Health and Healthcare

Amedica Slides on Mixed FDA Updates


Amedica Corp. (NASDAQ: AMDA) is watching its shares drop on Tuesday despite receiving mixed news from the U.S. Food and Drug Administration, along with a new appointment to its management team. Although the FDA did give some good news, the bad far outweighed the good.

First the company announced that Dana Lyons has been appointed to Vice President of Sales and Marketing, in an effort to increase the adoption of silicon nitride implants in the spinal fusion market. Previously, Lyons has worked in leadership positions with Stryker Orthopaedics, Zimmer Spine, and Zimmer Biomet Spine.

As for the good news, the FDA also notified Amedica that the new pedicle screw system, Taurus, has been cleared for commercialization. The company is on target for surgical implantation and a full market launch of the Taurus system by the end of the year.

B. Sonny Bal, MD, MBA, JD, PhD; the CEO and President of Amedica Corporation commented:

Amedica is building a top-tier sales team with skilled veterans from the spine industry, such as Mr. Lyons. Going forward, our focus is on driving sales, surgeon engagement, and data collection to validate the unparalleled volume of basic material science data that we have already published. Surgeon intrigue about our material, and a market need for clinical advantages that only our material can deliver, combine to make spine an attractive growth opportunity. As part of the new sales team, I will focus on driving clinical trials, surgeon relations, and publishing clinical data to impact our revenue growth.

However, the FDA separately did not clear Amedica’s 510(k) premarket application to commercialize Valeo C+CsC, a composite spinal fusion device. This device is already marketed in Europe with successful outcomes.

Dr Bal added:

While the FDA reluctance to clear our composite silicon nitride device that incorporates the world’s first structural porous bioceramic under the 510(k) program is disappointing, we are working with the FDA to examine other pathways to introduce this proprietary technology to the U.S. market as expeditiously as possible.

Excluding Tuesday’s move, Amedica has underperformed the broad markets with the stock down 41% year to date.

Shares of Amedica were last trading down 27% at $0.76, with a consensus analyst price target of $3.38 and a 52-week trading range of $0.60 to $3.62.

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