NASDAQ: SINT

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 potentially
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 AS9100D certified. The Company’s products are primarily sold in the United States.

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Our
Products

Silicon
Nitride

To
control the quality, cost and availability of our silicon nitride products and product candidates, we operate our own silicon nitride
manufacturing facility. Our 30,764 square foot corporate facility includes a 19,000 square foot FDA registered ISO 13485:2016 certified,
and AS9100D certified manufacturing space. It is equipped with state-of-the-art powder processing, spray drying, pressing and computerized
machining equipment, sintering furnaces, and other testing equipment that enables us to control the entire manufacturing process for
our silicon nitride products and product candidates. All operations, with the exception of raw material production, are performed in-house.
We purchase raw materials, consisting of silicon nitride ceramic powder and dopant chemical compounds, from several vendors which are
ISO registered and approved by us. These raw materials are characterized and tested in accordance with our specifications and then blended
to formulate our silicon nitride. We believe that there are multiple vendors that can supply these raw materials, and we continually monitor
the quality and pricing offered by our vendors to ensure high quality and cost-effective supply of these materials.

The
chemical composition of our in-house formulation of silicon nitride and our processing and manufacturing experience allows us to produce
silicon nitride in multiple distinct forms. This capability provides us with the ability to utilize our silicon nitride in a variety
of ways depending on the intended application, which, together with our silicon nitride’s key characteristics, distinguishes us
from other manufacturers of silicon nitride products.

We
currently produce silicon nitride for use in our commercial products and product candidates in the following forms:

●
Monolithic
Solid Silicon Nitride. This form of silicon nitride is a fully dense, load-bearing solid which can be used for devices that require
high strength, toughness, fracture resistance and low wear. Applications include medical devices – such as interbody spinal
fusion implants and foot and ankle wedges – and non-medical such as electrical and aerospace components.

●
Porous
Silicon Nitride. While this form of silicon nitride has a chemical composition that is identical to that of our monolithic solid
silicon nitride, this formulation has a porous structure, which is engineered to mimic cancellous bone, the spongy bone tissue that
typically makes up the interior of human bones. Our porous silicon nitride has interconnected pores similar to that of cancellous
bone ranging in size between about 90 and 600 microns. This form of silicon nitride can be used for the promotion of bone in-growth
and attachment. We believe our porous silicon nitride can act as a substitute for the orthobiologics currently used to fill interbody
devices to stimulate fusion, as a bone void filler, and as a porous scaffold for medical devices.

●
Silicon
Nitride Powder. We can produce silicon nitride powder that is osteogenic and antipathogenic. This powder can then be utilized
to produce composites or coatings.

●
Composites
of Silicon Nitride and PEEK and PEKK. We have demonstrated that it is possible to compound our silicon nitride powder and the
polymers PEEK (Polyether Ether Ketone) and PEKK
(Polyether Ketone Ketone) and that the ensuing composite material maintains the bioactive properties of silicon nitride. We have
engaged academic and commercial partners to assist us in developing this technology and have received NIH grants to assist in
advancing this work. This composite material would allow the straightforward 3D printing of complex spine and CMF devices that would
be more challenging to manufacture from silicon nitride alone.

●
Silicon
Nitride Coating. With a similar chemical composition as our other forms of silicon nitride, this form of silicon nitride can
be applied as an adherent coating to metallic substrates, including cobalt-chromium, titanium and steel alloys, polymers, and ceramics.
We believe applying an extremely thin layer of silicon nitride as a coating may provide a highly wear-resistant articulation surface,
such as on femoral heads, which may reduce problems associated with metal or polymer wear debris. We also believe that the silicon
nitride coating can be applied to devices that require firm fixation and functional connections between the device or implant and
the surrounding tissue, such as hip stems and screws. The use of silicon nitride coating may also create an antibacterial, antiviral,
and antifungal barrier between the device and the adjacent bone or tissue. We are currently evaluating several different coating
technologies.

We
believe we are the only FDA-registered and ISO 13485:2016 certified silicon nitride medical device manufacturing facility in the world,
and the only provider of structural ceramics-based medical devices used for spinal fusion applications.

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We
believe our silicon nitride is ideal as an implant material and is superior to other biomaterials currently used in the spine implant
market such as PEEK, allograft and autograft bone, metal and traditional oxide ceramics, none of which possess all of the favorable characteristics
of silicon nitride:

●
Promotes
Bone Growth. Our silicon nitride is osteointegrative through its inherent surface topography and surface chemistry. The surface
topography provides scaffolding for new bone growth. As a hydrophilic material, silicon nitride attracts protein cells and nutrients
that stimulate osteoprogenitor cells to differentiate into osteoblasts, which are needed for optimal bone growth environments. Our
silicon nitride has an inherent surface chemistry that favors bone formation and healing, much more so than PEEK and metals. These
properties were highlighted in an in vivo study, where we measured the force required to separate devices from the spine after
being implanted for three months, which indicates the quality of osteointegration. In the absence of bacteria, the force required
to separate our silicon nitride from its surrounding bone was approximately three times that of PEEK, and nearly two times that of
titanium. In the presence of bacteria, the force required to separate our silicon nitride from its surrounding bone was over five
times that of titanium, while there was effectively no separation force required for PEEK, indicating essentially no osteointegration
in a septic environment.

●
Antibacterial.
We have demonstrated in in vitro and in vivo studies that silicon nitride has inherent surface antibacterial properties,
which reduce the risk of bacterial infection and biofilm in and around a silicon nitride device. PEEK, traditional ceramics, metals
and bone do not have this bacterial resistance. These properties were highlighted in an in vitro study (Acta Biomater. 2012
Dec;8(12):4447-54. Doi: 10.1016/j.actbio.2012.07.038. Epub 2012 Jul 31.), where live bacteria counts were between 8 and 30 times
lower on our silicon nitride than PEEK and up to 8 times lower on our silicon nitride than titanium. In addition to improving patient
outcomes, we believe the antibacterial properties of our silicon nitride should make it an attractive biomaterial to hospitals and
surgeons who are not reimbursed by third-party payers for the treatment of acute, implant-related infections. Additionally, silicon
nitride is synthetic and, therefore, there is a lower risk of disease transmission through cross-contamination or of an adverse auto-immune
response, sometimes associated with the use of allograft bone.

●
Antiviral:
Solid-surface inactivation of microbial pathogens has ancient roots; the Smith Papyrus (2600~2200 B.C.) described the use of
copper surfaces to sterilize chest wounds and drinking water. Today, brass and bronze on doorknobs help prevent microbial spread
in hospitals, and metal particles and surface coatings of selected metals are used in hygiene-sensitive environments, both as inactivators
and adjuvants in inducing cellular immunity. Cellular toxicity limits these approaches because while the reactive oxygen radicals
generated at metal surfaces efficiently kill bacteria and viruses, they also damage cells by oxidizing their proteins and lipids.
Recent data have shown that silicon nitride surfaces are effective against several types of viruses. With surface-contact transmission
of viral pathogens, particularly influenza, and the increasing use of consumer touchscreens in various retail industries, we believe
that our material may have value to OEM partners focused on consumer glass-based surface coatings and treatments. We have filed a
U.S. patent application on this effect.

●
Antifungal:
We have conducted preliminary studies which suggest that our silicon nitride may be effective against fungal microbes. Plant-based
viruses, bacteria, and fungi affect some 15% of the world’s edible crops, or about 1 billion metric tons of edible produce
annually, with an economic impact in the US and Canada alone estimated to be between $1.5 to $5.0 billion per year. The mycotoxins
produced by these plant fungi have an overall negative impact on human health and longevity. The inorganic nature of silicon nitride
may prove to be more beneficial than the use of petrochemical or organometallic fungicides which are known to have residual effects
in soil, on plants, and in fruit. In 2025, we received the issuance of International Patent No. 7635292, which covers novel agricultural
uses of our silicon nitride, particularly in plant protection and antimicrobial treatment. This patent, combined with issued U.S.
Patent No. 11,591,217, creates a family of patents focused on addressing the antimicrobial agribiotech market.

●
Imaging
Compatible. Our silicon nitride interbody spinal fusion devices are semi-radiolucent, clearly visible in X-rays, and produce
no distortion under MRI and no scattering under CT. These characteristics enable an exact view of the device for precise intra-operative
placement and post-operative bone fusion assessment in spinal fusion procedures. These qualities provide surgeons with greater certainty
of outcomes with our silicon nitride devices than with other biomaterials, such as PEEK and metals.

●
Hard,
Strong and Resistant to Fracture. Our silicon nitride is hard, strong and possesses superior resistance to fracture over traditional
ceramics and greater strength than polymers currently on the market. For example, our silicon nitride’s flexural strength is
more than five times that of PEEK and our silicon nitride’s compressive strength is over twenty times that of PEEK. Unlike
PEEK interbody spinal fusion devices, we believe our silicon nitride interbody spinal fusion devices can withstand the forces exerted
during implantation and daily activities over the long term.

●
Resistant
to Wear. We believe our silicon nitride joint implant product candidates could have higher resistance to wear than metal-on-cross-linked
polyethylene and traditional oxide ceramic-on-cross-linked polyethylene joint implants, the two most commonly used total hip replacement
implants. Wear debris associated with metal implants increases the risk of metal sensitivity and metallosis. It is a primary reason
for early failures of metal and polymer articulating joint components.

●
Non-Corrosive.
Our silicon nitride does not have the drawbacks associated with the corrosive nature of metal within the body, including metal
sensitivity and metallosis, nor does it result in the release of metal ions into the body. As a result, we believe our silicon nitride
products will have lower revision rates and fewer complications than comparable metal and traditional oxide ceramic products.

We
are leveraging our proprietary Silicon Nitride (SiN) and Polyether Ether Ketone (PEEK) formulation to advance AI designed 3D printing
capabilities for Custom and Patient-Specific medical implants. This innovative material combination integrates the superior biocompatibility,
osteointegration, and antimicrobial properties of silicon nitride with the strength, durability, and radiolucency of PEEK, resulting
in next-generation implants that enhance mechanical performance, reduce infection risks, and improve imaging compatibility.

The
demand for personalized implants is growing as surgeons seek optimized solutions tailored to individual patient anatomy, improving surgical
outcomes and reducing complications. While demand for patient-matched implants continues to increase, regulatory pathways vary depending
on device classification and intended use. Many patient-specific devices are reviewed under traditional 510(k), De Novo, or PMA pathways,
depending on risk classification. Although FDA provides guidance regarding additive manufacturing and patient-matched devices, regulatory
requirements remain substantial and may require extensive validation and, in some cases, clinical data. The Custom Device Exemption is
available only in limited circumstances and is not applicable to most commercially marketed patient-specific implants.

The
benefits of AI designed 3D-printed SiN/PEEK implants extend across the entire healthcare ecosystem. For hospitals, these implants may
reduce hospital stays and operative times related to traditional custom implant manufacturing. It may also lower the costs associated
with revision surgeries and improve patient satisfaction scores.

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Physicians
may benefit from implants designed to match patient anatomy and incorporate radiolucent materials, which can assist with intraoperative
visualization using standard imaging modalities. Silicon nitride has been studied for its material properties, including surface characteristics
that may inhibit bacterial adhesion under laboratory conditions. However, clinical outcomes, recovery times, and complication rates depend
on numerous factors, including patient condition and surgical technique, and the Company makes no guarantee of improved outcomes relative
to other available materials.

With
our unique expertise and proprietary formulation and advanced manufacturing techniques of SiN/PEEK, we are well-positioned to capitalize
on this rapidly expanding market, providing innovative solutions that meet the needs of healthcare providers and patients alike.

We
and independent third parties have conducted biocompatibility, biomechanical, in vitro, and in vivo testing of our silicon nitride composition
to support regulatory submissions for certain of our devices. Additional testing has been performed on specific products and product
candidates. Findings from laboratory, animal, and limited human clinical investigations have been described in peer-reviewed publications
and scientific presentations. The results of this testing have been published in over 130 peer reviewed publications and presentations
that include basic science studies, small- and large-animal data, and human clinical studies. While these studies contribute to the scientific
understanding of silicon nitride as a biomaterial, regulatory clearance and market adoption depend on multiple factors, including demonstration
of safety and performance for specific indications and physician acceptance.

Our
Competitive Strengths

We
believe we can use our silicon nitride technology platform to become a leading advanced ceramic company and have the following principal
competitive strengths:

●
Sole
Provider of Silicon Nitride Medical Devices. We believe we are the only company that designs, develops, manufactures and sells
medical grade silicon nitride-based products. Due to its key characteristics, we believe our silicon nitride enables us to offer
new and transformative products across multiple medical specialties. In addition, with the FDA clearance of our silicon nitride Valeo
products and SiNAPTIC® Foot & Ankle Osteotomy Wedge System, we are the only company to develop and manufacture a ceramic for use
in FDA cleared spinal fusion medical devices, and FDA cleared osteotomy wedges, in the United States.

●
In-House
Manufacturing Capabilities. We operate a 19,000 square foot manufacturing facility located at our corporate headquarters in Salt
Lake City, Utah. This operation complies with the FDA’s quality system regulation, or QSR, and is certified under the International
Organization for Standardization’s, or ISO, standard 13485:2016 for medical devices. This facility allows us to design and
produce silicon nitride products while controlling the entire manufacturing process from raw material to finished components.

●
Extensive
Network of Scientific Collaborators. We have developed strong, multi-year, collaborative relationships with surgeons who have
used our products. These surgeons have supported us in collecting clinical data on silicon nitride and on reporting the successful
patient outcomes they have observed. We also have long standing relations with university laboratories in the U.S. and participate
in a European consortium on silicon nitride.

●
Highly
Experienced Management and Technical Advisory Team. Members of our management team have extensive experience in silicon nitride,
ceramics, research and development, manufacturing and operations, product development, and launching new silicon nitride products
into multiple industries. We also collaborate with a network of leading technical advisors in the design, development and use of
our silicon nitride products and product candidates.

Our
Strategy

Our
goal is to become a leading advanced ceramics company. Key elements of our strategy to achieve this goal are the following:

●
Develop
new silicon nitride manufacturing technologies. Our current manufacturing process has allowed us to successfully produce spinal
implants for over 10 years. We have made advancements in our processes – including the purchase of new manufacturing equipment
– which we have leveraged to develop new porous and textured implants, and new composite products of silicon nitride with rigid
polymers and fabrics. We have received three NIH grants to develop 3D printed silicon nitride / polymer implantable medical devices.

●
Apply
our silicon nitride technology platform to new medical opportunities. We believe our biomaterial expertise, flexible manufacturing
process, and strong intellectual property will allow us to transition currently available medical device products made of inferior
biomaterials and manufacture them using silicon nitride and our technology platform to improve their characteristics. We are seeking
partnerships to utilize our capabilities and manufacture products for medical OEM and private label partnerships. We see specific
opportunities in markets such as foot and ankle, dental, maxillofacial, and arthroplasty.

●
Develop
new products with antipathogenic properties, including inactivation of the SARS-CoV-2 virus, utilizing our silicon nitride technology.
We have conducted tests which have identified and verified the antipathogenic properties of our silicon nitride powders, fully
dense components, and silicon nitride-containing composites. Our research has explored the fundamental mechanisms responsible for
these antipathogenic properties with the objective of developing commercial products and revenue from them. We have several partnerships
exploring opportunities in face masks, filters, wound care, and coatings. In 2025, the United States Patent and Trademark Office
(“USPTO”) granted our patent application titled, “Antipathogenic Fibrous Materials.” This patent secures
broad protection for our proprietary silicon nitride-based antipathogen platform. Additionally, in 2025, the USPTO issued a Notice
of Allowance for our patent application containing method claims covering our antipathogenic fabric technology.

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Market
Opportunity

Biomedical

We
believe our silicon nitride biomaterial technology platform provides us with numerous competitive advantages in the biomaterials market.
We manufacture interbody spinal fusion devices for CTL Amedica and have approximately 2 years remaining of a 10-year exclusive right
to continue to manufacture them for CTL Amedica. We are developing products on our own behalf and for third party manufacturers –
including CTL – for use as components in spine, total hip and knee joint replacements, as well as dental, foot & ankle, and
maxillofacial applications. We believe we can also utilize our silicon nitride technology platform to develop future products in additional
medical markets.

We
believe that the main drivers for growth within the medical device markets are the following:

●
Introduction
of New Technologies. Better performing and longer-lasting biomaterials, improved diagnostics, and advances in surgical procedures
allow for surgical intervention earlier in the continuum of care and better outcomes for patients. We believe surgical options using
better performing and longer-lasting biomaterials will gain acceptance among surgeons and patients and drive accelerated growth and
increase the size of the spinal fusion and joint replacement markets. We are leveraging proprietary Silicon Nitride (SiN) and Polyether
Ether Ketone (PEEK) formulation to advance AI designed 3D printing capabilities for Custom and Patient-Specific medical implants.
This innovative material combination integrates the superior biocompatibility, osteointegration, and antimicrobial properties of
silicon nitride with the strength, durability, and radiolucency of PEEK, which we believe will lead to next-generation implants that
may enhance mechanical performance, reduce infection risks, and improve imaging compatibility.

●
Favorable
and Changing Demographics. With the growing number of elderly people, age-related ailments are expected to rise sharply, which
we believe will increase the demand and need for biomaterials and devices with improved performance capabilities. Also, middle-aged
and older patients increasingly expect to enjoy active lifestyles and consequently demand effective treatments for painful spine
and joint conditions, including better performing and longer-lasting interbody spinal fusion devices and joint replacements.

●
Market
Expansion into New Geographic Areas. We anticipate that demand for biomaterials and the associated medical devices will increase
as the applications in which biomaterials are used are introduced to and become more widely accepted in underserved countries, such
as South America and Asia.

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Intellectual
Property

We rely on a combination of patents, trademarks,
trade secrets, nondisclosure agreements, proprietary information ownership agreements and other intellectual property measures to protect
our intellectual property rights. We believe that to have a competitive advantage, we must continue to develop and maintain the proprietary
aspects of our technologies.

We have twenty-one issued U.S. patents, ten issued
foreign patents, three pending U.S. non-provisional patent applications, twenty-three pending foreign patent applications and no pending
PCT patent applications. Our first issued patent expired in 2016, with the last of these patents expiring in 2042.

We have been issued two U.S. patents directed
to articulating implants using our high-strength, high toughness doped silicon nitride solid ceramic. These issued patents, which include
U.S. Patent Nos. 9,051,639 and US 9,517,136 expire in 2032 and 2034, respectively.

We have been issued U.S. Patent No. 10,806,831
and U.S. Patent No. 11,738,122 both directed to antipathogenic implants which expire in 2037 and 2039, respectively.

We also have been issued U.S. Patent No. 11,192,787;
U.S. Patent No. 11,591,217; and U.S. Patent No. 12,017,912 directed to antipathogenic devices which all expire in 2038.

We have been issued U.S. Patent No. 9,353,010
directed to alumina-zirconia ceramic implants which expires in 2034.

We have been issued U.S. Patent No. 9,353,012
directed to charge-compensating dopant stabilized alumina-zirconia ceramic implants which expires in 2034.

We have been issued U.S. Patent No. 9,399,309
directed to directed to methods for threading a ceramic material which expires in 2034.

We have been issued U.S. Patent No. 9,925,295
directed to improved ceramic and/or glass materials which expires in 2032.

We have been issued U.S. Patent No. 11,672,252
directed to antifungal composites which expires in 2040.

We have been issued U.S. Patent No. 11,844,344
directed to rapid inactivation of SARS-CoV-2 which expires in 2039.

We have been issued U.S. Patent No. 11,850,214
directed to antiviral compositions and devices which expires in 2038.

We have been issued U.S. Patent No. 11,857,001
directed to antipathogenic face mask which expires in 2038.

We have been issued U.S. Patent No. 12,070,391
directed to improving wear performance of ceramic-polyethylene or ceramic-ceramic articulation couples utilized in orthopedic joint prostheses
which expires in 2038.

We have been issued U.S. Patent No. 12,239,761
directed to silicon nitride laser cladding which expires in 2042.

We have been issued U.S. Patent No. 12,162,807
directed to surface functionalization of zirconia-toughened alumina with silicon nitride which expires in 2040.

We have been issued U.S. Patent No. 12,433,294
directed to Directed to methods for treating or preventing a fungal pathogen in a plant which expires in 2039.

We have been issued U.S. Patent No. 12,433,356
directed to a fibrous material with embedded silicon nitride powder which expires in 2039.

We have been issued U.S. Patent No. 12,520,890
directed to methods of embedding silicon nitride powder in a fibrous material which expires in 2039.

With respect to PCT patent application serial
no. PCT/US2018/014781 directed to antibacterial biomedical implants, we have a pending patent application in Europe to seek potential
patent protection for our proprietary technologies in that country. In addition, we have a separate pending continuation patent application
in the United States. We also have issued patents in Australia, Canada, Japan, United States, and South Korea.

With respect to PCT patent application serial
no. PCT/US2019/026789 directed to methods for improving the wear performance of ceramic-polyethylene or ceramic-ceramic articulation couples
utilized in orthopedic joint prostheses, we have an issued patent in Japan and a separate issued patent in the United States.

With respect to PCT application serial no. PCT/US2019/048072
directed to antipathogenic devices and methods, we have pending national stage applications in Europe and China, to seek patent protection
for our proprietary technologies in those countries. In addition, we have two issued patents in Japan and three issued patents in the
United States for this technology.

With respect to PCT application serial no. PCT/US2020/037170
directed to methods of surface functionalization of zirconia-toughened alumina with silicon nitride, we have pending national stage application
in China to seek patent protection for our proprietary technologies in that country. In addition, we have an issued patent in Japan and
an issued patent in the United States for this technology.

With respect to PCT application serial no. PCT/US2021/014725
directed to antifungal composites and methods thereof, we have pending national stage applications in Europe, Australia, Canada, Mexico,
and South Korea to seek patent protection for our proprietary technologies in those countries. We also have a separate issued patent in
the United States for this technology.

With respect to PCT application serial no. PCT/US2021/027258
directed to antipathogenic face mask, we have pending national stage applications in Japan and Mexico to seek patent protection for our
proprietary technologies in those countries. In addition, we have an issued patent in the United States for this technology.

With respect to PCT application serial no. PCT/US2021/027263
directed to systems and methods for rapid inactivation of SARS-CoV2 by silicon nitride, copper, and aluminum nitride, we have no pending
national stage applications, although we obtained an issued U.S. patent for this technology.

With respect to PCT application serial no. PCT/US2021/038364 directed
to antipathogenic devices and methods thereof for antifungal applications, we have pending national stage applications in South Korea
and Mexico to seek patent protection for our proprietary technologies in those countries.

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With respect to PCT application serial no. PCT/US2021/028975
directed to methods for laser coating of silicon nitride on a metal substrate, we have pending national stage application in Mexico to
seek patent protection for our proprietary technologies in those countries.

With respect to PCT application serial no PCT/US2021/028641
directed to methods of silicon nitride laser cladding, we have a pending national stage application in Mexico to seek patent protection
for our proprietary technologies in that country. We also have a separate issued patent in the United States for this technology.

With respect to PCT application serial no. PCT/US2021/027270
directed to antiviral compositions and devices and methods of use thereof, we have pending national stage applications in China and Mexico
to seek patent protection for our proprietary technologies in those countries. In addition, we have a separate issued patent in the United
States for this technology.

With respect to PCT application serial no. PCT/US2021/056461
directed to systems and methods for selective laser sintering of silicon nitride and metal composites, we have a pending national stage
application in Mexico to seek patent protection for our proprietary technologies in that country.

With respect to PCT application serial no. PCT/US2021/056452
directed to systems and methods for hot-isostatic pressing to increase nitrogen content in silicon nitride, we entered the national stage
in India and Mexico to seek patent protection for our proprietary technologies in those countries.

With respect to PCT application serial no. PCT/US2021/062650
directed to nitride based antipathogenic compositions and devices and method of use thereof, we have a pending national stage application
in Mexico to seek patent protection for our proprietary technologies in that country.

With respect to PCT application serial no. PCT/US2022/023868
directed to systems and methods for physical vapor deposition silicon nitride coatings having antimicrobial and osteogenic enhancements,
we have pending national stage application in Mexico to seek patent protection for our proprietary technologies in that country.

With respect to PCT application serial no. PCT/US2022/076863
directed to methods for manufacturing silicon nitride materials, we have a pending national stage application in Europe. In addition,
we have a separate pending patent application in the United States for this technology.

In relation to the sale of our spine implant business to CTL Medical
under the Asset Purchase Agreement dated September 5, 2018, we assigned our entire right to forty-eight (48) U.S. patents, two (2) foreign
patents and three (3) pending patent applications from our patent portfolio to CTL Medical under that transaction. In addition, three
(3) U.S. patents (U.S. patent nos. 9,399,309; 9,517,136; and 9,649,197) directed to silicon nitride manufacturing processes were licensed
to CTL Medical under an irrevocable, fully paid-up, worldwide license for a ten-year term with CTL Medical also having a Right of First
Negotiation to acquire these patents if SINTX decides to later sell these IP assets to a third party.

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Our
remaining issued patents and pending applications are directed to additional aspects of our products and technologies including, among
other things:

●
designs
for intervertebral fusion devices;

●
designs
for hip implants;

●
designs
for coated, variable-density, and thin walled implants;

●
designs
for knee implants;

●
implants
with improved antibacterial characteristics;

●
implants
with improved wear performance and surface functionalization

●
antipathogenic,
antibacterial, antimicrobial, antifungal, and antiviral compositions, devices, and methods; and

●
methods
and systems for hot-isostatic pressing laser cladding, laser coating, and laser sintering of silicon nitride.

We also expect to rely on trade secrets, know-how, continuing technological
innovation and in-licensing opportunities to develop and maintain our intellectual property position. However, trade secrets are difficult
to protect. We seek to protect the trade secrets in our proprietary technology and processes, in part, by entering into confidentiality
agreements with commercial partners, collaborators, employees, consultants, scientific advisors and other contractors and into invention
assignment agreements with our employees and some of our commercial partners and consultants. These agreements are designed to protect
our proprietary information and, in the case of the invention assignment agreements, to grant us ownership of the technologies that are
developed.

Competition

The
main alternatives to our silicon nitride biomaterial include: PEEK, which is predominantly manufactured by Invibio; BIOLOX®
delta, which is a traditional oxide ceramic manufactured by CeramTec; allograft bone; metals; and coated metals.

We
believe our main competitors in the medical device market, which utilize a variety of competitive biomaterials, include: Medtronic, Inc.;
DePuy Synthes Companies, a group of Johnson & Johnson companies; Stryker Corporation; and Zimmer Biomet, Inc. Presently, these companies
buy ceramic components on an OEM basis from manufacturers such as CeramTec, Kyocera and CoorsTek, Inc., among others. We anticipate that
these and other orthopedic companies and OEMs will seek to introduce new biomaterials and products that compete with ours.

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Our
main competitors in the antipathogenic market segment include BactiGuard and MicroBan.

Competition
within our industries is primarily based on technology, innovation, product quality, and product awareness and acceptance by customers.
Our principal competitors have substantially greater financial, technical and marketing resources, as well as significantly greater manufacturing
capabilities than we do, and they may succeed in developing products that render our products and product candidates non-competitive.
Our ability to compete successfully will depend upon our ability to develop innovative products with advanced performance features.

Government
Regulation of Medical Devices

Governmental
authorities in the United States, at the federal, state and local levels, and other countries extensively regulate, among other things,
the research, development, testing, manufacture, labeling, promotion, advertising, distribution, marketing, and export and import of
products such as those we are commercializing and developing. Failure to obtain approval or clearance to market our products and products
under development and to meet the ongoing requirements of these regulatory authorities could prevent us from continuing to market or
develop our products and product candidates.

United
States

Pre-Marketing
Regulation

In
the United States, medical devices are regulated by the FDA. Unless an exemption applies, a new medical device will require either prior
510(k) clearance or approval of a premarket approval application, or PMA, or authorization through the De Novo classification process,
as applicable, before it can be marketed in the United States. The information that must be submitted to the FDA in order to obtain clearance
or approval to market a new medical device varies depending on how the medical device is classified by the FDA. Medical devices are classified
into one of three classes on the basis of the controls deemed by the FDA to be necessary to reasonably ensure their safety and effectiveness.
Class I devices, which are those that have the lowest level or risk associated with them, are subject to general controls, including
labeling, establishment registration and device listing, labeling requirements, and adherence to the Quality System Regulation (“QSR”),
which is being harmonized with ISO 13485:2016 under the FDA’s Quality Management System Regulation (“QMSR”), effective
February 2, 2026. Class II devices are subject to general controls and special controls, including performance standards. Class III devices,
which have the highest level of risk associated with them, are subject to most of the previously identified requirements as well as to
premarket approval. Most Class I devices and some Class II devices are exempt from the 510(k) requirements, although manufacturers of
these devices are still subject to registration, listing, labeling and applicable quality system requirements.

A
510(k) premarket notification must demonstrate that the device in question is substantially equivalent to another legally marketed device,
or predicate device, that did not require premarket approval. In evaluating the 510(k), the FDA will determine whether the device has
the same intended use as the predicate device, and (a) has the same technological characteristics as the predicate device, or (b) has
different technological characteristics, and (i) the data supporting the substantial equivalence contains information, including appropriate
clinical or scientific data, if deemed necessary by the FDA, that demonstrates that the device is as safe and as effective as a legally
marketed device, and (ii) does not raise different questions of safety and effectiveness than the predicate device. While many 510(k)
submissions do not require clinical data, FDA may require clinical or other additional data depending on the nature of the device, its
technological characteristics, and associated risks. The FDA’s review timelines are governed by performance goals established under
the Medical Device User Fee Amendments (“MDUFA”), which include target timeframes for substantive interaction and decision-making,
but it may take longer based on requests for additional information. In addition, requests for additional data, including clinical data,
will increase the time necessary to review the notice. If the FDA does not agree that the new device is substantially equivalent to the
predicate device, the new device will be classified in Class III, and the manufacturer must submit a PMA or pursue the De Novo classification
pathway, which provides a process for certain novel low- to moderate-risk devices for which no legally marketed predicate device exists.
Modifications to a 510(k)-cleared medical device may require the submission of another 510(k) or a PMA if the changes could significantly
affect the safety or effectiveness or constitute a major change in the intended use of the device.

Modifications
to a 510(k)-cleared device may require submission of a new 510(k); however, certain modifications may be eligible for review under FDA’s
Special 510(k) Program. If a device modification requires the submission of a 510(k), but the modification does not affect the intended
use of the device or alter the fundamental scientific technology of the device, then summary information that results from the design
control process associated with the cleared device can serve as the basis for clearing the application. Under the Special 510(k) Program,
a manufacturer may rely on design control activities and risk analysis to support certain modifications, provided eligibility criteria
are met; FDA may nevertheless request additional supporting information as needed. When the modification involves a change in material,
the nature of the “new” material will determine whether a traditional or Special 510(k) is necessary. For example, in its
Device Advice on How to Prepare a Special 510(k), the FDA uses the example of a change in a material in a finger joint prosthesis from
a known metal alloy to a ceramic that has not been used in a legally marketed predicate device as a type of change that should not be
submitted as a Special 510(k). However, if the “new” material is a type that has been used in other legally marketed devices
within the same classification for the same intended use, a Special 510(k) is appropriate. The FDA gives as an example a manufacturer
of a hip implant who changes from one alloy to another that has been used in another legally marketed predicate. Review timelines for
Special 510(k)s are subject to MDUFA performance goals and may vary depending on the complexity of the submission.

14

The
PMA process is more complex, costly and time consuming than the 510(k) clearance procedure. A PMA must be supported by extensive data
including, but not limited to, technical, preclinical, clinical, manufacturing, control and labeling information to demonstrate to the
FDA’s satisfaction the safety and effectiveness of the device for its intended use. After a PMA is submitted, the FDA has 45 days
to determine whether it is sufficiently complete to permit a substantive review. If the PMA is complete, the FDA will file the PMA. The
FDA is subject to performance goal review times for PMAs under MDUFA, which establish target timeframes for review and decision-making,
but if it has questions, it will likely issue a first major deficiency letter within 150 days of filing. It may also refer the PMA to
an FDA advisory panel for additional review and will conduct a preapproval inspection of the manufacturing facility to ensure compliance
with the applicable quality system regulations, including the QMSR once effective, either of which could extend the 180-day response
target. A PMA can take several years to complete and there is no assurance that any submitted PMA will ever be approved. Even when approved,
the FDA may limit the indication for which the medical device may be marketed or to whom it may be sold. In addition, the FDA may request
additional information or request the performance of additional clinical trials before it will reconsider the approval of the PMA or
as a condition of approval, in which case the trials must be completed after the PMA is approved. Changes to the device, including changes
to its manufacturing process, may require the approval of a supplemental PMA.

If
a medical device is determined to present a “significant risk,” the manufacturer may not begin a clinical trial until it
submits an investigational device exemption, or IDE, to the FDA and obtains approval of the IDE from the FDA. The IDE must be supported
by appropriate data, such as animal and laboratory testing results and include a proposed clinical protocol. These clinical trials are
also subject to the review, approval and oversight of an institutional review board, or IRB, which is an independent and multi-disciplinary
committee of volunteers who review and approve research proposals, and the reporting of adverse events and experiences, at each institution
at which the clinical trial will be performed. The clinical trials must be conducted in accordance with applicable regulations, including
but not limited to the FDA’s IDE regulations and current good clinical practices. A clinical trial may be suspended by the FDA,
the IRB or the sponsor at any time for various reasons, including a belief that the risks to the study participants outweigh the benefits
of participation in the trial. Even if a clinical trial is completed, the results may not demonstrate the safety and effectiveness of
a device or may be equivocal or otherwise not be sufficient to obtain approval.

Post-Marketing
Regulation

After
a device is placed on the market, numerous regulatory requirements apply. These include:

●
compliance
with the Quality System Regulation and, beginning February 2, 2026, the Quality Management System Regulation (QMSR), which require
manufacturers to follow stringent design, testing, testing, control, documentation, record maintenance, including maintenance of complaint
and related investigation files, and other quality assurance controls during the manufacturing process;

●
labeling
regulations, which prohibit the promotion of products for uncleared or unapproved or “off-label” uses and impose other
restrictions on labeling; and

●
medical
device reporting obligations, which require that manufacturers investigate and report to the FDA adverse events, including deaths,
or serious injuries that may have been or were caused by a medical device and malfunctions in the device that would likely cause
or contribute to a death or serious injury if it were to occur.

15

Failure
to comply with applicable regulatory requirements can result in enforcement action by the FDA, which may include any of the following
sanctions:

●
warning
letters;

●
fines,
injunctions, and civil penalties;

●
recall
or seizure of our products;

●
operating
restrictions, partial suspension or total shutdown of production;

●
refusal
to grant 510(k) clearance or PMA approvals of new products;

●
withdrawal
of 510(k) clearance or PMA approvals; and

●
criminal
prosecution.

To
ensure compliance with regulatory requirements, medical device manufacturers are subject to market surveillance and periodic, pre-scheduled
and unannounced inspections by the FDA, and these inspections may include the manufacturing facilities of our subcontractors.

International
Regulation

Sales
of our medical devices outside the United States are subject to the regulatory requirements of each jurisdiction in which the products
are marketed. These requirements vary by country and may require additional testing, clinical evidence, quality system documentation,
product registration, labeling modifications, and governmental approvals prior to commercialization. Regulatory approval timelines outside
the United States may differ from those of the FDA and may be longer or more burdensome.

European
Union

In
the European Union (“EU”), medical devices are regulated under Regulation (EU) 2017/745 on medical devices (“EU MDR”),
which establishes a harmonized regulatory framework across the 27 EU Member States. Under the MDR, devices are classified by risk (Class
I, IIa, IIb and III), and manufacturers must demonstrate compliance with the General Safety and Performance Requirements set forth in
the regulation.

Except
for certain low-risk devices, manufacturers must engage a designated Notified Body to assess conformity, including review of the manufacturer’s
quality management system and technical documentation, which may include clinical evaluation data. Upon successful completion of the
conformity assessment process, the manufacturer issues a Declaration of Conformity and affixes the CE marking, which permits commercial
distribution throughout the EU. The MDR imposes significant pre- and post-market obligations, including clinical evaluation, post-market
surveillance, vigilance reporting, and registration requirements. The transition to the MDR has increased regulatory scrutiny and compliance
costs, and limited Notified Body capacity may affect review timelines.

Manufacturers
established outside the EU must appoint an authorized representative within the EU.

United
Kingdom and Other European Markets

Following
the United Kingdom’s withdrawal from the EU, Great Britain is regulated separately by the Medicines and Healthcare products Regulatory
Agency (MHRA) and generally requires UKCA marking, subject to transitional arrangements. Northern Ireland continues to follow EU MDR
requirements. Switzerland and certain other European countries maintain regulatory systems that are broadly aligned with EU requirements
but may impose additional local obligations, including appointment of local representatives and registration requirements.

Other
International Markets

Other
jurisdictions, including Canada, Japan, China, Brazil and others, maintain independent regulatory approval processes that typically require
submission of technical documentation, evidence of quality system compliance, and, in some cases, local testing or clinical data. Although
some countries may consider prior approvals or certifications, such as CE marking, manufacturers must independently comply with applicable
local regulatory requirements.

Failure
to obtain or maintain required international approvals or certifications could restrict our ability to market our products in those jurisdictions.

16

Compliance
with Healthcare Laws

Our
operations are subject to numerous federal and state healthcare laws and regulations that govern fraud and abuse, transparency, privacy,
security, and interactions with healthcare professionals. These laws are interpreted broadly and enforced by federal and state authorities,
including the U.S. Department of Justice (“DOJ”), the U.S. Department of Health and Human Services Office of Inspector General
(“HHS-OIG”), and state attorneys general.

We
have entered into arrangements with certain surgeons and other healthcare professionals, including consulting, product development, royalty,
and other compensation arrangements. Some of these individuals may order or use our products, and some may hold equity interests in our
company. Such relationships are subject to scrutiny under applicable fraud and abuse laws. We structure these arrangements to comply
with applicable legal requirements, including fair market value and commercial reasonableness standards and policies intended to avoid
payments that are tied to the volume or value of referrals. However, these laws are complex and fact-specific, and there can be no assurance
that regulatory authorities would not challenge our arrangements.

The
federal Anti-Kickback Statute prohibits knowingly and willfully offering, paying, soliciting, or receiving remuneration to induce or
reward referrals for items or services reimbursable by federal healthcare programs. The statute is broadly interpreted, and compliance
with statutory exceptions or regulatory safe harbors is voluntary but often narrowly construed. Violations may result in criminal penalties,
civil monetary penalties, exclusion from federal healthcare programs, and liability under the federal False Claims Act.

The
federal False Claims Act imposes liability on persons who knowingly submit, or cause the submission of, false or fraudulent claims for
payment to federal healthcare programs. The statute permits private whistleblowers to bring actions on behalf of the government and share
in any recovery. Claims arising from alleged kickbacks, improper marketing practices, or other regulatory violations may give rise to
liability. Many states have enacted similar fraud and abuse and false claims laws that may apply to claims submitted to commercial payors
as well as government programs.

We
are also subject to federal and state transparency laws. The federal Physician Payments Sunshine Act requires medical device manufacturers
to report certain payments and other transfers of value to physicians, teaching hospitals, and certain non-physician practitioners, as
well as certain ownership and investment interests. Various states impose additional reporting, marketing compliance, or gift restriction
requirements.

Our
business may involve the receipt or processing of health-related information, and we are subject to applicable federal and state privacy
and data security laws. To the extent we act as a “business associate” under the Health Insurance Portability and Accountability
Act of 1996 (“HIPAA”), we are directly subject to HIPAA’s privacy, security, and breach notification requirements.
In addition, numerous states have enacted consumer privacy and data protection laws that impose obligations regarding the collection,
use, storage, and protection of personal information. Outside the United States, we may be subject to foreign data protection laws, including
the European Union’s General Data Protection Regulation (“GDPR”).

Clinical
research activities are subject to FDA regulations governing investigational devices and the protection of human subjects, including
requirements for informed consent and Institutional Review Board oversight, as well as applicable international regulations where studies
are conducted.

If
our operations are found to violate any applicable healthcare, fraud and abuse, transparency, privacy, or other regulatory requirements,
we could be subject to significant civil or criminal penalties, exclusion from participation in federal healthcare programs, corporate
integrity obligations, reputational harm, and other sanctions, which could materially and adversely affect our business, financial condition,
and results of operations.

17

Third-Party
Reimbursement

Our
products are purchased primarily by hospitals and surgical centers rather than directly by third-party payors. However, the commercial
success of our products depends in significant part on the availability of coverage and reimbursement for procedures in which our devices
are used. Hospitals and physicians are unlikely to utilize our products if reimbursement for the applicable procedures is insufficient
to cover associated costs.

In
the United States, Medicare reimburses inpatient hospital services under the Inpatient Prospective Payment System (“IPPS”),
which utilizes diagnosis-related groups (“DRGs”), and outpatient hospital services under the Outpatient Prospective Payment
System (“OPPS”), which utilizes ambulatory payment classifications (“APCs”). Ambulatory surgical centers are
reimbursed under a separate prospective payment system. These payment systems generally provide predetermined amounts intended to cover
facility costs associated with a procedure, including implantable devices. Payment amounts are established without regard to the cost
of a particular manufacturer’s product, and hospitals bear the risk if device costs exceed reimbursement.

Coverage
determinations may be made at the national or local level, and both governmental and private payors may deny or restrict coverage if
a procedure is determined to be not medically necessary, not cost-effective, or inconsistent with applicable labeling or standards of
care. Changes in coverage policies, reimbursement methodologies, payment rates, or site-of-service rules may adversely affect hospital
purchasing decisions and utilization of our products. Private payors frequently adopt policies consistent with Medicare coverage and
payment determinations.

Hospitals
often participate in group purchasing organizations (“GPOs”), which negotiate pricing arrangements with manufacturers. Our
ability to secure favorable contractual arrangements with GPOs, or to compete effectively outside of such arrangements, may affect our
market access and pricing.

Federal
and state healthcare programs and commercial payors continue to implement cost-containment measures, including value-based purchasing
initiatives, bundled payment programs, and other payment models designed to control healthcare spending. These measures may increase
pricing pressure on hospitals and, in turn, on medical device suppliers.

Outside
the United States, reimbursement systems vary by jurisdiction and frequently involve government-established pricing controls, health
technology assessments, or centralized procurement processes. In many countries, hospitals and healthcare facilities operate within budget
constraints that may limit the adoption of new or higher-cost technologies. We cannot assure that favorable coverage, reimbursement,
or pricing will be available in any market, and adverse changes in reimbursement policies could materially affect our business, financial
condition, and results of operations.

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Employees

As
of December 31, 2025, we had 32 employees. We believe that our success will depend, in part, on our ability to attract and retain qualified
personnel. We have never experienced a work stoppage due to labor difficulties, and believe our employee relations to be good. None of
our employees are represented by labor unions. We strive toward having a diverse team of employees and are committed to equality, inclusion
and workplace diversity.