Si3N4



Why is everything based off one study anyways? And that study showed it had similar outcomes, not better.

The FDA had inquiries regarding the firm’s CASCADE trial, a study which compared the 24-month outcomes from the C+Csc implant. The agency had questions about the outcomes at earlier time points. In November 2016 the FDA declined to award 510(k) clearance for Valeo C+Csc.
 
Why is everything based off one study anyways? And that study showed it had similar outcomes, not better.

The FDA had inquiries regarding the firm’s CASCADE trial, a study which compared the 24-month outcomes from the C+Csc implant. The agency had questions about the outcomes at earlier time points. In November 2016 the FDA declined to award 510(k) clearance for Valeo C+Csc.

Fusion was on par with AUTOGRAFT. There isnt anything on market that fuses as fast as the patients own bone.
 
PROFIT MARGIN: FAIL
This methodology seeks companies with a minimum trailing 12 month after tax profit margin of 7%. The companies that pass this criterion have strong positions within their respective industries and offer greater shareholder returns. A true test of the quality of a company is that they can sustain this margin. AMDA's profit margin of -91.52% fails this test.
RELATIVE STRENGTH: FAIL
The investor must look at the relative strength of the company in question. Companies whose relative strength is 90 or above (that is, the company outperforms 90% or more of the market for the past year), are considered attractive. Companies whose price has been rising much quicker than the market tend to keep rising. AMDA, with a relative strength of 6, fails this test.
COMPARE SALES AND EPS GROWTH TO THE SAME PERIOD LAST YEAR: FAIL
Companies must demonstrate both revenue and net income growth of at least 25% as compared to the prior year. These growth rates give you the dynamic companies that you are looking for. These rates for AMDA (-79.28% for EPS, and -30.17% for Sales) are not good enough to pass.
INSIDER HOLDINGS: FAIL
AMDA's insiders ownership is not available at the current time. Insiders of a company should own at least 15% of the outstanding shares. A high percentage typically indicates that the insiders are confident that the company will do well.
CASH FLOW FROM OPERATIONS: FAIL
A positive cash flow is typically used for internal expansion, acquisitions, dividend payments, etc. A company that generates rather than consumes cash is in much better shape to fund such activities on their own, rather than needing to borrow funds to do so. AMDA's free cash flow of $-2.06 per share fails this test.
PROFIT MARGIN CONSISTENCY: FAIL
The profit margin in the past must be consistently increasing. The profit margin of AMDA has been inconsistent in the past three years (Current year: -122.93%, Last year: -143.15%, Two years ago: -37.16%), which is unacceptable. This inconsistency will carryover directly to the company's bottom line, or earnings per share.
 
Hearing deal fell through with zimmer only willing to go as high as $96.7 million after backing out compensation for insiders. Amedica wanted an even $120 million. Long road to bringing the tech to the market but it is possible and should be interesting to see how they do.
 
That explains the need for more money at Amedica. Didn't know it was this bad.
 
Hearing deal fell through with zimmer only willing to go as high as $96.7 million after backing out compensation for insiders. Amedica wanted an even $120 million. Long road to bringing the tech to the market but it is possible and should be interesting to see how they do.

To this all i have to say is BS .

Under the distribution agreement, Weigao Orthopedic will have exclusive rights for the sale, marketing and distribution of Amedica-branded silicon nitride spinal implants in the People's Republic of China, and will abide by minimum annual purchase requirements in Year 1 of 20,000 units, growing annually to 50,000 units in Year 6, following regulatory clearance by the China Food and Drug Administration (CFDA). Weigao Orthopedic will leverage its expertise in acquiring CFDA clearance of medical devices, in order to accelerate Chinese clearance of Amedica's products.

"With more than 50,000 minimum unit sales to occur within the first two years following CFDA clearance, this agreement far surpasses total silicon nitride unit sales to-date, and marks a momentous time for Amedica," said Dr. Sonny Bal, Chairman and Chief Executive Officer. "This partnership with Weigao Orthopedic allows us to significantly increase our global sales footprint with a large-scale distribution partner who is familiar with the Chinese regulatory landscape. Weigao Orthopedic's expertise in sales and distribution is an excellent fit for our innovative silicon nitride technology platform. We look forward to this key strategic partnership to distribute our silicon nitride technology into Asian markets that are particularly receptive to bioceramic implants."

"We are very pleased with this exclusive distributor partnership as we plan to leverage the Amedica brand to offer a truly differentiated product to our broad network of hospitals and medical units in China," stated Mr. Gong Jianbo, Chief Executive Officer and Executive Director of Weigao Orthopedic. "We expect the combination of this technically advanced biomaterial with our well-established network to quickly gain significant market share. We also look forward to expanding our partnership beyond spine products and into hip and knee applications. Weigao Orthopedic is well positioned to facilitate the approval and commercial launch of Amedica's silicon nitride spinal fusion devices in one of the world's largest healthcare markets."

http://www.amedica.com/news-media/p...edica-signs-exclusive-chinese-silicon-nitride
 
Hearing deal fell through with zimmer only willing to go as high as $96.7 million after backing out compensation for insiders. Amedica wanted an even $120 million. Long road to bringing the tech to the market but it is possible and should be interesting to see how they do.

heard the same thing, Zimmer not going over 100.
 
PROFIT MARGIN: FAIL
This methodology seeks companies with a minimum trailing 12 month after tax profit margin of 7%. The companies that pass this criterion have strong positions within their respective industries and offer greater shareholder returns. A true test of the quality of a company is that they can sustain this margin. AMDA's profit margin of -91.52% fails this test.
RELATIVE STRENGTH: FAIL
The investor must look at the relative strength of the company in question. Companies whose relative strength is 90 or above (that is, the company outperforms 90% or more of the market for the past year), are considered attractive. Companies whose price has been rising much quicker than the market tend to keep rising. AMDA, with a relative strength of 6, fails this test.
COMPARE SALES AND EPS GROWTH TO THE SAME PERIOD LAST YEAR: FAIL
Companies must demonstrate both revenue and net income growth of at least 25% as compared to the prior year. These growth rates give you the dynamic companies that you are looking for. These rates for AMDA (-79.28% for EPS, and -30.17% for Sales) are not good enough to pass.
INSIDER HOLDINGS: FAIL
AMDA's insiders ownership is not available at the current time. Insiders of a company should own at least 15% of the outstanding shares. A high percentage typically indicates that the insiders are confident that the company will do well.
CASH FLOW FROM OPERATIONS: FAIL
A positive cash flow is typically used for internal expansion, acquisitions, dividend payments, etc. A company that generates rather than consumes cash is in much better shape to fund such activities on their own, rather than needing to borrow funds to do so. AMDA's free cash flow of $-2.06 per share fails this test.
PROFIT MARGIN CONSISTENCY: FAIL
The profit margin in the past must be consistently increasing. The profit margin of AMDA has been inconsistent in the past three years (Current year: -122.93%, Last year: -143.15%, Two years ago: -37.16%), which is unacceptable. This inconsistency will carryover directly to the company's bottom line, or earnings per share.

It is pretty obvious now that everyone is waiting for Amedica to be Delisted so they can be acquired for pennies on the dollar. If you stop drinking the Amedica koolaid for a second and look what's really going on, it's a flat out mess from the outside looking in.
 
http://investors.amedica.com/press-...a-announces-adjournment-of-special-meeting-of

Uh oh... "A description of those risks can be found in Amedica's Risk Factors disclosure in its Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 23, 2016, and in Amedica's other filings with the SEC."

Isn't this the same report that's currently MISSING?? Nothing annual about amedicas 10k form. They want us to view an old one for risks?? A NO Vote from lots of us coming.
 
Markets telling us the direction its heading...to porous interbody devices. Zimmer has one in TM Ardis but performance isn't great. Is it that much of a stretch to think that Zimmer signed the Letter of Intent with Amedica in 2015 to develop a Si3N4 version of Ardis?

Nuvasive announcement of its acquisition of Vertera Spine just further validates the desire to goto porous implants.

https://www.nuvasive.com/news/nuvasive-announces-acquisition-vertera-spine/
 
Be nice to read that letter. Maybe Zimmer was just slowing Amedica down so they could make their own product. Wouldn't be the first time it's happened. Like the IPO mess, possibly signing with Zimmer in 2015 was another horrible decision this company has made. A few years later and nothing still from Amedica, yet Zimmer isn't losing market share.
 
Be nice to read that letter. Maybe Zimmer was just slowing Amedica down so they could make their own product. Wouldn't be the first time it's happened. Like the IPO mess, possibly signing with Zimmer in 2015 was another horrible decision this company has made. A few years later and nothing still from Amedica, yet Zimmer isn't losing market share.

The PR is linked here. Zimmers has a measly 6% market share in spine. Lots of room to grow. LDR boost revenue but has been flat since acquisition.

Zimmer is also working with Amedica on hip just like this anonymous poster said they would 6 years ago. This has also been linked here.


http://spineblogger.blogspot.com/2011/05/whos-next.html?m=1
Jdki1HG.jpg
 
A hip is years away still if that's even happening. Nothing's been filed with the FDA, that's gonna take a long time once it starts. Problem with that is Amedica might not a company by then, things are falling apart internally as you can see with current issues with FDA and SEC.
 
A hip is years away still if that's even happening. Nothing's been filed with the FDA, that's gonna take a long time once it starts. Problem with that is Amedica might not a company by then, things are falling apart internally as you can see with current issues with FDA and SEC.

Lol

Taken together, this favorable combination of properties, supported by scientific data, reflect material science advancements that are necessary to differentiate total hip replacements in an otherwise commoditized market, and more importantly, toward extending the longevity of hip replacements beyond the second decade of life, post-implantation. These data will contribute to our continuing work and dialogue with the FDA to get the product approved for use clinically."

If clearance is eventually obtained, we intend to commercially launch products for use in total hip replacement in 2018 or 2019.


Our Total Knee Implant Product Candidates



We have developed a femoral condyle design made from our solid silicon nitride. The femoral condyle component will attach to the lower end of the femur. The femoral condyle is expected to articulate against a cross-linked polyethylene tibial insert that will attach to the tibial tray at the upper end of the tibia, which we expect will be made from metal. We have successfully made prototypes of this design. Following the potential clearance of the femoral head components (discussed above), we intend to initiate biomechanical testing with a strategic partner for silicon nitride components for use in knee replacement procedures to support a 510(k) submission to the FDA. If this clearance is eventually obtained, we intend to commercialize our products for use in total knee replacement surgeries post-FDA clearance.
 


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