UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-33624 SINTX Technologies, Inc. (Exact name of registrant as specified in its charter) DELAWARE 84-1375299 (State or other jurisdiction (IRS Employer of incorporati ...

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].

Core Insights - SINTX Technologies announced a new peer-reviewed study demonstrating the biomechanical advantages of silicon nitride in anterior cervical discectomy and fusion (ACDF) procedures [1][2] Group 1: Study Findings - The study, conducted by SRM Institute of Science and Technology in collaboration with SINTX, utilized finite element analysis to compare various cage designs and materials for cervical spine fusion, highlighting silicon nitride's superior biomechanical performance [2] - Key advantages of silicon nitride include reduced implant subsidence, improved load distribution, and enhanced spinal stability [2][6] Group 2: Market Implications - The findings reinforce the unique advantages of silicon nitride over traditional spinal implant materials like PEEK and titanium, indicating a transformative solution for spinal fusion applications [3] - With global spinal fusion procedures projected to exceed $10 billion annually, the integration of silicon nitride into commercial spinal implant systems presents a significant market opportunity for SINTX [3] Group 3: Product Benefits - Silicon nitride exhibits exceptional load-bearing capability, minimizing the risk of implant subsidence, a common complication in spinal fusion surgery [6] - The material provides enhanced stress distribution, reducing the risk of adjacent segment degeneration [6] - Silicon nitride promotes stronger bone fusion due to its osteoconductive and antimicrobial properties, unlike PEEK, which is biologically inert [6] - The radiolucency of silicon nitride allows for better post-surgical imaging and reduces artifacts in MRI and CT scans [6]

Core Insights - Sintx Technologies, Inc. announced the retirement of Dr. Sonny Bal as Chairman of the Board, with Eric Olson, the current CEO, appointed as the new Chairman effective immediately [1][2] Leadership Transition - Dr. Bal has been Chairman since 2015 and has significantly contributed to Sintx's transformation and growth in advanced materials [2] - Eric Olson expressed gratitude for Dr. Bal's leadership and emphasized the company's focus on high-value medical applications and strategic partnerships moving forward [3] - Since becoming CEO in August 2024, Olson has redirected the company towards high-growth opportunities in biomedical and medical device sectors [3] Company Overview - Sintx Technologies specializes in advanced ceramics for medical applications and is a leader in the research and manufacturing of silicon nitride, with products implanted in humans since 2008 [4] - The company has pursued strategic acquisitions and alliances to expand into new markets [4]