Company: SINT
Filing Date: 2025-08-14
Form Type: 10-Q
Source: 0001641172-25-024040
Chunk: 34

Company: Sintx Technologies, Inc.
Filing Date: 2025-08-14
Form: 10-Q
Item: Item 2
Chunk 34
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 to the U.S. Food and Drug Administration
(FDA) for its novel silicon nitride osteotomy wedges, marking its official entry into the foot and ankle reconstruction market. These
next-generation implants blend cutting-edge biomaterials science with surgical precision and are designed to elevate standards in orthopedic
procedures. SINTX silicon nitride products can be polished to a smooth and wear-resistant surface for articulating applications, such
as bearings for hip and knee replacements.

We believe that silicon nitride has a superb combination of properties that make it suited for long-term human implantation. Other biomaterials
are based on bone grafts, metal alloys, and polymers- all of which have well-known practical limitations and disadvantages. In contrast,
silicon nitride has a legacy of success in the most demanding and extreme industrial environments. Bacterial infection of any biomaterial
implants is always a concern. SINTX silicon nitride has been shown to be resistant to bacterial colonization and biofilm formation, making
it antibacterial. As a human implant material, silicon nitride offers bone ingrowth, resistance to bacterial and viral infection, ease
of diagnostic imaging, resistance to corrosion, and superior strength and fracture resistance, all of which claims are validated in our
large and growing inventory of peer-reviewed, published literature reports. We believe that our versatile silicon nitride manufacturing
expertise positions us favorably to introduce new and innovative devices in the medical and non-medical fields.

Antipathogenic
Applications: Today, there is a global need to improve protection against pathogens in everyday life. SINTX believes that by incorporating its unique
composition of silicon nitride antipathogenic powder into products such as face masks, drapes, filters, sutures, and wound care devices,
it is possible to manufacture surfaces that inactivate pathogens, thereby limiting the spread of infection and disease. The discovery
in 2020 that SINTX silicon nitride inactivates SARS-CoV-2, the virus which causes the disease COVID-19, has opened new markets and applications
for our material. We presently manufacture advanced ceramic powders and components in our manufacturing facilities based in Salt Lake
City, Utah.

The SINTX Salt Lake City facility is registered with
the FDA, is cGMP and ANVISA RDC 665 compliant, as well as being ISO 9001:2015, ISO 13485:2016 certified, and ASD9100D certified. The Company’s