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It doesn’t matter. There is no demand!
There have been lots of companies that have come up with great ideas, but there was no market demand for their product.
Also, PEEK is on the way out. That void is now rapidly getting filled by additive manufactured titanium. Not SiN.
Doesn’t matter how they are manufactured, it’s still silicon nitride.
The bottom line is, it’s all supply and demand. ANDA probably has maybe about a 0.25% market share in cages.
There is no demand for the SiN. Even if SiN powder cured cancer, if there is no demand their sales are not going to increase. When Invibio first brought PEEK into the market over 15 years ago, there was a demand as surgeons were looking for an alternative to titanium cages as PEEK is radiolucent and the surgeon capsule access the fusion.
However, since titanium can now be manufactured to be radiolucent with the advances of 3D printing, the market has shifted back to titanium. It’s a tried and tested material. Surgeons feel comfortable with it and will be reluctant to change at this stage.
So, no demand, lack of interest by the medical community and with a tiny market share, I highly doubt any major player is going to take a gamble on AMDA.
So, here is the problem of many ‘experts’ on this board. All their information comes from SEC filings and company press releases. There seems to be little or no knowledge about spine and orthopedics in general. A bunch of accountants are getting their financial info and press releases and trying to connect the dots. Obviously they have never stepped foot in an OR or spoken to any surgeons.
First, I have never spoken to a surgeon who has said, geez, I want to use SiN to prevent infection. All implants are implanted in the patient sterile and the chance of infection is very rare in the disc space. Patients are placed on prophylactic antibiotics prior to surgery to prevent infection. Almost all of the infections in hospitals post op are in the surgical skin wound, not in the spine or hip.
Second, as mentioned previously, 3D printed cages in spine is huge and gaining momentum. PEEK is losing market share and being replaced with titanium 3D printed cages. Some companies now even have expandable 3D printed cages, something Amedica does not have (expandable in SiN).
There is no additional appeal for the spine surgeon to use a SIN cage and some have said that they are nervous about placing a ceramic into the spine due to possible cracking post op.
I think AMDA had a shot at making it big when PEEK dominated the market 5 years ago, but they have missed their window of opportunity. Surgeons were looking for an alternative material to PEEK, but have now found it in 3D printed cages. Too bad, it could have been big!
I wouldn't know, maybe they are launching a new artificial disc!
you the one who said:
'This isn't just for spine and Si3N4 is applicable in other product lines'.
If you make a statement like that and say that the sales rep(s) need specialized training, you should be able to back up your claim.
Ok, so please give us an example where SiN in used in a different product line where the sales rep will require specialized training?
A femoral head made from zirconia ceramic or SiN is implanted the same way. Not going to change surgical technique. I’m confused.
Don’t need much training to be able to put a interbody cage in. Instruments are all standard trials, scrapers, inserters, etc. Nothing new.
Reps would also just need white papers on their anti-microbial data etc. to show to surgeons.
The Zimmer reps already have interbody experience. They must be referring to something else.
I would say that all of orthopedics is specialized and requires a specialized sales force. Some of the system implants and instruments are complex the sales reps have to undertake special training to be competent in the OR.
I didn’t see Amedica mentioned anywhere in the Zimmer's Q4 CC transcript
Can you point it out. Thanks
If they did $11-12 million in Q4, I am sure they would have been very excited and would have had a press release talking about a record quarter and releasing some unaudited financials.
Sorry, but it’s just not realistic, no matter what the data tends to say. Something else is going on with the data.
They don’t get paid by the insurance companies. They get paid directly from the hospital or hospital group.
Amedica is considered a hospital vendor and does not get involved in any insurance billing.
They would have had to purchase another 30-40 sets over the summer to see this revenue jump. Each instrument set costs around $25k. So would have had to put out $1million.
Do you see that expense anywhere?
Yes. They would first need to have surgeon agree to try product. Then get hospital approval, if not in the hospital system already. Hospital approval is the biggest hurdle and can take months in some cases. Once approved at the hospital, surgeries can begin and typically start to pick up after that.
Most companies recognize the revenue after the surgery and the sales sheet is submitted to the company. There is always a rush at the end of the month to get the sales sheets from the reps so the company can hit its monthly goals and realize the income. However, obviously if they don’t get paid, it would be bad debt.
Correct. Typically companies have a sales agreement with sales agent and a contract with the hospital. The set stays in the hospital (sterile wrapped) until needed. After surgery, rep sends Amedica a sales sheet on what was used in surgery. The company will then replenish the implants used in surgery (overnights products).
The hospital will then issue AMDA a purchase order ( takes anything from a few days to a week or so).
AMDA will then invoice the hospital. Payment typically can be anything from 30 to 60 days, depending on hospital contract.
Depending on the sales contract, the reps get paid their commission typically in 30-45 days, even if AMDA has not received payment from the hospital. On a rare occasion, you can have a sales contract where rep is paid ‘on invoice’, that’s when company receives payment and then rep is paid. Typically you want to keep your reps paid net 30 to keep them motivated.
They use independent sales distributors. Look at the sales and marketing figures. It’s over 50% of product revenue. Typically sales reps get paid anything from 25 up to 40%. Average is around 35%. This is very common on this industry.
Remember, ANDA does not have a full bag of products to offer, so it’s not uncommon for the reps to carry Amedica products plus products from other companies, like a cervical plate for example, which you would need to use when you are using the SiN cervical cage.
The company would be informed about any surgeries on the day of surgery, or maybe the day after. Reason is that the sales reps want to get paid ASAP and wouldn’t sit on any sales sheets of product used in surgery.
Being in the industry I can tell you that typically surgeons have surgery days and clinic days. So they may operate on a Monday and Wednesday for example. Now I do agree that some can do as much as 4 - 6 surgeries a week. But those are the exceptions. Most are around 6 a month. You have to also take into account vacations, a couple of times a year, conferences etc.
You also need to look at set ‘turns’. How many times does the set get used a month. Average set turn in the industry is 4.2 a month.
That affects how many sets you need to keep in the field at one time either as loaners or consigned.
Also, as detailed before. They are not going to get all the fusion procedures due to their limited product portfolio.
It’s 6 a month, not 6 a year. I believe the number of fusions is around 480,000, so at 6 a month that would be 6,667 surgeons. Which sound about correct.
Correct. So average takes about 4 hours.
I’ve been in many many spine cases. How about you?
So you failed to address my past two responses. Anyways doesn’t matter.
Personally with the history of AMDA I wouldn’t believe everything they say. Look at the big picture and use common sense. Look at other successful Spine company’s out there and see what was their best quarter over quarter sales increase. I have been in this industry for over 20 years and know that it’s not possible for a 280% increase in one quarter with their current run rate.
There is no point having this discussion if you are going to be blind to logical facts.
But, good luck with the Zimmer BO.
Lol. Ok, so I guess from that response you are not in the spine industry.
Firstly orthopods do a lot of other procedures other than spine. So 30 procedures a month can mean a lot of other things out of Spine
In addition, AMDA only has 2 products. Pedicle screws and cages, so that limits the number of cases they will get. The average a one lever lumbar decompression, lami, fusion and pedicle screw stabilization takes about 4-5 hours. So, do the math. It’s Impossible for a surgeon to do 1.5 surgeries a day, plus see patients, do clinic etc. look up the data for spine fusions performed. Unless they work 24 hours a day and ONLY use AMDA limited products.
In addition. ANDA does not have MIS pedicle screws, so they are missing out on a large volume of fusions performed.
Also they don’t have other fusion products. Such as:
No Cervical plates
No posterior cervical screws
No spinous process spacers
No anterior thoraco lumbar plates
No artificial discs
No facet screws (have but don’t use anymore)
No stand alone cervical cage
No stand alone ALIF
No lumbar lateral plates
No anterior screw system.
So. As you can see, ANDA is missing out on a lot of procedures. The list above shows how limited they are on what they offer. So they are really a one or two trick pony. As I have tried to tell this board before, they have not developed a significant new spine product for years and, except for bringing out ‘modified’ cages. However, that just cannibalizes their existing line. ( same with Taurus ).
They really only are a limited niche product. Similar to SI bone. SI joint products that they also don’t have.
Well, if you have been in this industry for any amount of time, you know that sales don't just pick up overnight. It takes time to bring on new surgeons, train them, get hospital approvals etc.
If 3,300 implants used in 3 months, you can say that was about 2350 surgeries (assuming some were 2 levels or bilateral PLIF's. that would equate to 38 surgeries a day. On average a surgeon does about 6 surgeries a month, so that would require 130 surgeons using their product consistently.
In addition, you would need at least 150 sets to support that volume as not all surgeons are consistent. I highly doubt Amedica has that sort of inventory.
On another note, its this wild unrealistic speculation that makes you lose your credibility! You KNOW that this is not possible and is not going to happen. If they had those sales in Q4, they would not be scrounging for more money!
I assume you mean 2017 annual revenue will be $11.25M. Q3 revenue was ~$3M with a nine months at $8.79M. So that would make Q4 about $2.46M.
You don't honestly believe they did $11.25 in Q4?
Btw, you don’t need IP protection to get FDA approval. Two separate issues. Pretty much all products are launched before the final patent is approved. As long as you have a patent application submitted that will cover you in any legal claims. First to file. FDA does not care about patents.
So if they have all these products in the pipeline, why don’t we see any at the trade shows? You are allowed to display a product as long as you mention it’s not FDA approved yet. So, if they are getting a SiN femoral head approved, why not display it to generate interest. I bet with the AAOS next month it will be the same old pedicle screws and cages, nothing new. There is nothing top secret about displaying a femoral head.
The problem is, is that it’s all talk and no action. Just because AMDA have so called ‘interest’ it means nothing if there are no sales. It seems that Sonny likes to throw out these ‘press releases if deals’ just to make the quarterly reports look good.
At some point you can only cry wolf so many times.
Ok, so you don’t have any hard evidence or proof that they received a LOI from Zimmer.
Like I said, your rational is very weak. I can take any 2 spine companies and attempt to ‘connect the dots’
Let’s be honest here. Zimmer can easily afford ANDA and they are so desperate they would take any valuation. But it hasn’t happened and no other company is interested either, or else it would have been picked up by the big boys long ago.
So your premise just doesn’t any make sense.
Can you please post a copy of the Zimmer to Amedica LOI. thanks
‘Besides only 1 company has a shot at acquiring Amedica, the company that signed the letter of intent in 2015.’
you mean like this? LOL.
SALT LAKE CITY, UT -- (Marketwired) -- 03/23/16 -- Amedica Corporation (NASDAQ: AMDA), a company that develops and commercializes silicon nitride ceramics as a biomaterial platform, is pleased to announce its first fabrication of complex, three-dimensional structures by a 3D printing process called robotic deposition, or robocasting.
You see how ridiculous this is. Once again, diversion. You have NOTHING, LOL
So the one thing you are good at is diversion and distraction (as now with semantics on material) and not looking at the evidence.
You have NO documented evidence except that a Zimmer poly cup was used in a test in Japan. Otherwise everything else is SPECULATION! As I have mentioned in previous posts you have been spinning this for years and NOTHING has materialized. When you come up with some concrete evidence, please let us all know.
You are kidding me right? NUVA says proprietary surface and STRUCTURAL TECHNOLOGIES. Maybe they are buying AMDA.
You see how silly this is?
That's a standard comment that every ortho company says, hardly evidence.
for example:
Through Advanced Materials Science, NuVasive strives to develop proprietary surface and structural technologies to enhance the osseointegration and biomechanical properties of surgical materials.
So, the only documented evidence you have is that there was some testing done in Tokyo done with Amedica SiN and a Zimmer acetabular cup. It is not unusual in orthopedics for researchers to use different company implants for comparison testing.
Other than that, everything else is speculation. The spine industry is relatively small, Its also not unusual for people to work for various company's (including Zimmer).
A Letter of Intent from a 'Strategic Partner' can be anyone. Amedica was working OMNI years ago and that didn't go anywhere.
I think you are desperately trying to connect the dots to connect Amedica to Zimmer. This has been going on for years now. Do you have any other DOCUMENTED
Ok. So they are a materials company. But the only SiN product that’s generating (declining) revenue is the spine cages that they have a 510k on.
All the other products are going to require FDA approval and the FDA requested a clinical trial for their SiN femoral head and acetabular cup as the 510k was rejected. That’s going to take 4-5 years and millions of dollars. The same probably goes for their dental product as it is seen as a ‘new material’ which requires an IDE.
All they have is a material that has not been clinically demonstrated in extremities except spine. I don’t see much value in that.
Stryker
Medtronic & Depuy
Nuvasive
All these company’s have both PEEK and titanium. Zimmer has peek interbody implants as well.
So the question still stands. No spine company has taken an interest in SiN.
Globus, K2M. Depuy/Synthes, Medtronic, Stryker, Nuvasive, etc. etc.
any one of these companies would buy Amedica ASAP if they knew it would take over the market and take competitors market share.
But no other company interested in technology. That’s a big red flag.
Please explain.
Zimmer spent years doing due diligence acquiring Implex for their Trabecular metal which turned out to not perform as they had hoped.
Now they are taking years to evaluate Amedica Silicon Nitride according to this board.
No other company seems interested in this technology. Can anyone explain why no other major player has made a play for Amedica?
There are NO increased sales! interbody is declining YOY. The market does not care!
There is no new SiN material except that they made the same material porous CSC and still could not get FDA approval. And it the so called ‘new material’ is better, why did they need to create it if the original was so fantastic as you have claimed! Give me a break!
Like I said. There is NO demand! You can claim all you want, but no one is buying it. Sorry.
Companies like Titan are killing it. Also, expandable metal 3D printed cages are coming on strong.
I don’t think we will ever see an expandable SiN cage anytime soon.
You need to accept the facts!! No market, no demand, equals no sales!