Composite Coating of PEKK + Silicon Nitride Efficiently Utilized to Ti-Alloy Substrate; Product to Tackle An infection Threat, Metallosis, & Bone Integration
South Windsor, CT and Salt Lake Metropolis, UT, Aug. 23, 2022 (GLOBE NEWSWIRE) — Oxford Efficiency Supplies, Inc. (OPM; https://oxfordpm.com/), an business chief in superior polymer science 3D-printed orthopedic units and coating applied sciences, and SINTX Applied sciences, Inc. (https://sintx.com/; NASDAQ: SINT), an unique gear producer (OEM) of superior ceramic supplies for medical and technical purposes, introduced their profitable improvement of a brand new class of orthopedic coatings. These coatings are focused at overcoming the scientific limitations of metallic implants, a few of which have come below growing scientific and regulatory scrutiny worldwide (see e.g., Organic Responses to Metallic Implants (FDA 2019)).
SINTX and OPM mixed their respective experience in polymer and ceramic materials science to create a novel composite coating expertise that may be utilized to biomedical metallic substrates. Silicon nitride (chemical formulation Si3N4) and polyetherketoneketone (PEKK) polymer are biomaterials that have already got FDA clearance for human implantation. OPM and SINTX collectively developed a suspension of PEKK and submicron silicon nitride powder that may be utilized to titanium, in addition to different metallic substrates utilized in fashionable orthopedic and dental surgical procedure. The suspension is then cured to type a troublesome and tenaciously adherent composite movie lower than one micron in thickness. Additional testing is underway towards submission of the expertise for regulatory approval. Underneath a licensing settlement in place, both firm can enter royalty-bearing business agreements with mutually chosen clients.
“We started our work with SINTX with the aim of addressing a number of well-recognized scientific shortcomings of metallic implants which can be broadly utilized in orthopedics, dentistry, and other forms of reconstructive surgical procedure. For instance, metallic implants are prone to bacterial an infection; when this happens, the implants normally require surgical removing with appreciable value and affected person morbidity. Additionally, the potential dangerous results from long-term publicity to metallic ions arising from floor corrosion and degradation of metallic implants are of rising concern. Third, bone ingrowth into porous metallic implants, whereas usually dependable, might be delayed such that therapeutic between metallic and bone might be impeded, thus impairing outcomes from surgical procedure,” mentioned Scott DeFelice, CEO of OPM. “We needed to handle these scientific issues utilizing well-accepted biomaterials, enabled by a extremely novel, cost-effective, and patented course of expertise that fully encapsulates metallic 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 surgical procedure, I’m accustomed to the benefits and limitations of metallic implants and gratified that we have now developed a brand new expertise with OPM to enhance implant efficiency. Metallic implants are well-accepted by surgeons due to the confirmed sturdiness of titanium, chrome steel, and cobalt-chrome, as evidenced by a long time of scientific knowledge. The PEKK-silicon nitride composite coating could be very thrilling as a result of it provides to the confirmed attributes of metallic implants by imparting bacterial resistance, rushing up bone ingrowth, and decreasing metallic ion publicity within the physique. Within the subsequent part of our collaboration with OPM, we are going to optimize the coating course of, apply the coating to advanced gadget surfaces, conduct rigorous chemical and organic evaluations with clinically related bacterial strains and bone cells, and undertake standardized testing protocols towards securing regulatory clearances and product claims. Preliminary business response to our new expertise has been very encouraging, and we see large purposes for OEMs, hospitals, and clinicians who’ve an curiosity in stopping post-surgical infections and enhancing bone integration. Consultant goal areas for the brand new composite expertise embody implants utilized in trauma reconstruction, hip and knee replacements, spine fusion, sports activities drugs, and dentistry.”
Not like different applied sciences, the PEKK/Silicon Nitride composite coating doesn’t depend on the discharge of antibiotics or the presence of antibacterial supplies, resembling silver ions or peptides. As an alternative, the product leverages each passive and energetic floor mechanisms to discourage bacterial adhesion, whereas stimulating osteoblast cell interplay with bone. These properties are inherent to the biomaterials used and have been validated in quite a lot of scientific findings and publications which have undergone rigorous peer overview. Along with testing protocols, the businesses have begun preliminary software discussions with a number of orthopedic and dental OEM’s who’re occupied with evaluating business purposes of the composite product on titanium, chrome steel, and cobalt chrome substrates.
For extra info, please go to https://oxfordpm.com/ and https://sintx.com/.
About Oxford Efficiency Supplies, Inc.
Oxford Efficiency Supplies, Inc. was based in 2000 to take advantage of and commercialize the world’s highest performing thermoplastic, PEKK (poly-ether-ketone-ketone). OPM’s Supplies enterprise has developed a variety of proprietary, patented applied sciences for the synthesis and modification of a variety of PAEK polymers which can be bought below its OXPEKK® model, together with coating applied sciences for a variety of business and biomedical purposes. OPM is a pioneer in 3D printing. OPM’s OsteoFab® expertise is in business manufacturing in quite a few orthopedic implant purposes, together with cranial, facial, spinal, and sports activities drugs units, and OPM’s OXFAB® manufacturing components are designed for extremely demanding industrial purposes.
Enterprise or Media Inquiries for Oxford Efficiency Supplies:
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About SINTX Applied sciences, Inc.
SINTX Applied sciences is a complicated ceramics firm that develops and commercializes supplies, parts, and applied sciences for medical and technical purposes. SINTX is a worldwide chief within the analysis, improvement, 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 services in Utah and Maryland.
For extra info on SINTX Applied sciences or its silicon nitride materials platform, please go to https://sintx.com/.
Ahead-Wanting Statements for SINTX Applied sciences, Inc.
This press launch incorporates forward-looking statements inside the that means of the Personal Securities Litigation Reform Act of 1995 (PSLRA) which can be topic to quite a lot of dangers and uncertainties. Dangers and uncertainties that will trigger such variations embody, amongst different issues: the collaboration with Oxford Efficiency Supplies could not lead to new and revolutionary merchandise or a rise in income; the FDA could not clear any merchandise for commercialization; the business could not settle for the brand new merchandise or could flip to merchandise they deem simpler or cheaper; sufferers could not understand the anticipated advantages of our merchandise; volatility within the value of SINTX’s frequent inventory; the uncertainties inherent in new product improvement, together with the fee and time required to commercialize such product(s); market acceptance of our merchandise as soon as commercialized; SINTX’s capability to boost further funding and different aggressive developments. Readers are cautioned to not place undue reliance on the forward-looking statements, which communicate solely as of the date on which they’re made and replicate administration’s present estimates, projections, expectations, and beliefs. There might 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 might be present in SINTX’s Threat Elements disclosure in its Annual Report on Kind 10-Ok, filed with the Securities and Alternate Fee (SEC) on March 25, 2022, 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 replicate occasions or circumstances that come up after the date of this report.
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