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TOPIC: China Aproval

China Aproval 06 Apr 2015 07:27 #4066

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China Aproval 06 Apr 2015 07:43 #4067

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A couple of things concern me. first, what kind of celution are we talking about? 5 million a year is big(will pay for couple of months) but 500K doesn't pay for much.

Second: what does clearance mean when it comes to China?

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China Aproval 06 Apr 2015 07:55 #4070

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Yeah :happy:

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China Aproval 06 Apr 2015 08:08 #4071

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SAN DIEGO & BEIJING--(BUSINESS WIRE)-- Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today that its exclusive licensee, Lorem Vascular, has been granted regulatory clearance for the Cytori Celution® System by the State Food and Drug Administration of the People’s Republic of China (CFDA). This regulatory clearance officially makes Cytori’s Celution System available in the largest healthcare market in the world and triggers a substantial 2015 product purchase order for Cytori from Lorem Vascular.

Cytori’s exclusive licensee in the region, Lorem Vascular, has worked closely with Cytori during the last year preparing for CFDA clearance and planning for commercial introduction of the Celution family of products in China. Today’s news marks the first time that Cytori’s Celution System has gained any level of access to the mainland Chinese healthcare market. Lorem Vascular will begin product launch of Celution in key hospitals in China immediately.

“Our combined teams have spent the past year examining the delivery of healthcare in China and it is clear that diseases endemic is western countries are a rapidly growing burden on millions of citizens and already represent a heavy drain on resources of the healthcare system,” said David C. Oxley, Chief Executive Officer of Lorem Vascular. “With CFDA clearance, Lorem Vascular will now begin to consummate partnerships with key hospitals throughout China to address specific vascular and non-vascular applications using patients’ own adipose derived regenerative cells, which have demonstrated clinical promise in studies around the world.”

In November 2013, Cytori Therapeutics and Lorem Vascular entered into a 30-year exclusive licensing agreement to commercialize Cytori Celution System in China, Hong Kong, Malaysia, Singapore, and Australia. As part of that agreement, Lorem Vascular agreed to pay up to $500 million in fees to Cytori for a 30-year exclusive license for all indications, excluding alopecia, in the licensed territories following specific revenue milestones, as well as royalties of 30% on gross profits from Lorem’s operations in China, Malaysia and Hong Kong. Furthermore, following today’s news, Lorem Vascular placed an opening order of 23 Celution Devices and 1,100 Celution Consumable Sets, which is anticipated to be fulfilled throughout 2015. Following this opening order, Lorem Vascular has agreed to purchase annually a minimum of fifty (50) Celution Devices and fifty (50) Celution Consumable Sets for each of the Celution Devices for the next three years from CFDA clearance.

“Lorem Vascular’s commitment to the Chinese market, along with today’s CFDA clearance and receipt of the opening order from Lorem Vascular is an important part of our 2015 plan and a key milestone for the year,” said Tiago Girao, Vice President of Finance and CFO of Cytori Therapeutics. “We intend to continue our full support of Lorem Vascular as it expands its commercial efforts throughout its territories in the years ahead.”

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

China Aproval 06 Apr 2015 08:12 #4072

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A couple of things concern me. first, what kind of celution are we talking about? 5 million a year is big(will pay for couple of months) but 500K doesn't pay for much.


Surely its Celution 800 since CTX-2 is a late 2015 or early 2016 event,

Second: what does clearance mean when it comes to China?


Good question- write cytori IR and see what answer you get. I am very unpopular there- at least get no answers. :grin:

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

China Aproval 06 Apr 2015 08:26 #4073

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Well, what you are saying is that 800 for the first year and the cheaper model for the second and third year?

Again, is it price based or quantity?

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China Aproval 06 Apr 2015 08:33 #4074

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Well, what you are saying is that 800 for the first year and the cheaper model for the second and third year?


Yes

Again, is it price based or quantity?


Quantity based of course. Minimum orders in contracts are useless, when there isnt a market. I assume both partners think there is is one in China, albeit is this clause pretty irrelevant. Time will tell if they are right, but Deeside is ready and waiting to churn out those devices.... :yep:
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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

China Aproval 06 Apr 2015 09:32 #4075

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****Good question- write cytori IR and see what answer you get. I am very unpopular there- at least get no answers***

One could never trust the answers you got anyway...at least in the past.....so unknown if you are really losing out..LOL :grin:

We will have to see how the weeks trading plays out to see what value the market is willing to give to the news.

Cash news still being waited upon, Sabby group warrant converts ? Oxford loan ?

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China Aproval 06 Apr 2015 09:58 #4076

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One question. When warrants were extended to the friends of Cytori insider group ,were they not extended until just may 2015 and at a price of $2.50 strike price ? Any shot these warrantsget excerised, which would mean stock would have to climb above $.2.50. Today's news seemes to be good, but with the severe credibility issue this company has, it looks to be pretty much a non event. Guess the long term holders continue to get screwed while Sabby and Oxford profit.

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China Aproval 06 Apr 2015 10:05 #4077

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Roth -

I opened a topic just for the sake of following that. :grin:

I will make a post there... :cool:

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

China Aproval 06 Apr 2015 10:19 #4079

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My understanding is that it means approval into the private pay market. No reimbursement yet. Found it interesting that they mentioned baldness.

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China Aproval 06 Apr 2015 10:38 #4080

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My understanding is that it means approval into the private pay market. No reimbursement yet.


Yes- of course. Class I approval in China is said to be similar to Class I in Japan, which is comparable to general 510K in the US.

It means that doctors can treat a patient with Cytori cell Therapy if they think it helps the patient and the patient is willing to pay for it. In my mind it opens up the same pathway as we had in Europe in 2008 after receiving CE mark.

The big question to me is- what translational work has been done in Asia and China specifically to make these Vascular Lorem guys so eager to start marketing. Obviously Hedrick has to let his pants down sometime, in case his partner i.e. Lorem, get some specific approval, since that would be material news effecting Cytori too.

Found it interesting that they mentioned baldness.


Global rights on Alopecia lie with Bimini i.e. KeraStem

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

China Aproval 06 Apr 2015 11:20 #4081

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I am the voice of optimism. This approval is a big deal just like BARDA.. The Shorts will always belittle any long term advancement that doesn't immediately show up on the bottom line. We are here at $1.35 because of the shorts success not because of the intrinsic potential value of CYTX .As Scleraderma and other positives become a reality, we will forge forward on Price Share. Our progess may be slow,but a better CYTX is out there. There will always be short term trading which will limit the upward price movement .And Yes that may include Sabby. We all have been worried about the Loan. If you are a long term investor let Tiago & Co.solve that problem however they wish. They know the company and what realistic options are available. We have limited understanding of what is going on. They will make mistakes. Hopefully thy will be small ones. If you get too scared, use the sell option and have a good night's sleep. I again thank DOV and his spread sheet that may be folley but at least shows what is possible, GLTA
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China Aproval 06 Apr 2015 14:27 #4082

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Hi keysman,

i am also optimistic. But for me it is easy. I am sitting on ++, and have not the experience of the last tow years of investment...

holdi

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China Aproval 06 Apr 2015 15:13 #4083

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Anyone have any advice on how to trade this news?

I was almost certain this PPS was going to go sub $1.10 but this China approval threw my scottrade purchase order askew.

I just want to load up as much as I possibly can before this catapults up to $25 pps (God willing).


I'm figuring the volume is all computer generated so I'll let it settle back down before I re-calibrate my limit purchase orders.

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China Aproval 06 Apr 2015 15:51 #4084

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To me, trading this stock is difficult at the present.

On the positive side, 1. the fundamentals of this company has changed drastically from a going concern to a much better company; 2. the new management team and the new corporate strategy are quiet good; 3. more positive news may come soon: Japan, EU and Athena, etc.; 4. financially, the company should be better off now than it was this time last year.

There is a big gap around $2 that may be filled soon.

On the negative side, 1. this is another gap below 1.30, which the shorts are hoping to fill; 2. shorties are everywhere and CYTX needs more good news to fight off these wolves.

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China Aproval 06 Apr 2015 16:05 #4085

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I would be shocked if CYTX didn't sell stock thru the ATM today I really hope they did. If not the sellers at !.35 are hard to figure out. Shorting here is hard to figure out

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China Aproval 06 Apr 2015 18:08 #4086

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My first inclination was to write that I would be surprised if they DID tap the ATM today. But then again, nothing surprises me with CYTX anymore.

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