Tuesday’s Bull of the Day: Amedica (AMDA)


It’s a very rewarding trading day for investors in Amedica (NASDAQ:AMDA) with shares up over 150%, making the stock Wall Street’s bull of the day. Why the excitement? The drug maker shared this morning an encouraging update regarding the current status of its clinical trials.

Maxim analyst Jason Kolbert recently wrote, “We fundamentally believe that Amedica’s silicon nitride product line represents a paradigm shift in the implant industry but the company has been hampered by a lack of capital. Success with Valeo C + CSC will help establish silicon nitride as an innovative material with both osteoinductive and bacteriostatic properties. With that said, capital in this industry is one of the keys to achieving critical mass. While superior product attributes matter, the implant industry remains dominated with well-financed device companies that literally have an army of sales reps and account relationships that make winning market share more than just good data. We look for the company to both strengthen its balance sheet and build its revenues as management executes on business fundamentals.”

Clinical Updates

  • 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.
  • Goat Study – 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.

 

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