Amedica plans 510(k) submission for new cervical implant in Oct, touts Q1, Q2 prelim earnings

Amedica (NSDQ:AMDA) said today that after a 510(k) pre-submission meeting with the FDA, it is on track to submit a 510(k) application for a modified porous cervical implant next month, and announced preliminary earnings for its 1st and 2nd quarters.

The company said it is entering the beta launch of its Taurus pedicle screw system which won FDA clearance last November, looking to release additional sets of the device during the 4th quarter as it looks to increase access to the devices.

For its 1st quarter, the Salt Lake City, Utah.-based company said it expects to report revenue of $2.6 million, with net loss per share of 7¢, down from 30¢ during the same quarter last year. For the 2nd quarter, Amedica said it expects to post revenue of $3.2 million, with a net loss of 5¢ per share, down from 40¢ net loss per share reported during the same period next year.

“Our focus at Amedica is 3-fold. First, we are focused on product sales, i.e., increasing revenue so that the company is self-sustaining. Second, we will continue engagement with a number of major, external partners, developing biomedical applications of silicon nitride outside spinal implants. Third, we will continue to strengthen our leadership position in the science and data related to silicon nitride and its biomedical applications,” chair & CEO Dr. B. Bal said in a press release.

Amedica shares rose 1.6% today to close at 32¢.

In June, Amedica saw shares jump up as much as 20% after releasing preliminary earnings for its 4th quarter for the previous year.

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