Amedica Corporation Provides Update on its Clinical Studies
SALT LAKE CITY, May 08, 2018 (GLOBE NEWSWIRE) -- Amedica Corporation (NASDAQ: AMDA), an innovative biomaterial company that develops and commercializes silicon nitride for biomedical applications, today provided an update on its clinical study activities.
Single Center Retrospective Comparative Study
A clinical study comparing silicon nitride spinal implants to allograft spacers in cervical fusion showed faster and more effective outcomes with silicon nitride. “While silicon nitride might have been expected to perform better in light of its properties, the surprising finding in our study was how good the outcomes with silicon nitride proved to be. Significantly earlier and more effective bone fusion was observed with silicon nitride than allograft spacers at 3- 6-, and 12-month time points after surgery, all the way to 24 months” said Dr. Micah Smith, orthopaedic surgeon in Fort Wayne, Indiana, who is the principal investigator. Study findings have been submitted to for release at the December 2018 Cervical Spine Research Society meeting.
Multi-Center Retrospective Study
Amedica reported completion of an exhaustive retrospective survey of over 2,000 silicon nitride spinal implants implanted in more than 1,000 patients over the last eight years. The study was designed to understand clinical outcomes from silicon nitride implants in spine fusion from four different clinics in the US. “Preliminary data analysis toward publication of this study is very encouraging in this large cohort of patients derived from our long-term surgeon users. Not only are the data consistent with our other clinical studies, but the outcomes corroborate our basic science understanding of the surface chemistry of the material, the key strength of silicon nitride,” said Dr. Sonny Bal, President of Amedica.
Silicon Nitride Against PEEK (SNAP)
SNAP, a 24-month double-blinded multicenter randomized controlled human trial for lumbar fusion comparing intervertebral cages from either silicon nitride or polyetheretherketone (PEEK), has been completed. The purpose of the study was to show that fusion using silicon nitride cages was at least non-inferior to PEEK devices. Preliminary data at 3, 6, and 12-months on the Roland Morris Disability Questionnaire and VAS back and leg pain scores, as well as quantitative radiographic data at 24 months appear to confirm the study’s hypothesis of silicon nitride’s non-inferiority. Additional detailed analyses are currently being conducted in anticipation of publishing the overall results in a prominent scientific journal later this year.
An interbody fusion study using a goat model comparing silicon nitride to PEEK was just accepted for publication in the Journal of Biomedical Materials Research, Part B – Applied Biomaterials. The results of the study showed improved fusion and greater bone volume using silicon nitride implants versus PEEK at the study’s six-month end-point. These results also suggest that silicon nitride is not inferior to PEEK and that silicon nitride implants may be more effective in promoting arthrodesis.
About Amedica Corporation
Amedica is focused on the development and application of medical-grade silicon nitride ceramics. Amedica markets spinal fusion products and is developing a new generation of wear- and corrosion-resistant implant components for hip and knee arthroplasty. The Company manufactures its products in its ISO 13485 certified manufacturing facility. Amedica's spine products are FDA-cleared, CE-marked, and are currently marketed in the U.S. and select markets in Europe and South America through its distributor network and its OEM partnerships.
For more information on Amedica or its silicon nitride material platform, please visit www.amedica.com.
This press release contains statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties. For example, silicon nitride and our products may not have the impact we expect, the outcomes of our ongoing studies may not be positive, and the results of our studies may not come in the anticipated timeframes. Other factors that could cause actual results to differ materially from those contemplated within this press release can also be found in Amedica's Risk Factors disclosure in its Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 29, 2018, and in Amedica's other filings with the SEC. Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.
Released May 8, 2018