SINTX Technologies announces commercial launch of OsseoSculpt biologic, enhancing their SINAPTIC wedge system for improved bone healing.
Quiver AI Summary
SINTX Technologies, Inc. has announced a private label agreement to supply OsseoSculpt™, a new biologic product designed to complement its FDA-approved SINAPTIC® Foot & Ankle Osteotomy Wedge System. Following successful evaluations by design surgeons, SINTX recorded its first commercial revenue from OsseoSculpt™ in Q3 2025. The product features a technologically advanced surface designed to enhance bone healing. SINTX plans to market OsseoSculpt™ alongside its existing wedge system, simplifying procedures for surgeons and fostering early commercial momentum. Initial feedback from surgeons has been positive, and the company expects to expand its commercial reach through targeted education and training efforts as it aligns broader U.S. rollout with ongoing surgeon utilization and training through early 2026.
Potential Positives
- Successful clinical evaluation by design surgeons demonstrates strong validation for the OsseoSculpt™ product, indicating potential for broad acceptance in the market.
- First commercial revenue recorded from OsseoSculpt™ in Q3 2025, which highlights early commercial traction and demand for the product.
- Introduction of OsseoSculpt™ alongside the SINAPTIC wedge system offers a comprehensive solution for surgeons, likely enhancing procedural efficiency and improving patient outcomes.
- Planned broader rollout of OsseoSculpt™ in alignment with surgeon training and product availability suggests a strategic approach to scaling commercialization and increasing market presence.
Potential Negatives
- Forward-looking statements highlight significant risks and uncertainties related to commercialization, which could negatively impact future revenue and growth.
- The press release indicates challenges in surgeon training and utilization, suggesting potential barriers to market adoption of the new product.
- It does not provide detailed financial projections or robust sales expectations, which could raise concerns about the company's future revenue potential.
FAQ
What is OsseoSculpt™ and its purpose?
OsseoSculpt™ is a biologic designed to complement the SINAPTIC Wedge System, enhancing bone healing in osteotomy procedures.
How was OsseoSculpt™ evaluated?
Multiple design surgeons completed clinical evaluations, providing feedback that informed training and launch materials for the product.
When did SINTX achieve commercial revenue from OsseoSculpt™?
SINTX recorded its first commercial revenue from OsseoSculpt™ in the third quarter of 2025.
What are the key features of the SINAPTIC Wedge System?
The SINAPTIC Wedge System is engineered for stable correction with precision fit and compatibility for biologic augmentation.
What does SINTX's commercialization plan include?
The commercialization plan includes limited release through early-adopter sites and a broader rollout aligned with surgeon training by Q1 2026.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$SINT Insider Trading Activity
$SINT insiders have traded $SINT stock on the open market 17 times in the past 6 months. Of those trades, 17 have been purchases and 0 have been sales.
Here’s a breakdown of recent trading of $SINT stock by insiders over the last 6 months:
- GREGG R. HONIGBLUM (Chief Investment Officer) has made 10 purchases buying 50,000 shares for an estimated $185,000 and 0 sales.
- ERIC K. OLSON (President and CEO) has made 5 purchases buying 16,275 shares for an estimated $57,190 and 0 sales.
- MARK LEWIS ANDERSON purchased 10,000 shares for an estimated $33,000
- JAY M MOYES purchased 3,000 shares for an estimated $10,756
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$SINT Hedge Fund Activity
We have seen 1 institutional investors add shares of $SINT stock to their portfolio, and 0 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- CALDWELL TRUST CO added 1 shares (+inf%) to their portfolio in Q3 2025, for an estimated $4
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$SINT Analyst Ratings
Wall Street analysts have issued reports on $SINT in the last several months. We have seen 1 firms issue buy ratings on the stock, and 0 firms issue sell ratings.
Here are some recent analyst ratings:
- Ascendiant Capital issued a "Buy" rating on 09/22/2025
To track analyst ratings and price targets for $SINT, check out Quiver Quantitative's $SINT forecast page.
Full Release
Clinical evaluation of the product by design surgeons completed, driving early commercial momentum
SALT LAKE CITY, Utah, Nov. 03, 2025 (GLOBE NEWSWIRE) -- SINTX Technologies, Inc. (NASDAQ: SINT) (“SINTX” or the “Company”), a leader in advanced ceramic biomedical applications of silicon nitride (Si ₃ N ₄ ), today announced the execution of a private label agreement to supply OsseoSculpt ™ , a next-generation biologic designed to complement the Company’s FDA 510(K) cleared SINAPTIC ® Foot & Ankle Osteotomy Wedge System. Following successful evaluations by multiple design surgeons, SINTX recorded its first commercial revenue from OsseoSculpt ™ in Q3 2025.
OsseoSculpt features a nanocrystalline HCA surface with a biomimetic pore architecture that provides an enhanced osteoconductive scaffold. SINTX will market this biologic alongside its SINAPTIC wedge system to augment bone healing in indicated procedures, providing surgeons with a streamlined solution from a single supplier.
“Pairing our SINAPTIC wedges with a custom-built biologic closes a critical gap at the point of care,” said Lisa Marie Del Re, Chief Commercial Officer. “Design-surgeon feedback has been positive, and we recorded Q3 revenue from early evaluations. We expect biologic product utilization will improve the overall economic profile of our wedge portfolio as we scale commercialization.”
Why this matters:
- Accelerates adoption: Offering a ready-to-use biologic with the SINAPTIC wedge system simplifies the procedure stack for surgeons and facilities.
- Validated by Key Opinion Leaders (KOLs): Several of the Company’s design surgeons have evaluated the product, informing training, positioning, and launch materials.
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Commercial momentum already visible: Initial orders demonstrate real-world demand.
Commercial plan & near-term milestones:
- Limited release now through select design and early-adopter sites.
- Broader U.S. rollout aligned with wedge availability and surgeon training cycles through Q4 2025–Q1 2026.
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Growth drivers include: targeted in-service education, case support, and data capture on attach rate, procedure time, and outcomes for evidence-driven adoption.
For more information on SINTX Technologies or its materials platform, visit www.sintx.com .
About the SINAPTIC
®
Foot & Ankle Osteotomy Wedge System
The SINAPTIC wedge system, manufactured with silicon nitride biomaterial, is engineered to deliver stable correction in foot and ankle osteotomy procedures. Its design offers precision fit, predictable technique, and compatibility with biologic augmentation, supporting both surgical reproducibility and optimal bone healing.
(Refer to device labeling for indications, contraindications, warnings, and instructions for use.)
About SINTX Technologies, Inc.
Located in Salt Lake City, Utah, SINTX Technologies is an advanced ceramics company that develops and commercializes materials, components, and technologies for medical and other high-value applications. SINTX is a global leader in the research, development, and manufacturing of silicon nitride, and its products have been implanted in humans since 2008. Through innovation and strategic partnerships, SINTX continues to expand its portfolio across multiple markets.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, without limitation, statements regarding SINTX’s plans and expected timing for commercialization of the SINAPTIC Foot & Ankle Osteotomy Wedge System and OsseoSculpt biologic; anticipated surgeon adoption, procedural efficiencies, and revenue impact; expected U.S. manufacturing scale-up and supply-chain performance; and the Company’s ability to execute its commercialization strategy, generate clinical impact, and build shareholder value. Forward-looking statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied. These risks include, among others, challenges in commercialization, surgeon training and utilization, manufacturing scale-up, supply-chain and quality control issues, pricing and reimbursement dynamics, competitive developments, intellectual property protection, and broader economic conditions. Additional information about these and other risk factors can be found in SINTX’s filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, available at
www.sec.gov
. Forward-looking statements speak only as of the date of this release, and SINTX undertakes no obligation to update them, except as required by law.
SINTX Contacts:
Jack Perkins or Maria Hocut
KCSA Strategic Communications
[email protected]
SINTX Technologies, Inc.
801.839.3502
[email protected]
