New Employees and R&D

Alot has happened since my last post including Amedica selling off its spine sales unit and changing its name to Sintx. Still the underlying thesis still stands with more connections being discovered, the biggest of which is the hire of Senior Research Engineer Dr. Saurabh Lal, PhD.

Saurabh Lal

Senior Research Engineer

Zimmer Biomet

– Present 1 year 4 months

Biological Impact of Silicon Nitride for Orthopaedic Applications: Role of Particle Size, Surface Composition and Donor Variation

Published: 14 June 2018

Irrespective of the particle size, silicon nitride did not cause any adverse responses whereas cobalt-chromium wear particles caused donor-dependent cytotoxicity, TNF-α cytokine release, oxidative stress, and DNA damage in PBMNCs after 24 h. Despite being similar in size and morphology, silicon dioxide nanoparticles caused the release of significantly higher levels of TNF-α compared to silicon nitride nanoparticles, suggesting that surface composition influences the inflammatory response in PBMNCs. Ti-6Al-4V wear particles also released significantly elevated levels of TNF-α cytokine in one of the donors. This study demonstrated that silicon nitride is an attractive orthopaedic biomaterial due to its minimal biological impact on human PBMNCs.

Dr. Lal has many publications pertaining to Silicon Nitride and the use of it as a coating on metals. This was done while Dr. Lal was working on the LifeLongJoints project in the EU. Zimmer has hired several Research Engineers with experience working with Ceramics, antibacterial materials, porous ceramics, and even a microbiologist whom is part of the anti-infection technologies team in Swindon, UK. Dr. Lal also works at the Swindon location and he maybe part of the anti-infection team. There are several personnel hired since 2018 working in Swindon with specific talents that align with working with Silicon Nitride. I have profiled this elsewhere over the last 2 years.

On a slightly different note, Zimmer hired in 2018, an individual that worked with Dr. Ball and Dr. Pezzotti as a research assistant. The project encompassed infusing Silicon Nitride into PEEK to increase its ostoeconductivity and ability to resist bacteria. Last checked, she worked for Zimmer Biomet as a Supply Chain Specialist in Italy.

Lastly, before switching over to Sintx Technologies, formerly Amedica, there was several postings that Zimmer Biomet posted on Linkedin in 2018:

Research Sr Engineer II (607126)
inApply with LinkedIn®
|more
Requisition NumberAMER12944
Employment TypeFull-time
LocationWarsaw
Job Summary
Provides advanced technical support towards the accomplishment of research and product development team objectives. Incumbent will be responsible for several research and testing projects relating to the thermomechanical processing of metals and ceramics

One example of thermomechanical processing of metals and ceramics is Selective Laser Sintering.

While this was happening over at Zimmer, Sintx has been studying their tech in combination with what was Biomet’s tech before the merger in 2015. For example, there was this in 2017:

 

completed a five million cycle (Mc) comparative hip simulator study examining the wear behavior of an advanced highly cross-linked and vitamin E stabilized polyethylene (E1® Zimmer-Biomet, Warsaw, IN, USA) against two different types of ceramic femoral heads — MC2®silicon nitride (Amedica Corporation, Salt Lake City, UT, USA) and BIOLOX®delta (CeramTec, Plochingen, Germany).

Amedica Announces Results of Independent Femoral Head Wear Testing

In 2019, Sintx was awarded a patent which also referenced testing MC articulating against Stryker’s X3 liner & Biomet’s E1 liner. This sort of testing is not abnormal, but what does seem out of place was this:

Although a direct comparison between the two types of UHMWPE liners (i.e., X3 v. E1®) has yet to be made, it appears that the amount of surface oxidation associated with the E1® liners was about one order of magnitude lower than the X3 in spite of the fact that the E1® liners had ~10 times the number of testing cycles. Nevertheless, an increase in the oxidation index for the E1® liners coupled to ZTA heads was a tangible result of this Example. With 5 million cycles being kinematically equivalent to about 2.5 years in vivo , it appears that addition of vitamin-E does not completely eliminate liner oxidation in artificial hip joints coupled to oxide ceramics.

METHOD FOR IMPROVING THE WEAR PERFORMANCE OF CERAMIC-POLYETHYLENE OR CERAMIC-CERAMIC ARTICULATION COUPLES UTILIZED IN ORTHOPAEDIC JOINT PROSTHESES

It is not odd to state one product seemed superior than another, but unless you have an interest in the product, it seems odd to go into details how liner is superior than another. Especially considering that Zimmer Biomet donated said liner in a previous test.

The patent shows that Sintx MC2 is superior articulating against both liners because of its ability to scavenge oxygen from the liner while Biolox releases oxygen into the liner enhancing degradation.  Still, MC2 articulating against E1 was even better as E1 liners resist oxidation.

So far, we have seen Sintx testing its femoral head against a donated Zimmer-Biomet Vitamin-E liner. However, the testing of Sintx IP and ZB IP doesnt stop there. Below is a paper Sintx published showing Si3N4 coated G7 acetabular shell. Sure, its a commercially available shell but why choose a shell that E1 liners are FDA cleared to be used with? All thats needed is to apply this same coating to the femoral stem, which according to their twitter feed they did do.

Our team even coated an entire prosthetic hip implant with silicon nitride, and as shown in the paper, the coated implant repelled bacteria. This #breakthrough technology widens the application of silicon nitride onto other material platforms.

Silicon Nitride coating on orthopaedic titanium substrate

 

3D-additive deposition of an antibacterial and osteogenic silicon nitride coating on orthopaedic titanium substrate

Coated G7 Shell.jpg

Coated Titanium -Bacterial Resist.jpg

 

 

SiNTx Technologies, moving beyond Orthopeadics

As i posted earlier, Sintx Technologies was Amedica Corporation. The name change was the result of selling off the Spine sales Unit. This sale involved selling off the old Valeo brand but did not include their core IP, Silicon Nitride. The other reason for name change was rebranding to reflect a fundamental shift in scope of IP. No longer was Amedica’s Si3N4 restricted to just orthopedic applications. No Sintx Si3N4 has been found to be one of the strongest formulation of Si3N4 on the market. This has opened up new markets in Aerospace, Defense, automotive, & even engery conversion technology. These markets are also opening up for Sintx because they are working on a formulation higher thermal resistance than whats currently on market.

As if this wasnt enough, Dr. Pezzotti also found that Sintx Si3N4 is effective against viruses and fungi. This is in addition to the fact that Sintx Si3N4 is also antibacterial making it a truly antimicrobial material.  This discovery opens new markets in medical supplies, filtration, pharmacology, and even agriculture. I’ll add more to this in the future.

 

Index Page

This blog post will hold direct links to each of my pertinent posts. I’ll update it with with links to new posts and i’ll indicate when a post has been updated. This way you’ll know when there is something new to look at. If you are going to bookmark my blog, this is the page to do so.

Zimmer and Amedica

  1. Exposè on the failure of Zimmer’s Trabecular Metal, how Si3N4 can fill the void, & the future (Posted: September 11, 2017. Last Update: None)
  2. Certain R&D Related Expenses (Posted: September 12, 2017. Last Update: September 29nd, 2017)
  3. Zimmer & Amedica Connections via Personnel (Posted: September 12, 2017. Last Update: September 13th, 2017)
  4. Steps Taken in Preparation for Acquisition (Posted: September 13, 2017. Last Update: None)
  5. CNS & NASS 2017 Collaboration or Union? (Posted: September 14, 2017. Last Update: None)
  6. Six Degrees of Zimmer-Biomet (Posted: September 29th, 2017. Last Update: February 24th, 2018)
  7. Certain R&D Agreements Part 2: Natural Bone Regeneration (Posted: October 30th, 2017. Last Update: None)
  8. Comparable Company Analysis (Posted: November 6th, 2017. Last Update: None)
  9. Pertinent Filings & Press Releases (Posted:November 9th, 2017.Last Update: November 21st, 2017) Updated as relevant news is released.
  10. De-Risk: Another Step in Preparation for Acquisition(Posted: November 27th, 2017. Last Update: None)
  11. Conclusion Part 1: Timeline of Events  (Posted: December 3rd, 2017. Last Update: 1/21/2018)
  12. Conclusion Part 2: Inside Men, a Commentary (Posted: December 7th, 2017. Last Update: None)
  13. Amedica’s Three Year Audit (Posted: December 24th, 2017. Last Update: 1/21/2018)
  14. Zimmer’s Q4 Conference Call(Posted: February 3rd, 2018. Last Update: February 26th, 2018)
  15. Q4 & 2017 Revenue (Posted: February 22nd, 2018. Last Update: March 30th, 2018)
  16. Five Year Joint R&D Agreement (signed 2015) (Posted: April 2nd, 2018)
  17. Amedica’s Corporate Strategy, Need I Say More? (Posted: May 22nd, 2018)

 

Most Recent Update: Q4 & 2017 Revenue(Updated: March 30, 2018)

Silicon Nitride (Si3N4)

  1. Why Material Matters! (Posted: September 18, 2017. Last Update: None)
  2. Porous Fusion Device (Posted: October 13, 2017. Last Update: None)
  3. Amedica’s Silicon Nitride: Current and Potential Markets (Posted: December 10, 2017. Last Update: None)

Not Zimmer & Amedica related

Outside the Z&A box

Amedica’s Corporate Strategy, Need I Say More?

Our current corporate strategy includes the possibility of entering into additional collaborative arrangements with third parties to expand and improve the commercialization of all our products, including our silicon nitride ceramics. Consistent with this strategy, we continue to seek to identify opportunities and, if possible, secure a transaction or transactions relating to our business, including, but not limited to, partnering or other collaborative agreements, a sale of the Company or of assets and/or other strategic arrangements. There can be no assurance that the exploration of strategic alternatives will result in any agreements or transactions, or that, if completed, any agreements or transactions will be successful or on attractive terms. If we are unable to successfully execute a strategic transaction we may be unable to continue as a going concern.

4/25/2018 S-1/A pg 1

The above paragraph has not been present in any filings until the S-1/A filed late April. If you recall, Amedica hired Ryan Long November 2016 from Zimmer & this is essentially his job as Director of Strategic Development.

  • Mergers and acquisitions, including setting objectives {7}, sourcing {4}, funding {2}, negotiation {4}, and post-deal integration {4}
  • Oranization and management of due diligence projects (not necessarily all related to M&A activity) {7}
  • Partner management, including alliances, joint ventures, and distribution partnerships {7}

Steps Taken in Preparation for Acquisition

After 2 years of preparation, why reveal now their intention of selling the company? I’m not sure but it could have to do with the newest patent Amedica was awarded in March in the US.

SALT LAKE CITY, March 30, 2018 (GLOBE NEWSWIRE) — Amedica Corporation (Nasdaq:AMDA), an innovative biomaterial company which develops and manufactures silicon nitride as a platform for biomedical applications, is pleased to announce the issuance of a key material and process patent. US patent 9,925,295 was issued to Amedica March 27, 2018, covering “Ceramic and/or glass materials and related methods.” The patent covers various methods for improving the antibacterial, osteoconductive, and osteoinductive characteristics of silicon nitride and other ceramic materials, particularly to make them more suitable for use in manufacturing a variety of biomedical implants. Amedica now has 59 US patents and 6 foreign patents.

“This patent reflects the scientific inquiry and accomplishments in which Amedica has invested heavily during the past few years. Other biomaterials usually require surface textural engineering to make them suitable for applications such as spinal fusion. Silicon nitride is unique in having a favorable nanostructure in the “as-fired” state already. Therefore, our focus has been to move beyond surface topography toward engineering the precise surface chemistry of silicon nitride through thermal, chemical, and/or mechanical treatments to achieve a broad-based material platform that has applications throughout the biomedical space. The innovative strength of this patent has attracted several potential developing partnerships with other companies, both in spine and outside. From an intellectual property standpoint, this patent alone contributes to the lasting and refreshed value in Amedica, specifically our scientific knowledge and our ability to modify and control the material toward specific, desired product applications.” said Dr. Sonny Bal, CEO and Chairman at Amedica.

Not that i’m fluent in patenting, but there has been an evolution of this patent over the last 2 years. This, being the culmination I assume, shows the wide ranging applications of Si3N4 to include markets I had not covered in my blog post, Amedica’s Silicon Nitride: Current and Potential Markets. I have, since this patents release, added only the potential catheter market just to further illustrate the reach of this material and Amedica’s R&D achievement.

Here is a list of potential applications as indicated in the patent received March 27th, 2018.

The inventive techniques disclosed herein, including but not limited to the silicon nitride coatings and roughened surface finishes, may be applied to any number and type of biomedical components including, without limitation,spinal cages, orthopedic screws, plates, wires, and other fixation devices, articulation devices in the spine, hip, knee, shoulder, ankle and phalanges, catheters, artificial blood vessels and shunts, implants for facial or other reconstructive plastic surgery, middle ear implants, dental devices, and the like. Ceramic and/or glass materials and related methods

The potential scope & the proven benefits truly show how much this material could be worth in the hands of one or multiple companies. If Amedica wasn’t going to sell themselves they should have gone the route of a IP company collecting royalties like Invibio. No need to manufacture or sell products, just license IP. I guess this could now be accomplished with this recent patent. As i’ve pointed out repeatedly however, I believe one company will get their hands on this particular IP. Still, if you look at Amedica’s recent filings you’ll see there is the possibility of hostile acquisitions despite Amedica’s layers of anti-takeover provisions.

I hope to one day see Zimmer acquire this tech and push it to market. If they don’t manage to I hope another company pushes the tech to its fullest.

I’ll be updating my Why Material Matters! blog post this week to further illustrate the advantages of Si3N4 and the disadvantages of other current ortho materials.

Outside the Z&A box

Phase II

Within a week of the announcement of M&A, i’ll add a new blog post here to usher in early stages of phase II.

Phase II will give people the opportunity to follow my research in a private forum as i branch out from Zimmer/Amedica. The forum will not be up and running right away as I had intended to take a break after announcement. However I recently found another company that looks to be positioning itself for merger. Now i’ll have to move faster than I  originally intended. The window on this potential merger is unclear at this time but there is a good opportunity to buy before they begin increasing revenue from their recent sales & manufacturing expansion. I hope to actually fly out to talk with members of the company in the future. This will work to take my research to the next level.

In addition to this company I have another research project I am doing that could be extremely valuable in the future but will take sometime to develop. I am still collating data on this as there is a lot of information to sift through, understand and compile.

I ‘ll continue to cover Silicon Nitride in my forum however as I intend to stay invested long into the future.

 

Forum

I have not determined exactly what format i’ll utilize but the forum will be invite only with a collection of mine and potentially others research. I intend on building upon what I have tried to do up to this point. That means that this forum will also have a social component where we can exchange ideas and provide constructive feedback to each other. The ultimate goal is a forum that is mutually beneficial for each member without the more unsavory elements of other social platforms. The focus of this forum will be on companies and products that are beneficial to society while also providing an opportunity to increase our trading accounts. For instance you will not see me covering bitcoin or any other digital currency as I do not believe these products benefit society. To me it actually highlights the more negative aspects of society.

 

Amedica Blog

This blog will remain live and open for all of those that wish to look deeper into their investments. This blog was always intended to be used for educational purposes. I hope everyone uses this as a springboard for their future research endeavors. Build upon what I have shown & learn from the missteps I made along the way.

‘May the fires of knowledge ignite you & the waters of wisdom help guide you.’


 

Click this link to access each one of my blog posts:

Index Page

 

Five Year Joint R&D Agreement (signed 2015)

When reading this blog post, make sure to keep Zimmer CEO Bryan Hanson’s statement during its Q4 CC in the back of your mind:

In terms of our innovation capabilities, Zimmer Biomet is uniquely positioned to leverage platform technologies across our entire portfolio, including advanced proprietary materials and surgical robotics applications. As a company, we plan to build on this foundation. We will have an unwavering emphasis on patient safety and quality excellence, creating an engaged and innovative workplace and working to position the company to deliver top quartile total shareholder returns.

Zimmer Biomet’s (ZBH) CEO Bryan Hanson on Q4 2017 Results – Earnings Call Transcript


Amedica’s R&D Agreement

Hidden at the bottom of Amedica’s 2016 10k pg F-25, strangely missing from Amedica’s 2015 10k, you can find the following quote:

On May 13, 2015, the Company entered into a joint agreement for research and development of silicon nitride based devices. This agreement is effective for a period of five years from the date of commencement. The Company incurred payments of $270,000 and $270,000 related to this agreement for the years ended December 31, 2016 and 2015, respectively.

2017 10k pg F-27, says pretty much the same thing but I think they made a mistake in the amounts paid:

On May 13, 2015, the Company entered into a joint agreement for research and development of silicon nitride-based devices. This agreement is effective for a period of five years from the date of commencement. The Company incurred payments of $0.03 million related to this agreement for each of the years ended December 31, 2017 and 2016.

Since they paid 270,000 in 2016 I think they meant to say they incurred payments of $0.3 million 2017 & 2016.

In 2015 Amedica entered into a R&D agreement with an entity, but whom? If you’ve been following my blog at all you know I believe this is with Zimmer. Of course for it to be with Zimmer, Zimmer should have evidence of agreements on its 10k as well right?

We have entered into various agreements that may result in future payments dependent upon various events such as the achievement of certain product R&D milestones, sales milestones, or, at our discretion, maintenance of exclusive

39


rights to distribute a product.  Since there is uncertainty on the timing or whether such payments will have to be made, we have not included them in this table.  These payments could range from $0 to $61 million.

Zimmer Biomet 2017 10K

This language as been present in Zimmer for years so this is not a smoking gun. However, the above information shows the R&D agreement between Zimmer & Amedica to be very possible. In fact, in 2017, Zimmer paid $2.5 million payment Q2 to one of the companies it has an agreement with. I cover this in my blog post Certain R&D Related Expenses. However Amedica, at no point, shows as receiving said $2.5 million payment. However, July 2017, Amedica’s CEO Sonny Bal loans Amedica $2.5 million via his LLC, North Stadium. If in fact this is the same 2.5m, this would be considered a backdoor payment and a great way to preserve the appearance that there is no relationship between companies; despite the preponderance of evidence that suggests otherwise.


 

What might a joint R&D Agreement look like?

Lets look at how a deal might be structured by examining a joint R&D agreement between RandH Co and AQ:

BACKGROUND

1.1. AQ has conducted research in the areas of biopesticide microbials and
biochemicals to develop environmentally friendly natural pesticide
products. From this microbial and biochemical research initiative, AQ
has identified a number of product leads.

1.2. RandH possesses considerable expertise in research, development,
registration and commercialization of agricultural chemical products.
Using this expertise, RandH is interested in assessing AQ’s product
leads to identify those materials which RandH and AQ, will develop,
register and bring to market.

1.3. To advance these goals, RandH and AQ have determined to enter into a
commercial relationship regarding the future development, registration
and commercialization of AQ’s product leads.

Research and Development Agreement – Rohm and Haas Co. and AgraQuest Inc.

Right off the bat we see that AQ has the IP and RandH has the expertise just like an agreement between Amedica & Zimmer would likely say.

What about IP, how is that handled?

AQ is obligated to, at AQ’s expense, prepare and file one or more patent
application(s) for any Lead Candidate(s) and Improvements and is obligated to
pursue Patent Prosecution of such patent application(s) and patent(s) which
issue from such application(s). AQ shall pursue any Patent Prosecution in a
manner that it in good faith believes to be scientifically and commercially
reasonable; provided, however, that (i) AQ shall determine in consultation with
the Joint Project Team the timing and manner of such Patent Prosecution and the
amount of resources, personnel, and effort, devoted by AQ to such Patent
Prosecution, patent protection or the scope of the protection afforded by any
allowed patent claim and (ii) provided that AQ diligently and in good faith
pursues Patent Prosecution of a particular Lead Candidate, AQ shall have no
liability or obligation to RandH for the failure to obtain any patent protection
relating to any Lead Candidate or the scope of the protection afforded by any
allowed patent claim. AQ shall pursue the prosecution of any actual or alleged
infringement by a third party of any of the Licensed Technology (as defined in
Section 9.1 below).

AQ is obligated, at its expense, to do everything it can to protect any IP developed and that all IP would remain AQ’s. RandH would essentially provide guidance to aid AQ in properly protecting IP. RandH would also aid AQ in discovery and prosecution of any potential patent infringers as spelled out here:

RandH shall cooperate with AQ’s efforts regarding the Patent Prosecution,
notify AQ of any possible claims of infringement of the Licensed Technology and
cooperate with AQ in the prosecution of any actual or alleged infringement by a
third party of any of the Licensed Technology.

While RandH has no claims over any IP, it has exclusivity over Lead Candidates:

5.2. Exclusivity; Reservation of Right.
———————————-

(a) AQ shall not work, collaborate or coordinate with any third party to
develop a Lead Candidate or any analog or homolog of a Lead Candidate as a
Biopesticide, unless such Lead Candidate (i) has been abandoned by RandH as
provided at section 6.1(c) herein or (ii) is within AQ’s Field. Any such work,
collaboration or coordination shall be considered a material breach of this
agreement.

(b) Notwithstanding anything herein to the contrary, AQ reserves the right
to conduct research and development in conjunction with third parties on analogs
and homologs of Lead Candidates which do not and will not qualify as
Biopesticides.

If Zimmer has exclusivity with Amedica how could Amedica collaborate with outside companies? This is where the OEM model comes into play. Amedica isn’t developing product candidates with other companies, its simply converting a product already designed by those companies to a Si3N4 version. This would fall outside of the scope of Lead Candidates or products.

Whats the result of this joint R&D? That Si3N4 went from being developed for products in spine, hip, knee & maybe dental to:

Such materials may be useful in, for example, manufacturing biomedical implants, such as intervertebral spacers or other spinal implants, orthopedic screws, plates, wires, or other fixation devices, articulation implants in the spine, hip, knee, shoulder, ankle or phalanges, catheters, implants for facial or other reconstructive plastic surgery, dental implants, and the like.

That’s quite the expansion of applications plus Si3N4 has been improved through manufacturing techniques that increases its osteointegration and antibacterial properties. Not to mention expanding manufacturing to include 3D printing. Do people honestly believe that Amedica did all this by itself over the last 3 years while development was slow the previous 9 years (2006-2015).


Benefits of Joint R&D agreements

Outside of developing product candidates with a competitor, another benefit of R&D agreements is it provides protection from antitrust lawsuits.

Protection against legal challenges under Sherman and Clayton Antitrust laws is a significant benefit for members of NCRPA-approved, R&D joint ventures. In fact, no successful lawsuit has ever been filed against an NCRPA-approved R&D joint venture. Why? A “rule of reason” antitrust analysis shelters these protected collaborative activities. Without NCRPA protection, a more general “per se” viewpoint is used, where the behavior itself can be deemed to violate antitrust law. Also, if a violation occurs, the claimant can only receive actual damages, rather than treble damages available without NCRPA protection. This is a powerful deterrent against lawsuits.

Legal protections aside, R&D joint ventures can conduct a wide variety of activities, including:

  • perform theoretical analysis, experimentation or testing of basic engineering techniques
  • extend investigative findings into practical application for experimental and demonstration purposes
  • conduct experiments on models, prototypes and processes
  • perform product certification testing
  • collect, exchange and analyze research or production information

What You Need to Know about R&D Joint Ventures

This would give blanket protection for the above activities. It also means that any actual product development would likely require a Merger, Joint Development Agreement or formation of a co-owned company to commercialize product(s).

This would likely mean that the LOI in 2015 was not signed with Zimmer as i thought. However, it may have been signed with a company that’s now under Zimmer’s umbrella.

Spotlight On…

Published on Thursday, July 23, 2015

Amedica signs additional OEM letter of intent supply agreement: 5 things to know


Amedica, a biomaterial company of orthopedic implants, signed an original equipment manufacturer letter of intent supply agreement with an orthopedic device design and manufacturing company.

LDRTeam Spotlight On

Also i recently updated in my blog post, Zimmer & Amedica Connections via Personnel, that Amedica’s recent clinical study was conducted by a consultant of LDR & Biomet.

Dr. Hieu Ball, MD

Dr. Hieu Ball was the Principle Investigator for Amedica’s 3 year Clincal study:

Accelerated Cervical Fusion of Silicon Nitride versus PEEK Spacers: A Comparative Clinical Study

2015 Consulting revenue from LDR & Zimmer Biomet – $92,500

2014 Consulting revenue from LDR, Biomet, & Amedica – $107,000

*Dr. Hieu Ball has also has received royalties from Depuy, and smattering of compensations/reimbursements from other companies. Most of his revenue has come from consulting for Zimmer-Biomet + subsidiaries 2014 onward.

All 3 of Amedica’s clinical studies ran by surgeons that consult for Zimmer-Biomet.


Is this study an example of Joint R&D research:

PolyLinerStudy.jpg

Giuseppe Pezzotti is an integral player in Amedicas research team and here he’s doing research on Zimmer’s liners which is also being tested with Amedica’s femoral head. Would you classify these studies as examples of R&D agreement?


Is a R&D Agreement with University a possibility?

Ownership
“UW IP” means Intellectual Property developed solely by UW Personnel. “Company IP” means Intellectual Property developed solely by Company Personnel. “Joint IP” means Intellectual Property developed jointly by Company Personnel and UW Personnel, as determined in accordance with US Patent Law. In the case of works subject to copyright, Joint IP shall mean only those works in which UW and Company intend that their contributions be merged into inseparable or interdependent parts of a unitary whole. “UW Background IP” means Background IP in the possession of UW. “Company Background IP” means Background IP in the possession of Company. UW and Company shall not, by performance under this Agreement, obtain any
ownership interest in the other parties’ Background IP. RESEARCH AND TECHNOLOGY DEVELOPMENT AGREEMENT

As you can see joint R&D efforts with university opens up potential for IP issues as university has claims over anything jointly created.

Kyoto University provides an alternative to joint R&D efforts that could aid in preventing joint IP issues.

The university provides a system for researchers from private companies and from the university to collaborate on research subjects of mutual interest in an equal partnership. Under this system, the companies and the university mutually pool researchers, research expenses, and facilities so that the human resources and R&D capability of the university can be effectively used. Depending on the type of research, the following two methods are available:

Forms of Collaboration

There are two main forms of collaborative research, illustrated below.

Forms of CollaborationPattern 1 The university hosts a researcher from a private company and collaborative research on a subject of mutual interest is conducted on campus.

Assuming Amedica is using Pattern 1 it is unlikely that there would be an issue from this as Pezzotti would be the Principle Investigator with Kyoto personnel taking more of an aid role for better understanding of the research being done. This would seem to be more of a partnership than a joint venture.

IP Terms and Conditions

Determined based on the researchers’ contributions. The terms will be established in a collaborative research agreement.

While a R&D agreement with a university is possible, there is a potential for IP issues as any IP developed by the university the university would have rights to. However a R&D agreement structured similarly to that of RandH Co with AQ would allow for Amedica to maintain its IP integrity. Logically this sort of arrangement makes the most sense. Zimmer would have first rights to distribute any developed candidates securing both parties. This is pretty much exactly what Zimmer did with Implex back in 2000.


Links to all my blog posts can be found here:

Index Page

Zimmer’s Q4 Conference Call

Although the pacing may not be what you expected or hoped for, I’m 100% confident that the end game is going to be something you’re going to be very happy about. I’m looking forward to connecting with you between now and earnings call, I’m sure, through various events, but really looking forward to connecting on the first quarter earnings call as we give guidance for 2018~Bryan Hanson

This particular quote, and all quotes on this blog post, can be found in the transcript provided by Seeking Alpha. Here Hanson alludes to various events occurring in the first quarter of 2018 where Hanson will be corresponding with investors; events that correlate with some sort of end game.

I will just give you my viewpoint on it, Kristen and then Dan, he will provide any color. When I look at this as I’ve mentioned, there are a lot of moving pieces and parts right now, pretty material events that need to happen here over the relatively short term. And until we get through some of those and in either one burn down risk as a result of passing those milestones or experience risk, I think that we just want to be cautious in giving you guidance until we get a little smarter on those topics.
And the only thing that’s going to make us smarter beyond the assumptions that we made is actually pushing through the milestones and experiencing the good or the bad. And when we get to the earnings call after Q1, we’re going to be a lot smarter on that topic. And so we’re really just trying to enable guidance for you that is more realistic and more informed and that’s the reason why we’re delaying. There isn’t a specific thing. There are a number of things that are pushing us in that direction. ~Bryan Hanson

In this quote, Hanson mentions that Zimmer has to get through some “pretty material events” which correlates with the previous quote where he also talks about various events. These events need to occur and only after they occur can Hanson/Florin give proper guidance for 2018. Hanson also says that by Q1 conference call, these things will come into focus enough for them to give said guidance. What material events must occur during this quarter that impact financials to the point they cant disclose yet? Sounds like a pretty major event to me with long-term revenue impact!

then I do want to take a step back and take a look to say, are we in the right markets to allow for a better weighted average market growth and ultimately through that weighted average market growth, allow us to grow in that mid-single digit growth rate at some point in the future, because that’s the only way you’re going to get to double digit EPS growth on a consistent basis. And so I don’t want to go there yet. I’m not always patient, but right now I’m trying to be patient, put that on the back burner. Let’s get to health first and then ultimately let’s take a look at the portfolio and make the right decisions. So hopefully that answers your question. ~Bryan Hanson

The goal is to get to mid-single digit growth so company can achieve double digit EPS growth for its investors. Hanson wants to make the right decision in regards to their portfolio to achieve this. But how?

In terms of our innovation capabilities, Zimmer Biomet is uniquely positioned to leverage platform technologies across our entire portfolio, including advanced proprietary materials and surgical robotics applications. As a company, we plan to build on this foundation. We will have an unwavering emphasis on patient safety and quality excellence, creating an engaged and innovative workplace and working to position the company to deliver top quartile total shareholder returns.

Hanson could very well be explaining how they plan to achieve the mid-single digit growth, through leveraging platform technologies like an advanced proprietary material across its entire portfolio (this sounds like Silicon Nitride to me)! Whatever the materials might be, it will aid Zimmer in delivering returns for shareholders in the top 25%.

We’re going to have a biased near-term growth I think you guys would want that as well, but inside of it we’re still going to make sure that we earmarked money for research and development. We’ve got to spend more on research and development and bring on innovations that don’t just help us in the near term, but also help us in the longer term. So, some of the money will go to R&D and unfortunately, there will be a longer tail to the impact of that from a revenue recognition standpoint. But that will be where some of the money goes.~Bryan Hanson

Here Hanson tells investors that Zimmer must invest in R&D & bring on innovations that will drive the mid-single digit growth he mentioned earlier. It seems whatever the R&D is, its significant but it will take time before it can really impact revenue; not impact short-term revenues as much as long-term.

We expect improvement from our Q1 sales growth rate as the year progresses, driven by the normalization of billing days, increasing supply levels as we progress through the year, enhanced commercial execution and to a lesser extent, the contribution from new product launches. Importantly, these new product launches should create momentum for our sales teams as we exit 2018 and enter 2019.~Bryan Hanson

In addition to sales recapture, we will also be focused on the significant number of commercial releases we have scheduled in 2018, including the critical additions of cementless and revision systems for our Persona knee family as well as the limited launch of the robotic application for knees.

This pertains to the long tail Hanson mentioned in the last quote. That their R&D efforts will create momentum as 2018 comes to a close and 2019 kicks off with a significant number of products launching 2018.

Recently, Amedica released a Business update:

The product pipeline was prioritized and defined for 2018 and beyond, with the goal of launching several new products in 2018. Business Update

Do you not find it interesting that both Zimmer & Amedica have several & significant products launching this year?

Second piece is, we’re going to launch these products, excellent product pipeline that I’ve talked about and we got to get to full launch as quickly as we can. I’m seeing that as being somewhere in the mid-2019 timeframe but that has to happen and we’ve got to do it effectively, right?
…..
I already said the pipeline is really full swing in mid-2019 and anyone who’s done any kind of a culture change knows that it takes time. We’re having immediate impact in this area. We’re going to get quick results out of the gate, but to make it sustainable, it’s just going to take time. It’s a continuous improvement game. So when I just kind of put all those things together, I think realistically the way we should be thinking about this is a gradual recovery towards market growth if you will through 2019.

Here again Hanson talks about excellent product pipeline with full launch by mid 2019.

Snap953.jpg

On pg 13 of Amedica’s 2016 10K/A you’ll see this reference to their Total Hip implant launching 2018 or 2019. I thought this was worth mentioning.

These excellent products in development are going to give Zimmer quick results out of the gate but will only gradually impact their overall revenues until mid-2019.

In terms of strength in the US market, we call that Asia-Pacific. Asia-Pac, really since the merger closed, continues to post above market growth on a consistent basis. The team is driving excellent execution in Japan, China, other countries as well. ~Dan Florin
Outside the general narrative of the other quotes, I thought i would highlight this quote by CFO Dan Florin as he emphasized the Japanese & Chinese markets in terms of global growth. Of course these are 2 markets Amedica has applications pending for its Valeo product line.
Yeah. Probably, one of the and I’m not going to get into too much detail, but I think just probably when we think about supply recovery, which I think all of us would agree is one of the most important components of that revenue acceleration we’ve been talking about, the first and foremost, you’ve got to again kind of bifurcate the activities that we’ve got in place, one of these is taking those processes that are most important to us with high volume products that are non-automated in the North campus and moving them to contract manufacturing that ultimately have a more automated process, proven track record of supplying products like these for others in the industry and transitioning that volume to them. ~ Bryan Hanson
Moving away from revenue focus we move over to supply side of things. Here Mr. Hanson talks about moving to contract manufacturing with vendors that proven record of supplying products like these in OTHER INDUSTRIES! Reading this screamed Kyocera, NGK, & Morgan Ceramics who all produce Si3N4 products for other industries.
Just inside that one piece, that has to go right, this is not just one or two codes, these are families of codes. There’s a lot of the SKUs that have to go through this process. There is a verification, and validation process that ensues. And there’s nothing you can really do to speed this up. It’s time sequence because a lot of it would be like fatigue testing for instance for an implant, but you can get through a million different iterations or movements with this product to check speed testing, find out that it fails, because you got to get 5 million. Then you got to find out why it failed and restart the whole process.So verification and validation is something that sounds very easy and ultimately we will absolutely get through it, but things always go wrong inside of that and you got to restart the clock as a result. So one of the biggest things that I’m focused on is what is our target dates associated with families that we have that we’re moving out on that verification and validation timeframe, when do we think that should close, right? And so when we hit those and we passed them and that will be, we should hit all of those before the quarter earnings call. And so we’ll get a lot smarter on whether or not we had major issues or not. ~Bryan Hanson

This final quote Hanson talks about some of their struggles with product testing of implants they are moving to contract manufacturers. This may have delayed plans some but ultimately they plan to hit their target dates before Q1 earnings call!


Conclusion

There isn’t much to be said that I haven’t already said. I just think its interesting that they suddenly mention their stellar product line currently in development. Go back and read their previous conference call transcripts…nothing. They’ve been keeping these products under wraps for sometime. We can see cracks forming on Zimmer’s side as time is coming to a close. We have Hanson assuring his investors that they will be very pleased with Zimmer’s end game, some sort material event or events will require their interaction with major investors during this quarter, major investment in R&D, & multiple product launches that are key to Zimmer’s viable growth 2019 onward!

Now combine the above quotes with all the information contained in this blog and you should see what I see. Zimmer is in bed with Amedica and should announce the definitive agreement this quarter.

Another important point is that Zimmer believes that these new products will drive significant revenue to yield solid steady returns for shareholders, in the top 25%. If these products are made out of Silicon Nitride as I believe, then Silicon Nitride will be a major driver of revenue for Zimmer into the future. This should increase the offer price for Amedica substantially! Goto this link if you want to understand the value of synergy which should be a significant portion of Amedica’s valuation & Zimmer’s/Amedica’s combined valuation.


Update

I already alluded to this in this blog post but its definitely more compelling visually pointed out. Here it is, provided by a fellow researcher:

Talk about yearly guidance…why there is no guidance for 2018 yet??? Still can’t figure out how much Amedica tech will help Zimmer to boost up revenue in 2018!

Full Year 2012 Report:

The Company expects full-year revenues for 2013 to increase between 2.5% and 4.5% on a constant currency basis.

https://www.sec.gov/Archives/edgar/data/1136869/000119312513031002/d475932dex991.htm

Full Year 2013 Report:

The Company expects full-year revenues for 2014 to increase between 3.0% and 5.0% on a constant currency basis.

https://www.sec.gov/Archives/edgar/data/1136869/000119312514027376/d667348dex991.htm
Full Year 2014 Report, NO FULL YEAR GUIDANCE for 2015:

This guidance does not contemplate the projected accretion associated with the pending Biomet merger. Guidance for the full year 2015 will be provided after the closing of the transaction with Biomet, expected before the end of this quarter.

https://www.sec.gov/Archives/edgar/data/1136869/000119312515024461/d862570dex991.htm

Full Year 2015 Report:

The Company expects constant currency revenue for the full year 2016, as compared to adjusted pro forma 2015 revenue, to increase between 1.5% and 2.5%.

https://www.sec.gov/Archives/edgar/data/1136869/000119312516440674/d95315dex991.htm

Full Year 2016 Report:

The Company expects constant currency revenue for full-year 2017, as compared to 2016 revenue, to increase between 3.7% and 4.7%

https://www.sec.gov/Archives/edgar/data/1136869/000119312517024528/d338232dex991.htm
Full Year 2017 Report, NO FULL YEAR GUIDANCE FOR 2018, WHY? Only talked about Q1 2018 Guidance (there must be a good reason!):

For the first quarter of 2018, the Company expects revenue in the range of $1.955 billion to $1.995 billion, representing a change of negative 1.0% to positive 1.0% compared to the prior year period, and negative 4.0% to negative 2.0% on a constant currency basis compared to the prior year period, inclusive of negative impact related to approximately one less billing day compared to the prior year period.

Additionally, the Company expects its diluted earnings per share for the first quarter of 2018 to be in a range of $0.73 to $0.88, and in a range of $1.84 to $1.91 on an adjusted basis.

https://www.sec.gov/Archives/edgar/data/1136869/000156459018001032/zbh-ex991_6.htm

What event was Hanson referring to & hinting the investors? Sounds exciting, isn’t it? & what was the hold back on the 2018 Full Year Revenue Guidance disclosure? Why so much misleading information about Amedica by some individuals here? Even create a new alias to post to distort the FACT! What is cooking between Zimmer & Amedica? How big the transaction will be?
ALL FACT! All SOURCED information with links to verify!


Look to this blog after announcement comes as I’ll provide a brief expose on another product with major implications for its market. Multiple companies are already researching the tech. For a full collection of my research on Amedica click on the link below:

Index Page

Amedica’s Three Year Audit

Acquisition Rule: One or Three Year Audit

Both PEIs and strategic buyers alike are frequently faced with the question of how many years of a target’s financial statements are needed for the deal. Public strategic buyers have to comply with SEC Regulation S-X, Rule 3.05 (Rule 3.05), which requires them to provide financial statements for significant consummated or  probable business acquisitions. The significant acquisition rule focuses on three principle criteria: the investment test, the asset test, and the income test. If any of those tests exceeds a threshold of 20%, at least one year of audited financial   statements (and potentially up to three if any of the tests exceeds 50%) will be required. In addition, financial statements for probable acquisitions that exceed a 50% significance threshold will also be required.

Navigating the Waters of the SEC—An M&A Perspective


Timeline of Events for Audit

May 2016Change in Audit firms by acquisition. As you can see BDO just absorbed Mantyla into its network of CPA offices throughout the world. Mantyla would continue to operate as usual with the BDO name and would operate with the full resources of BDO. Mantyla had been under BDO’s umbrella since joining the BDO Alliance in 2008. This was just the next step in their relationship for Mantyla but strategic for BDO.

Chicago, IL – BDO USA, LLP, one of the nation’s leading professional service organizations, today announced an expansion into the Utah market through the addition of 64 staff, including 10 partners, from Mantyla McReynolds, LLC.  Founded in 1989, Mantyla McReynolds provides a full range of accounting and consulting services to a diversified client base of public and private businesses.  The firm has significant strength in the technology and life sciences, real estate, hospitality and entertainment, equipment leasing, outdoor recreation and ski resorts, auto dealerships, and manufacturing and distribution industries. Based in Salt Lake City, the firm has been a member of BDO Alliance USA since 2008.  The combination of BDO and Mantyla McReynolds is subject to customary closing conditions and is expected to be completed on July 1, 2016.

Q3 2016: It appears at some point Q3, Amedica paid BDO upfront $485,991 (pg 72) in audit fees as there was a corresponding spike in G&A fees of $480,000 (pg 4) over 2015.

October 4th, 2016

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
(b) In connection with Amedica’s staff reduction, Ty Lombardi, the company’s Chief Financial Officer and Principal Financial Officer, left the employ of the company.
(c) Effective October 4, 2016, B. Sonny Bal, MD, has been appointed to serve as the company’s Principal Financial Officer. Dr. Bal currently serves as the company’s President and Chief Executive Officer and Chairman of the Board.

Take note of this, because it will be brought up again later. Fast Forward to March 31st, 2017 and the first notification of an audit is revealed with the filing of Amedica’s first NT-10K filing.

Amedica Corporation (the “Company”) has not yet completed certain financial and other information necessary for an accurate and full completion of the Annual Report

Q2′ 2017: Amedica incurs an increase in Accounts Payable expenses of 700k Q2’17 as compared to Q2’16. Likely related to audit costs incurred during the ongoing audit in 2017.

This is then followed by a 10-Q/A on April 19th, 2017:

Sole purpose of this Amendment No. 1 is to correct the condensed consolidated statements of operations

That same day we also find out that the delay in filings was due to:

The Company requires additional time to fully consider whether there is any potential impairment in relation to certain of its long-lived assets. Management and the Audit Committee of the Company’s Board of Directors are continuing to work diligently to complete its Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and file it with the SEC as soon as possible.

Amedica Announces Delayed Filing of Annual Report on Form 10-K and Receipt of Nasdaq Letter

NT filings followed for Quarter 1 & Quarter 2 before submission of 2016 10k September 20th, 2016. Also filed with 2016’s 10k, Amedica announced it has let BDO go and has retained the services of Tanner, LLC to oversee audit of 2017’s financials.

On September 20, 2017, Amedica Corporation (the “Registrant”) informed BDO USA, LLP (“BDO”) of their dismissal as its independent registered public accounting firm. The dismissal was authorized by the Audit Committee of the Registrant’s Board of Directors. On the same date, the Audit Committee engaged Tanner LLC (“Tanner”) as the Registrant’s independent registered public accounting firm for the fiscal year ending December 31, 2017.

Quarter’s 1 & 2 follow October 31st, which also happened to be the deadline given by NASDAQ or face delisting. Quarter 3 was submitted on it’s due date as well, November 14th, 2017, maintaining compliance with Nasdaq.

December 11th, 2017 – Amedica announces that all of 2017, 2016 10k, & Q3’16 financial statements are no longer worthy of being relied upon.

On December 8, 2017, the Audit Committee of the board of directors of Amedica Corporation (the “Company”), following discussions with management, concluded that the Company will restate the audited consolidated financial statements contained in its annual report on Form 10-K for the year ended December 31, 2016, as well as the unaudited condensed consolidated financial statements contained in its Quarterly Reports on Form 10-Q for the quarters ended September 30, 2016, March 31, 2017, June 30, 2017, and September 30, 2017. Accordingly, the financial statements contained in these reports should no longer be relied upon. Further, the Audit Committee concluded that the Report of the Independent Registered Public Accounting Firm for the year ended December 31, 2016 should no longer be relied upon. The Company intends to present the restated financial statements and other financial data in amendments to its Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and its Quarterly Reports on Form 10-Q for the quarters ended September 30, 2016, March 31, 2017, June 30, 2017, and September 30, 2017, (the “Restated Filings”)


Three Years Audited financials: 2015, 2016, 2017 in Progress

We now know that 2017 is currently being audited, 2016 was audited but will see further restatement, & 2015 was audited along with 2016 with a minor change being made to 2015’s Balance Sheet. I highlighted the change from original Balance Sheet.

As i said, the change is relatively minor which explains why they didn’t feel the need to issue a restated financial statement. Its funny that all the problems came after the company let its CFO go and used outside services to assist in preparation of their financials. However the most intriguing part was only recently disclosed in the companies 10K/A.

Audit fees for 2016 saw a significant jump in costs after BDO acquired Mantyla. Its odd, that BDO would charge so much more than Mantyla when the same employees would have worked on Amedica’s financials.

On average, typical audit fees are 1.04% of revenues. Amedica’s revenue for 2016 was $15.23 million which equates to ~$158,000. Amedica’s 2015 fees are actually less than the average fee per million in revenue. What about BDO average cost? In 2013, BDO had approximately 157 small business clients in the following article, Audit Fees for Smaller Reporting Companies.

Taking $29,818,114 and dividing it by 157 clients, you get an average cost of $189,622. Factoring in inflation that means BDO’s average cost should be ~$210,000 now or approximately 25% premium over Mantyla’s cost. Why then is BDO’s cost $486,000 for 2H16? Certainly it has to do with the audit of Q3’16 financials due to the error in the filing? The problem with that line of thinking is that Q3’16 financials were not filed until mid November. That means in the span of 45 days, BDO managed to accumulate a 135% increase over its usual ANNUAL fee. Not only that, but Q3 audit did not complete until April of this year meaning the costs for an audit of Q3’16 is even greater than the $486,000 reported. I wonder what their total audit fees will be in 2017.

To put this into context, Amedica’s audit fees (pg 19) for its IPO was $1.2 million with 2016 fees equating to 40% of that. Since i do not have audit experience and am unfamiliar with the full costs i thought i would compare this to a few other companies that BDO has done audits for.

Update:

10-3Q/A 2016 Amedica saw a spike in general & administrative costs of $480,000 compared to Q3’15. From July 19th, 2016 – December 31st, Amedica paid BDO, LLP $485,991 suggesting that Amedica prepaid BDO for the audit 2H16 BEFORE both the CFO left the company & before the misstatement was caught on Q3’16 financials.

Snap925.jpg

10-Q2/A 2017 Amedica incurred an increase in accounts payable of exactly 700k over 2016.

Snap924.jpg

The only explanation for this spike in AP is, at least partially, the cost incurred from the ongoing audit 2017. The full amount would bring the total estimated costs of the audit that began Q3’16 to $1,185,991 compared to Amedica’s IPO audit costs of $1,187,300.


ANTHERA PHARMACEUTICALS, INC.

March 2014 Athera Pharmaceuticals announced that it too had to restate its financials due to failure to book warrants correctly.

On March 10, 2014, in connection with an internal review initiated by the Company of the accounting for certain warrants issued in conjunction with an equity offering in September 2010, the Company, in consultation with its Audit Committee concluded to restate its previously issued financial statements for the years ended 2010, 2011 and 2012, including inception to date ended December 31, 2012, and the unaudited quarterly financial information for the first three quarters of 2012 (“Affected Periods”) because of a misapplication in the guidance around accounting for the warrants and that such financial statements, with the accompanying independent auditors report, as applicable, should no longer be relied upon.

Three years of annual financials statements had to be restated along with 2012 quarterly financials. How much did this end up costing Anthera? To answer this, we should first take note that Anthera engaged BDO as its independent audit firm August 2013. The total costs for BDO in 2013 was $211,257. In 2012, Anthera’s audit fees were only $216,005. So BDO’s fees for 2013 were right on par with Athera’s previous year. Maybe the error wasn’t caught until 2014? Sure enough, 2014’s audit fees spiked to $368,450 or an increase of 75%. Mind you, this was for the entire year of 2014. In July of 2014, Anthera announced it had acquired Sollpura from Eli Lilly. It also sub licensed the drug to its subsidiary:

Anthera intends to sublicense all rights, obligations, and intellectual property for the development and commercialization of Sollpura to Alkira Therapeutics, Inc. (“Alkira”). In the future, Alkira will secure appropriate funding as a wholly-owned subsidiary of Anthera to advance Sollpura into a phase 3 pivotal registration trial as agreed with the United States Food and Drug Administration in 2013. It is intended that Alkira will make all future contingent milestone payments under the license agreement upon product approval and on certain annual sales achievements and will make royalty payments on any product sales after achieving certain sales thresholds of cumulative net sales of Sollpura.

After 2014, Anthera’s audit fees only increased due to more complicated nature of its consolidated financials and likely contributed to the 75% increase in audit fees for 2014.


InfuSystem Holdings, Inc

On November 1, 2016, the Audit Committee of the Board of Directors of InfuSystem Holdings, Inc. (the “Company”) concluded, after review and discussion with management and the Company’s independent registered public accounting firm, BDO USA, LLP (“BDO”), that the Company’s audited financial statements for the fiscal year ended December 31, 2015, and the Company’s unaudited financial statements for each of the fiscal quarters ended March 31, 2015 through June 30, 2016 (collectively, the “Financial Statements”) should no longer be relied upon. The Financial Statements contained an error related to an overstatement of estimated accounts receivable collections which in turn overstated revenues and pre-tax income by a corresponding amount.

InfuSystem restated its 2015 10k along with the first 2 quarters of 2016 1 month later. Total cost for audit 2016 was $663,835 up from 2015 $546,154. Overall that’s an increase of just 22% over 2015.

Like Anthera, there was an underlying trigger for the audit:

June 19 (Reuters) – Infusystem Holdings Inc

* 22Nw fund lp – transmitted a letter to board of infusystem holdings inc. To acquire all outstanding shares of infu for $2.00 per share

* 22Nw fund lp – proposal is an all cash offer Source text for Eikon: Further company coverage:

Just like Anthera acquisition of assets triggered the audit by BDO but in Infusystem’s case it was another company trying to acquire their assets.


TerraForm Power, Inc

I saved the best example for last. This research was compiled by CL101 and posted on ihub at this link. The paralleled events are uncanny.

Ticker = TERP

https://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001599947&type=&dateb=&owner=exclude&count=40

1. AMDA had “NT” Filings … They also had “NT” Filings:

NT 10-K = 2016-02-29

NT 10-Q = 2016-05-11

NT 10-Q = 2016-08-10

NT 10-Q = 2016-11-10

2. No Annual Meeting in 2016 = No DEF 14A = Same like AMDA in 2017!

https://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001599947&type=def+14a&dateb=&owner=exclude&count=40

3. No CFO too = 15 months prior to M&A event, they said “Adios!” to their CFO … 1 executive took 2 jobs like Sonny (CEO & CFO):

Mr. Alejandro Hernandez was removed as Executive Vice President and Chief Financial Officer of the Company and Mr. Manavendra Sial was appointed to serve as interim Chief Financial Officer of the Company.”

“On November 22, 2015, Ms. Rebecca Cranna was appointed to serve as Executive Vice President and Chief Financial Officer of the Company on a permanent basis, and Mr. Sial correspondingly stepped down as interim Chief Financial Officer of the Company.”

https://www.sec.gov/Archives/edgar/data/1599947/000159994716000244/terp201510-k.htm

14+ months ago, AMDA’s CFO “Adios” as well:

“In connection with Amedica’s staff reduction, Ty Lombardi, the company’s Chief Financial Officer and Principal Financial Officer, left the employ of the company.”

https://www.sec.gov/Archives/edgar/data/1269026/000149315216013858/form8-k.htm

CFO surplus on the job market, why?

https://www.wsj.com/articles/merger-boom-spawns-a-cfo-surplus-1433808509

4. $1.7 Billion Market Cap company had this issues:

A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the company’s annual or interim financial statements will not be prevented or detected on a timely basis. The following material weaknesses have been identified and included in Management’s Report on Internal Control over Financial Reporting:

Ineffective Board oversight and management monitoring activities over the information technology systems development and implementation of financial reporting processes and internal controls by the parent company service provider;

Insufficient number of trained resources with assigned responsibility and accountability for financial reporting processes and internal controls conducted by the parent company service provider;

Ineffective risk assessment process that responds to changes in generally accepted accounting principles, changes in its business operations, modifications to information technology systems, and changes within the parent company service provider and key personnel;

Ineffective information and communication processes that ensure appropriate and accurate information is available to financial reporting personnel on a timely basis;

Ineffective monitoring activities;

132


Ineffective general information technology controls over the consolidation and Solar segment operating systems, databases, and IT applications and ineffective access controls over the Wind Segment operating system, databases, and IT applications, both resulting in ineffective process level automated controls and compensating manual controls dependent upon the information derived from relevant IT systems;

Ineffective controls over the completeness, existence, and accuracy of: (i) revenues and accounts receivable transactions (ii) allocated general and administrative expenses, (iii) the transfer of historical costs related to renewable energy facilities acquired from the parent company;

Ineffective operation of reconciliation controls over the completeness, existence and accuracy of various balance sheet accounts;

Ineffective controls over the completeness and presentation of restricted cash; and

Ineffective controls over the completeness and accuracy of information used as part of goodwill impairment, business combinations, hypothetical liquidation of book value, debt covenant compliance, and going concern processes.

https://www.sec.gov/Archives/edgar/data/1599947/000159994716000244/terp201510-k.htm#se7f57f2b8e904090afadcbdde851baf1 (Page 132 – Page 133)

I won’t be surprise that a tiny nano-cap like AMDA has the same issues too…not a big deal at all.

5. Principal Accounting Fees and Services.

Year ended December 31, 2014 = $ 1,608.9 in (1000s) = $ 1,608,900

Year ended December 31, 2015 = $ 10,141.0 in (1000s)= $10,141,000

*** 2015 increased more than 6X compared to 2014 ***

https://www.sec.gov/Archives/edgar/data/1599947/000159994716000244/terp201510-k.htm#se7f57f2b8e904090afadcbdde851baf1 (Page 130)

Year ended December 31, 2016 = $ 8,498.4 in (1000s) = $ 8,498,400

* TERP filed 10-K = Dec 6th, 2016 … really late (w/ Executive Compensations Disclosure for 2015 fiscal year)…obviously their books & records were complicated than AMDA’s.

* They filed their 2016 – 3rd Quarter Financial Statement = 2017-02-24 (WAY OVER DUE = rolled over to the next fiscal year = 2017! AMDA filed 3Q ER 11 weeks earlier than them as in comparison)

* 10 plus days after they filed 3Q ER, they announced the M&A news:

https://www.sec.gov/Archives/edgar/data/1599947/000156761917000392/0001567619-17-000392-index.htm

Then they filed DEFM14A to vote on the M&A.

*** 10-Q/As should be out soon or even out the same day w/ M&A news ***
@ As you can see, there are similarities in terms of events between AMDA & TERP @

As CL101 shows, the events that transpired at TERP are pretty much exactly like Amedicas. Even had the same material weaknesses despite it being a billion dollar company to Amedica’s 9 million marketcap. They also let their CFO go over a year before announcing M&A. CFO is a redundant position when you have external parties combing through your books; not to mention target CFOs are not usually needed because acquiring company already has one.


Conclusion

As you should be able to see audits of this nature are usually triggered by an event not yet disclosed. The more thorough the audit the more expensive it will be. There are two primary causes for more in-depth and expensive audits, when a company first goes public or when a company mergers into another. I doubt tender offers require as extensive of audits because the target company’s books will no longer be needed. Amedicas audit is obviously  expensive, rivaling the cost of its audit when it went public; 40% of IPO costs seen in 2H16 and the audit is still ongoing with up to an additional 700k incurred 2017.

Anthera was auditing its books to both create a subsidiary and to acquire an asset. In both Infusystems & Terraform Power’s cases the audits were triggered because interested party was trying to acquire them. Infusystems audit was not thorough at all based on the small increase in audit costs. Terraform however saw significant increase in audit costs in 2015 & 2016 when Brookfield Asset Management acquired 51% stake in them. All the evidence i and others have compiled clearly show Amedica is getting itself ready to merge with Zimmer-Biomet and that’s the cause of this expensive thorough audit!

  • 3 year audit of financials
  • Almost no debt or any real liabilities with enough capital in warrants to close shop
  • Clean capital structure with small share count that will minimally impact acquiring companies EPS.
  • Close to operational black and vastly improved EPS (only -.68 per share  post RS) to date.
  • Greater operational efficiency that has allowed for improved EPS while revenues have declined (all about margins!)
  • Significantly de-risked IP through 10 years of clinical use, 2 clinical trials, and some 60+ odd scientific publications showcasing the clinical benefits of Silicon Nitride

 

Check out these two recent publications:

Surface topography of silicon nitride affects antimicrobial and osseointegrative properties of tibial implants in a murine model.

Moreover, SEM imaging demonstrated that MRSA cannot directly adhere to native as-fired Si3 N4 . Subsequently, a cross-sectional study was completed in which sterile or MRSA contaminated as-fired and machined Si3 N4 implants were inserted into the tibiae of 8-week old female Balb/c mice, and harvested on day 1, 3, 5, 7, 10, or 14 post-operatively for SEM. The findings demonstrated that the antimicrobial activity of the as-fired implants resulted from macrophage clearance of the bacteria during biofilm formation on day 1, followed by osseointegration through the apparent recruitment of mesenchymal stem cells on days 3-5, which differentiated into osteoblasts on days 7-14.

Human osteoblasts grow transitional Si/N apatite in quickly osteointegrated Si3N4 cervical insert.

Si and N elements stimulated progenitor cell differentiation and osteoblastic activity, which ultimately resulted in accelerated bone ingrowth. (important in regards to Porous Silicon Nitride)

Identical analyses conducted on a polyetheretherketone (PEEK) spinal explant showed no chemical changes and a lower propensity for osteogenic activity. Silicon and nitrogen are key elements in stimulating cells to generate bony apatite with crystallographic imperfections, leading to enhanced bioactivity of Si3N4 biomedical devices.

Data show that the formation of hydroxyapatite on silicon nitride bio-ceramic surfaces happens with a peculiar mechanism inside the human body. Silicon and nitrogen were incorporated inside the bony tissue structure allowing the developing of off-stoichiometric bony apatite and stimulating progenitor cell differentiation/osteoblastic activity.


Commentary

 

There are a few individuals claiming there is nothing to see here other than a company in a complete mess. However the evidence i and others have compiled show something else entirely. It seems like some want to disguise Amedica as being a POS company when it fact its nothing of the sort. Amedica is the epitome of a diamond in the rough! I’ve been trying to wipe off the coal dust to show the world the diamond that awaits just beneath the surface.

Amedica’s Si3n4 could completely change the world of orthepeadics with it’s natural ability to essentially feed bone growing cells and its ability to prevent bacteria growth or even kill bacteria like MRSA.

This should be my last post about Amedica unless there is some other major revelation discovered. After M&A is announced i’ll post an email address to contact me and some other information. Amedica is the first company i have profiled but they will not be the last. I will also maintain coverage of Silicon Nitride after Zimmer M&A with Amedica because I believe in the tech and its future in orthepeadics and its potential uses in bio-electronics! I ‘ll be on the look out for other technologies and companies to profile into the future. In fact ill briefly touch on an upcoming tech after M&A is announced here.

For now, I wish everyone reading Happy Holidays and a wonderful New Year!


For access to all my posts about Amedica, Zimmer, & Silicon Nitiride go here:

Index Page

Amedica’s Silicon Nitride: Current and Potential Markets

Most people who know about Amedica know that Amedica makes spined based products. However, Silicon Nitride is not limited to just the spine markets. I thought i would take a moment to highlight the various products that Amedica’s Silicon Nitride has currently been commercialized for, products in development, & potential products in the future. I’ll also touch on the potential global market sizes of each product line to the best of my ability.


Current Product Line

Valeo Interbody & Pedicle Screw system

The global market for spinal fusion, which includes spinal plating systems, interbody devices, vertebral body replacement devices, and pedicle screw systems (excluding minimally invasive spine devices), is set to rise from approximately $7.1 billion in 2016 to just under $9 billion by 2023

Spinal fusion market to approach $9 billion by 2023 as technology improves

Currently the global spinal fusion market is over $7 billion growing to ~$9 billion by 2023. This does not include minimally invasive spine devices or the biological products that accompany these fusion devices.

Porous Silicon Nitride

Currently porous silicon nitride is part of the Valeo composite device sold in Europe and pending clearance in the US. At some point this technology will branch out to additional products. For now, porous Silicon Nitride in the spinal market is about $2 billion growing to about $2.6 billion by 2022.

Porous Si3N4 would take the place of biologics like autografts, allograts, and wouldnt need products like BMP or Infuse to aid in fusion.


Products in Development

Hip Implant

Product that is likely being developed with Zimmer in some capacity pairs Amedica’s Silicon Nitride MC2 (femoral head) with Zimmer’s Vivacit-E®liners. So far testing results have been promising showing MC2 to be incrementally better than current gold standard Biolox Delta when articulating against a poly liner at 5 million cycles. Testing is still underway on this product but given Silicon Nitrides ability to scavenge oxygen (leads to degradation of the liner) from Zimmer’s poly liner, 12 million cycle testing should show vastly superior results compared to Biolox. I am curious if any other components will be made out of silicon nitride or just coated with it like in this patent:

Fig 3A shows SiNi applied to upper section of stem. Fig 3B the entire fem stem is coated with textured surface on the lower section

A coating applied to the femoral stem or a SiNi based stem would help combat osteolysis in the femur. I assume the same would be true for the cup that attaches to the acetabulum ( i have not seen a patent pertaining to this).

According to the research report, the global hip replacement implant market was worth US$6.5 bn in 2015 and is expected to reach US$9.1 bn by the end of 2024. During the forecast years of 2016 and 2024, the global market is estimated to progress at a CAGR of 3.9%.

Global Hip Replacement Implant Market to Reach US$9.1 Billion by 2024:

Knee Implant

Next in line after Hip is Knee implant for which little is known about in regards to testing. So far there has been one study dealing with osteointegrative and anitmicrobial of tibial implants in mice and a brief mention from a PR 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.

Obviously they are working with Morgan Ceramics to develop a SiNi/Metal implant utilizing, i assume, the same type of liner as with hip, Vivacit-E®.

Knee market is currently about $10 billion as of this year and is expected to grow to $13.5 billion by 2025

Future Prospects and Competitive Analysis, 2017-2025” the market was valued at USD 9.0 Bn in 2015, and is expected to reach USD 13.5 Bn by 2025, expanding at a CAGR of 4.5% from 2017 to 2025.

Global Knee Implants Market To Reach Worth USD 13.5 Bn By 2025

Dental Implants

Currently Amedica is turning a dental implant designed by Dentsply and converting it into a Silicon Nitride version. Very little details are known outside of that the implant has been developed and that a JDA is expected 2017.

The global market for this type of implant is currently about $4.5 billion  and is estimated to grow to about $6 billion by 2022.

The Global Dental Implants Market was around USD 4.3 billion in 2015 and it is expected to reach USD 5.9 billion by 2022 at a CAGR of 4.6% during the forecast period of 2015 to 2022.

Dental Implants Market Estimated to Upsurge at 4.6% CAGR to Reach Market Size of 5.9 Billion by 2022

Other Products in Development

Other types of products in development of course is an all porous 3D printed spinal implant that will significantly reduce costs to manufacture. If I recall correctly, this was mentioned to be slated for submission sometime 2018.

As i already mentioned, Amedica is working with Morgan Ceramics on brazing Si3N4 with Metal for a spine implant and knee implant. I’m betting this will expand to include other implants in the future.

Another product Amedica is working on is a coating for medical implants. Using a spray or slurry of Si3N4 and applying it to metals like Cobalt-Chromium & Titanium.

Silicon Nitride Coating. With a similar chemical composition as our other forms of silicon nitride, this form of silicon nitride can be applied as an adherent coating to metallic substrates, including cobalt-chromium, titanium and steel alloys. We believe applying an extremely thin layer of silicon nitride as a coating may provide a highly wear-resistant articulation surface, such as on femoral heads, which may reduce problems associated with metal or polymer wear debris. We also believe that the silicon nitride coating can be applied to devices that require firm fixation and functional connections between the device or implant and the surrounding tissue, such as hip stems and screws. The use of silicon nitride coating may also create an antibacterial barrier between the device and the adjacent bone or tissue

Amedica 2016 10K

A few more prototypes have been developed:

a suture anchor for sports medicine applications, an osteotomy wedge for extremities applications, and prototypes of silicon nitride-coated plates for potential trauma applications. We have also developed a process to apply our silicon nitride as a coating on other biomaterials.

Morgan Ceramics is also working on adapting Amedica’s Si3N4 for a potential ceramic brazed metal device for aerospace industry.  This is an example but I have no idea if this is what Morgan Ceramics is in fact working on: Active Metal Brazing and Characterization of Silicon Nitride-to-Metal Joints


 

Future Potential Products:

Ankle Implant (Foot & Ankle devices global market estimated to be $6.4B by 2022)

Shoulder implant (projected to be $3B by 2025)

Really any major product for the extremities, sports medicine and trauma markets


 

Outside the realm of orthopedic implants is an area I am curious if Amedica’s Silicon Nitride will be utilized in as this is very very lucrative market in the future!

In every press release you see that management believes they are the only producer of medical grade silicon nitride. My question is, will Amedica’s Silicon Nitride be used to encapsulate implantable bioelectronics and biosensors in the future? The antimicrobial properties alone could make it worth it. There is also bioresorbable implants being designed at Northwestern (Dr. Bal got his MBA from Northwestern).

Bioresorbable electronic systems have the potential to create important new categories of technologies, ranging from temporary biomedical implants to environmentally benign, green consumer devices. The results presented here provide a collection of ideas that establish the foundations for a realistic technology of this type, in which state-of-the-art silicon complementary metal-oxide-semiconductor foundries serve as the source of microscale, water-soluble electronic components configured for rapid assembly and electrical interconnection on soft, biocompatible polymer substrates. Demonstrations in various high-performance electronic systems illustrate the concepts, and fundamental studies establish the chemical kinetics and end products of dissolution in aqueous environments.

Materials and processing approaches for foundry-compatible transient electronics

CENTER FOR BIO-INTEGRATED ELECTRONICS at Northwestern University

The Bioelectronics and biosensor market is currently valued at $11.4 billion and expected to grow to $28 billion by 2024 mostly driven by implantable devices. However the slow pace at which these devices are commercialized may reduce the pace of growth that is anticipated.

The global bioelectronics and biosensors market was estimated at USD 11.4 billion in 2013. The market is anticipated to grow at a healthy CAGR over 10%, exceeding USD 28 billion in the forecast period (from 2016 to 2024). Bioelectronics & biosensors pertain to the application of electronics in the fields of medicine & biology.

Bioelectronics and Biosensors Market Analysis, Market Size, Application Analysis, Regional Outlook, Competitive Strategies and Forecasts, 2016 To 2024


 

Total Addressable Market over the next 5-10 years

Spine: $11.5 Billion (including biologics)

Hip: $9 Billion

Knee: $13.5 Billion

Dental: $6 Billion

Ankle & Foot: $6.4 Billion

Shoulder: $3 Billion

Total addressable market within the next 10 years: ~50 Billion

Not including many other products used in orthopedics, aerospace market, or bioelectronic/biosensor market.

UPDATE:

Amedica was just awarded a new patent that shows that its proprietary material is suited for more markets than I listed above, including adding Si3N4 powder to PEEK  to enhance PEEK based devices with Si3N4 antibacterial properties. Here is the newest list of potential product applications:

The inventive techniques disclosed herein, including but not limited to the silicon nitride coatings and roughened surface finishes, may be applied to any number and type of biomedical components including, without limitation,spinal cages, orthopedic screws, plates, wires, and other fixation devices, articulation devices in the spine, hip, knee, shoulder, ankle and phalanges, catheters, artificial blood vessels and shunts, implants for facial or other reconstructive plastic surgery, middle ear implants, dental devices, and the like. Ceramic and/or glass materials and related methods

Every market i mentioned above is included in this patent plus a few others. For instance the global catheter market is worth $26+ billion and is growing ~10% a year. Thats just one of the many additional markets mentioned in this patent.

The global catheters market size was estimated at USD 26.38 billion in 2014 and is expected to grow at a CAGR of 9.7% from 2014 to 2020. Global Catheter Market


 

I suggest reading or even re-reading my blog post Why Material Matters! to understand why Silicon Nitride is so special in the realm of orthopedics. I also suggest reading Comparable Company Analysis.

Conclusion Part 2: Inside Men, a Commentary

The acquiring corporation seeks to have its own candidates installed on the board of directors. By installing friendly candidates on the board of directors, the acquiring corporation can easily make the desired changes at the target corporation.

The above quote is exactly what I believe Zimmer has done with Amedica and its hard to see much different based on the evidence.

As shown in my last blog post, Conclusion Part 1: Timeline of Events, months after Zimmer acquires Centerpulse AG, Dr. Max Link, PHD (former Centerpulse CEO) ends up on Amedica’s board of directors as chairman. Also in that blog post, you can see evidence that Dr. Link was not on the board of any other medical device company but instead biotechnology firms from 2003-2014.

What this suggests to me is Zimmer, while working with Implex and Trabecular Metal, saw something interesting in Amedica. So it likely suggested to Dr. Link to become a board member to keep an eye on the tech and open the door for Zimmer to acquire the company in the future.

As time passed Silicon Nitride became more intriguing to Zimmer so Zimmer likely suggested to one of its surgeons, Dr. Bal, to work with the technology. In 2005, Dr. Bal joins Amedica’s Total Joint Reconstruction Clinical Advisory Panel (Links to all this information is provided in my previous post). By 2006 Dr. Bal is aiding in the development of Silicon Nitride after signing a development contract with Amedica.

Over the years, both Dr. Bal & Dr. Link invested large sums in Amedica’s private offerings. If you go through Amedica’s Form 3’s at IPO you’ll see that Dr. Bal & Dr. Link are the biggest employee investors in Amedica outside of Truetzel (who has his own Hedge Fund). In fact if you look at long-term employee CTO Bryan McEntire, you’ll see he never invested in the companies series offerings. This to me suggests Dr. Bal & Dr. Link knew something Mr. McEntire did not; perhaps outside interest? Just speculation but there is definitely a level of confidence shown by Dr. Bal & Dr. Link that you don’t see by other employees. It should be noted, as CTO Mr. McEntire has been one of the main players in the development of Silicon Nitride.

Fast forward to 2011 and we begin to see industry leaks of Zimmer wanting to acquire Amedica. While this was leaking, Zimmer was experiencing issues with its material Trabecular Metal; i touch on this in my blog post Exposè on the failure of Zimmer’s Trabecular Metal, how Si3N4 can fill the void, & the future. In fact in 2011 Zimmer’s cervical trial for TM had come to an end with unfortunate results, failure to fuse sufficiently. Whats interesting to me is at the same time these results were being realized, Amedica was putting together it’s own trial for its cervical implant currently CE marked in Europe. Very interesting parallels going on here especially when you consider that the same month Zimmer published the results of its cervical implant failure, Amedica began recruiting for its trial almost as a problem solution scenario; Trabecular Metal’s the problem, Silicon Nitide is the possible solution.

I’m not sure how many people think this is as interesting as I do, but Amedica’s cervical trial, CASCADE, was being ran by two Zimmer consulting surgeons in the Netherlands. This suggests to me that Zimmer had input on the designing of the trial and that Zimmer wanted people it could trust to oversee the trial. This way Zimmer could be certain the trial was ran to Zimmer’s satisfaction and that the results would be reliable; if you are going to invest in a technology you want results you can trust.

The following month, January 2012, after Cascade trial began recruiting, Dr. Bal joins Amedica’s Board of directors. Now Zimmer has 2 friendly persons on Amedica’s BOD. To me Zimmer is stepping up its interest in Amedica and Silicon Nitride’s development.

2014, Amedica goes public to raise funds it needs to further the develop of its IP. I’m guessing, but given the timing of Dr. Links retirement and his unfortunate passing, i believe Dr. Link was experiencing health problems. Anyways, when Dr. Link retired in August 2014, its Dr. Bal that takes over as chairman. Now Zimmer is down to 1 friendly board member.

Cascade trial officially began October 2013 and it was just before it reached its 1 year milestone, that Dr. Bal becomes CEO. I believe the timing of Dr. Bal becoming CEO had everything to do with the initial results as it was now time to get Amedica ready for M&A. What does Dr. Bal do after becoming CEO? He begins to de-risk the companies financials; i go into this more on my blog post De-Risk: Another Step in Preparation for Acquisition.  Dr. Bal begins phase 1, laying off non essential personnel. That’s one of the easiest ways to reduce costs and those employees may not be needed after M&A anyways; bit the bullet and get it over with.

2016, after Dr. Bal reduced costs and was reducing debt load, a 2nd round of layoffs occurred. This time, the Amedica’s CFO was let go; a redundant position anyways post M&A. After letting go of Amedica’s CFO, Dr. Bal assumed the position of Principle Accounting Officer; in 2017 it was revealed Dr. Bal is now the CFO. That means Dr. Bal is Chairman of the Board, Chief Executive Officer, & Chief Financial Officer as well as very friendly with Zimmer and its now former CEO David Dvorak; the ultimate trifecta for exerting control of a potential acquisition target.

Through a consent solicitation launched by an activist investment group, the three non-independent directors, which included the company’s chairman of the board and chief executive officer and the company’s chief financial officer, were removed without cause and replaced, a new chairman of the board was elected and a new chief executive officer was appointed. As a result of this consent solicitation, this activist investment group, which held only 11.7 percent of Six Flags’ issued and outstanding shares when it commenced the consent solicitation, acquired substantial influence and effective control of the company. Two weeks following the conclusion of this consent solicitation, representatives of this activist investment group would assume the positions of chairman of the board and chief executive officer of Six Flags.

Ten Ways to Prevent a Company from Being Vulnerable to a Consent Solicitation

(Direct link doesn’t always work so Google article title)

 

I would like to add that this post takes a very simplistic view of events and is not meant as cannon. Its meant to convey an idea or concept.

Conclusion Part 1: Timeline of Events

2002: Dr. Sonny Bal joins Zimmer’s Designer Surgeon Panel,  2002 to ???.

May 20th, 2003: Zimmer acquires Centerpulse AG

October 2003: Former CEO of Centerpulse AG, Dr. Max Link joins Amedica as Chairman of Board. (Click link to see that Amedica was the ONLY medical device company Dr. Link was chairman for. All the other companies were biotechnology related)

2005: Dr. Bal joins Amedica’s Total Joint Reconstruction Clinical Advisory Panel.

2005: Zimmer subsidizes Dr. Bal’s research at University of Missouri on Zinmer’s minimally invasive surgery technique.

May 2005: Dr. Bal receives $125,406.00 from Zimmer for research on “Comparison of tissue-engineered osteochondral grafts fabricated with mesenchymal stem cells and trabecular metal or allograft bone”

December 2006: Dr. Bal signs a development agreement with Amedica.

February 2009: Publication,Porous Tantalum Metal Outperforms Devitalized Bone as a Substrate for Osteochondral Tissue Engineering” with Dr. Bal as one of the authors. (DISCLOSURE: Dr. Sonny Bal has received financial support from Zimmer unrelated to the current project).

November 2009: Zimmer K.K., now known as Zimmer GK, and Japan Medical Dynamic Marketing, INC, enter into a Joint Sales Agreement.

In November 2009, we concluded a joint sales agreement with Zimmer K.K. to further strengthen our product lineup and promote joint sales, thus expanding our market share at the same time.

May 2011: 

Anonymous May 24, 2011 at 3:42 PM

Zimmer is looking at purchasing Amedica flat out for their techology to bolster sales in spine through licensing and to purchase the next generation of hip and knee implants. You heard it here on TSB.

Musculoskeletal Man May 24, 2011 at 3:46 PM

Sounds like a good fit if Si3N4 is the real thing when it comes to joints, or could this be another trabecular metal FUBAR? First pull the trigger, then show us that you can finally integrate something successfully. Stop resting on your total joint laurels, your time is coming to an end.

July 2011: Dr. Bal receives $342,847 research grant from Zimmer for “Design and testing of a canine biological femoral head replacement.” Study goes from July 2011 – June 2014.

December 2011: Published study showing failure of Trabecular Metal to fuse with patient bone. Failure of Porous Tantalum Cervical Interbody Fusion Devices Two-year Results From a Prospective, Randomized, Multicenter Clinical Study

December 2011: Cascade Trial (Cervical fusion device composite featuring solid & porous Si3N4) begins enrolling patients.  Principal Investigators are consultants for Zimmer-Biomet

The authors MA and JW receive research grants from Zimmer-Biomet, EIT and Intrinsics. MA and JW are consultants for Zimmer-Biomet and Silony and they receive royalties from EIT.

January 2012: Dr. Sonny Bal is appointed to Amedica’s Board of Directors just 1 month after publication of failure of cervical TM & launch of Amedica’s cervical trial.

September 2012:

Anonymous September 20, 2012 at 6:50 PM

Please… they are making a last ditch effort not to sink and to sell for pennies to Zimmer. They have a nice factory for SiN problem is no one wants it. There stuff is and always will be a missed opportunity for joints.
Hence, Zimmer will sweep up the shards, I mean pieces, and finish out a PMA for the joint called the 40 Year Squeeker.

October 2013: Cascade trial begins!

November 2013: Amedica Signs Agreement with Kyocera for Commercial Manufacture of Silicon Nitride Medical Devices

Amedica Corporation, a biomaterials company, today announced a collaboration with Kyocera Industrial Ceramics Corporation, a worldwide leading ceramics producer, to manufacture medical devices from Amedica’s Silicon Nitride biomaterial at Kyocera’s Vancouver, WA facility.

June 2014: Kyocera contemplates Vancouver expansion

Kyocera Industrial Ceramics Corp. is contemplating an expansion of its Vancouver manufacturing plant, potentially adding 20 more workers to a factory that now employs 100.

A preliminary planning application filed last week with the city of Vancouver describes 10,000 square feet of additional manufacturing space and 1,500 square feet of associated office space. The company currently has 40,000 square feet of space at its site on Northeast Fourth Plain Boulevard.

July 2014: Amedica receives loan of $20 million from Hercules Technology. 3.5 year loan that must be paid off by January 1st 2018. Loan prevents M&A (hostile takeovers) without Hercules Technologies permission.

7.5 Mergers and Investments. No Loan Party shall, and no Loan Party shall permit any of its Subsidiaries to, directly or indirectly, (a) merge or consolidate with or into any other Person (other than mergers of a Subsidiary of Borrower into Borrower so long as Borrower is the surviving entity), or (b) acquire, own or make any Investment in or to any Person other than Permitted Investments.

September 30th, 2014: Amedica appoints Dr. Sonny Bal as President & Chief Executive Officer.

October 2014: Cascade Trial Primary Completion Date is reached just after Dr. Bal takes over Amedica.

July 21st 2015: Kyocera plans Vancouver expansion adds an addition 5,000 sq ft to the original plans. What was once a 1 story building, is now 2 stories.

Plans filed with the city of Vancouver call for Kyocera to expand its 40,000-square-foot factory by more than 18,000 square feet with a two-story addition.

July 22nd, 2015: Amedica files change in control agreement with certain executives, Sonny Bal & Ty Lombardi.

July 22, 2015:

Word on the street is a merger/buyout with Amedica….any info or thoughts?

Zimmer + Amedica

July 23, 2015: Signed letter of intent development deal with a leading orthopedic company. Letter of intents are part of the first steps in mergers & acquisitions.

The LOI helps identify and resolve key issues in the negotiation process and hopefully narrows down outstanding issues prior to spending the time and money associated with conducting due diligence and drafting the transaction contracts and supporting documents. Among other key points, the LOI may set the price or price range, the parameters of due diligence, necessary pre-deal recapitalizations, confidentiality, exclusivity, and time frames for completing each step in the process. Along with an LOI, the parties’ attorneys prepare a transaction checklist which includes a “to do” list along with a “who do” identification.

Mergers and Acquisitions: An Outline of a Transaction

August 2015: Dr. Bal announces testing of Amedica’s Si3N4 femoral head has begun or will be underway soon.

Now first of these opportunities is our femoral head testing protocol for total hip replacement. We received very constructive and meaningful feedback on our proposed testing protocol, which is very comprehensive. We now have a more thorough understanding of the pathway to market for our silicon nitride femoral heads in the US. The commentary by the FDA will ensure that the testing of a material as compared to all other ceramic predicated devices on the market will meet or exceed every testing standard.

We anticipate being able to provide additional details on this test later on this year and look forward to a direct comparison of all femoral heads to our material.

U of Nebreaska: Amedica – Comparative Testing of Ceramic Femoral Heads for Total Hip Arthroplasty, 2015-2016. Only 1 top 10 ortho company uses U of N, Biomet.

November 2015: A published paper on trabecular metal by Dr. Bal & others from the University of Missouri. Paper submitted March 2015 so bulk of the work likely took place in 2014. Still its possible that Dr. Bal was working on Zimmer’s TM even after becoming Amedica CEO.

April 18th, 2016: Amedica Signs Exclusive Chinese Silicon Nitride Distribution Agreement

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)

10 year agreement totaling 425,000 units

April 20th, 2016: NGK-NTK acquired a 30% stake in Japan MDM.

April 25, 2016: KYOCERA Breaks Ground to Expand Industrial Ceramic Manufacturing Operations in Washington State. Announced 1 week after Amedica announces deal with Weigao Orthopedic.

May 2016: BDO USA, LLP Announces Expansion into Utah Through Addition of Mantyla McReynolds, LLC

Chicago, IL – BDO USA, LLP, one of the nation’s leading professional service organizations, today announced an expansion into the Utah market through the addition of 64 staff, including 10 partners, from Mantyla McReynolds, LLC.  Founded in 1989, Mantyla McReynolds provides a full range of accounting and consulting services to a diversified client base of public and private businesses.  The firm has significant strength in the technology and life sciences, real estate, hospitality and entertainment, equipment leasing, outdoor recreation and ski resorts, auto dealerships, and manufacturing and distribution industries. Based in Salt Lake City, the firm has been a member of BDO Alliance USA since 2008.  The combination of BDO and Mantyla McReynolds is subject to customary closing conditions and is expected to be completed on July 1, 2016

At the time of this acquisition, McRynolds was the audit firm that handled Amedica’s yearly audits. It appears at some point Q3, Amedica paid BDO upfront $485,991 (pg 72) in audit fees as there was a corresponding spike in G&A fees of $480,000 (pg 4) over 2015.

May 31st, 2016: Orthopaedic Research and Education Foundation Welcomes New Board and Committee Members

In addition, the trustees welcome to the board: Jeffrey S. Abrams, MD (Princeton, NJ); Christopher R. Adams, MD (Naples, FL); B. Sonny Bal, MD, JD, MBA (Columbia, MO); Paul C. Collins, MD (Boise, ID); David C. Dvorak, JD (Warsaw, IN); James R. Ficke, MD (Baltimore, MD); and Joshua J. Jacobs, MD (Chicago, IL).

Only CEO’s on the board of trustees last year were Dr. Bal and Mr. Dvoark, Zimmer-Biomet’s CEO.

August 31st, 2016: Zimmer Biomet Spine Inc. is relocating and expanding its operations in the city of Westminster. It will occupy 104,000 sf at Westmoor Technology Park. Renovations to cost $6.3 million.

October 2016: Amedica lays off 40% of workforce including its CFO & Investor Relations. Brings in former Chief Legal Officer Kevin Ontiveros as a consultant to handle Investor Relations and uses outside firm to handle some CFO functions.

Offer proven strengths in working with and supporting business units in commercialization and joint venture agreements, sales and distribution matters, merger and acquisition activities, and supply, manufacturing, and development agreements.

November 22, 2016: Amedica announces that Dana Lyons has joined Amedica as Vice President of Sales & Marketing.  Dana was Area Vice President for Zimmer Spine prior to Amedica. It seems Dana may have brought Ryan Long with him or separately hired at the same time. Mr Long, who is now Area Vice President of Sales & Director of Strategic Development at Amedica Corporation, was also a former Zimmer VP.

During his tenure as Sales Vice President with Zimmer Spine and in conjunction with the Zimmer Spine executive leadership team, Zimmer Spine delivered 5 consecutive quarters of growth during 2014-2015. After the Zimmer and Biomet merger in June of 2015, Mr. Lyons successfully integrated the sales organizations of both Zimmer Spine and Biomet Spine in the Central Region of the United States.

January 2017: Dr.Bal gives expert testimony for plaintiff lawsuit against Zimmer.

Febuary 2017: Amedica Announces Results of Independent Femoral Head Wear Testing

This independent wear study was conducted in accordance with international standards at the Medical Technology Laboratory of the Rizzoli Orthopaedic Institute (Bologna, Italy) by Professor Aldo Toni MD under the supervision of Dr. Saverio Affatato PhD (Rizzoli Institute) with consultation and support from Professor Giuseppe Pezzotti PhD (Ceramic Physics Laboratory, Kyoto Institute of Technology, Sakyo-ku, Kyoto Japan). Amedica and Zimmer-Biomet (Tokyo Office) provided the femoral heads and acetabular liners; however, neither company actively sponsored the research.

April 20th, 2017: Grand opening for Kyocera’s new manufacturing building in Vancouver. An additional 5,000 sq ft was added to construction after groundbreaking occurred in 2016. It should be noted that before Amedica, this manufacturing site was used for Research and Development

Originally conceived as a research and development center for engineered ceramics, the facility now serves as a custom-order manufacturing site specializing in high-added-value components made from advanced ceramic materials.

Quarter 2 2017: Zimmer pays $2.5 million payment for certain R&D related payment to unknown entity. Zimmer Q2’16 10-Q pg 7

Amedica incurs an increase in Accounts Payable expenses of 700k Q2’17 as compared to Q2’16. Likely related to audit costs ongoing in 2017.

July 11th 2017: Zimmer CEO, David Dvorak, steps down as CEO.

July 21st 2017: Zimmer announces Group President for the Spine, Dental, Craniomaxillofacial and Thoracic business unit Adam R. Johnson will step down September 1st, 2017.

August 3rd, 2017: Dr. Bal’s investment company, North Stadium Investments, gives Amedica $2.5 million bridge loan, the same amount Zimmer paid Q2’17.

On July 28, 2017, Amedica Corporation (“Amedica” or the “Company”) closed on a $2.5 million term loan (the Loan”) with North Stadium Investments, LLC (“North Stadium”), a company owned and controlled by the Company’s Chief Executive Officer and Chairman of the Board, Dr. Sonny Bal.

September 22nd, 2017: Zimmer GK enters into a new loan for $189 million US in Japan.

September 27th, 2017: Dr. Bal reveals partnership with NGK-NTK in Japan and that clearance in Japan is due “very soon”. 2017 milestones shows before end of year. Recall that NGK -NTK owns 30% stake in Japan Medical Dynamics Marketing, INC.

September 28th, 2017: Zimmer Biomet Spine Opens New Headquarters in Westminster Colorado

This new facility combines research, marketing, development, and administrative functions that had previously been dispersed between Austin, Minneapolis, and Broomfield.

OZ transformed the interiors of a former call center in the Westmoor office park into cutting-edge research laboratories, development facilities, and high-end office space with sweeping views of the Front Range. The research labs include simulation rooms where implants are placed in simulated spines and tested using machines that mimic the human forces of standing, sitting, walking and lifting. With the new facilities, the company hopes to delve further into the research of new robotic tools and devices that would provide minimally-invasive spinal surgery.