SALT LAKE CITY, Oct. 11, 2023 (GLOBE NEWSWIRE) — SINTX Applied sciences, Inc. (www.sintx.com) (NASDAQ: SINT) (“SINTX” or the “Firm”), an unique gear producer of superior ceramics, introduced as we speak it has been awarded a Part II grant of $1,972,826 by the Nationwide Institutes of Health (NIH) to develop a 3D printed (3DP) composite silicon nitride – polyetheretherketone (SN-PEEK) spinal implant. This represents the fourth NIH grant awarded to SINTX because the Part I award for this challenge was obtained in September of 2021.
Representing roughly 40% of spine implants inside the $10 billion world spine market, PEEK-based gadgets are favored due to their confirmed scientific efficacy. By means of the event of 3DP SN-PEEK spinal implants, SINTX goals to mix the familiarity and advantages of PEEK with the antibacterial and osteoconductive traits of silicon nitride. These composite implants will likely be manufactured with trendy, cost-effective 3D printing applied sciences.
“Our profitable completion of Part I goals has proven the feasibility and reliability of 3DP SN-PEEK spinal implants. These 3DP implants met minimal load thresholds in accordance with established mechanical testing requirements, demonstrated primary biocompatibility, and resisted bacterial adhesion. These findings established the muse for this Part II Small Enterprise Innovation Analysis (SBIR) award,” stated Dr. Ryan Bock, SINTX Vice President of Analysis and Growth and Principal Investigator for the challenge. “In Part II, SINTX and exterior collaborators will conduct formal design validation actions; check static and dynamic mechanical properties of implants 3DP in keeping with the revised design; perform formal biocompatibility assessments; and assess in vivo antimicrobial exercise, biocompatibility, and osseointegration for a 3DP SN-PEEK cervical implant in opposition to acceptable controls.”
SINTX will collaborate with the College of Pennsylvania College of Veterinary Drugs (Penn Vet) over the subsequent 24 months to execute this challenge. The NIH grant will assist resourcing and acquisition of supplies in addition to testing and trials at SINTX and Penn Vet. Upon the profitable execution of the Part II grant utility targets, SINTX may have the vast majority of the benchtop and huge animal in vivo information wanted to hunt FDA regulatory clearance utilizing the 510(ok) pathway. Moreover, profitable demonstration of an infection prevention in vivo will likely be a essential step in the direction of enabling an antimicrobial machine declare. These preliminary animal information will likely be used to hunt future funding from NIH or different Federal companies to additional validate antimicrobial properties of gadgets created from SN-PEEK.
“Within the Part I effort, Dr. Steven Kurtz of Drexel College and Dr. Noreen Hickok of Thomas Jefferson College have been the lead college investigators whereas Dr. Thomas Schaer of Penn Vet supplied valued consultative assist for research and implant design. These scientists supplied important contributions to the proposal, and we’re grateful for his or her continued assist,” stated Dr. Sonny Bal, President, and CEO. “Dr. Schaer would be the lead investigator at Penn Vet whereas Drs. Kurtz and Hickok will assume advisory roles on the challenge throughout execution of Part II actions. Because the NIH grant will fund the acquisition of wanted benchtop information and the primary ever in vivo efficiency information for SN-PEEK gadgets, the award represents a essential milestone in increasing the antibacterial and osseointegrative properties of silicon nitride into composite buildings. From a business standpoint, this NIH-funded challenge is a vital step in our technique to introduce a brand new era of extremely differentiated implants into the spine market.”
Analysis reported within the “3D Printed Silicon Nitride Porous PEEK Composite Spinal Cages for Anti-An infection” proposal was supported by the Nationwide Institute of Arthritis and Musculoskeletal and Pores and skin Illnesses of the Nationwide Institutes of Health below award quantity 2R44AR083836-02.
The content material included on this launch is solely the accountability of the authors and doesn’t essentially characterize the official views of the Nationwide Institutes of Health.
About SINTX Applied sciences, Inc.
SINTX Applied sciences is a sophisticated ceramics firm that develops and commercializes supplies, elements, and applied sciences for medical and technical functions. SINTX is a world chief within the analysis, growth, and manufacturing of silicon nitride, and its merchandise have been implanted in people since 2008. Over the previous two years, SINTX has utilized strategic acquisitions and alliances to enter into new markets. The Firm has manufacturing amenities in Utah and Maryland.
For extra info on SINTX Applied sciences or its supplies platform, please go to www.sintx.com.
This press launch comprises forward-looking statements inside the which means of the Non-public Securities Litigation Reform Act of 1995 (PSLRA) which are topic to a lot of dangers and uncertainties. Dangers and uncertainties which will trigger such variations embrace, amongst different issues: growth of SN-PEEK spinal implant merchandise might take longer than anticipated and such merchandise might not show to be as efficient as different merchandise at the moment being commercialized or to be commercialized sooner or later by rivals; dangers inherent in manufacturing and scaling as much as business portions whereas sustaining qc; volatility within the worth of SINTX’s widespread inventory; the uncertainties inherent in new product growth, together with the fee and time required to commercialize such product(s); market acceptance of our merchandise as soon as commercialized; SINTX’s skill to boost funding and different aggressive developments. Readers are cautioned to not place undue reliance on the forward-looking statements, which converse solely as of the date on which they’re made and mirror administration’s present estimates, projections, expectations and beliefs. There could be no assurance that any of the anticipated outcomes will happen on a well timed foundation or in any respect because of sure dangers and uncertainties, a dialogue of which could be present in SINTX’s Threat Elements disclosure in its Annual Report on Type 10-Okay, filed with the Securities and Trade Fee (SEC) on March 29, 2023, and in SINTX’s different filings with the SEC. SINTX disclaims any obligation to replace any forward-looking statements. SINTX undertakes no obligation to publicly revise or replace the forward-looking statements to mirror occasions or circumstances that come up after the date of this report.
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