Replies to post #40651 on SiNtx Technologies Inc (SINT)

[boston745]

Looks like the connections between Sintx and Biomet on the R&D front goes all the way back to before 2007 when the company first tried to IPO.

2007 (ORS Annual Meeting Feb 11-14)

THERMAL CONDUCTIVITY OF FEMORAL BALL STRONGLY INFLUENCED UHMWPE WEAR IN A HIP SIMULATOR STUDY

Ten 28 mm ID isostatically moulded UHMWPE liners were investigated: GUR 1050 resin, gamma-sterilized with 25ñ40 kGy in argon (ArComô, Biomet Inc, Warsaw, IN). The liners were coupled with zirconia (Y-ZrO 2 : ProzyrÆ), cobalt-chrome (Biomet, Inc), silicon nitride (Si3 N 4 : Amedica-Inc, UT) and alumina femoral balls (Al2 O 3 : Biolox-forteÆ) (Figure 1).

Acknowledgements The authors thank Amedica, Utah, US and Biomet Inc, US for their support

2015 - Signed JDA

In 2015 Sintx signed a JDA with a company to develop Si3N4 based devices and since that time, their products have been used with Biomet IP and tested at a facility Biomet was already testing. The JDA was signed before Dr Pezzotti joined Sintx Scientific Board Sept 2015 who happened to have done years worth of studies for Biomet. I have always thought this R&D agreement was connected to Zimmer. If it was indeed signed with Biomet, it was signed in May just a month before the merger between Zimmer and Biomet officially closed June 24th. The timing of which i always felt was suspect and purposeful.

To kick off things there is the JDA that was not revealed until Sept 2017 on the delayed 10K filing.

On May 13, 2015, the Company entered into a joint agreement for research and development of silicon nitride based devices. This agreement is effective for a period of five years from the date of commencement. The Company incurred payments of $270,000 and $270,000 related to this agreement for the years ended December 31, 2016 and 2015, respectively.

Next, on the 2015 10k, its reveled that they have initiated testing of their femoral head with a strategic partner that is to run into 2016.

Together with a strategic partner, we have initiated biomechanical testing of our solid silicon nitride femoral heads. This testing is expected to continue through 2016. 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.

During that same period of time Sintx just happened to fund (partially fund?) a study testing its femoral head at the University of Nebraska the same location that Biomet uses for some of its testing. By itself could just be a coincidence but coupled with other connections it looks like Biomet is the reason this testing is going on at this location.

Amedica - Comparative Testing of Ceramic Femoral Heads for Total Hip Arthroplasty, 2015-2016

Separately, it seems, another study was underway in Japan testing Sintx femoral Head and Biomet's E1 liner, for which Zimmer Biomet supplied for testing. 2020, that testing was officially published.

2017

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)

Amedica and Zimmer-Biomet (Tokyo Office) provided the femoral heads and acetabular liners; however, neither company actively sponsored the research.

Published study on this testing:

Wear Simulation of Ceramic-on-Crosslinked Polyethylene Hip Prostheses: A New Non-Oxide Silicon Nitride versus the Gold Standard Composite Oxide Ceramic Femoral Heads

Last we have publication of another component which involved Sintx using Biomet's G7 shell to test its Si3n4 coating tech. The only thing missing from a hip implant is a femoral stem. This could be the final component being worked on with Sintx collaboration with 3DCeram Sinto to perfect 3D printing of a Si3n4 which would allow Sintx to print a porous femoral stem that has a much lower modulus of elasticity.

2019

3D-additive deposition of an antibacterial and osteogenic silicon nitride coating on orthopaedic titanium substrate

Zimmer Biomet G7 OsseoTi Limited Actabular Shell (4 Hole) - Si3N4 Coated

Quote Sources:

1. http://c.eqcdn.com/_5c7526ae538a6086a4025ef13f5136d2/amedica/db/265/660/pdf/0278.pdf
2. https://www.sec.gov/Archives/edgar/data/1269026/000149315217010752/form10-k.htm pg F-24
3. https://www.sec.gov/Archives/edgar/data/1269026/000149315216008221/form10-k.htm pg 12
4. https://web.archive.org/web/20230519175028/http://www.unmc.edu/orthosurgery/research/grants.html
5. https://ir.sintx.com/news-events/press-releases/detail/95/amedica-announces-results-of-independent-femoral-head-wear
6. https://www.mdpi.com/1996-1944/13/13/2917
7. https://www.sciencedirect.com/science/article/abs/pii/S1751616119309099


Extra information on the status of a Si3n4 based hip implant:

Silicon nitride, silicon carbide and diamond-like carbon as non-oxide ceramics are considered to be the new generation of materials used in hip prosthetics, particularly in the manufacture of acetabular cups, due to their excellent biocompatibility, osteointegration, and tribological and mechanical properties, but all three materials need more study. However, silicon nitride is the nearest to commercialization, through businesses such as Amedica Corp. and SyntX Technologies

Im guessing the authors meant Sintx Technologies. Amedica being the companies former name before the name was sold to CTL.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10422432/