustments[121](index=121&type=chunk) - Net cash provided by investing activities was **$0.3 million** for H1 2025, a **$0.5 million** increase from H1 2024, primarily due to a **$0.5 million** decrease in property and equipment purchases and a **$0.3 million** increase in proceeds from asset sales[122](index=122&type=chunk) - Net cash provided by financing activities decreased by **$2.2 million** to **$4.1 million** for H1 2025, mainly due to a **$3.4 million** decrease in proceeds from warrant derivative liabilities, partially offset by a **$1.3 million** increase in proceeds from common stock and prefunded warrant issuance[123](index=123&type=chunk) [Indebtedness](index=30&type=section&id=Indebtedness) Information regarding the Company's indebtedness is detailed in Note 7 to the condensed consolidated financial statements - Details on indebtedness are provided in **Note 7** of the financial statements[124](index=124&type=chunk) [Off-Balance Sheet Arrangements](index=30&type=section&id=Off-Balance%20Sheet%20Arrangements) The Company has no off-balance sheet arrangements as defined by SEC regulations - The Company has no off-balance sheet arrangements[125](index=125&type=chunk) [Critical Accounting Policies and Estimates](index=31&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) No material changes occurred to the Company's critical accounting policies and estimates for the six months ended June 30, 2025, as discussed in the prior Annual Report on Form 10-K - No material changes to critical accounting policies and estimates for H1 2025[127](index=127&type=chunk) [Recent Accounting Pronouncements](index=31&type=section&id=Recent%20Accounting%20Pronouncements) Information regarding recent accounting pronouncements is detailed in Note 1 to the condensed consolidated financial statements - Details on recent accounting pronouncements are provided in **Note 1** of the financial statements[128](index=128&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This item is marked as "Not applicable," indicating no material quantitative or qualitative disclosures about market risk are provided - No quantitative or qualitative disclosures about market risk are applicable for this period[129](index=129&type=chunk) [Item 4. Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) The CEO and Principal Financial Officer certified the effectiveness of disclosure controls and procedures as of June 30, 2025, reporting no material changes in internal control over financial reporting during Q2 2025 [Evaluation of Disclosure Controls and Procedures](index=31&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) The Chief Executive Officer concluded that the Company's disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control over financial reporting during Q2 2025 - The Chief Executive Officer concluded that disclosure controls and procedures were effective as of **June 30, 2025**[132](index=132&type=chunk) - No material changes in internal control over financial reporting occurred during **Q2 2025**[133](index=133&type=chunk) [Part II. Other Information](index=32&type=section&id=Part%20II.%20Other%20Information) Part II covers other information not in financial statements, including legal proceedings, risk factors, unregistered equity sales, defaults, mine safety, and exhibits [Item 1. Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) The Company is unaware of any pending or threatened legal proceedings that could materially adversely affect its business, operating results, or financial condition, though it may be involved in ordinary course legal proceedings - No pending or threatened legal proceedings are expected to have a material adverse effect on the Company[134](index=134&type=chunk) [Item 1A. Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) No material changes occurred from the risk factors previously disclosed in the Company's Annual Report on Form 10-K for the year ended December 31, 2024 - No material changes to risk factors from the Annual Report on Form 10-K[135](index=135&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=32&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section details the Company's share repurchase program, which authorized repurchases of up to **$500,000** of common stock, with **20,759 shares** repurchased in April 2025 at **$2.25**, leaving **$366,935.45** remaining [Share Repurchase Program](index=32&type=section&id=Share%20Repurchase%20Program) The Board authorized a share repurchase program for up to **$500,000** of common stock in November 2024, with **20,759 shares** repurchased in April 2025 at **$2.25**, leaving **$366,935.45** remaining as of June 30, 2025 - The Board authorized a share repurchase program for up to **$500,000** of common stock in **November 2024**[136](index=136&type=chunk) Share Repurchase Activity | Period | Total shares purchased | Average price paid per share | Maximum number (or approximate dollar value) of shares that may yet be purchased under the plans or programs | | :---------------- | :--------------------- | :--------------------------- | :--------------------------------------------------------------------------------------------------------- | | 04/01/25 – 04/30/25 | 20,759 | $2.25 | $366,935.45 | | Total | 20,759 | $2.25 | $366,935.45 | [Item 3. Defaults Upon Senior Securities](index=32&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The Company reported no defaults upon senior securities - No defaults upon senior securities were reported[137](index=137&type=chunk) [Item 4. Mine Safety Disclosures](index=32&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is marked as "Not applicable" in the report - Mine safety disclosures are not applicable[138](index=138&type=chunk) [Item 5. Other Information](index=32&type=section&id=Item%205.%20Other%20Information) The Company reported no other information - No other information was reported[139](index=139&type=chunk) [Item 6. Exhibits](index=33&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with Form 10-Q, including forms of warrants, asset purchase agreements, and Sarbanes-Oxley Act certifications - Exhibits include Form of Warrant, Form of Asset Purchase Agreement, and certifications (**31.1**, **31.2**, **32**) required by the Sarbanes-Oxley Act[140](index=140&type=chunk) [Signatures](index=34&type=section&id=Signatures) The report is duly signed on behalf of SINTX Technologies, Inc. by Eric Olson, Chief Executive Officer and Principal Financial Officer, on August 14, 2025 - The report was signed by Eric Olson, CEO and Principal Financial Officer, on **August 14, 2025**[143](index=143&type=chunk)

Core Insights - SINTX Technologies has published a peer-reviewed study validating the use of silicon nitride (Si₃N₄) surface coatings on carbon fiber-reinforced polyetherketoneketone (CFR-PEKK) trauma plates, expanding its biomaterial platform into polymer-carbon-ceramic constructs [1][2][3] Group 1: Study Findings - The study demonstrates that SINTX's proprietary process can integrate silicon nitride into 3D-printed continuous carbon fiber PEKK composites without compromising flexural strength or stiffness [2] - Hybrid-manufactured CFR-PEKK trauma plates achieved flexural modulus values within the range of cortical bone (1.7–16.3 GPa), optimizing stress distribution for bone healing [6] - Si₃N₄ surface coatings had no statistically significant effect on flexural modulus or strength, confirmed by standardized four-point bending tests [6] Group 2: Clinical and Market Implications - The integration of silicon nitride with CFR-PEKK positions SINTX to address unmet needs in orthopedic trauma, spine, and custom surgical implants [3] - Si₃N₄'s osteoconductive and antimicrobial properties may enhance clinical outcomes by promoting osseointegration and reducing infection risk, which are critical in trauma and reconstructive surgery [6] - The findings support SINTX's commercialization strategy to develop differentiated implant solutions using hybrid manufacturing and surface bioactivation [5]

Core Insights - SINTX Technologies has submitted a 510(k) premarket notification to the FDA for its silicon nitride osteotomy wedges, marking its entry into the foot and ankle reconstruction market [1][2] - The global foot and ankle fusion market is valued at approximately $750.5 million and is projected to grow to $1.38 billion by 2032 [2] - SINTX's silicon nitride (Si₃N₄) biomaterial has a proven clinical track record with over 50,000 spinal interbody fusion devices implanted since 2008 [2] Clinical Advantages - Si₃N₄ is positioned to address key challenges in orthopedic reconstruction, particularly in infection risk, healing rate, and long-term stability [3] - The material promotes bone cell adhesion, proliferation, and differentiation, enhancing osseointegration and fusion potential [6] - Si₃N₄ inhibits bacterial colonization without additives, crucial for reducing hardware-related infections in foot and ankle procedures [6] Surgical Innovation - SINTX has developed proprietary implant geometries and disposable instrumentation to improve surgical outcomes [4] - The implants are designed in collaboration with leading surgeons to optimize biomechanical correction and ease of insertion [7] - The single-use instrument kits aim to enhance surgical efficiency and reduce intraoperative delays [7] Strategic Launch and Financial Outlook - The FDA submission is supported by over a decade of clinical and preclinical data, including peer-reviewed publications and biocompatibility studies [5] - The company anticipates strong early adoption of its foot and ankle portfolio, which is expected to drive revenue growth through market penetration and increasing procedural demand [8] Value Proposition - The platform is built on a proven material with extensive clinical experience and thoughtful surgical design [10] - The combination of sterile, single-use kits and advanced biomaterial technology aligns with evolving value-based care models [14]

Core Insights - SINTX Technologies has executed a Definitive Agreement to acquire the surgical business assets of SiNAPTIC Holdings, enhancing its product portfolio in the foot and ankle fusion market [1][2] - The acquisition includes all intellectual property and product designs related to six differentiated foot and ankle implant systems, which are expected to accelerate commercial launch activities [2][3] - The global ankle fusion market is valued at approximately $750.5 million and is projected to grow to $1.38 billion by 2032, with a CAGR of 9.1% [2] Company Strategy - The acquisition is seen as transformative for SINTX, shifting the focus from R&D to revenue generation and commercial scale [3] - Key members of the SiNAPTIC executive team will join SINTX, bringing expertise in product development, regulatory strategy, and commercialization [3][4] - SINTX will manufacture all devices under its FDA-registered and ISO-certified quality system, leveraging existing FDA clearances to streamline regulatory approvals [4] Financial Details - SINTX issued $750,000 in common shares at a price of $3.465 per share, representing a 10% premium to the closing price on June 20, 2025, along with performance-based common stock purchase warrants [3] - The warrants are exercisable over five years at a strike price of $6.30, vesting upon achieving specific regulatory and commercial milestones [3] Market Position - The acquisition reflects a shared belief in the potential of silicon nitride ceramic-enhanced implants, aiming to accelerate the development of disruptive products [5] - SINTX has been a leader in the research and development of silicon nitride, with products implanted in humans since 2008 [6]

Core Insights - SINTX Technologies has announced a renewed corporate vision and strategic plan aimed at accelerating the commercialization of its proprietary silicon nitride technologies following a successful recapitalization and leadership restructuring [1][5]. Company Overview - SINTX Technologies is the only FDA-registered producer of implantable silicon nitride and a global leader in advanced ceramics, with a history of innovation dating back to 2008 when it introduced the first FDA-cleared implant material made from medical-grade silicon nitride [1][2][3]. - The company holds 18 issued U.S. patents and has 84 pending applications, positioning itself as an industry leader in silicon nitride technology with applications across various markets, including a $62 billion global orthopedic implant sector [3]. Strategic Initiatives - The company is focusing on developing next-generation hybrid biomaterials that combine the biological performance of silicon nitride with the flexibility of polymers like PEEK and PEKK, targeting applications in spine, oral/maxillofacial, cranio-maxillofacial, and oncologic reconstruction [4][5]. - SINTX is pursuing strategic partnerships and licensing opportunities to expand its technology reach, with initiatives including joint ventures in orthopedics, wound care, and agribiotech, as well as monetizing its extensive patent portfolio [5][8]. Commitment to Stakeholders - The company emphasizes its commitment to transparency, disciplined execution, and long-term value creation for all stakeholders, expressing gratitude for the support from shareholders and partners [6].

Core Insights - SINTX Technologies has announced the issuance of International Patent No. 7635292, covering novel agricultural uses of silicon nitride (Si₃N₄) for plant protection and antimicrobial treatment, complementing U.S. Patent No. 11,591,217 [1][2] - The company is launching a wholly-owned subsidiary, SINTX Agribiotech, Inc., to focus on developing and commercializing agricultural and environmental technologies [2][4] - The global antimicrobial fertilizer and crop protection market is projected to reach $10.36 billion by 2030, presenting a significant market opportunity for SINTX's Si₃N₄ technology [3] Company Strategy - The new agribiotech subsidiary will operate independently from SINTX's medical device business, allowing for focused resource allocation and potential partnerships with agricultural companies [4] - The company aims to deploy Si₃N₄ in various agricultural settings, starting with wine production, leveraging its antifungal properties against grapevine diseases [5][6] Product Advantages - SINTX's Si₃N₄ formulation offers broad-spectrum antimicrobial action without damaging plant tissue, positioning it as a sustainable alternative to traditional copper-based fungicides [6] - Internal research indicates that Si₃N₄ can reduce the growth and sporulation of the grapevine pathogen Plasmopara viticola by 80-90%, with complete protection observed in select trials [5][6]

[SINTX Technologies, Inc. Form 8-K](index=1&type=section&id=SINTX%20Technologies%2C%20Inc.%20Form%208-K) SINTX Technologies, Inc. filed a Form 8-K on May 15, 2025, to report Q1 2025 financial results - SINTX Technologies, Inc. filed a Form 8-K Current Report on May 15, 2025, to announce its financial results for the first quarter of 2025[1](index=1&type=chunk)[2](index=2&type=chunk)[5](index=5&type=chunk) [Item 2.02. Results of Operations and Financial Condition](index=2&type=section&id=Item%202.02.%20Results%20of%20Operations%20and%20Financial%20Condition) SINTX Technologies, Inc. announced Q1 2025 financial results via a press release, furnished but not filed under Section 18 - The company announced its financial results for the quarter ended March 31, 2025, via a press release issued on May 15, 2025[5](index=5&type=chunk) - The information, including the press release (Exhibit 99.1), is being "furnished" and not "filed," which limits its liability under Section 18 of the Securities Exchange Act of 1934[6](index=6&type=chunk) [Item 7.01. Regulation FD. Disclosure](index=2&type=section&id=Item%207.01.%20Regulation%20FD.%20Disclosure) This section incorporates financial results from Item 2.02 by reference, fulfilling Regulation FD requirements - The information regarding the financial results announcement under Item 2.02 is incorporated by reference into this section[7](index=7&type=chunk) [Item 9.01 Financial Statements and Exhibits](index=2&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) This section lists exhibits attached to the Form 8-K filing, including the press release and interactive data file Exhibits List | Exhibit No. | Description | | :--- | :--- | | 99.1 | Press Release, dated May 15, 2025 | | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | [Signatures](index=3&type=section&id=Signatures) The report is officially signed and authorized by Eric K. Olson, CEO of SINTX Technologies, Inc., on May 15, 2025 - The report was duly authorized and signed on May 15, 2025, by Eric K. Olson, the company's Chief Executive Officer[10](index=10&type=chunk)[12](index=12&type=chunk)

Core Insights - SINTX Technologies is undergoing a disciplined transformation to focus on high-growth medical applications of silicon nitride, aiming for sustainable value creation [2][3] Operational Progress - The company is transitioning from a diversified industrial-ceramics business to a pure-play medical device innovator, targeting large clinical needs in infection resistance and tissue healing [3] - Recent initiatives include improved financial positioning, operational streamlining, and strengthened governance with a reconstituted Board of Directors [4][5][6] Financial Position - As of March 31, 2025, SINTX reported $6.5 million in cash, nearly doubling from $3.6 million at year-end 2024 [8] - The company reduced operating cash burn from $2.7 million in Q1 2024 to $1.3 million in Q1 2025 due to cost optimization efforts [8] - A recent $5 million private placement in February 2025 supports strategic initiatives, with potential to raise an additional $5 million from warrant exercises [8] Strategic Focus Areas - SINTX is strategically aligned around orthopedic implants, spinal fusion devices, dental products, and medical textiles, including wound care and surgical masks [7] - The company is actively developing new R&D programs targeting implantable and antipathogenic products, with ongoing partnerships and licensing discussions with leading medical OEMs [8]

Part I. Financial Information [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) For the quarter ended March 31, 2025, SINTX Technologies reported a significant decrease in total revenue to $0.37 million from $0.69 million year-over-year, primarily due to a drop in grant revenue. The company's net loss widened to $2.3 million from $0.9 million in the prior-year period. Despite the loss, total assets and stockholders' equity increased, driven by $4.3 million in net cash from financing activities, including a $5.0 million private placement. Key strategic moves included the disposition of the TA&T subsidiary to reduce operating expenses [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets increased to $11.4 million from $9.4 million at year-end 2024, primarily due to a rise in cash and cash equivalents to $6.5 million. Total liabilities saw a slight decrease to $5.4 million. Consequently, total stockholders' equity improved significantly to $6.1 million from $3.9 million, reflecting recent financing activities Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $6,500 | $3,598 | | Total current assets | $7,617 | $4,771 | | Total assets | $11,449 | $9,413 | | **Liabilities & Equity** | | | | Total current liabilities | $2,211 | $1,982 | | Total liabilities | $5,357 | $5,519 | | Total stockholders' equity | $6,092 | $3,894 | | Total liabilities and stockholders' equity | $11,449 | $9,413 | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the three months ended March 31, 2025, total revenue decreased by 46% to $0.37 million compared to $0.69 million in the same period of 2024, mainly due to a sharp decline in grant and contract revenue. Despite a 32% reduction in total operating expenses, the net loss increased to $2.3 million from $0.9 million year-over-year, driven by a significant negative change in other income related to derivative liabilities Q1 2025 vs. Q1 2024 Statement of Operations (in thousands) | Metric | Three Months Ended Mar 31, 2025 | Three Months Ended Mar 31, 2024 | | :--- | :--- | :--- | | Total revenue | $369 | $687 | | Gross profit | $123 | $464 | | Loss from operations | $(2,383) | $(3,197) | | Net loss | $(2,292) | $(886) | | Net loss per share – basic | $(1.29) | $(10.26) | [Condensed Consolidated Statements of Stockholders' Equity](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) During the first quarter of 2025, total stockholders' equity increased from $3.9 million to $6.1 million. This was primarily driven by the issuance of common stock and pre-funded warrants for cash, which raised approximately $4.4 million net of fees, offsetting the $2.3 million net loss for the period Changes in Stockholders' Equity (Q1 2025, in thousands) | Description | Amount | | :--- | :--- | | Balance as of December 31, 2024 | $3,894 | | Common stock and prefunded warrants issued for cash, net | $4,399 | | Stock based compensation | $177 | | Purchase of common stock into Treasury | $(86) | | Net loss | $(2,292) | | **Balance as of March 31, 2025** | **$6,092** | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the first quarter of 2025, net cash used in operating activities decreased to $1.3 million from $2.7 million in the prior-year period. The company generated $4.3 million in cash from financing activities, primarily through stock and warrant issuances. This resulted in a net increase in cash and cash equivalents of $2.9 million, ending the period with a balance of $6.5 million Cash Flow Summary (in thousands) | Cash Flow Activity | Three Months Ended Mar 31, 2025 | Three Months Ended Mar 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(1,301) | $(2,733) | | Net cash used in investing activities | $(63) | $(173) | | Net cash provided by financing activities | $4,266 | $5,328 | | **Net increase in cash** | **$2,902** | **$2,422** | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's business as an advanced ceramics firm, its reliance on equity financing, and recent strategic actions. Key events include the February 2025 disposition of the TA&T subsidiary to reduce costs, a $5.0 million private placement in February 2025, and cost-cutting measures like a workforce reduction. Management has concluded that these actions alleviate substantial doubt about the company's ability to continue as a going concern through at least May 2026 - On February 19, 2025, the company sold its subsidiary TA&T to Tethon Corporation in exchange for Tethon assuming TA&T's outstanding liabilities. This involved disposing of **$743k** in assets and **$719k** in liabilities[52](index=52&type=chunk)[53](index=53&type=chunk) - The company raised aggregate gross proceeds of **$5.0 million** from a private placement of common stock and warrants, which closed on February 25, 2025[34](index=34&type=chunk)[70](index=70&type=chunk) - Strategic cost-saving measures include a company-wide workforce reduction in August 2024 and a decision to cease efforts to make the armor plant operational, resulting in a **$4.6 million** impairment charge in 2024[41](index=41&type=chunk)[42](index=42&type=chunk) - Following recent financing and cost reductions, management has determined there is **no significant uncertainty** about the company's ability to continue as a going concern through at least May 15, 2026[45](index=45&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses a 46% year-over-year revenue decline in Q1 2025, driven by the disposition of its TA&T subsidiary, which eliminated most grant revenue. Operating loss narrowed due to cost-cutting in R&D and other areas. The company's liquidity has been bolstered by a $5.0 million private placement in February 2025. These measures, combined with a workforce reduction, have led management to conclude there is no uncertainty about its ability to continue as a going concern through at least March 2026 [Results of Operations](index=27&type=section&id=Results%20of%20Operations) Total revenue for Q1 2025 decreased by $0.3 million (46%) compared to Q1 2024, primarily due to a 79% drop in grant and contract revenue following the disposition of TA&T. Operating expenses fell by $1.2 million (32%), with significant decreases in R&D (-45%) and grant-related expenses (-81%). Despite a lower operating loss, net loss increased by 159% to $2.3 million, mainly because of a $2.2 million negative swing in other income related to the change in fair value of derivative liabilities Q1 2025 vs Q1 2024 Operating Results (in thousands) | | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Total revenue | $ 369 | $ 687 | $ (318) | -46% | | Grant and contract revenue | $ 78 | $ 378 | $ (300) | -79% | | Gross profit | $ 123 | $ 464 | $ (341) | -73% | | Research and development | $ 1,116 | $ 2,019 | $ (903) | -45% | | Loss from operations | $ (2,383) | $ (3,197) | $ 814 | -25% | | Net loss | $ (2,292) | $ (886) | $ (1,406) | 159% | [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) The company has historically relied on equity financing to fund its operations. In Q1 2025, net cash used in operations was $1.3 million, a significant improvement from $2.7 million in Q1 2024. The company's cash position was strengthened by a $5.0 million private placement in February 2025, resulting in $4.3 million of net cash from financing activities. Following this capital raise and cost reductions, management believes it can fund operations through at least March 31, 2026 - The company's continuation as a going concern is dependent on increasing sales, decreasing expenses, and raising additional funds[115](index=115&type=chunk) - In February 2025, the company raised **$5.0 million** in gross proceeds from a private placement transaction[117](index=117&type=chunk) - The company sold its subsidiary TA&T on February 19, 2025, in exchange for the assumption of its liabilities[122](index=122&type=chunk) - Management has determined there is **no uncertainty** of the Company's ability to continue as a going concern through at least March 31, 2026[123](index=123&type=chunk) Cash Flow Summary (in thousands) | | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $ (1,301) | $ (2,733) | | Net cash provided by financing activities | $ 4,266 | $ 5,328 | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable for the company - **Not applicable**[138](index=138&type=chunk) [Item 4. Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) Based on an evaluation conducted by management, including the CEO, the company's disclosure controls and procedures were deemed effective as of March 31, 2025. There were no material changes to internal controls over financial reporting during the first quarter of 2025 - Management concluded that disclosure controls and procedures were **effective** as of March 31, 2025[141](index=141&type=chunk) - No material changes in internal control over financial reporting occurred during the first quarter of 2025[142](index=142&type=chunk) Part II. Other Information [Item 1. Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not aware of any pending or threatened legal proceedings that would have a material adverse effect on its business, financial condition, or operating results - The company is not aware of any pending or threatened legal proceeding against it that could have a **material adverse effect** on its business[143](index=143&type=chunk) [Item 1A. Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes from the risk factors previously disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2024 - No material changes from the risk factors previously disclosed in the Annual Report on Form 10-K[144](index=144&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=34&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company completed a private placement on February 20, 2025, for aggregate gross proceeds of $5.0 million. Additionally, under its share repurchase program, the company purchased 29,665 shares in March 2025 at an average price of $2.91 per share, leaving approximately $414,000 available for future repurchases - On February 20, 2025, the Company entered into a private placement transaction for aggregate gross proceeds of **$5.0 million**[145](index=145&type=chunk) Share Repurchase Activity (Q1 2025) | Period | Shares Purchased | Average Price Paid | Max Value Remaining | | :--- | :--- | :--- | :--- | | 03/01/25 – 03/31/25 | 29,665 | $2.91 | $413,736.72 | [Item 3. Defaults Upon Senior Securities](index=35&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) None reported - **None**[148](index=148&type=chunk) [Item 4. Mine Safety Disclosures](index=35&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable - **Not applicable**[149](index=149&type=chunk) [Item 5. Other Information](index=35&type=section&id=Item%205.%20Other%20Information) None reported - **None**[150](index=150&type=chunk) [Item 6. Exhibits](index=36&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including the Entity Acquisition Agreement for the TA&T sale, forms of warrants and securities purchase agreements from recent financings, and certifications by the CEO and PFO

Company Overview - SINTX Technologies has established itself as a leader in advanced ceramics, focusing on biomedical applications with a strong emphasis on silicon nitride, which has been successfully used in spinal implants since 2008[27]. - The company aims to leverage its competitive strengths to become a leading advanced ceramic company in the biomedical sector[45]. - The company aims to become a leading advanced ceramics company, focusing on silicon nitride medical devices, claiming to be the sole provider of such products in the U.S. with FDA clearance for spinal fusion devices[46]. Manufacturing and Technology - The company operates a 31,000 square foot FDA registered and ISO 13485:2016 certified manufacturing facility, ensuring control over the quality and availability of its silicon nitride products[33]. - The manufacturing facility spans 19,000 square feet and is certified under ISO 13485:2016, allowing rapid design and production of silicon nitride products while maintaining quality control[46]. - The company has received three NIH grants to develop 3D printed silicon nitride/polymer implantable medical devices, indicating a commitment to innovation in manufacturing technologies[46]. - The company is advancing AI-designed 3D printing capabilities for custom medical implants, integrating silicon nitride with PEEK to enhance biocompatibility and mechanical performance[37][39]. Product Features and Market Demand - SINTX's silicon nitride exhibits superior properties compared to traditional biomaterials, with a flexural strength over five times that of PEEK and compressive strength over twenty times that of PEEK, enhancing its suitability for long-term human implantation[36]. - The silicon nitride products have demonstrated antibacterial properties, with live bacteria counts being 8 to 30 times lower compared to PEEK, significantly reducing the risk of infection[36]. - The demand for personalized implants is increasing, with regulatory pathways for custom devices being more streamlined, allowing for quicker market entry[38]. - The company is exploring new markets for its silicon nitride, including antipathogenic applications, particularly in products like face masks and filters[29]. Research and Development - SINTX has published over 130 peer-reviewed studies validating the safety and efficacy of its silicon nitride products, supporting its product development strategy[43]. - The company is focused on developing products with anti-pathogenic properties, including those that inactivate the SARS-CoV-2 virus, showcasing its commitment to addressing current health challenges[46][47]. - The company is developing new manufacturing technologies and product candidates, including ceramic armor products, to expand its product lines[131]. Financial Performance - The company incurred a net loss of $11.0 million and $8.3 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $281.7 million as of December 31, 2024[118]. - Cash used in operations was $8.6 million and $14.1 million for the years ended December 31, 2024 and 2023, respectively[118]. - Product revenue for the year ended December 31, 2024, was $1,246,000, a 2% increase from $1,226,000 in 2023[220]. - Grant and contract revenue increased by $240,000, or 17%, from $1,401,000 in 2023 to $1,641,000 in 2024[220]. - Total revenue rose by $260,000, or 10%, from $2,627,000 in 2023 to $2,887,000 in 2024[220]. - Gross profit increased by $233,000, or 13%, from $1,843,000 in 2023 to $2,076,000 in 2024[220]. - Research and development expenses decreased by $3,512,000, or 40%, from $8,713,000 in 2023 to $5,201,000 in 2024[220]. - General and administrative expenses decreased by $225,000, or 5%, from $4,222,000 in 2023 to $3,997,000 in 2024[220]. - Operating expenses totaled $16,123,000 in 2024, an increase of $922,000, or 6%, from $15,201,000 in 2023[220]. Regulatory Environment - Medical devices in the U.S. require either 510(k) clearance or PMA approval before marketing, with the FDA aiming to review 510(k) submissions within 90 days[81]. - The PMA process is more complex and can take several years, requiring extensive data to demonstrate safety and effectiveness, with a first action decision typically within 180 days of filing[84]. - The FDA may classify a new device as Class III if it is not deemed substantially equivalent to a predicate device, necessitating a PMA submission[82]. - The European Union has unified regulations for medical devices, allowing for CE Marking, which certifies compliance with applicable directives[89]. - Notified Bodies in the EU are responsible for assessing conformity for medium and higher risk devices, which is necessary for commercial distribution[90]. Competitive Landscape - The company competes with major players like Medtronic and Stryker, which have greater resources, emphasizing the need for innovative product development to maintain competitiveness[76]. - The orthopedic market is highly competitive, with major players like Medtronic and Stryker dominating, posing challenges for the company[123]. Risks and Challenges - The company may face challenges in obtaining third-party reimbursement for its products, which could significantly reduce potential revenues[101]. - Medicare's reimbursement policies, including DRGs and APCs, may not adequately cover the costs associated with the company's products, affecting their market acceptance[102]. - The company is exposed to risks related to capital resources, including the need for additional financing to support product development and commercialization efforts[113]. - The company may face adverse changes in payment rates from third-party payors, which could negatively impact marketing and sales of its products[106]. - The company is dependent on its senior management and engineering teams, and any loss could materially affect business operations and financial condition[144]. - Cybersecurity risks could expose the company to data loss and litigation, harming its reputation and increasing expenses[146]. - The company may face significant costs and management distraction due to potential product liability claims, which could exceed its insurance coverage[190]. Strategic Partnerships and Collaborations - The company has developed strong collaborations with surgeons and university laboratories, collecting clinical data that supports the efficacy of its silicon nitride products[46]. - The company has licensed certain patents to CTL Medical under a ten-year agreement, indicating strategic partnerships to enhance its market position[71]. - The company has entered into agreements with orthopedic surgeons for product development, which may lead to claims regarding royalty entitlements[183]. Future Outlook - The company anticipates growth in the medical device market driven by new technologies, favorable demographics, and market expansion into underserved regions like South America and Asia[50]. - The company anticipates requiring substantial future capital to continue operations, conduct research and development, and establish marketing and sales capabilities[113]. - The company expects to incur additional research and development costs as it continues to develop new medical devices and other products[218].