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.
Read the entire press release here: https://globenewswire.com/news-release/2015/11/10/785893/0/en/Amedica-Submits-24-Month-Clinical-Data-to-FDA-for-Clearance-of-Composite-Interbody-Spinal-Device.html
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
Broadstreetalerts is a wholly owned subsidiary of Small Cap Specialists LLC, herein referred to as SCS LLC.
Our reports/releases are a commercial advertisement and are for general information purposes ONLY. We are engaged in the business of marketing and advertising companies for monetary compensation. Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. The disclaimer is to be read and fully understood before using our services, joining our site or our email/blog list as well as any social networking platforms we may use.
PLEASE NOTE WELL: SCS LLC and its employees are not a Registered Investment Advisor, Broker Dealer or a member of any association for other research providers in any jurisdiction whatsoever.
Release of Liability: Through use of this website viewing or using you agree to hold SCS LLC, its operators owners and employees harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damage (monetary or otherwise), or injury (monetary or otherwise) that you may incur. The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data. SCS LLC encourages readers and investors to supplement the information in these reports with independent research and other professional advice. All information on featured companies is provided by the companies profiled, or is available from public sources and SCS LLC makes no representations, warranties or guarantees as to the accuracy or completeness of the disclosure by the profiled companies. None of the materials or advertisements herein constitute offers or solicitations to purchase or sell securities of the companies profiled herein and any decision to invest in any such company or other financial decisions should not be made based upon the information provide herein. Instead SCS LLC strongly urges you conduct a complete and independent investigation of the respective companies and consideration of all pertinent risks. Readers are advised to review SEC periodic reports: Forms 10-Q, 10K, Form 8-K, insider reports, Forms 3, 4, 5 Schedule 13D. SCS LLC is compliant with the Can Spam Act of 2003. SCS LLC does not offer such advice or analysis, and SCS LLC further urges you to consult your own independent tax, business, financial and investment advisors. Investing in micro-cap and growth securities is highly speculative and carries and extremely high degree of risk. It is possible that an investor’s investment may be lost or impaired due to the speculative nature of the companies profiled.
The Private Securities Litigation Reform Act of 1995 provides investors a ‘safe harbor’ in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions or future events or performance are not statements of historical fact may be “forward looking statements”. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as “projects”, “foresee”, “expects”, “will”, “anticipates”, “estimates”, “believes”, “understands”, or that by statements indicating certain actions & quote; “may”, “could”, or “might” occur. Understand there is no guarantee past performance will be indicative of future results.
In preparing this publication, SCS LLC has relied upon information supplied by its customers, publicly available information and press releases which it believes to be reliable; however, such reliability cannot be guaranteed. Investors should not rely on the information contained in this website. Rather, investors should use the information contained in this website as a starting point for doing additional independent research on the featured companies. The advertisements in this website are believed to be reliable, however, SCS LLC and its owners, affiliates, subsidiaries, officers, directors, representatives and agents disclaim any liability as to the completeness or accuracy of the information contained in any advertisement and for any omissions of materials facts from such advertisement. SCS LLC is not responsible for any claims made by the companies advertised herein, nor is SCS LLC responsible for any other promotional firm, its program or its structure. SCS LLC has been compensated twenty two thousand dollars cash via bank wire by Star Media LLC for a two day investor relations / advertising campaign of AMDA. Our coverage of AMDA may continue beyond the advertising contract at our discretion.
Please Note: We do NOT accept free trading or restricted securities as payment for our services.
SCS LLC is not affiliated with any exchange, electronic quotation system, the Securities Exchange Commission or FINRA. SCS LLC is not a Broker/Dealer and does not engage in high frequency trading.