Sintx Technologies, Inc. (SINT) Business Model Canvas

Sintx Technologies, Inc. (SINT): Business Model Canvas [Dec-2025 Updated]

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You're looking past the old technical ceramics business to see if Sintx Technologies, Inc.'s aggressive pivot into high-margin, infection-resistant medical implants is finally paying off. As a seasoned analyst, I can tell you the core value proposition-biocompatible silicon nitride (Si₃N₄) implants-is strong, backed by 18 issued U.S. patents and an FDA-registered facility. However, the near-term reality shows high-stakes execution: Q3 2025 saw product revenue of only $208,000 while R&D expenses jumped 59%, all while maintaining a cash position of $6.25 million as of September 30, 2025. To see exactly how they plan to bridge that gap by targeting orthopedic surgeons and locking in licensing deals with major medical OEMs, check out the full Business Model Canvas breakdown below.

Sintx Technologies, Inc. (SINT) - Canvas Business Model: Key Partnerships

You're looking at the core relationships Sintx Technologies, Inc. (SINT) relies on to get its advanced ceramics into the operating room. These aren't just vendor agreements; they are strategic enablers for their proprietary silicon nitride technology.

Evonik Corporation for SiN/PEEK Composite Manufacturing

The agreement with Evonik Corporation, announced on December 1, 2025, is a major step for scaling up material supply. Evonik, a global leader in high-performance polymers, will use its commercial-scale capability to produce Sintx Technologies, Inc.'s proprietary silicon nitride-PEEK compound (SiN/PEEK) to the Company's specifications. This material is engineered specifically for AI-assisted additive manufacturing of patient-specific implants. This collaboration immediately enables the production of these custom devices at Sintx Technologies, Inc.'s U.S.-based facility.

Sintx Technologies, Inc. is already leveraging this supply to respond to physician requests for humanitarian-use vertebral body replacement (VBR) implants for oncology patients following tumor resections in the spine. The Company also intends to use the SiN/PEEK compound to support regulatory clearances for both patient-matched and traditional subtractive manufactured implantable devices.

CTL/Amedica for Continued Spinal Interbody Device Supply

The relationship with CTL/Amedica represents a proven, ongoing revenue stream for Sintx Technologies, Inc.'s existing spinal technology. This partnership involves the continued supply of spinal interbody devices manufactured using Sintx Technologies, Inc.'s proprietary silicon nitride ceramic biomaterial. To date, over 50,000 devices have been successfully implanted through this channel. This historical performance provides a baseline for the commercial viability of their core material in the spine segment.

Leading Medical OEMs for Licensing and Joint Ventures

Sintx Technologies, Inc. is actively pursuing strategic commercial alliances, including licensing and joint venture discussions with leading medical Original Equipment Manufacturers (OEMs). This is a key part of the Company's strategic realignment, aiming to move away from lower-margin technical ceramics contracts. For context, the Company's Q3 2025 product revenue was $208,000, while grant and contract revenue was only $60,000, reflecting this purposeful pivot. The trailing twelve months (TTM) revenue as of December 2025 was reported at A$1.45 Million.

The goal here is to embed their technology into larger commercial platforms, which should translate into more predictable, higher-margin revenue streams than past OEM manufacturing work.

Key Opinion Leaders (KOLs) for Clinical Adoption and Training

While specific financial figures tied directly to KOL engagement aren't public, the clinical adoption strategy heavily relies on these relationships. Sintx Technologies, Inc. collaborates with academic institutions to advance clinical evaluation and regulatory approvals worldwide. The unique properties of their silicon nitride platform-including its antipathogenic behavior and osteogenic potential-are critical selling points to KOLs in trauma, spine, and oncology.

Key aspects of the KOL and clinical strategy include:

  • Focus on humanitarian-use VBR implants for complex oncology cases.
  • Leveraging SiN/PEEK's improved visualization versus standard PEEK for imaging.
  • Driving regulatory clearances for new and existing implantable devices.
  • Building a portfolio of patents covering composition and device designs.

Here's a quick look at how these partnerships map against the current operational reality:

Partner/Focus Area Key Metric/Status (as of late 2025) Significance to Business Model
Evonik Corporation Supply agreement signed December 1, 2025. Enables immediate, scalable production of proprietary SiN/PEEK material for 3D-printed implants.
CTL/Amedica Over 50,000 devices implanted to date. Provides established commercial channel and validation for silicon nitride spinal interbody devices.
Leading Medical OEMs Active licensing and joint venture discussions underway. Strategic shift to higher-margin, less capital-intensive revenue sources.
Clinical Adoption (KOLs) New 510(k) submission for Foot and Ankle Implant System in July 2025. Drives clinical acceptance and expands the addressable market for proprietary SiN technology.

Finance: draft the projected Q1 2026 revenue contribution breakdown from the CTL/Amedica channel versus anticipated licensing milestones by next Wednesday.

Sintx Technologies, Inc. (SINT) - Canvas Business Model: Key Activities

You're looking at the core actions Sintx Technologies, Inc. (SINT) is taking to drive its business forward as of late 2025. This is where the rubber meets the road, turning their material science into market presence.

Manufacturing silicon nitride (Si₃N₄) biomaterials and devices

Sintx Technologies, Inc. is focused on leveraging its proprietary silicon nitride (Si₃N₄) platform. The company's Salt Lake City facility is noted as the only FDA-registered and ISO 13485 certified, silicon nitride ceramic manufacturer. This capability is now being extended through strategic partnerships for advanced materials.

The company signed a supply agreement with Evonik Corporation to manufacture its proprietary silicon nitride-PEEK compound (SiN/PEEK) for AI-assisted additive manufacturing of patient-specific implants. This compound is engineered to offer antipathogenic surface behavior and osteogenic support.

Research and Development (R&D) for new antipathogenic products

The commitment to R&D remains high as SINTX Technologies, Inc. transitions its focus toward proprietary medical devices. Research and development expenses rose by 59% in the third quarter of 2025 compared to the third quarter of 2024, reflecting necessary investments in the proprietary silicon nitride product pipeline, including work supporting the SiNAPTIC clearance. The company maintains an active technology pipeline focused on surgical-grade silicon nitride devices and new R&D programs targeting implantable and antipathogenic products.

Key R&D focus areas include:

  • Silicon nitride for orthopedic implants.
  • Spinal fusion devices.
  • Dental products.
  • Medical Textiles with antipathogenic surfaces.

Commercialization of the SiNAPTIC® Foot & Ankle Wedge System

A major activity is the commercialization push for the SiNAPTIC® Foot & Ankle Osteotomy Wedge System. SINTX Technologies, Inc. received U.S. Food and Drug Administration (FDA) 510(k) clearance for this system, enabling entry into the U.S. reconstructive foot and ankle surgery market. The planned U.S. commercial launch for the system is scheduled for Q1 2026.

The target market context is significant; industry estimates placed the global foot & ankle device market at approximately $4.75-$5.4 billion in 2024.

Furthermore, the company recorded its first commercial revenue from the private-labeled orthobiologic product OsseoSculpt™ in the third quarter of 2025, which is designed to complement the SiNAPTIC wedges.

Managing and enforcing a large Intellectual Property (IP) portfolio

Protecting the technology platform is a core function. Sintx Technologies, Inc. announced the receipt of a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a patent application covering its antipathogenic fabric technology. This follows other allowances for antipathogenic fabric method claims.

Strategic operational streamlining and cost reduction

The company has actively worked to tighten its operational footprint to support the medical device pivot. A key action was executing a sublease of its Armor facility, which is projected to save approximately $950,000 in lease costs over the sublease term. This aligns with a broader reduction in operating expenses, which fell by 51% year-over-year in Q3 2025, totaling approximately $3.4 million.

The strategic review also involved workforce adjustments, reducing the number of employees from 40 to 23. The company also saw a reduction in operating cash burn, falling from $2.7 million in Q1 2024 to $1.3 million in Q1 2025.

Here's a quick look at some key financial and operational metrics as of late 2025:

Metric Value (as of Q3 2025 or latest reported) Context/Date
Cash and Equivalents $6.25 million As of September 30, 2025
Q3 2025 Revenue $0.2 million Q3 2025
Q3 2025 Product Revenue $208,000 Q3 2025
Q3 2025 Operating Expenses ~$3.4 million Down 51% YoY
Q3 2025 Net Loss $3.5 million Q3 2025
Q3 2025 Adjusted EBITDA Loss $2.3 million Q3 2025
Projected Lease Cost Savings ~$950,000 From sublease execution

Sintx Technologies, Inc. (SINT) - Canvas Business Model: Key Resources

You're looking at the core assets Sintx Technologies, Inc. (SINT) relies on to execute its business model, especially as it pivots toward commercial revenue in late 2025. These aren't just line items; they are the foundation of their competitive moat, built on material science and strategic M&A.

The intellectual property surrounding its proprietary silicon nitride ($\text{Si}_3\text{N}_4$) technology is paramount. Sintx Technologies, Inc. has secured a total of 18 issued U.S. patents protecting its material science innovations, including the composition and methods for its antipathogenic fibrous materials. This IP portfolio is designed to create a competitive barrier around their surface-level pathogen-inactivation technology, covering applications from wound dressings to surgical drapes.

Manufacturing capability is anchored by a facility that meets stringent quality requirements. Sintx Technologies, Inc. operates an advanced ceramics medical device manufacturing facility that is both FDA-registered and ISO 13485:2016 certified. This certification is non-negotiable for producing medical-grade devices under a controlled quality system.

The acquisition of $\text{SiNAPTIC Surgical, LLC}$ in mid-2025 significantly bolstered the product portfolio, moving the company faster toward revenue generation. This transaction brought in intellectual property, product designs, and development assets focused on the foot and ankle fusion market, which is a key area of focus for the company.

Here's a quick look at what the $\text{SiNAPTIC Surgical, LLC}$ asset acquisition brought into the Sintx Technologies, Inc. fold:

Asset Category Quantity/Detail Status/Note
Foot and Ankle Implant Systems Six (6) differentiated systems Acquired IP, designs, and development assets
Spinal Implants Interbody spinal implants Made from proprietary silicon nitride ceramic; 510(k)-cleared
Foot and Ankle Wedges Fusion wedges New 510(k) premarket notification submitted in July 2025
Transaction Consideration (Shares) $750,000 in common shares Priced at $3.465 per share (10% premium to June 20, 2025 close)
Performance Warrants Issued 325,000 warrants Exercisable over five years at $6.30 per share

Beyond the IP and manufacturing base, the immediate financial resource is critical for sustaining operations while scaling commercial efforts. As of the end of the third quarter, the company held a specific amount of accessible capital.

The tangible financial resource position as of September 30, 2025, is as follows:

  • Cash and equivalents: $6.25 million

To be fair, these resources represent both hard assets and critical intangible value. The combination of the $\text{Si}_3\text{N}_4$ patents and the FDA-cleared product pipeline from the $\text{SiNAPTIC}$ deal forms the core value proposition.

The key resource summary looks like this:

  • Proprietary $\text{Si}_3\text{N}_4$ material science platform
  • 18 issued U.S. patents covering composition and methods
  • FDA-registered and ISO 13485:2016 certified facility
  • Portfolio of six (6) acquired foot and ankle implant systems
  • $6.25 million in cash and equivalents (as of September 30, 2025)

Finance: draft 13-week cash view by Friday.

Sintx Technologies, Inc. (SINT) - Canvas Business Model: Value Propositions

Biocompatible, infection-resistant silicon nitride implants offer intrinsic antimicrobial properties. Sintx Technologies, Inc. is the only FDA-registered producer of implantable silicon nitride. The company has an active technology pipeline focused on surgical-grade silicon nitride devices. This material has demonstrated reduced bacterial adhesion compared with conventional metallic implants. The company is targeting the $62 billion global orthopedic implant sector. As of Q1 2025, cash on hand was $6.5 million, nearly doubling from year-end 2024.

Enhanced osteointegration and pro-regenerative properties are key differentiators. Silicon nitride promotes stronger bone fusion due to its osteoconductive properties. This contrasts with PEEK, which is biologically inert and can induce scar tissue formation at the implant interface. A peer-reviewed study confirmed silicon nitride provides enhanced stress distribution, reducing the risk of implant subsidence. The company also reported superior osseointegration compared to PEEK. The Salt Lake City facility remains ISO 13485 certified.

Patient-specific implants are supported via AI-assisted 3D manufacturing capabilities. Sintx Technologies, Inc. signed a supply agreement to manufacture Silicon Nitride-PEEK Compound for AI-Assisted, 3D-Printed Patient-Specific Implants. The company employs proprietary ceramic processing and additive manufacturing techniques. New patents have been filed related to composite implant design and additive manufacturing. The company is developing hybrid biomaterials combining silicon nitride with polymers.

The clinical legacy stands at over 50,000 spinal implants placed worldwide. This figure was confirmed as of June 2025 and again in August 2025. The company pioneered FDA-cleared silicon nitride implants in 2008. The current portfolio includes FDA 510(k)-cleared interbody spinal implants. The company also submitted a new 510(k) premarket notification for Foot and ankle fusion wedges in July 2025. The Q3 2025 revenue was $0.2M, with operating expenses of approximately $3.4M.

Here's a quick look at material advantages:

  • Reduced Cage Subsidence.
  • Superior Osseointegration.
  • Antimicrobial properties confirmed.
  • Radiolucency for enhanced imaging.

The following table summarizes material comparisons based on published findings:

Material Property Silicon Nitride PEEK (Polyetheretherketone) Titanium
Infection Resistance Intrinsic Antimicrobial Properties Not specified Not specified
Bone Fusion Promotion Osteoconductive; Promotes stronger bone fusion Biologically inert; Can induce scar tissue Not specified
Imaging Characteristics Radiolucent (favorable for MRI/CT) Not specified Causes artifacts in MRI/CT
Load Bearing Exhibited exceptional load-bearing capability Not specified Not specified

The intellectual property foundation includes 18 issued U.S. patents and 84 pending applications as of June 2025. The company reported $6.25 million cash on hand as of September 30, 2025. Operating expenses decreased by 51% year-over-year in Q3 2025.

Sintx Technologies, Inc. (SINT) - Canvas Business Model: Customer Relationships

Direct engagement with Key Opinion Leaders (KOLs) and surgeons

Sintx Technologies, Inc. lists KOL engagement as a near-term priority following the U.S. FDA 510(k) clearance for the SINAPTIC Foot & Ankle Osteotomy Wedge System. The acquisition of SiNAPTIC Surgical in July 2025 brought key expertise onto the team, including the appointment of Bryan Scheer, M.D., as Chairman of the Clinical Advisory Board. This structure supports the commercialization plan for proprietary devices.

Dedicated sales and support for proprietary medical devices

The company is executing a focused commercialization plan centered on infection-resistant silicon nitride devices. The U.S. launch for the SINAPTIC foot & ankle wedge system is planned for Q1 2026. Early traction is evidenced by the recording of first commercial revenue from the private-labeled OsseoSculpt product during the third quarter of 2025. The company reported total revenue of $0.2 million for Q3 2025, with an operating loss of $3.4 million for the same period.

  • Cash and cash equivalents stood at $6.25 million as of September 30, 2025.
  • Operating expenses for Q3 2025 were approximately $3.4 million, a 51% decrease year-over-year.
  • Net loss for Q3 2025 was $3.5 million.
  • Adjusted EBITDA loss for Q3 2025 was $2.3 million.

Long-term, high-touch relationships with medical OEMs

Sintx Technologies, Inc. maintains a long-standing relationship, continuing to provide spinal interbody devices to CTL/ Amedica. To date, over 50,000 devices supplied to this partner have been successfully implanted. This relationship exists alongside a strategic pivot away from lower-margin technical ceramics contracts, which contributed to a revenue decrease from $0.8 million in Q3 2024 to $0.2 million in Q3 2025. The company is now strategically aligned to focus on proprietary biomedical devices.

Relationship Type Partner/Focus Area Quantifiable Metric
Long-Term OEM Supply CTL/ Amedica (Spinal Interbody Devices) Over 50,000 devices successfully implanted to date
Strategic Transition Technical Manufacturing Contracts Revenue contribution decreased in Q3 2025 as part of a pivot away from low-margin work
New Device Commercialization SINAPTIC Foot & Ankle Wedge System U.S. launch planned for Q1 2026
New Product Revenue OsseoSculpt (Private-labeled orthobiologic) Recorded first commercial revenue in Q3 2025

Licensing and technology transfer support for partners

Sintx Technologies, Inc. explicitly states that its path forward includes Licensing and commercialization of proprietary technologies. The company is actively engaged in Partnerships and licensing discussions with leading medical OEMs. The acquisition of SiNAPTIC Surgical, which involved issuing $750,000 in common shares, was executed to accelerate the shift to revenue generation and expand the product portfolio in the foot and ankle fusion market, which is valued at approximately $750.5 million.

Sintx Technologies, Inc. (SINT) - Canvas Business Model: Channels

You're looking at Sintx Technologies, Inc.'s approach to getting its advanced ceramic products to the medical market as of late 2025. The strategy clearly pivots toward direct commercialization of proprietary devices, supported by key material supply partnerships.

Direct sales and distribution for proprietary devices (e.g., SiNAPTIC®) is now the primary focus, especially following the FDA 510(k) clearance for the SINAPTIC® Foot & Ankle Osteotomy Wedge System on October 20, 2025, which opened the U.S. market for direct entry. The company plans its U.S. commercial launch for Q1 2026. Early traction is visible with the recording of first commercial revenue from the private-labeled OsseoSculpt product during Q3 2025.

The established channel for spinal implants continues through the existing relationship with CTL/Amedica, which serves as a distribution route for their spinal interbody devices.

Channel Metric Value/Status (As of Late 2025)
Total Spinal Interbody Devices Implanted (To Date) 50,000 devices
Q3 2025 Product Revenue $208,000
Q3 2025 Total Revenue $0.2M (Reflecting pivot from lower-margin contracts)
SINAPTIC Foot & Ankle System Launch Date (Planned) Q1 2026

Licensing agreements with major medical device manufacturers remain a strategic component, though specific late-2025 financial details aren't public. As of May 2025, Sintx Technologies was actively pursuing 'Partnerships and licensing discussions with leading medical OEMs' as part of its strategy to expand the use of silicon nitride. This channel is intended to leverage the material science across a broader range of applications beyond their direct implant focus.

The supply chain for SiN/PEEK compound to partners like Evonik solidified significantly at the very end of 2025. Sintx Technologies signed a supply agreement with Evonik Corporation on December 1, 2025, to manufacture the proprietary silicon nitride-PEEK compound (SiN/PEEK). This is critical because it enables the immediate production of AI-designed, 3D-printed, patient-specific implants using equipment already at Sintx Technologies' U.S. facility.

The company is also using scientific validation to drive adoption through its research output:

  • Published peer-reviewed research validating silicon nitride performance.
  • Received a USPTO Notice of Allowance on antipathogenic fabric method claims.
  • The SINAPTIC implant system highlights material claims such as being Pro-osteogenic and Bacteriostatic.

The operational focus supports this channel shift; Q3 2025 operating expenses were reduced by 51% YoY to approximately $3.4M, while the cash balance stood at $6.25M as of September 30, 2025. Finance: draft Q4 2025 cash flow projection by January 15, 2026.

Sintx Technologies, Inc. (SINT) - Canvas Business Model: Customer Segments

You're looking at Sintx Technologies, Inc.'s customer base as of late 2025, and honestly, the picture is one of intense, deliberate transformation. The company has been aggressively pivoting away from its older, lower-margin technical ceramics business to focus almost entirely on high-growth, high-margin medical devices. This means the customer segments are being redefined by this strategic realignment.

Orthopedic surgeons and hospitals (Spine, Foot & Ankle)

This is the primary, forward-looking customer segment for Sintx Technologies, Inc. The focus here is on leveraging their proprietary silicon nitride biomaterials for implantable devices. You see this commitment clearly in the recent corporate actions. In July 2025, Sintx Technologies completed the acquisition of SiNAPTIC Surgical, LLC, which brought in a differentiated portfolio of orthopedic and spine technologies.

The key product focus areas for this segment include:

  • FDA 510(k)-cleared Interbody spinal implants using proprietary silicon nitride ceramic.
  • Foot and Ankle Fusion Wedges, for which a new 510(k) premarket notification was submitted in July 2025.
  • The newly cleared SINAPTIC® Foot & Ankle Osteotomy Wedge System, receiving FDA 510(k) clearance in October 2025.
  • Spinal interbody devices provided to CTL/Amedica, with over 50,000 total devices successfully implanted to date.

The company recorded its initial commercial revenue from OsseoSculpt™, an advanced biologic companion product, in the third quarter of 2025. This segment is where the near-term growth catalysts are centered.

Medical device Original Equipment Manufacturers (OEMs)

This segment represents a transitional customer group. Sintx Technologies has been purposefully moving away from technical ceramics contracts that didn't align with long-term profitability goals, which is reflected in the recent revenue figures. The strategy is now geared toward partnerships and licensing discussions with leading medical OEMs for their silicon nitride platform, rather than just being a contract manufacturer.

The financial impact of this pivot is visible in the latest reported revenue:

Metric Value (as of Q3 2025) Context
Product Revenue (Q3 2025) $208.00K Represents a decrease of 73.97% year-over-year.
Revenue (TTM) $1.27M Down 60.89% year-over-year.
Grant and Contract Revenue (Q3 2025) $60,000 Plummeted by 87% compared to Q3 2024.

The overall revenue trend shows the deliberate reduction in lower-margin OEM technical manufacturing work.

Industrial and aerospace customers (legacy contracts)

This segment is largely being wound down or divested as part of the pure-play medical device focus. You should view this as a legacy customer base, not a growth driver for late 2025. The company officially shut down its armor ceramics facility in August 2024. Furthermore, in February 2025, Sintx Technologies sold its Maryland-based subsidiary, Technology Assessment & Transfer, Inc. (TA&T), which was involved in non-medical applications.

The last concrete number tied to this area was from a 2023 Long-Term Agreement (LTA) for jet engine components, where annual revenues were projected to be less than $0.25 million.

Wound care and performance textile manufacturers

This represents an emerging application area leveraging the silicon nitride's proven antimicrobial properties. While not yet a major revenue driver based on the Q3 2025 figures, the intellectual property is advancing. Sintx Technologies received a Notice of Allowance from the USPTO for a patent covering its antipathogenic fabric technology in Q3 2025.

The potential customer applications in this area include:

  • Wound care products.
  • Surgical masks, sutures, and drapes.
  • Other antipathogenic surfaces for medical textiles.

The company is pursuing new R&D programs and licensing discussions specifically targeting these antipathogenic markets.

Finance: review the cash burn rate against the Q3 2025 operating loss of $3.35 million by next Tuesday.

Sintx Technologies, Inc. (SINT) - Canvas Business Model: Cost Structure

You're looking at the cost side of Sintx Technologies, Inc. (SINT) as they push toward the SINAPTIC wedge launch. The structure shows significant investment in R&D alongside major shifts in overhead management.

The company's total operating expenses for the third quarter ending September 30, 2025, were approximately $3.4 million. This figure represented a 51% decrease year-over-year, reflecting restructuring actions taken to tighten the operating footprint.

Here's a quick look at the key cost components for Q3 2025:

  • Cost of Revenue for Q3 2025 was $115,000.
  • Gross profit for the quarter was $93,000, yielding a gross margin of approximately 44.7%.
  • Facility optimization included executing a sublease of the Armor facility.
  • This sublease is estimated to save up to approximately $950,000 in lease costs over the sublease term.

The expense categories showing the largest increases were concentrated in strategic and administrative areas, which you need to watch closely as they scale commercialization.

The changes in operating expenses for the third quarter of 2025 compared to the prior period were:

Cost Component Q3 2025 Change Key Driver/Context
Research & Development (R&D) Expenses Up 59% Investments for strategic initiatives, including FDA clearance for the SINAPTIC Foot & Ankle Osteotomy Wedge System.
General and Administrative (G&A) Costs Up 162% Surge driven by increased stock-based compensation and headcount-related costs.
Cost of Revenue Decreased by 45% Primarily due to lower sales volumes in the period.

The net loss for Q3 2025 was $3.5 million, with an adjusted EBITDA loss of $2.3 million for the same period. Finance: draft 13-week cash view by Friday.

Sintx Technologies, Inc. (SINT) - Canvas Business Model: Revenue Streams

You're looking at how Sintx Technologies, Inc. (SINT) is bringing in cash as of late 2025. The focus has clearly shifted toward proprietary medical devices, even though the latest reported quarterly numbers show a significant drop in overall revenue year-over-year, largely due to a reduction in non-device income.

The company's total revenue for the three-month period ending September 30, 2025, was reported as $0.2 million, a decline from $0.8 million in Q3 2024. This shift reflects a strategic pivot away from lower-margin OEM technical manufacturing contracts toward higher-value medical technology sales.

Here's a breakdown of the key revenue components based on the Q3 2025 filing:

Revenue Source Category Specific Product/Activity Q3 2025 Amount
Product Revenue from Medical Devices General Medical Device Sales $208,000
Product Revenue from Medical Devices OsseoSculpt™ (First commercial revenue recorded) Included in Product Revenue
Product Revenue from Medical Devices SiNAPTIC® Foot & Ankle Osteotomy Wedge System Included in Product Revenue
Grant and Contract Revenue Non-Device Related Income $60,000

The product revenue from medical devices for the third quarter of 2025 was exactly $208,000. This stream is now anchored by the recent U.S. FDA 510(k) clearance for the SiNAPTIC® Foot & Ankle Osteotomy Wedge System, which creates the regulatory pathway for U.S. commercial sales.

Sales of proprietary products are central to the near-term strategy. You should note the following regarding these specific product lines:

  • Sales of proprietary products (SiNAPTIC®, OsseoSculpt™)
  • Recorded first commercial revenue from the private-labeled orthobiologic product OsseoSculpt™ during Q3 2025.
  • The SiNAPTIC® system is positioned for a U.S. launch planned for Q1 2026.

Grant and contract revenue showed a sharp contraction, which is a major driver of the overall revenue decline compared to the prior year. For Q3 2025, this revenue stream amounted to $60,000, representing an 87% decrease from the prior period. This drop aligns with the company's stated strategy to pivot from these lower-margin contracts.

Regarding intellectual property monetization, while specific royalty or licensing fee amounts for Q3 2025 aren't itemized in the top-line revenue, the company is actively expanding its IP portfolio. This includes a Notice of Allowance from the USPTO for method claims covering its antipathogenic fabric technology.

To summarize the known, itemized revenue sources for the quarter:

  • Product revenue from medical devices: $208,000
  • Grant and contract revenue: $60,000
  • Total reported revenue: $0.2 million

The company is definitely banking on the SiNAPTIC® and OsseoSculpt™ sales to replace the lost grant revenue and drive future growth, so keep an eye on Q4 and Q1 2026 product sales figures. Finance: draft 13-week cash view by Friday.


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