Amedica Corporation (NASDAQ:AMDA) is trading at a 52-week low this week. The stock has negative momentum and will be worth $763,200 less if the 0.26 price mark is reached. AMDA has declined 73.26% since June 8, 2016. It has underperformed by 89.96% the S&P500. The company has 36.2 million shares outstanding that normally trades 6.53% of its float. Some analysts have speculated that AMDA could be in for a bounce back, but we are cautious.
AMDA is focused on the development and application of spinal interbody implants made with medical-grade silicon nitride ceramic. Amedica markets spinal fusion products and is developing implants for other biomedical applications, such as wear-and-corrosion-resistant hip and knee bearings as well as dental implants.
Amedica Corporation (NASDAQ:AMDA) reported preliminary revenue of $3.6 million for the fourth quarter of 2016 and $15.2 million for the full year. Preliminary GAAP net loss for the fourth quarter of 2016 was $0.16 per share, compared to net loss of $0.57 per share in the fourth quarter of 2015. For the full year, the company reported preliminary GAAP net loss of $1.19 per share, compared to a net loss of $5.50 per share in 2015. The company’s cash and cash equivalents were $6.9 million at December 31, 2016, a decrease of $4.5 million from December 31, 2015.
The Alpha launch of Amedica’s Taurus™ Pedicle Screw System, a spine fixation product line that received FDA clearance in November 2016, has completed over 60 surgeries, generating a total of $450,000 in new revenue with 10 new surgeons trialing the system for the first time. The company expects the Beta launch in mid-summer as additional instrument sets become available for new surgeon users.
Amedica continues to promote its Valeo ® line of silicon nitride spine implants with the addition of new surgeon users and distributors. With solid material science data supporting its silicon nitride, the company is now focused on clinical studies. The company has been successful in entering purchasing agreements for its products with multiple national and regional hospital groups. These purchasing agreements should lead to increased usage of the company’s products at those hospitals, resulting in increased revenue.
Results from Amedica’s CASCADE clinical trial showing effective spine fusion with porous silicon nitride without added bone graft are now published in the European Spine Journal. A similar trial (SNAP) compared silicon nitride to PEEK in lumbar fusion; preliminary data from the SNAP trial are consistent with previous observations that silicon nitride shows enhanced and earlier spine fusion than PEEK.
In December 2016, Amedica re-filed an application with the FDA with a modified porous cervical implant. After a 510(k) pre-submission meeting, the company is using FDA feedback to prepare a 510k submission to be filed in October 2017. Amedica’s Quality and Regulatory systems were audited exhaustively by the U.S. FDA and ANVISA — Brazil’s equivalent to the FDA — and the company is fully compliant with these regulatory bodies.
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“Going forward, we are focused on growing spine sales, first and foremost, while pursuing a robust R&D program with academic and industry leaders, to assure leadership in medical ceramic technology,” said Dr. Bal, Chairman and CEO of Amedica. In addition to adding new U.S. surgeons, Amedica is aggressively targeting revenue opportunities in Brazil, Europe, and Australia, all markets where its silicon nitride implants are approved for sale. With recent submission of favorable clinical data to the Japan PMDA, the company expects approval in that market as well.
It is normal for smaller companies to run afoul of the exchange listing requirements, good companies bounce back from these hurdles and regain compliance.
The focus for Amedica Corporation (NASDAQ:AMDA) is in the ceramic femoral head development for the hip replacement market, AMDA has fabricated and tested a silicon nitride dental implant with FDA pre-submission, and expects FDA feedback in June 2017. A metal-ceramic brazing project with a global ceramics manufacturer is underway, targeting the total knee market, and composite devices in the spine market. These strides should help shareholders here as management looks to rebound the share price. For continuing coverage on shares of $AMDA stock, as well as our other hot stock picks, sign up for our free newsletter today and get our next hot stock pick!