SINTX Submits Master Access File to FDA for Silicon Nitride-Polymer Composite Material
March 03 2021 - 9:00AM
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.SINTX Technologies is an OEM ceramics company that
develops and commercializes silicon nitride for medical and
non-medical applications. The core strength of SINTX Technologies
is the manufacturing, research, and development of silicon nitride
ceramics for external partners. The company presently manufactures
silicon nitride powders and components in its FDA registered, ISO
9001:2015 certified, ISO 13485:2016 certified, and AS9100D
certified manufacturing facility.
For more information on SINTX Technologies
or its silicon nitride material platform, please
visit www.sintx.com.
Forward-Looking StatementsThis
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: incorporation of silicon nitride into personal
protective equipment may not be safe or effective; 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 26, 2020, 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 Inquiries for SINTX:SINTX
Technologies801.839.3502IR@sintx.com
Media Inquiries for SINTX: Amanda Barry
Associate Director, Content and PR The Summit Group
abarry@summitslc.com
SiNtx Technologies (NASDAQ:SINT)
Historical Stock Chart
From Aug 2024 to Sep 2024
SiNtx Technologies (NASDAQ:SINT)
Historical Stock Chart
From Sep 2023 to Sep 2024