Good morning loyal members,
Update AMDA news regarding the FDA and a possible approval within the next 90 days
Big news dropped from Amedica Corp. (NASDAQ: AMDA) in after market close yesterday at 4:19 PM which sent the securities on a tear trading as high as .31/share in after hours trading. This marks in excess of a 24% increase from our call at 24-.25/share on Monday however, it is just the beginning here.
This one appears to be just now starting to get very interesting and exciting. With the potential FDA approval looming in the next 90 days we could see a good short covering start to happen very soon here. See an excerpt and link to the full after hours press release below.
Amedica Submits 24-Month Clinical Data to FDA for Clearance of Composite Interbody Spinal Device
SALT LAKE CITY, Nov. 10, 2015 (GLOBE NEWSWIRE) — Amedica Corporation (Nasdaq:AMDA), a company that develops and commercializes silicon nitride ceramics as a biomaterial platform, is pleased to announce that it has submitted to the FDA the 24-month clinical data outcomes from its CASCADE study, a blinded, randomized clinical trial that compared outcomes of cervical fusion between Amedica’s composite silicon nitride devices manufactured with an integrated core of cancellous structured ceramic (CsC), to the existing standard, i.e., PEEK (polyether ether ketone plastic) spacers filled with bone autograft.
Excerpt from the full PR
“Porous silicon nitride is the first synthetic material to demonstrate spinal fusion outcomes that are similar to the patient’s own bone,” said Dr. Sonny Bal, chairman and CEO of Amedica Corporation. “These outcomes are consistent with our investigations of the surface chemistry and nano-topography of silicon nitride. This 24-month data has been submitted to the FDA in support of our application seeking clearance to commercialize our composite cervical interbody fusion device. Achieving clearance for this product is very important to us, as it furthers our mission to improve patient health through the enhancement of clinical outcomes for those patients who utilize our products, which is why we invested the necessary time in data gathering and analysis to ensure that we had it right before FDA submission.”
Pursuant to Section 510(k), the FDA has 90 days in which to either clear the Class II medical device for commercial distribution or to seek additional information. The FDA previously confirmed that it would review the product as a medical device. Following notification of FDA clearance, the Company would immediately have the right to commence manufacturing, marketing and sales of the product in the United States and its possessions subject to FDA jurisdiction.
Your partners on Broad Street
Good morning traders,
This week’s NASDAQ alert is the lowest priced with more upside potential than we have covered in a long time. Another reason we like this one so much their technology is proprietary. (NASDAQ: AMDA) is in the hot biotech / biomaterial space currently holding 56 patents issued and another 37 patents pending. As if that’s not enough to get you excited, (NASDAQ: AMDA) has earnings due this week Thursday November 12th, 2015.
Earnings PR- http://finance.yahoo.com/news/amedica-corporation-release-third-quarter-201500678.html
Amedica Corp. (NASDAQ: AMDA)
Current price- .25/share
52 week range- .20 – $3.43/share
Source Yahoo Finance
Revenue (TTM) $20.67M
Gross Profit (TTM) $14.86M
Cash on hand (MRQ) $12.39M
Shares outstanding- 78.9M
Shares in the public- float 57.62M
Held by insiders- 7%
Held by institutions- 4.7%
Very interesting recent press release from AMDA on November 5th, 2015
Amedica Corporation Signs Additional Silicon Nitride Private Label Agreement
Newest Alliance to Positively Impact Future Financial Results
SALT LAKE CITY, Nov. 05, 2015 (GLOBE NEWSWIRE) — Amedica Corporation (AMDA), a company that develops and commercializes silicon nitride ceramics as a biomaterial platform, is pleased to announce it has entered into a multi-year private label agreement with a regional medical device company that markets solutions for the treatment of spinal disorders.
Pursuant to the terms of the non-exclusive agreement, Amedica will provide sterile-packed silicon nitride spinal interbody fusion devices to be available in key domestic markets. The agreement underscores Amedica’s continued focus to provide superior and innovative solutions to the market.
“We are very pleased to announce an additional private label partner,” said Dr. Sonny Bal, chairman and CEO of Amedica Corporation. “This newest alliance should positively impact our financial results and further validates our uniquely differentiated biomaterial technology, while complementing our current distribution structure. We remain committed to offering our partners a biomaterial with inherent distinct benefits to improve the efficacy of spinal fusion procedures, resulting in enhanced patient care.”
Amedica’s spinal interbody fusion devices are made of a micro-composite silicon nitride biomaterial – a breakthrough ceramic containing the world’s first natural nano-surface biotechnology. This unique biomaterial is also hydrophilic to attract both osteoblasts and physiologic proteins to ensure reliable osteointegration, and its surface biochemistry inhibits bacterial biofilm adhesion. This combination of optimal material properties is unique to Amedica’s silicon nitride material platform.
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 and, through its partnership with Kyocera, the world’s largest ceramic manufacturer. 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 growing private label and OEM partnerships.
For more information on Amedica or its silicon nitride material platform, please visit www.amedica.com
As usual this initial introduction should be enough to get you started on your due diligence, however we will be back with more and plan to have additional updates over the next couple of days.
Your partner on Broad Street
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