Financial Performance - For the three months ended June 30, 2021, product revenue was $0.1 million, a decrease of 50% compared to $0.2 million in the same period of 2020, primarily due to reduced orders from CTL Amedica[91]. - Gross profit for the three months ended June 30, 2021, was $28,000, down 32% from $41,000 in the same period of 2020, with a gross profit margin increase of 8% year over year[92]. - For the six months ended June 30, 2021, the Company incurred a net loss of $4.8 million, compared to a net loss of $2.9 million for the same period in 2020, reflecting an increase in losses[100]. - The Company had an accumulated deficit of $245.9 million as of June 30, 2021, up from $241.1 million as of December 31, 2020[100]. - Net cash used in operating activities was $5.3 million for the six months ended June 30, 2021, an increase of $0.4 million from $4.9 million used in the same period in 2020[108]. - Net cash provided by financing activities decreased significantly to $0.7 million for the six months ended June 30, 2021, down from $20.4 million in the same period in 2020, a decrease of $19.7 million[110]. Research and Development - Research and development expenses increased by $0.1 million, or 13%, for the three months ended June 30, 2021, reflecting a rise in R&D activities to support new technology development[94]. - The Company expects to incur additional research and development costs as it continues to develop new products, including armored plates and dental applications[87]. Sales and Marketing - Sales and marketing expenses surged by $0.2 million, or 151%, for the three months ended June 30, 2021, driven by increased marketing efforts for new product lines[96]. Other Income and Financial Activities - Other income for the three months ended June 30, 2021, rose by $2.2 million, or 108%, primarily due to a change in the fair value of derivative liabilities in the previous year[97]. - Net cash provided by investing activities increased to $1.5 million for the six months ended June 30, 2021, compared to $0.9 million for the same period in 2020[109]. - The Company has raised approximately $30.3 million through various offerings since its initial public offering in February 2014, including $9.4 million from a rights offering in February 2020 and $20.9 million from direct offerings between June and August 2020[102]. Operations and Market Strategy - The company operates a 30,000 square foot manufacturing facility in Salt Lake City, Utah, and is the only vertically integrated silicon nitride medical device manufacturer globally[79]. - The company is targeting OEM and private label partnerships to accelerate the adoption of silicon nitride in various markets, including hip and knee replacements and dental implants[75]. - The company believes its silicon nitride technology addresses limitations of existing biomaterials in medical applications[76]. - The Company is focusing on expanding the use of its silicon nitride material beyond spinal fusion applications, with potential applications in personal protection products[101]. COVID-19 Impact and Financial Outlook - The Company received a Paycheck Protection Program loan of $0.5 million in March 2021, which has a five-year term and an interest rate of 1.0% per annum[112]. - The Company has implemented protective measures in response to the COVID-19 pandemic, which may impact its operations and liquidity[106]. - Management believes existing capital resources will be sufficient to fund operations for at least the next 12 months, through August 2022[105].

[Part I. Financial Information](index=3&type=section&id=Part%20I.%20Financial%20Information) [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents SINTX Technologies' unaudited condensed consolidated financial statements for Q1 2021 and 2020, including balance sheets, statements of operations, stockholders' equity, and cash flows, with detailed notes on accounting policies and financial disclosures [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20(unaudited)) Total assets decreased from **$30.4 million** at December 31, 2020, to **$28.7 million** at March 31, 2021, while total liabilities slightly increased and stockholders' equity decreased | Metric (in thousands) | March 31, 2021 | December 31, 2020 | | :-------------------- | :------------- | :---------------- | | Total Assets | $28,685 | $30,447 | | Total Liabilities | $5,087 | $4,643 | | Total Stockholders' Equity | $23,598 | $25,804 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20(unaudited)) SINTX Technologies reported a **net loss of $2.6 million** for Q1 2021, a significant decline from **net income of $1.2 million** in the prior-year period, driven by a 51% decrease in product revenue, increased operating expenses, and sharply lower other income | Metric (in thousands) | 3 Months Ended March 31, 2021 | 3 Months Ended March 31, 2020 | Change ($) | Change (%) | | :-------------------- | :---------------------------- | :---------------------------- | :--------- | :--------- | | Product Revenue | $101 | $207 | $(106) | -51% | | Gross Profit | $40 | $41 | $(1) | -2% | | Total Operating Expenses | $2,881 | $1,895 | $986 | 52% | | Loss from Operations | $(2,841) | $(1,854) | $(987) | 53% | | Other Income, Net | $208 | $3,023 | $(2,815) | -93% | | Net Income (Loss) | $(2,633) | $1,169 | $(3,802) | -325% | | Basic EPS | $(0.11) | $0.19 | $(0.30) | -158% | | Diluted EPS | $(0.11) | $(0.37) | $0.26 | -70% | [Condensed Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity%20(unaudited)) Total stockholders' equity decreased from **$25.8 million** at December 31, 2020, to **$23.6 million** at March 31, 2021, primarily due to a net loss, partially offset by stock-based compensation and warrant exercises | Metric (in thousands) | December 31, 2020 | March 31, 2021 | Change | | :-------------------- | :---------------- | :------------- | :----- | | Common Stock (shares) | 24,552,409 | 24,684,574 | 132,165 | | Common Stock (amount) | $245 | $247 | $2 | | Additional Paid-In Capital | $266,666 | $267,091 | $425 | | Accumulated Deficit | $(241,107) | $(243,740) | $(2,633) | | Total Equity | $25,804 | $23,598 | $(2,206) | - Stock-based compensation contributed **$36 thousand** to equity, and warrant exercises for cash added **$196 thousand**[14](index=14&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20(unaudited)) The company experienced a **net decrease in cash and cash equivalents of $1.9 million** for Q1 2021, compared to a **net increase of $6.4 million** in the prior-year period, primarily due to a significant reduction in cash provided by financing activities | Metric (in thousands) | 3 Months Ended March 31, 2021 | 3 Months Ended March 31, 2020 | Change ($) | | :-------------------- | :---------------------------- | :---------------------------- | :--------- | | Net Cash Used in Operating Activities | $(2,992) | $(3,398) | $406 | | Net Cash Provided by Investing Activities | $406 | $396 | $10 | | Net Cash Provided by Financing Activities | $706 | $9,439 | $(8,733) | | Net Increase (Decrease) in Cash | $(1,880) | $6,437 | $(8,317) | | Cash and Cash Equivalents at End of Period | $23,471 | $8,224 | $15,247 | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) These notes provide detailed information supporting the condensed consolidated financial statements, covering the company's organization, significant accounting policies, liquidity, capital resources, and specific financial statement line items [1. Organization and Summary of Significant Accounting Policies](index=9&type=section&id=1.%20Organization%20and%20Summary%20of%20Significant%20Accounting%20Policies) SINTX Technologies, Inc. is an OEM ceramics company focused on developing and commercializing silicon nitride for medical and non-medical applications, serving as an exclusive OEM provider for CTL Medical after selling its retail spine business in 2018 - SINTX Technologies, Inc. (formerly Amedica Corporation) was incorporated in Delaware on **December 10, 1996**[19](index=19&type=chunk) - The company is an OEM ceramics company specializing in silicon nitride for medical and non-medical applications, serving as CTL Amedica's exclusive OEM provider for silicon nitride spinal implants[19](index=19&type=chunk)[22](index=22&type=chunk) - In **October 2018**, the company sold its retail spine business to CTL Medical, retaining manufacturing, R&D, and IP for core silicon nitride biomaterial technology[20](index=20&type=chunk) [2. Basic and Diluted Net Income (Loss) per Common Share](index=12&type=section&id=2.%20Basic%20and%20Diluted%20Net%20Income%20(Loss)%20per%20Common%20Share) For Q1 2021, basic and diluted net loss per share were both **$(0.11)**, with no dilutive effect due to the net loss, contrasting with Q1 2020's basic net income per share of **$0.19** and diluted net loss per share of **$(0.37)** | Metric | 3 Months Ended March 31, 2021 | 3 Months Ended March 31, 2020 | | :-------------------------------- | :---------------------------- | :---------------------------- | | Basic Net Income (Loss) per Share | $(0.11) | $0.19 | | Diluted Net Loss per Share | $(0.11) | $(0.37) | | Basic Weighted Average Shares Outstanding | 24,668,106 | 6,020,889 | | Diluted Weighted Average Shares Outstanding | 24,668,106 | 8,035,392 | - For Q1 2021, there was no difference between basic and diluted shares due to the anti-dilutive effect of the net loss[39](index=39&type=chunk) [3. Inventories](index=13&type=section&id=3.%20Inventories) Total inventories increased slightly from **$487 thousand** at December 31, 2020, to **$515 thousand** at March 31, 2021, with raw materials constituting the largest portion and most inventories classified as long-term | Inventory Type (in thousands) | March 31, 2021 | December 31, 2020 | | :---------------------------- | :------------- | :---------------- | | Raw materials | $407 | $388 | | WIP | $106 | $97 | | Finished goods | $2 | $2 | | Total Inventories | $515 | $487 | - As of March 31, 2021, approximately **$0.1 million** of inventories were current, and **$0.4 million** were long-term[41](index=41&type=chunk) [4. Intangible Assets](index=13&type=section&id=4.%20Intangible%20Assets) Intangible assets, primarily trademarks, remained stable at **$35 thousand** net of accumulated amortization as of March 31, 2021, with consistent amortization expense of approximately **$1.3 thousand** for both periods | Metric (in thousands) | March 31, 2021 | December 31, 2020 | | :-------------------- | :------------- | :---------------- | | Trademarks | $50 | $50 | | Accumulated Amortization | $(15) | $(14) | | Net Intangible Assets | $35 | $36 | - Amortization expense for intangible assets was approximately **$1.3 thousand** for both the three months ended March 31, 2021, and 2020[42](index=42&type=chunk) [5. Fair Value Measurements](index=14&type=section&id=5.%20Fair%20Value%20Measurements) The fair value of common stock warrants, classified as Level 3 derivative liabilities, increased from **$1.238 million** at December 31, 2020, to **$1.285 million** at March 31, 2021, with valuation based on the Monte Carlo Simulation - Common stock warrants are classified as **Level 3 derivative liabilities** and are re-measured to fair value each reporting period[43](index=43&type=chunk)[45](index=45&type=chunk) Derivative Liability (in thousands) | Metric (in thousands) | March 31, 2021 | December 31, 2020 | | :-------------------- | :------------- | :---------------- | | Derivative liability (Common stock warrants) | $1,285 | $1,238 | - The valuation of common stock warrant liability uses the Monte Carlo Simulation, with key assumptions including risk-free interest rates (**0.05%-0.70%** for March 2021) and expected volatility (**137.8%-178.1%** for March 2021)[45](index=45&type=chunk)[46](index=46&type=chunk) [6. Accrued Liabilities](index=16&type=section&id=6.%20Accrued%20Liabilities) Accrued liabilities increased from **$909 thousand** at December 31, 2020, to **$1.086 million** at March 31, 2021, primarily driven by an increase in payroll and related expenses | Accrued Liability Type (in thousands) | March 31, 2021 | December 31, 2020 | | :------------------------------------ | :------------- | :---------------- | | Payroll and related expense | $690 | $600 | | Other | $396 | $309 | | Total Accrued Liabilities | $1,086 | $909 | [7. Debt](index=16&type=section&id=7.%20Debt) The company received forgiveness for its **$0.4 million 2020 PPP Loan** in January 2021 and secured a new **$0.5 million 2021 PPP Loan** in March 2021 with a 1.0% interest rate, maturing in March 2026, which may also be forgiven - The **$0.4 million 2020 PPP Loan** was forgiven on **January 5, 2021**, and recorded as other income[50](index=50&type=chunk) - A new **$0.5 million 2021 PPP Loan** was received on **March 15, 2021**, with a **1.0% interest rate** and a five-year term, potentially eligible for forgiveness[51](index=51&type=chunk)[52](index=52&type=chunk) [8. Equity](index=17&type=section&id=8.%20Equity) In February 2021, the company entered into a new Equity Distribution Agreement to sell up to **$15.0 million** of common stock through an at-the-market offering, and during Q1 2021, issued **130,275 shares** for **$0.2 million** cash from warrant exercises - On **February 25, 2021**, SINTX entered into a new Equity Distribution Agreement to sell up to **$15.0 million** of common stock via an at-the-market offering, with no sales as of March 31, 2021[54](index=54&type=chunk)[55](index=55&type=chunk) - During Q1 2021, **130,275 common shares** were issued from cash warrant exercises, generating **$0.2 million**, and **1,890 shares** from cashless warrant exercises[58](index=58&type=chunk) - In **February 2020**, a rights offering generated **$9.4 million gross proceeds** from units of convertible preferred stock and warrants, and in **June-August 2020**, four registered direct offerings issued **11,015,000 common shares** for **$20.9 million gross proceeds**[56](index=56&type=chunk)[59](index=59&type=chunk)[60](index=60&type=chunk)[61](index=61&type=chunk) [9. Stock-Based Compensation](index=19&type=section&id=9.%20Stock-Based%20Compensation) As of March 31, 2021, the company had **833,893 stock options** outstanding with a weighted-average exercise price of **$3.98**, and granted **368,500 options** in Q1 2021 with an estimated fair value of approximately **$0.6 million** | Metric | March 31, 2021 | December 31, 2020 | | :-------------------------------- | :------------- | :---------------- | | Options Outstanding | 833,893 | 465,393 | | Weighted Average Exercise Price | $3.98 | $5.53 | | Weighted Average Remaining Contractual Life (Years) | 9.4 | 9.3 | - **368,500 stock options** were granted in Q1 2021, with an estimated fair value of approximately **$0.6 million**[62](index=62&type=chunk) Unrecognized Stock-Based Compensation (in thousands) | Unrecognized Stock-Based Compensation (in thousands) | Amount | Weighted Average Remaining Recognition Period (in years) | | :--------------------------------------------------- | :----- | :------------------------------------------------------- | | Stock options | $779 | 2.5 | | Stock grants | $17 | 2.1 | [10. Commitments and Contingencies](index=20&type=section&id=10.%20Commitments%20and%20Contingencies) The company has executive agreements for change-in-control payments and accelerated vesting of stock options, and management believes potential liabilities from ordinary course legal proceedings will not materially affect its financial position - Executive agreements include payments and accelerated stock option vesting upon a change in control[66](index=66&type=chunk) - Management believes potential liabilities from ordinary course legal proceedings will not materially affect financial position, operating results, or cash flows[67](index=67&type=chunk) [11. Note Receivable](index=20&type=section&id=11.%20Note%20Receivable) The company holds a **$6.0 million noninterest-bearing note receivable** from CTL Medical, maturing **October 1, 2021**, with a net carrying value of **$1.3 million** as of March 31, 2021, and expected cash proceeds of **$1.4 million** for the remaining term - A **$6.0 million noninterest-bearing note receivable** from CTL Medical matures on **October 1, 2021**[68](index=68&type=chunk) Note Receivable Metrics (in thousands) | Metric (in thousands) | March 31, 2021 | | :-------------------- | :------------- | | Net Carrying Value | $1,300 | | Expected Cash Proceeds (remaining 7 months) | $1,400 | [12. Leases](index=21&type=section&id=12.%20Leases) The company leases office, warehouse, and manufacturing space under an operating lease extended through 2024, with both the operating lease right-of-use asset and liability approximately **$1.8 million** as of March 31, 2021, and a weighted-average discount rate of **6.5%** - The company leases office, warehouse, and manufacturing space under an operating lease extended through **2024**[70](index=70&type=chunk) Operating Lease Metrics (in thousands) | Metric (in thousands) | March 31, 2021 | | :-------------------- | :------------- | | Operating Lease Right-of-Use Asset | $1,819 | | Operating Lease Liability | $1,782 | | Current Portion of Operating Lease Liability | $413 | | Long-Term Portion of Operating Lease Liability | $1,369 | | Weighted-Average Discount Rate | 6.5% | - Non-cash operating lease expense for Q1 2021 was approximately **$0.1 million**[70](index=70&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides an overview of SINTX Technologies' business as an advanced materials company focused on silicon nitride, details its financial results, analyzes Q1 2021 operating performance, and discusses liquidity, capital resources, and COVID-19 impact [Overview](index=22&type=section&id=Overview) SINTX Technologies is an advanced materials company developing and commercializing silicon nitride for medical and non-medical applications, leveraging its unique properties and expanding into new markets beyond spinal fusion, including anti-viral applications - SINTX Technologies develops and commercializes silicon nitride for medical and non-medical applications, highlighting its properties for human implantation (bone ingrowth, infection resistance, strength)[74](index=74&type=chunk) - Independent study showed silicon nitride inactivates **SARS-CoV-2 virus within a minute**, opening opportunities for anti-viral applications in products like face masks, PPE, and high-contact surfaces[75](index=75&type=chunk) - The company is the first to commercialize silicon nitride medical implants and, after selling its spine business to CTL Amedica in 2018, now focuses on OEM and private label partnerships for various markets (e.g., hip/knee replacements, dental, aerospace, antipathogenic applications)[76](index=76&type=chunk)[77](index=77&type=chunk)[78](index=78&type=chunk) [Components of our Results of Operations](index=23&type=section&id=Components%20of%20our%20Results%20of%20Operations) The company operates as a single reportable segment, deriving product revenue primarily from spinal fusion products sold to CTL, with gross profit margins expected to decrease due to a focus on OEM and private label partnerships, and R&D expenses anticipated to increase with new product development - The company operates within **one reportable segment**[81](index=81&type=chunk) - Product revenue is primarily from manufacturing and selling spinal fusion products to CTL under a **10-year exclusive sales agreement**[83](index=83&type=chunk) - Gross profit percentage is expected to decrease due to expansion through OEM and private label partnerships, which offer lower margins than retail sales[86](index=86&type=chunk) - Research and development costs are expensed as incurred and are expected to increase with the development of new products for various applications (e.g., total joint replacements, dental, antipathogenic)[87](index=87&type=chunk)[88](index=88&type=chunk) [Results of Operations](index=25&type=section&id=RESULTS%20OF%20OPERATIONS) For Q1 2021, SINTX Technologies reported a **net loss of $2.6 million**, a significant decline from **net income of $1.2 million** in Q1 2020, primarily due to a **51% decrease in product revenue**, a **52% increase in total operating expenses**, and a **93% decrease in other income** | Metric (in thousands) | 3 Months Ended March 31, 2021 | 3 Months Ended March 31, 2020 | $ Change | % Change | | :-------------------- | :---------------------------- | :---------------------------- | :------- | :------- | | Product Revenue | $101 | $207 | $(106) | -51% | | Costs of Revenue | $61 | $166 | $(105) | -63% | | Gross Profit | $40 | $41 | $(1) | -2% | | Research and Development | $1,595 | $994 | $601 | 60% | | General and Administrative | $1,000 | $764 | $236 | 31% | | Sales and Marketing | $286 | $137 | $149 | 109% | | Total Operating Expenses | $2,881 | $1,895 | $986 | 52% | | Loss from Operations | $(2,841) | $(1,854) | $(987) | 53% | | Other Income, Net | $208 | $3,023 | $(2,815) | -93% | | Net Income (Loss) | $(2,633) | $1,169 | $(3,802) | -325% | - Product revenue decreased by **51%** due to fewer orders from CTL Amedica[92](index=92&type=chunk) - Gross profit remained essentially unchanged despite decreased revenue and costs, attributed to new revenue sources with higher profit margins[93](index=93&type=chunk) - Other income decreased by **93%** primarily due to a **$4.4 million** change in fair value of derivative liabilities in 2020, partially offset by **$0.4 million** from 2020 PPP Loan forgiveness in 2021[98](index=98&type=chunk) [Liquidity and Capital Resources](index=26&type=section&id=Liquidity%20and%20Capital%20Resources) The company continues to operate as a going concern, despite incurring a **net loss of $2.6 million** and using **$3.0 million** in cash from operations in Q1 2021, contributing to an accumulated deficit of **$243.7 million**, but management projects sufficient capital for the next 12 months - The company's ability to continue as a going concern relies on increasing sales and/or raising additional capital[101](index=101&type=chunk) - Management believes existing capital resources, including a **$15.0 million Equity Distribution Agreement** and **$1.4 million** from a note receivable, will fund operations for at least the next **12 months** (through May 2022)[105](index=105&type=chunk)[106](index=106&type=chunk)[107](index=107&type=chunk) - The company is actively generating scientific and clinical data to support sales efforts and is expanding its sales strategy beyond spinal fusion to other silicon nitride applications, including potential anti-viral products[102](index=102&type=chunk) [Cash Flows](index=28&type=section&id=Cash%20Flows) Net cash used in operating activities decreased by **$0.4 million** to **$3.0 million** in Q1 2021, while net cash provided by financing activities significantly decreased by **$8.7 million** to **$0.7 million**, mainly due to the absence of large rights offerings seen in Q1 2020 | Cash Flow Activity (in thousands) | 3 Months Ended March 31, 2021 | 3 Months Ended March 31, 2020 | Change ($) | | :-------------------------------- | :---------------------------- | :---------------------------- | :--------- | | Net Cash Used in Operating Activities | $(2,992) | $(3,398) | $406 | | Net Cash Provided by Investing Activities | $406 | $396 | $10 | | Net Cash Provided by Financing Activities | $706 | $9,439 | $(8,733) | - Decrease in cash used in operating activities was primarily due to a **$0.7 million** decrease in cash used in accounts payable, offset by increases in prepaid expenses and accounts receivable[110](index=110&type=chunk) - The significant decrease in financing cash flow was due to **$9.4 million** from rights offerings in 2020, partially offset by **$0.5 million** from a PPP loan and **$0.2 million** from warrant exercises in 2021[112](index=112&type=chunk) [Indebtedness](index=28&type=section&id=Indebtedness) The company's **$0.4 million 2020 PPP Loan** was forgiven in January 2021, and a new **$0.5 million 2021 PPP Loan** was secured in March 2021 with a **1.0% interest rate**, maturing in March 2026, and is also eligible for forgiveness - The **$0.4 million 2020 PPP Loan** was forgiven on **January 5, 2021**[113](index=113&type=chunk) - A new **$0.5 million 2021 PPP Loan** was received on **March 15, 2021**, with a **1.0% interest rate** and a five-year term, subject to forgiveness conditions[114](index=114&type=chunk)[115](index=115&type=chunk) [Off-Balance Sheet Arrangements](index=29&type=section&id=Off-Balance%20Sheet%20Arrangements) The company has no off-balance sheet arrangements as defined by SEC regulations - The company does not have any off-balance sheet arrangements[116](index=116&type=chunk) [Critical Accounting Policies and Estimates](index=29&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) There have been no material changes to the company's critical accounting policies and estimates for Q1 2021, which include judgments and assumptions regarding income taxes, contingencies, valuation of derivative liabilities, asset impairment, and accounts receivable collectability - No material changes to critical accounting policies and estimates for Q1 2021[117](index=117&type=chunk) - Significant estimates include accounting for income taxes, contingencies, valuation of derivative liabilities, asset impairment, and collectability of accounts receivable[117](index=117&type=chunk) [New Accounting Pronouncements](index=29&type=section&id=New%20Accounting%20Pronouncements) Information on new accounting pronouncements is discussed in Note 1 to the Condensed Consolidated Financial Statements - New accounting pronouncements are discussed in **Note 1** of the financial statements[118](index=118&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=29&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This item is not applicable to the company - Not applicable[119](index=119&type=chunk) [Item 4. Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) The CEO and Principal Financial Officer concluded that the company's disclosure controls and procedures were effective as of March 31, 2021, with no material changes in internal control over financial reporting during Q1 2021 - Disclosure controls and procedures were effective as of **March 31, 2021**, as concluded by the CEO (principal executive and financial officer)[122](index=122&type=chunk)[136](index=136&type=chunk) - No material changes in internal control over financial reporting occurred during Q1 2021[124](index=124&type=chunk) [Part II. Other Information](index=30&type=section&id=Part%20II.%20Other%20Information) [Item 1. Legal Proceedings](index=30&type=section&id=Item%201.%20Legal%20Proceedings) The company is not aware of any pending or threatened legal proceedings that could materially affect its business, operating results, or financial condition, though it may be involved in various legal proceedings in the ordinary course of business - No material pending or threatened legal proceedings are known[125](index=125&type=chunk) - The medical device industry is characterized by frequent claims and litigation, and the company may be involved in various additional legal proceedings from time to time[125](index=125&type=chunk) [Item 1A. Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the Annual Report on Form 10-K for the year ended December 31, 2020 - No material changes to risk factors from the **2020 Annual Report on Form 10-K**[126](index=126&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=30&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds to report - None[127](index=127&type=chunk) [Item 3. Defaults Upon Senior Securities](index=30&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities to report - None[128](index=128&type=chunk) [Item 4. Mine Safety Disclosures](index=30&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[129](index=129&type=chunk) [Item 5. Other Information](index=30&type=section&id=Item%205.%20Other%20Information) There is no other information to report under this item - None[130](index=130&type=chunk) [Item 6. Exhibits](index=31&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including a Patent License Agreement, Promissory Note, Equity Distribution Agreement, and various certifications - Key exhibits include a Patent License Agreement (**10.1**), Promissory Note (**10.2**), Equity Distribution Agreement (**10.3**), and CEO/PFO certifications (**31.1, 31.2, 32**)[132](index=132&type=chunk) [Signatures](index=32&type=section&id=Signatures) The report was signed on May 13, 2021, by B. Sonny Bal, Chief Executive Officer (Principal Executive Officer and Principal Financial Officer) of SINTX Technologies, Inc. - Report signed by **B. Sonny Bal**, CEO (Principal Executive Officer and Principal Financial Officer) on **May 13, 2021**[136](index=136&type=chunk)

Medical Applications and Innovations - SINTX Technologies focuses on silicon nitride for medical implants, with over 35,000 spinal implants successfully implanted, demonstrating an excellent safety record[30]. - The company has received regulatory approvals for its silicon nitride spine implant products, including 510(k) clearance in the U.S. and CE mark in Europe[30]. - SINTX is the only FDA-registered and ISO 13485:2016 certified silicon nitride medical device manufacturer globally, emphasizing its unique market position[40]. - The silicon nitride material promotes bone growth, with studies showing it has up to three times the osteointegration force compared to PEEK and nearly two times that of titanium[41]. - SINTX's silicon nitride exhibits inherent antibacterial properties, with live bacteria counts being 8 to 30 times lower compared to PEEK and up to 8 times lower than titanium[42]. - The company is targeting OEM and private label partnerships to accelerate the adoption of silicon nitride in various medical fields, including hip and knee replacements[31]. - SINTX has published over 130 peer-reviewed studies supporting the safety and efficacy of its silicon nitride products[44]. - New bone formation around silicon nitride was approximately 69% in the absence of bacteria, compared to 36% for titanium and 24% for PEEK[48]. - In the presence of bacteria, new bone growth for silicon nitride was 41%, while titanium and PEEK showed 26% and 21% respectively[48]. - The force required to separate silicon nitride from surrounding bone was three times that of PEEK and nearly two times that of titanium in the absence of bacteria[48]. - The average burst test strength for silicon nitride femoral heads was 75 kN, representing a 15% improvement over BIOLOX delta at 65 kN[54]. - Silicon nitride exhibited approximately half the wear rate compared to cobalt chrome-on-cross-linked polyethylene articulating hip components[59]. - The company is actively developing a silicon nitride-based dental implant system, indicating a strategic expansion into the dental market[83]. - The company has a 10-year exclusive right to manufacture interbody spinal fusion devices for CTL Amedica, highlighting its competitive position in the spinal fusion market[74]. - The company has developed a femoral head made from solid silicon nitride for total hip replacement, expected to outperform traditional materials in wear performance and strength[93]. - A femoral condyle design made from solid silicon nitride has been created for knee implants, with plans for biomechanical testing and FDA submission following femoral head clearance[94]. - The company is exploring opportunities in cranial-maxillofacial, extremities, sports medicine, and trauma markets using its silicon nitride technology platform[95]. - The company is exploring new product candidates for total hip and knee replacements, dental implants, and personal protective equipment[175]. Non-Medical Applications - The company has expanded its focus to non-medical applications, including partnerships for face masks that incorporate silicon nitride to enhance antiviral properties[34]. - Silicon nitride inactivated the SARS-CoV-2 virus within one minute after exposure, indicating potential for reducing viral spread[58]. - The company has entered into a joint development agreement with O2 DESIGN to develop face masks with antiviral properties, expecting royalties and milestone payments from sales[82]. - The company has made its first shipments of non-medical products in 2020 and anticipates transitioning prototype orders into regular production[71]. - The company has entered into an exclusive licensing agreement with O2 Design for face masks incorporating silicon nitride, with potential royalties and milestone payments[115]. Manufacturing and Facilities - The company operates a 30,000 square foot facility in Salt Lake City, Utah, which is vertically integrated for silicon nitride medical device manufacturing[36]. - The company operates an 18,000 square foot FDA-compliant manufacturing facility in Salt Lake City, Utah, certified under ISO 13485:2016 for medical devices[71]. - The company produces silicon nitride in four distinct forms, allowing for various applications in medical devices[65]. - The porous silicon nitride structure is engineered to mimic cancellous bone, promoting bone in-growth and attachment[67]. - The manufacturing process for silicon nitride products is complex, requiring specialized knowledge and equipment, and any delays could adversely impact operations[171]. Financial Performance and Market Challenges - The company incurred net losses of $7.0 million and $4.8 million for the years ended December 31, 2020, and 2019, respectively, with an accumulated deficit of $241.1 million as of December 31, 2020[158]. - The company reported cash and cash equivalents of $25.4 million as of December 31, 2020, indicating limited liquidity and a need for substantial future capital to continue product development and commercialization efforts[191]. - The company relies on CTL for sales of spinal fusion products, which account for all its product revenue, and has a 10-year manufacturing agreement with CTL[169]. - The company has limited market acceptance of its silicon nitride-based products and must increase market awareness to succeed[161]. - The commercial success of the company's products depends on adequate reimbursement from third-party payers for procedures utilizing its products[179]. - The company anticipates that hospitals will obtain coverage for procedures using its products, but reimbursement levels may change over time, affecting financial performance[148]. - Third-party payors may deny reimbursement if procedures are deemed not medically necessary or not cost-effective, impacting product acceptance[149]. - The healthcare industry is experiencing a trend toward cost containment, with government and private payers seeking to control healthcare costs, which may affect the payment levels for procedures using the company's products[182]. - The company faces uncertainty in market acceptance due to varying reimbursement policies from private and governmental payers, which could materially adversely affect its business[180]. Regulatory Environment - Government regulations extensively control the development and marketing of medical devices, which could affect the company's product launch[122]. - 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[123]. - The PMA process is more complex and can take several years, with the FDA having 45 days to determine if a PMA is complete and a decision typically issued within 180 days[126]. - The FDA may require a limited one to two-year clinical trial for the clearance of new devices, impacting the timeline for commercialization[93]. - The FDA's 510(k) clearance process typically takes one to six months, but the premarket approval (PMA) process can take two to three years or longer, impacting the timeline for product commercialization[198]. - The company has obtained FDA clearance for its spinal fusion products and intends to seek further FDA approvals through the 510(k) or PMA process[201]. - Clinical trials are expected to be required for regulatory approval of some product candidates, which may proceed more slowly than anticipated due to the company's limited experience in conducting such trials[203]. - The company may face significant delays in clinical trials due to various factors, including financing issues, regulatory approvals, and patient enrollment challenges[205]. - Delays in clinical trials could lead to increased development costs and may allow competitors to introduce products to the market first, impacting the commercial viability of the company's product candidates[206]. - The European Union has a unified regulatory framework for medical devices, allowing for CE Marking which facilitates market access across member states[132]. - The CE Mark is mandatory for medical devices sold in the EU, indicating compliance with applicable directives and standards[132]. Intellectual Property and Competition - The company holds thirteen issued U.S. patents and multiple pending applications, with core patents expiring between 2022 and 2036[102]. - The company relies on a combination of patents, trade secrets, and proprietary information to protect its intellectual property rights[100]. - The company has no patent protection for the composition of matter or manufacturing process of solid silicon nitride, allowing competitors to create similar formulations[224]. - The company faces potential challenges in enforcing its intellectual property rights, which may divert management's attention and resources[222]. - There is a risk of costly intellectual property litigation that could impact the company's ability to market its products and reduce profit margins[225]. - Competitors may successfully challenge and invalidate the company's issued patents, limiting its market capabilities[220]. - The likelihood of patent infringement claims increases as the orthopedic market expands and the company gains visibility[225]. - If found to infringe on patents, the company could face substantial damages and may be required to redesign products or obtain licenses[226]. - The company has pending patent applications that may not result in issued patents, impacting its competitive position[224]. - The enforcement of intellectual property rights may be complicated by varying international laws, potentially weakening protection outside the U.S.[222]. - The main competitors in the orthopedic implant market include Medtronic, DePuy Synthes, and Stryker, which have greater resources and capabilities[111]. Management and Operational Risks - The company had 32 employees as of March 1, 2021, and believes that attracting and retaining qualified personnel is crucial for success[154]. - The company is dependent on its senior management and engineering teams, and any loss of key personnel could have a material adverse effect on its business[188]. - Prolonged negative economic conditions could harm the company's financial position and its ability to maintain or grow operations[185]. - The company may face challenges in negotiating favorable purchase contracts with group purchasing organizations, impacting sales success[181]. - Legislative and regulatory changes under healthcare reform could adversely affect the company's business and financial results, creating uncertainty in future operations[184]. - The company relies on a limited number of third-party suppliers for key raw materials, and any loss of these suppliers could harm its business[174]. - The company is dependent on O2 DESIGN for the commercialization of face masks and filters incorporating silicon nitride technology, with a two-year exclusive patent license agreement in place[170]. Impact of COVID-19 - The COVID-19 pandemic has materially impacted the company's sales and cash flows in fiscal 2021, with ongoing monitoring of the situation[156]. - Future outbreaks of contagious diseases could adversely affect the company's ability to raise funds and engage with third parties for manufacturing and development[157].