Oxford Performance Materials and SINTX Technologies Collaboration Yields Major Breakthrough in Orthopedic & Dental Coatings
August 23 2022 - 9:00AM
Oxford Performance Materials, Inc. (OPM; https://oxfordpm.com/), an
industry leader in advanced polymer science 3D-printed orthopedic
devices and coating technologies, and SINTX Technologies, Inc.
(https://sintx.com/; NASDAQ: SINT), an original equipment
manufacturer (OEM) of advanced ceramic materials for medical and
technical applications, announced their successful development of a
new class of orthopedic coatings. These coatings are targeted at
overcoming the clinical limitations of metallic implants, some of
which have come under increasing scientific and regulatory scrutiny
worldwide (see e.g., Biological Responses to Metal Implants (FDA
2019)).
SINTX and OPM combined their respective
expertise in polymer and ceramic material science to create a novel
composite coating technology that can be applied to biomedical
metallic substrates. Silicon nitride (chemical formula Si3N4) and
polyetherketoneketone (PEKK) polymer are biomaterials that already
have FDA clearance for human implantation. OPM and SINTX jointly
developed a suspension of PEKK and submicron silicon nitride powder
that can be applied to titanium, as well as other metallic
substrates used in modern orthopedic and dental surgery. The
suspension is then cured to form a tough and tenaciously adherent
composite film less than one micron in thickness. Further testing
is underway toward submission of the technology for regulatory
approval. Under a licensing agreement in place, either company can
enter royalty-bearing commercial agreements with mutually selected
customers.
“We began our work with SINTX with the goal of
addressing several well-recognized clinical shortcomings of
metallic implants that are widely used in orthopedics, dentistry,
and other kinds of reconstructive surgery. For example, metal
implants are susceptible to bacterial infection; when this occurs,
the implants usually require surgical removal with considerable
cost and patient morbidity. Also, the potential harmful effects
from long-term exposure to metal ions arising from surface
corrosion and degradation of metal implants are of growing concern.
Third, bone ingrowth into porous metal implants, while generally
reliable, can be delayed such that healing between metal and bone
can be impeded, thus impairing outcomes from surgery,” said Scott
DeFelice, CEO of OPM. “We wanted to address these clinical concerns
using well-accepted biomaterials, enabled by a highly novel,
cost-effective, and patented process technology that entirely
encapsulates metal implants in a sub-micron layer of our PEKK
polymer, enhanced with SINTX’s silicon nitride.”
SINTX’s CEO Sonny Bal added: “Having practiced
orthopedic surgery, I am familiar with the advantages and
limitations of metal implants and gratified that we have developed
a new technology with OPM to improve implant performance. Metal
implants are well-accepted by surgeons because of the proven
durability of titanium, stainless steel, and cobalt-chrome, as
evidenced by decades of clinical data. The PEKK-silicon nitride
composite coating is very exciting because it adds to the proven
attributes of metal implants by imparting bacterial resistance,
speeding up bone ingrowth, and reducing metal ion exposure in the
body. In the next phase of our collaboration with OPM, we will
optimize the coating process, apply the coating to complex device
surfaces, conduct rigorous chemical and biological evaluations with
clinically relevant bacterial strains and bone cells, and undertake
standardized testing protocols toward securing regulatory
clearances and product claims. Initial industry response to our new
technology has been very encouraging, and we see wide applications
for OEMs, hospitals, and clinicians who have an interest in
preventing post-surgical infections and enhancing bone integration.
Representative target areas for the new composite technology
include implants used in trauma reconstruction, hip and knee
replacements, spine fusion, sports medicine, and dentistry.”
Unlike other technologies, the PEKK/Silicon
Nitride composite coating does not rely upon the release of
antibiotics or the presence of antibacterial materials, such as
silver ions or peptides. Instead, the product leverages both
passive and active surface mechanisms to discourage bacterial
adhesion, while stimulating osteoblast cell interaction with bone.
These properties are inherent to the biomaterials used and have
been validated in a number of scientific findings and publications
that have undergone rigorous peer review. In addition to testing
protocols, the companies have begun initial application discussions
with several orthopedic and dental OEM’s who are interested in
evaluating commercial applications of the composite product on
titanium, stainless steel, and cobalt chrome substrates.
For more information, please visit https://oxfordpm.com/ and
https://sintx.com/.
About Oxford Performance Materials, Inc.
Oxford Performance Materials, Inc. was founded
in 2000 to exploit and commercialize the world’s highest performing
thermoplastic, PEKK (poly-ether-ketone-ketone). OPM’s Materials
business has developed a range of proprietary, patented
technologies for the synthesis and modification of a range of PAEK
polymers that are sold under its OXPEKK® brand, including coating
technologies for a range of industrial and biomedical applications.
OPM is a pioneer in 3D printing. OPM’s OsteoFab® technology is in
commercial production in numerous orthopedic implant applications,
including cranial, facial, spinal, and sports medicine devices, and
OPM’s OXFAB® production parts are designed for highly demanding
industrial applications.
Business or Media Inquiries for Oxford Performance
Materials:Bernard PlishtinOxford Performance Materials,
Inc.917.494.3649bplishtin@oxfordpm.com
About SINTX Technologies,
Inc.SINTX Technologies is an advanced ceramics company
that develops and commercializes materials, components, and
technologies for medical and technical 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. Over the past two years, SINTX has utilized strategic
acquisitions and alliances to enter into new markets. The Company
has manufacturing facilities in Utah and Maryland.
For more information on SINTX Technologies
or its silicon nitride material platform, please
visit https://sintx.com/.
Forward-Looking Statements for SINTX
Technologies, Inc. This press release contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995 (PSLRA) that are subject
to a number of risks and uncertainties. Risks and uncertainties
that may cause such differences include, among other things: the
collaboration with Oxford Performance Materials may not result in
new and innovative products or an increase in revenue; the FDA may
not clear any products for commercialization; the industry may not
accept the new products or may turn to products they deem more
effective or less expensive; patients may not realize the expected
benefits of our products; volatility in the price of SINTX’s common
stock; the uncertainties inherent in new product development,
including the cost and time required to commercialize such
product(s); market acceptance of our products once commercialized;
SINTX’s ability to raise additional funding and other competitive
developments. Readers are cautioned not to place undue reliance on
the forward-looking statements, which speak only as of the date on
which they are made and reflect management’s current estimates,
projections, expectations, and beliefs. There can be no assurance
that any of the anticipated results will occur on a timely basis or
at all due to certain risks and uncertainties, a discussion of
which can be found in SINTX’s Risk Factors disclosure in its Annual
Report on Form 10-K, filed with the Securities and Exchange
Commission (SEC) on March 25, 2022, and in SINTX’s other filings
with the SEC. SINTX disclaims any obligation to update any
forward-looking statements. SINTX undertakes no obligation to
publicly revise or update the forward-looking statements to reflect
events or circumstances that arise after the date of this
report.
Business or Media Inquiries for SINTX:SINTX
Technologies801.839.3502IR@sintx.com
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