News 
Market Data 
Discover
Replies to post #11914 on SiNtx Technologies Inc (SINT)
Our Total Hip Implant Product Candidates
We have developed a femoral head that is made from our solid silicon nitride, which could be used for total hip replacement product candidates. This femoral head is expected to articulate against a cross-linked polyethylene liner fixed into a metal acetabular cup. Together with a strategic partner, we have initiated biomechanical testing of our solid silicon nitride femoral heads. The results of this test will be released in 2017. If the tests indicate that silicon nitride femoral heads are superior in terms of wear performance, taper corrosion, strength and in vitro hydrothermal stability, we eventually intend to commercialize this product in cooperation with a strategic partner. However, clearance of these types of devices by the FDA will be required. Currently, the FDA has indicated that a limited one to two year clinical trial may be necessary to obtain clearance. If clearance is eventually obtained, we intend to commercially launch products for use in total hip replacement in 2018 or 2019.
SALT LAKE CITY, UT -- (Marketwired) -- 02/27/17 -- Amedica Corporation (NASDAQ: AMDA), an innovative biomaterial company which develops and manufactures silicon nitride as a platform for biomedical applications, announced today that Researchers from the Department of Orthopaedic Surgery of Tokyo Medical University (Shinjuku-ku, Tokyo, Japan) led by Professor Kengo Yamamoto MD PhD recently completed a five million cycle (Mc) comparative hip simulator study examining the wear behavior of an advanced highly cross-linked and vitamin E stabilized polyethylene (E1® Zimmer-Biomet, Warsaw, IN, USA) against two different types of ceramic femoral heads -- MC2®silicon nitride (Amedica Corporation, Salt Lake City, UT, USA) and BIOLOX®delta (CeramTec, Plochingen, Germany). BIOLOX®delta is currently considered the "gold standard" for ceramic femoral head materials. While the polyethylene wear loss induced by both types of ceramic heads was extremely small (< 0.60 mg/Mc), mean wear associated with MC2®silicon nitride heads was approximately 15% lower than the BIOLOX®delta components.
This independent wear study was conducted in accordance with international standards at the Medical Technology Laboratory of the Rizzoli Orthopaedic Institute (Bologna, Italy) by Professor Aldo Toni MD under the supervision of Dr. Saverio Affatato PhD (Rizzoli Institute) with consultation and support from Professor Giuseppe Pezzotti PhD (Ceramic Physics Laboratory, Kyoto Institute of Technology, Sakyo-ku, Kyoto Japan). Amedica and Zimmer-Biomet (Tokyo Office) provided the femoral heads and acetabular liners; however, neither company actively sponsored the research.
The testing was independently conceived by Professors Yamamoto and Pezzotti, and funded by the Department of Orthopaedic Surgery of Tokyo Medical University. This is the first reported improvement in polyethylene wear performance by a ceramic other than BIOLOX®delta; and it is part of a series of planned comparative wear tests that will culminate at 12 Mc. Further details of this interim hip simulation test will be provided in a joint publication planned for release in a scientific journal.
These two independent analytical techniques consistently found an increase of ~80% in expressed hydroxyapatite when compared to a biomedical titanium alloy. This study suggests that surface-treated Si3N4 may have a powerful anabolic, differentiating, and antiapoptotic effect on osteoblasts in vitro, and a concurrent inhibitive action on osteoclastogenesis. Given additional research, Si3N4 may represent a new therapeutic solution for bone disorders and for engineered implants that physiologically regulate bone growth processes.
