Regulatory Approvals - SINTX received FDA 510(k) clearance for the SINAPTIC® Foot & Ankle Osteotomy Wedge System, marking a significant milestone for commercial entry into reconstructive foot and ankle surgery in the U.S.[6] Financial Performance - Total revenue for Q3 2025 was $208 million, a decrease of 74.0% compared to $799 million in Q3 2024[17]. - Product revenue for the nine months ended September 30, 2025, was $541 million, down 48.7% from $1,054 million in the same period of 2024[17]. - Gross profit for Q3 2025 was $93 million, significantly lower than $589 million in Q3 2024, reflecting a gross margin decline[17]. - The net loss for Q3 2025 was $3,539 million, compared to a net loss of $6,239 million in Q3 2024, indicating an improvement[17]. - The company reported a net loss attributable to common stockholders of $10,258 million for Q3 2025, compared to $6,239 million in Q3 2024[17]. - Basic net loss per share for Q3 2025 was $(1.19), compared to $(6.96) in Q3 2024[17]. - Adjusted EBITDA loss was $2.3 million in Q3 2025, a significant improvement from a loss of $6.1 million in Q3 2024[6]. - Adjusted EBITDA for Q3 2025 was $(2,308) million, an improvement from $(6,085) million in Q3 2024[19]. Operating Expenses - Operating expenses decreased by 51% year-over-year to approximately $3.4 million, leading to an operating loss of $3.4 million compared to $6.4 million in Q3 2024[6]. - Total operating expenses for Q3 2025 were $3,448 million, a decrease of 50.7% from $6,997 million in Q3 2024[17]. - Research and development expenses for Q3 2025 were $1,264 million, up 58.7% from $796 million in Q3 2024[17]. Liquidity and Cash Management - Cash and cash equivalents increased to $6.25 million as of September 30, 2025, up from $3.60 million on December 31, 2024, reflecting improved liquidity management[6]. - SINTX raised an additional $4.3 million in gross proceeds through warrant inducement and common stock warrant exercises, strengthening its liquidity position[6]. Asset and Liability Management - Total assets increased to $11.36 million as of September 30, 2025, compared to $9.41 million on December 31, 2024[15]. - Total liabilities rose to $7.30 million as of September 30, 2025, up from $5.52 million on December 31, 2024[15]. Strategic Initiatives - The company plans to prepare the SINAPTIC wedge system for launch and expand clinical engagement in targeted surgical specialties[7]. - The company executed a sublease of the Armor facility, estimated to save approximately $950,000 in lease costs over the sublease term[6]. Shareholder Information - Weighted average common shares outstanding for Q3 2025 were 2,963,539, significantly higher than 896,305 in Q3 2024[17].

Core Insights - SINTX Technologies, Inc. reported third quarter financial results and provided a business update, focusing on its commercialization plan for infection-resistant silicon nitride devices and polymer composites [1][2]. Business Highlights and Key Milestones - The company received FDA 510(k) clearance for the SINAPTIC Foot & Ankle Osteotomy Wedge System, marking a significant milestone for commercial entry into reconstructive foot and ankle surgery in the U.S. [5][7]. - Initial product revenue was recorded from the OsseoSculpt™ product, a companion biologic to the SINAPTIC wedge portfolio [7]. - SINTX executed a sublease of the Armor facility, projected to save approximately $950,000 in lease costs, aligning resources with medical device priorities [7]. - The company raised an additional $4.3 million through warrant inducement and common stock warrant exercises, strengthening its liquidity [7]. Financial Results - Cash and cash equivalents increased to $6.25 million as of September 30, 2025, compared to $3.60 million on December 31, 2024 [7]. - Total revenue for Q3 2025 was $0.208 million, a decrease from $0.799 million in Q3 2024, primarily due to reduced grant revenue [7]. - Operating expenses were approximately $3.4 million, a 51% decrease year-over-year [7]. - The operating loss was $3.4 million, down from $6.4 million in Q3 2024, while the net loss was $3.5 million, or $1.19 per fully diluted share, compared to a net loss of $6.2 million, or $6.96 per fully diluted share in Q3 2024 [7]. Future Priorities - SINTX plans to prepare the SINAPTIC wedge system for launch, expand clinical engagement in targeted surgical specialties, and leverage its material science into adjacent indications [5]. - The company is also evaluating options for partnering, licensing, and capital formation to enhance market access and shareholder value [5].

Revenue Performance - For the three months ended September 30, 2025, product revenue decreased by $0.2 million, or 59%, compared to the same period in 2024, while grant and contract revenue decreased by $0.4 million, or 87%[106]. - For the nine months ended September 30, 2025, product revenue decreased by $0.5 million, or 49%, and grant and contract revenue decreased by $1.1 million, or 86% compared to the same period in 2024[107]. - Total revenue for the three months ended September 30, 2025, was $208,000, a decrease of $591,000, or 74%, and for the nine months, total revenue was $728,000, a decrease of $1.617 million, or 69%[105]. Expenses - Research and development expenses increased by $0.5 million, or 59%, for the three months ended September 30, 2025, primarily due to increased costs related to the Research Agreement[112]. - General and administrative expenses increased by $1.3 million, or 162%, for the three months ended September 30, 2025, primarily due to increased stock-based compensation and headcount-related costs[114]. - Total operating expenses for the three months ended September 30, 2025, were $3.448 million, a decrease of $3.549 million, or 51%, compared to the same period in 2024[105]. Net Loss - The net loss for the three months ended September 30, 2025, was $3.539 million, a decrease of $2.7 million, or 43%, compared to the same period in 2024[105]. - For the nine months ended September 30, 2025, the company incurred a net loss of $8.1 million, compared to a net loss of $9.3 million for the same period in 2024, reflecting a decrease of approximately 12.9%[125]. Cash Flow - Cash used in operating activities decreased to $6.2 million for the nine months ended September 30, 2025, from $7.5 million in the same period of 2024, a reduction of $1.3 million[138]. - Net cash provided by investing activities was $0.955 million during the nine months ended September 30, 2025, compared to a net cash used of $0.204 million in the same period of 2024, an increase of $1.159 million[139]. - Net cash provided by financing activities was $7.9 million for the nine months ended September 30, 2025, down from $9.2 million in the same period of 2024, a decrease of $1.3 million[140]. Strategic Developments - The company received FDA 510(k) clearance for the SiNAPTIC® Foot & Ankle Osteotomy Wedge System in October 2025, marking its entry into reconstructive foot and ankle surgery in the U.S.[93]. - The company is transitioning away from low-margin OEM technical manufacturing contracts to focus on proprietary silicon nitride-based biomedical devices, which are expected to offer stronger margins[108]. - The company began recognizing commercial revenue from OsseoSculpt™, a next-generation biologic, in Q3 2025, which is anticipated to be a key revenue driver starting in 2026[109]. - The company received FDA 510(k) clearance for a new foot and ankle osteotomy wedge system in October 2025, with revenue expected to begin in the first half of 2026[134]. - The company is focused on advancing its business strategy in the biomedical sector, particularly in developing innovative medical devices using advanced ceramics and biomaterials[128]. Asset Management - The company incurred an impairment charge of approximately $4.6 million related to the write-down of long-lived assets associated with the armor plant, which was shut down in October 2023[132]. - The company entered into an Entity Acquisition Agreement with Tethon Corporation on February 19, 2025, selling all issued shares of TA&T in exchange for the assumption of its liabilities[133]. - The company expects to save approximately $950,000 over the sublease term of the SINTX armor facility, which was leased in October 2025[136]. Accumulated Deficit - The company had an accumulated deficit of $290 million as of September 30, 2025, compared to $282 million as of December 31, 2024[125].

Core Insights - SINTX Technologies has successfully completed clinical evaluations of its product, OsseoSculpt™, leading to early commercial momentum and the first recorded revenue in Q3 2025 [1][3] Product Overview - OsseoSculpt™ features a nanocrystalline HCA surface with a biomimetic pore architecture, enhancing osteoconductive properties and providing a scaffold for bone healing [2] - The product is designed to complement the SINAPTIC® Foot & Ankle Osteotomy Wedge System, which is engineered for stable correction in foot and ankle procedures [4] Commercial Strategy - The company has executed a private label agreement to market OsseoSculpt™ alongside the SINAPTIC wedge system, aiming to streamline the surgical process for healthcare providers [1][3] - Initial orders indicate real-world demand, with a limited release through select design and early-adopter sites [7] Market Positioning - The combination of SINAPTIC wedges and OsseoSculpt™ addresses a critical gap in surgical care, as noted by the positive feedback from design surgeons [3][7] - The broader rollout in the U.S. is planned to align with the availability of the wedge system and surgeon training cycles, targeting Q4 2025 to Q1 2026 [7] Growth Drivers - Key growth drivers include targeted in-service education, case support, and data capture on attach rates, procedure times, and outcomes to support evidence-driven adoption [7]

Core Insights - SINTX Technologies has received FDA approval for its SINAPTIC® Foot & Ankle Osteotomy Wedge System, marking a significant milestone for the company as it enters the U.S. market for foot and ankle reconstruction surgeries [1][2] - The company plans to launch the system in the U.S. commercial market in the first quarter of 2026, leveraging its domestic manufacturing advantages to enhance revenue growth and operational efficiency [1][2] Company Overview - SINTX Technologies is a leader in advanced ceramics, focusing on the application of silicon nitride (Si₃N₄) in the biomedical field [1][4] - The company has been a pioneer in the research and manufacturing of silicon nitride since 2008, with its products already used in human implants [4] Product Details - The SINAPTIC implant system combines proprietary silicon nitride biomaterials with a specially designed sterile single-use instrument kit, aimed at improving surgical efficiency, precision, and repeatability [2] - The system is expected to meet the growing demand for non-metal solutions in orthopedics, enhancing surgical outcomes in the foot and ankle reconstruction sector [2] Market Potential - The global foot and ankle device market is estimated to be between $4.75 billion and $5.4 billion in 2024, presenting a lucrative revenue opportunity for SINTX despite the wedge osteotomy device being a niche segment [2] - Factors such as increasing surgical volumes, the trend towards outpatient surgery centers (ASC), and the use of single-use instruments are expected to drive market growth [2]

Core Insights - Sintx Technologies, Inc. has received FDA 510(k) clearance for the SINAPTIC Foot & Ankle Osteotomy Wedge System, allowing entry into the billion-dollar reconstructive foot and ankle surgery market [1][2] - The system combines SINTX's proprietary silicon nitride biomaterial with surgeon-informed implant designs and a single-use instrument kit, expected to be available in the U.S. market by Q1 2026 [1] Company Strategy - CEO Eric Olson emphasized the potential for meaningful clinical impact and shareholder value through the differentiated biomaterial and surgeon-validated designs in a high-value, procedure-driven market [2] - The stock is currently trading at $4.08, reflecting a 3.53% increase in pre-market hours on the Nasdaq [2]

Core Insights - SINTX Technologies has received FDA 510(k) clearance for the SINAPTIC® Foot & Ankle Osteotomy Wedge System, marking its entry into the reconstructive foot and ankle surgery market in the U.S. with a planned commercial launch in Q1 2026 [1][3] - The global foot & ankle device market is estimated to be approximately $4.75–$5.4 billion in 2024, with SINTX targeting a significant revenue opportunity through its innovative implant system [3] Company Overview - SINTX Technologies specializes in advanced ceramics, particularly in the biomedical applications of silicon nitride (Si₃N₄), and has been a leader in this field since 2008 [5] - The SINAPTIC implant system integrates proprietary silicon nitride biomaterial with surgeon-informed designs and a sterile, single-use instrument kit to enhance surgical efficiency and outcomes [2][3] Market Positioning - The SINAPTIC system is positioned to meet the growing demand for non-metal solutions in orthopedics, aiming to improve surgical outcomes through the proven performance of silicon nitride [3] - The company anticipates that the combination of procedure growth, migration to Ambulatory Surgery Centers (ASC), and single-use instrumentation will create a compelling revenue opportunity in the foot and ankle device market [3] Product Features - The silicon nitride material used in the SINAPTIC system offers unique benefits, including superior protein absorption, osteointegration, bacteriostatic properties, hydrophilicity, and enhanced visibility in imaging compared to traditional metal implants [7]

Core Insights - SINTX Technologies has received a new patent from the USPTO for its antimicrobial fabric technology, further solidifying its competitive advantage and expanding its intellectual property (IP) portfolio [1][2] - The new patent complements a previously approved patent for the composition of antimicrobial fiber materials, enhancing SINTX's position in the infection prevention market [2] - The dual patent strategy strengthens SINTX's IP barrier in various applications, including wound dressings, surgical drapes, personal protective equipment (PPE), and clinical surfaces [1][3] Company Developments - The CEO of SINTX, Eric K. Olson, emphasized that the new patent is a significant milestone that broadens the protection of their proprietary silicon nitride technology platform [2] - The company plans to engage in licensing and joint development with partners in the textile, wound care, and PPE sectors, leveraging its dual patent portfolio for flexible collaboration models [3] Market Context - The infection prevention market is estimated to be around $30 billion, covering medical textiles, wound management, and PPE, which is supported by the new patents [3] - There is a pressing need for passive surface-level solutions to combat hospital-acquired infections (HAIs), with approximately 1 in 31 hospitalized patients experiencing an HAI on any given day in the U.S. [3]

Core Viewpoint - Momentum investing focuses on following a stock's recent price trends, aiming to buy high and sell higher, with the expectation that established trends will continue [1] Company Overview: SINTX Technologies, Inc. - SINTX Technologies, Inc. currently holds a Momentum Style Score of B and a Zacks Rank of 2 (Buy), indicating a positive outlook for the stock [3][4] - The stock has shown significant price performance, with a 5.08% increase over the past week, contrasting with a 2.74% decline in the Zacks Medical - Instruments industry during the same period [6] - Over the past quarter, SINT's shares have risen by 56.36%, and by 44.78% over the last year, outperforming the S&P 500, which increased by 7.25% and 16.06% respectively [7] Trading Volume and Market Position - SINT's average 20-day trading volume is 106,104 shares, which serves as a baseline for price-to-volume analysis, indicating bullish or bearish trends [8] Earnings Outlook - In the last two months, one earnings estimate for SINT has increased, while none have decreased, leading to a consensus estimate improvement from -$3.44 to -$2.87 for the full year [10] - For the next fiscal year, one estimate has also moved upwards with no downward revisions, suggesting a positive earnings outlook [10] Conclusion - Considering the positive momentum indicators and earnings outlook, SINTX Technologies, Inc. is positioned as a promising investment opportunity with a Momentum Score of B and a Zacks Rank of 2 (Buy) [12]

Core Insights - SINTX Technologies has received a Notice of Allowance for a patent application covering its antipathogenic fabric technology, enhancing its competitive advantage and broadening licensing opportunities [1][2][4] - The new patent complements an existing patent for Antipathogenic Fibrous Materials, creating a comprehensive intellectual property (IP) barrier around SINTX's pathogen-inactivation technology [2][3][4] - The company aims to leverage its dual-patent estate to pursue partnerships in medical textiles, wound care, and filtration/PPE sectors, enhancing its commercialization potential [6][7] Intellectual Property Development - The newly allowed method patent strengthens the protection of SINTX's silicon nitride technology platform, covering both the composition and manufacturing processes of its fabrics [4][5] - The dual coverage of composition and method allows SINTX to defend and license various manufacturing and application pathways, crucial for engaging with potential partners [4][5] Market Context - The infection-prevention market is estimated to be around $30 billion, encompassing medical textiles, wound management, filtration/PPE, and healthcare infrastructure, supported by the new patent coverage [6] - Approximately 1 in 31 U.S. hospital patients experience healthcare-associated infections (HAIs), highlighting the demand for effective surface-level infection prevention solutions [7] Scientific Validation - Peer-reviewed studies have demonstrated that silicon nitride can achieve up to ~99.97% reduction of infectious SARS-CoV-2 in laboratory conditions, validating its effectiveness in antipathogenic applications [5]