Milestone enables immediate production of SiN/PEEK custom devices
SALT LAKE CITY, Utah, Dec. 01, 2025 (GLOBE NEWSWIRE) -- SINTX Technologies, Inc. (NASDAQ: SINT) (SINTX or the Company), an advanced ceramics and biomaterials company, today announced that it has signed a supply agreement with Evonik Corporation (EVONIK), a global leader in highperformance polymers, to manufacture the Companys proprietary silicon nitridePEEK compound (SiN/PEEK) (U.S. Patent No. 10,806,831) engineered for AIassisted additive manufacturing of patientspecific implants that will be produced using equipment already in place at SINTXs U.S.-based production facility.
Under the agreement, EVONIK will produce SiN/PEEK compound leveraging its commercial-scale capability to SINTXs specifications, enabling the Company to immediately begin manufacturing AIdesigned, 3Dprinted, patientspecific implants. SINTX has already received physician requests to provide humanitarianuse vertebral body replacement (VBR) implants for orthopedic and neurosurgical oncology patients following tumor resections in the spine. In addition, the Company intends to use the SiN/PEEK compound to support regulatory clearances of patient matched and traditional subtractive manufactured implantable devices.
Eric K. Olson, Chairman, President & CEO of SINTX, said, This agreement with EVONIK is another pivotal moment for SINTX and for the field of patientspecific implants. By combining EVONIKs industrialscale PEEK polymer manufacturing expertise with SINTXs silicon nitride biomaterial manufacturing capabilities, we can deliver nextgeneration implants that address critical needs in trauma, spine, oncology, and beyond. We believe SiN/PEEK offers compelling advantages over standard PEEK, including antipathogenic surface characteristics, osteogenic potential, and improved visualizationfeatures that matter in complex, highrisk procedures.
Marc Knebel, head of EVONIKs Medical Devices & Systems market segment, said, We are excited to support SINTX in bringing a highperformance SiN/PEEK composite filament to market for additive and subtractive manufacturing of regulated medical devices. This is another example of enabling innovation that EVONIK has delivered to improve medical outcomes. Our collaboration is designed to provide consistent quality, supply reliability, and scalabilityfoundational elements for our continued broader collaboration and data generation to support future medical device market work.
SINTXs silicon nitride has been studied for its antipathogenic behavior and osteogenic properties, while PEEK composites are valued for radiolucency and mechanical tunability. The SiN/PEEK combination aims to deliver:
With todays supply agreement, the parties envision making SiN/PEEK compound available to other qualified manufacturers for complex implant indications where silicon nitrides attributes may add clinical and economic value.
SINTXs nearterm humanitarian efforts are focused on trauma and oncology indications for posttumor resection cases, where surgeons face challenging anatomy and infection risk, and where patientspecific designs may facilitate better fit, fixation and overall clinical outcomes, stated Dr. Ryan Bock, SINTX Chief Technology Officer. Were responding to realworld surgeon requests in oncologyrelated care. Our immediate focus is on humanitarianuse cases while we build the quality systems, regulatory files, and production capacity to expand into additional indications through appropriate FDA pathways.
For more information on SINTX Technologies or its materials platform, visit www.sintx.com.
EVONIK Business High Performance Polymers, including its affiliate Evonik Operations GmbH, is one of the world leaders in specialty chemicals companies and active in over 100 countries. EVONIK has more than 30 major production sites in the U.S. and Canada, as well as numerous offices, labs, warehouses and distribution centers, employing about 5,000 people in North America. In 2024, the North America region generated 24% of global sales, amounting to 3.7 billion. EVONIK goes far beyond chemistry to create innovative, profitable, and sustainable solutions for customers.
Headquartered in Salt Lake City, Utah, SINTX Technologies, Inc. (NASDAQ: SINT) is an advanced ceramics company that develops, manufactures, and commercializes silicon nitride biomaterials, composites, devices, and related technologies for medical and other high-value applications. With thousands of medical devices implanted since 2008 and nearly two decades of peer-reviewed research, SINTX has established itself as a leader in high-performance biomaterials that enhance clinical outcomes and patient safety. Supported by a strong patent portfolio, U.S.-based manufacturing, and strategic industry partnerships, the company continues to expand its technology platform through innovation and market diversification, including the recently FDA-cleared SINAPTIC® Foot & Ankle Implant System for reconstructive surgery.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: the Companys ability to manufacture SiN/PEEK composite materials and patient-specific implants; the timing, scope, and expected benefits of the Companys supply agreement with Evonik; anticipated product performance attributes of the SiN/PEEK compound and related additive-manufacturing workflows; the Companys plans to pursue regulatory clearances for patient-specific and traditionally manufactured implantable devices; expectations regarding humanitarian-use vertebral body replacement implants; the potential availability of SiN/PEEK materials to additional manufacturers; the projected clinical, operational, or economic advantages of SiN/PEEK compared with standard PEEK; and the Companys expectations concerning quality-system development, production scale-up, broader market opportunities, and future indications. Forward-looking statements are based on current assumptions and are often identified by words such as may, will, could, should, expect, anticipate, intend, plan, believe, estimate, project, target, aim, and similar expressions. These statements involve risks and uncertainties that could cause actual results to differ materially from those projected, including risks related to manufacturing readiness, quality-system development, supply-chain reliability, EVONIKs third-party performance, regulatory requirements and the timing or outcome of FDA submissions, clinical adoption of patient-specific implants, surgeon training and utilization, competitive technologies, intellectual-property protection, market acceptance, pricing and reimbursement dynamics, and macroeconomic or industry-specific conditions. Statements regarding potential antipathogenic or osteogenic attributes of silicon nitride refer to general material-level research and do not imply regulatory clearance or clinical benefit for any specific device or indication. Additional risks and uncertainties are described in SINTXs filings with the 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.
