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Re: boston745 post# 20078

Wednesday, 09/26/2018 1:07:44 PM

Wednesday, September 26, 2018 1:07:44 PM

Post# of 41321

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.



we intend to initiate biomechanical testing with a strategic partner for silicon nitride components for use in knee replacement procedures to support a 510(k) submission to the FDA.



We obtain our non-silicon nitride spinal fixation products and instruments from third-party manufacturers.



We seek to protect the trade secrets in our proprietary technology and processes, in part, by entering into confidentiality agreements with commercial partners



We believe our main competitors in the orthopedic implant market, which utilize a variety of competitive biomaterials, include: Medtronic, Inc.; DePuy Synthes Companies, a group of Johnson & Johnson companies; Stryker Corporation; Biomet, Inc.; Zimmer Holdings, Inc.; Smith & Nephew plc; and Aesculap Inc. Presently, these companies buy ceramic components on an OEM basis from manufacturers such as CeramTec, Kyocera and CoorTek, Inc., among others. We anticipate that these and other orthopedic companies and OEMs will seek to introduce new biomaterials and products that compete with ours.



https://www.sec.gov/Archives/edgar/data/1269026/000149315217010752/form10-k.htm

So basically no clue. Not an insider and if I was I would have signed a confidentiality agreement. The only additional insight I can offer is there's no reason why Zimmer wouldn't squash AMDA rumors if theres no confidentiality agreement in place. Is WEGO out of the picture? Do they pop back in the picture? No clue.
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