SINTX Technologies Announces Launch of OsseoSculpt™ an Advanced Biologic for Use with SINAPTIC® Foot & Ankle Osteotomy Wedge System
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 (Si₃N₄), 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.
- 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.
- 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
Sintx@kcsa.com
SINTX Technologies, Inc.
801.839.3502
IR@sintx.com
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