SINTX ANNOUNCES SUCCESSFUL FDA 510(k) PRE-SUBMISSION MEETING FOR SILICON NITRIDE-PEEK COMPOSITE SPINE IMPLANTS
September 08 2022 - 9:00AM
SINTX Technologies, Inc. (www.sintx.com) (NASDAQ: SINT) (“SINTX” or
the “Company”), an original equipment manufacturer (OEM) of
advanced ceramic materials for medical and technical applications,
announced today it has held a successful 510(k) pre-submission
meeting with the United States Food and Drug Administration (FDA)
concerning the potential development and commercialization of
silicon nitride-PEEK (FleX-SN PEEK) spine implants.
In the meeting, FDA officials provided
supportive feedback related to the company’s underlying regulatory
assumptions and strategies. SINTX intends to utilize the FDA’s
guidance to move forward with 510(k) filing and initiate
commercialization efforts to introduce spine implants made of its
novel FleX-SN PEEK composite material. FleX-SN PEEK is among a new
line of biomedical innovations created by the Company and is not
restricted to any exclusive commercial partner.
"We are pleased to have made such great progress
towards the commercialization of FleX-SN PEEK spine implants,"
stated Dr. Sonny Bal, President and CEO, SINTX Technologies.
“With the guidance from the FDA in hand, we can now confidently
move forward with our 510(k) submission and discussions with
commercial partners. It is very reassuring that FDA has agreed with
our approach towards regulatory clearance, and further agreed that
a clinical trial is not required with this material.”
To create FleX-SN PEEK, SINTX partnered with
Solvay (www.solvay.com), a global leader in materials, chemicals,
and solutions, to enhance their Zeniva PEEK biomaterial which
already features a favorable material modulus and an established
clinical track record. The resultant FleX-SN PEEK product is
expected to facilitate faster bone healing, improve radiographic
imaging, avoid metal ion release in the body, and have
broad-spectrum resistance to infection. This makes the composite
material attractive for many surgical applications such as spinal
implant surgery. Individually, both silicon nitride and PEEK are
already FDA-cleared for human implantation with many years of
clinical success.
SINTX submitted a Master Access File (MAF) for
FleX-SN PEEK to the FDA in early 2021. This file can be referenced
under license by SINTX customers using the material for new medical
implant designs and products. SINTX continues to collaborate with
many partners around the world in the development and testing of
novel embodiments and applications of silicon nitride and other
advanced ceramic materials. The recent acquisition of Technology
Assessment & Transfer (TA&T) expanded the Company’s product
portfolio into other ceramic biomaterials such as zirconia and
alumina for both medical and industrial applications.
For more information, please visit
https://sintx.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.
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: preparation of the 510(k)
may take longer than currently expected and may not support
clearance by the FDA; products containing FleX-SN PEEK composite
material may not be accepted by the market; FleX-SN PEEK products
may not facilitate faster bone healing, improve radiographic
imaging, avoid metal ion release in the body, nor have
broad-spectrum resistance to infection, which would significantly
limit commercial success. 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
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