SINTX Submits Master Access File to FDA for Silicon Nitride-Polymer Composite Material |
Wednesday, 03. March 2021 15:00 |
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SALT LAKE CITY, UT, March 03, 2021 (GLOBE NEWSWIRE) -- SINTX Technologies, Inc. (NASDAQ: SINT) (“SINTX” or the “Company”) (www.sintx.com), an original equipment manufacturer (OEM) of silicon nitride ceramic, announced its FDA submission of a Master Access File (MAF) for a new Silicon Nitride – Polyetheretherketone (PEEK) composite material (SN-PEEK). The MAF can be referenced by SINTX customers toward developing new medical implant designs and products. SN-PEEK is an innovative material platform that combines the best of two materials that are used to make spinal fusion implants, i.e., silicon nitride and PEEK. Clinical and basic science data demonstrate that SINTX’s silicon nitride facilitates faster bone healing, improves radiographic imaging, avoids metal ion release in the body, and has broad-spectrum resistance to infection. PEEK is an accepted standard polymeric biomaterial that is used worldwide, especially by spine surgeons. PEEK’s advantages include its low cost, favorable material modulus, ease of manufacturing, established clinical record, and a familiar fit and feel. The most immediate biomedical applications of this product are expected to be in the spine and craniomaxillofacial medical device markets, with other applications to follow. SINTX said the knowledge and learning gained from this project has had many collateral benefits, such as identifying simpler and lower cost options for its materials, learning how powdered silicon nitride interacts with cells versus the as-fired material, and understanding in greater detail the surface chemistry of silicon nitride to develop newer technologies for the future. SINTX believes the SN-PEEK product is the result of the company’s commitment to innovation and looks forward to expanding its customer base with this new and exciting platform. About SINTX Technologies, Inc. For more information on SINTX Technologies or its silicon nitride material platform, please visit www.sintx.com. Forward-Looking Statements Business Inquiries for SINTX: Media Inquiries for SINTX: |
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