SINTX Technologies Announces Launch of OsseoSculpt™ an Advanced Biologic for Use with SINAPTIC® Foot & Ankle Osteotomy Wedge System
SINTX Technologies (NASDAQ: SINT) announced the launch and private‑label supply of OsseoSculpt™, a next‑generation biologic designed to complement the company’s FDA 510(k) cleared SINAPTIC® Foot & Ankle Osteotomy Wedge System. Clinical evaluations by multiple design surgeons were completed and SINTX recorded its first commercial revenue in Q3 2025 from early OsseoSculpt orders.
OsseoSculpt features a nanocrystalline HCA surface with biomimetic pore architecture to enhance osteoconduction. The company launched a limited release to select design and early‑adopter sites, with a broader U.S. rollout aligned with wedge availability and surgeon training cycles through Q4 2025–Q1 2026.
SINTX Technologies (NASDAQ: SINT) ha annunciato il lancio e l'approvvigionamento in private‑label di OsseoSculpt™, un biologico di nuova generazione progettato per integrare il sistema SINAPTIC® Foot & Ankle Osteotomy Wedge System già autorizzato dalla FDA con la procedura 510(k). Le valutazioni cliniche da parte di diversi chirurghi progettisti sono state completate e SINTX ha registrato i suoi primi ricavi commerciali nel terzo trimestre 2025 dagli early order di OsseoSculpt.
OsseoSculpt presenta una s superficie HCA nancristallina con un'architettura di pori biomimetici per migliorare l'osteoconduttività. L'azienda ha avviato un rilascio limitato a siti selezionati di progettazione e early adopter, con un roll-out statunitense più ampio in linea con la disponibilità della wedge e i cicli di formazione dei chirurghi fino al Q4 2025–Q1 2026.
SINTX Technologies (NASDAQ: SINT) anunció el lanzamiento y el suministro con marca privada de OsseoSculpt™, un biológico de próxima generación diseñado para complementar el sistema SINAPTIC® Foot & Ankle Osteotomy Wedge System con aprobación 510(k) de la FDA. Evaluaciones clínicas realizadas por varios cirujanos diseñadores se completaron y SINTX registró su primer ingreso comercial en el 3er trimestre de 2025 a partir de los primeros pedidos de OsseoSculpt.
OsseoSculpt cuenta con una superficie HCA nanocristalina con una arquitectura de poros biomimética para mejorar la osteoconducción. La empresa lanzó una versión limitada a sitios de diseño seleccionados y a adopción temprana, con un despliegue más amplio en EE. UU. alineado con la disponibilidad de la cuña y los ciclos de entrenamiento de los cirujanos hasta el Q4 2025–Q1 2026.
SINTX Technologies (NASDAQ: SINT)은/는 OsseoSculpt™의 출시와 PRIVATE-LABEL 공급을 발표했으며, 이는 회사의 FDA 510(k) 승인된 SINAPTIC® Foot & Ankle Osteotomy Wedge System를 보완하기 위한 차세대 생물학적 재료입니다. 여러 설계 외과의가 수행한 임상 평가가 완료되었고, SINTX는 2025년 3분기에 첫 상업적 매출을 OsseoSculpt 초기 주문으로 기록했습니다.
OsseoSculpt는 나노크리스탈린 HCA 표면과 생체모방 다공 구조를 갖추고 있어 골유도(conduction)를 향상시킵니다. 회사는 설계 및 조기 도입 사이트에 한정 출시를 시작했으며, 벽기(쐐기) 가용성과 외과의 교육 주기에 맞춰 2025년 4분기–2026년 1분기 사이 미국 내 보다 광범위한 롤아웃을 진행할 예정입니다.
SINTX Technologies (NASDAQ: SINT) a annoncé le lancement et l'approvisionnement en marque blanche de OsseoSculpt™, un biologiques de nouvelle génération conçu pour compléter le système SINAPTIC® Foot & Ankle Osteotomy Wedge System validé par la FDA via la procédure 510(k). Les évaluations cliniques par plusieurs chirurgiens concepteurs ont été réalisées et SINTX a enregistré ses prements revenus commerciaux au T3 2025 à partir des premières commandes d'OsseoSculpt.
OsseoSculpt présente une surface HCA nanocrystaline avec une architecture poreuse biomimétique pour améliorer l’ostéoconduction. L’entreprise a lancé une édition limitée à des sites de conception et d’adoption précoce, avec un déploiement plus large aux États-Unis aligné sur la disponibilité des wedges et les cycles de formation des chirurgiens jusqu’au Q4 2025–Q1 2026.
SINTX Technologies (NASDAQ: SINT) kündigte die Einführung und private‑Label-Beschaffung von OsseoSculpt™ an, einem Biologikum der nächsten Generation, das die von der FDA 510(k) freigegebene SINAPTIC® Foot & Ankle Osteotomy Wedge System ergänzen soll. Klinische Bewertungen durch mehrere Design-Chirurgen wurden abgeschlossen, und SINTX verzeichnete seine ersten kommerziellen Umsätze im Q3 2025 aus den ersten OsseoSculpt-Bestellungen.
OsseoSculpt verfügt über eine nanokristalline HCA‑Oberfläche mit biomimetischer Porenarchitektur zur Verbesserung der Osteokonduktion. Das Unternehmen startete eine Limited‑Release für ausgewählte Design‑ und Early‑Adopter‑Standorte, mit einem breiteren US‑Rollout, der sich an die Verfügbarkeit der Wedge-Komponenten und an Schulungszyklen der Chirurgen bis zum Q4 2025–Q1 2026 orientiert.
شركة SINTX تكنولوجيز (ناسداك: SINT) أعلنت عن إطلاق وتوريد OsseoSculpt™ بعلامة خاصة، وهوBiologic من الجيل التالي مصمم ليُكمل SINAPTIC® Foot & Ankle Osteotomy Wedge System المعتمد من إدارة الغذاء والدواء الأمريكية عبر 510(k). تم الانتهاء من التقييمات السريرية من قبل عدة جراحين مصممين، وسجلت SINTX أول إيرادات تجارية في الربع الثالث من 2025 من طلبات OsseoSculpt المبكرة.
تتميّز OsseoSculpt بواجهة سطح HCA نانوكريستالينيّة مع بنية مسامية مذهلة تحاكي الطبيعة لتعزيز التوصيل العظمي. أطلقت الشركة إصدارًا محدودًا لمواقع التصميم والتبني المبكر، مع طرح أوسع في الولايات المتحدة يتوافق مع توافر الأسطوانة (الويج) وجولات تدريب الجراحين حتى الربع الرابع 2025–الربع الأول 2026.
- First commercial revenue from OsseoSculpt recorded in Q3 2025
- FDA 510(k) cleared SINAPTIC wedge system already in market
- Product feature: nanocrystalline HCA surface with biomimetic pore architecture
- Initial distribution is a limited release to select design and early‑adopter sites
- Broader U.S. rollout dependent on wedge availability and surgeon training through Q4 2025–Q1 2026
Insights
New biologic launch plus early revenue suggests tangible commercialization momentum for the SINAPTIC wedge platform.
The company pairs its FDA 510(K) cleared SINAPTIC wedge with a private‑label biologic, OsseoSculpt, creating a bundled procedural solution that may simplify surgeon workflow and procurement. Multiple design surgeons completed clinical evaluations and the company recorded initial commercial revenue in
Key dependencies include scale of supply, training cadence, and the planned wider rollout tied to wedge availability and surgeon education through
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
FAQ
What is OsseoSculpt from SINTX (SINT) and how does it relate to SINAPTIC wedges?
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