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TOPIC: Take-One Specific EU claim (2010) for fistulae

Take-One Specific EU claim (2010) for fistulae 13 Apr 2014 12:07 #1543

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Transparency and "honesty" is a definite issue at Cytori. At least I can "delve" in a lot of old write-ups to keep folks honest a bit- so thought I will deal on this board with one topic of the list per week, which recently appeared in

This is NOT the Company I know on this board.

And will elaborate more on the topic- so Take-one first- Fistula.




Actually- this is the first time ever that I read in a slide presented by a corporate official, that the Crohns Fistula data stem from INDEPENDENT studies by investigators !!!!!!!! :nice:

I have been digging in my writings of 2010 a bit- below you will find my Newsletter of August 2010- in respect of the approval I wrote the following in this newsletter-

August 6 2010- an absolute "low-light" in corporate communications to shareholders
The conference call had only one reference to the key issue, when Brian Gagnon of Gagnon Securities
congratulated on the achievement of receiving the additional claims on Celution and specifically inquired on the
wound healing added claim referenced above. Marc Hedrick, president of Cytori and former CSO answered the
question.
Marc stated that the received claims were "data driven and the result of a lot of- and long work". Certainly there
are no objections to or flaws in these statements- no doubt the truth and nothing but that thruth. However the
next statement voiced in the same breath, that Cytori is assembling a strong database for wound healing with
ADRC´s and that the cells in particularwork very well with radiation wound healing, therefore implying that these
data are the main reason of receiving the added claims is (in MHO) a
MAJOR "STRATEGIC" DECEPTION
Why is that you ask? Answer- since the label provided by the MHRA in the UK relate to a population of patients,
which have been suffering from chronic inflammation of the bowel called Crohn´s disease, which is a
debilitating condition and severely impairs the ability of the body to heal itself. Obviously all the wound healing
trials and cases, which Cytori is pursuing in Nagasaki Japan(Radiation injury) and Hannover Germany (burns)
relate to more complicated wounds, but at patients where the immune system is still intact, so which have no
relation at all to the label provided by the MHRA.
The question of course should be, why this strategy? Simple answer is- Cytori doesnt own the trial data, which
belongs to Olympus, which company must have conducted the trials in the UK., resulting in the label for
Celution. The label finally CONFIRMED the compelling evidence thereof which I assembled on CYTXInvestor.
com and which you can re-visit on the following pages- "Partner1" and "Gastro1" of the site.
I do consider Hedrick´s answer on the Gagnon question however as another "low-light" in corporate
communications, since this label event should have been the perfect occasion for Cytori "to come out of the
closet" by stating- "yes-we have a partner who however prefers to stay anonymous at this point and who
provided the added claims for Celution". Would have been fair- Hedrick´s answer on the question however was
almost an insult to the investors intelligence (see last page)
As I have stated in the past- there is more to Cytori than the eye sees and what Management
tells you- the fistula label is not the only thing. But lets have a look what this fistula thing is first


I will elaborate on this tomorrow- fact is - Corporate Managers tend to be notorious liars"- Marc Hedrick is a prime example of this breed. :bang:
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Take-One Specific EU claim (2010) for fistulae 14 Apr 2014 06:17 #1544

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Fas, it is amazing that over 3.5 years after the CE approval for fistula, and your newsletter concerning CYTX's FOCUS on radiation/burn induced wound healing nothing has progressed as regards reimbursement for the APPROVED fistula wound indication. This raises a number of serious questions.

- Why has Olympus chosen not to advance the deal negotiations concerning this indication with CYTX.??

- Even without CelutionOne development there is money to be made by Olympus in progressing this indication. Surely the incremental data required would not constitute such an onerous financial hurdle.

- Has Olymous signed such an advantageous deal that they have locked CYTX out of the majority of wound healing indications.? Is it so broad that CYTX has to go and find specific subgroups that are outside the mandate of the basic partnership agreement?

- Are other researchers doing translational work for the benefit of Olympus in a wide range of other wound indications such as PAD????
If so, how long can Olympus delay or block these indications........ is this another bad deal ala Macropore/Medtronic ???? :KO:

I raise these questions as they seem warranted given the facts ............ or rather the lack of them.
I don't like conspiracy theories, but there is certainly a conspiracy of silence with regards to Fistula ........which I find deafening.

Fas, thank you for the role of historian in the ongoing saga of Cytori.

If you have any thoughts on the above they would be most welcome. Is it possible that something like the above has been keeping other companies from signing a deal with CYTX?. Is Celution and ADRC therapy so DISRUPTIVE in so many areas/indications that it is hard to structure partnership deals that don't overlap (except for georgraphic deals such as LOREM)? :really:

Shareholders have a right to answers for these questions. I propose that a formal letter be sent to the BoD and mangement. :write:
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Take-One Specific EU claim (2010) for fistulae 14 Apr 2014 09:37 #1545

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I am very much behind a formal letter to the board. Hopefully we can get DOV and WST on board along with some other sizeable shareholders

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Take-One Specific EU claim (2010) for fistulae 14 Apr 2014 13:24 #1546

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John-
yes - maybe you are right and maybe I should put something in motion to the BOD, with the help of my "behind the scene" friends.

This is the "oldest" application (2005/6), half the clinicians on this globe working with cultured ADRCs are working for a solution for the app. We have one, which is approved and nothing is moving now for 3,5 years- at least not that we know. Hopefully reality is different and that should be cleared. Yes.

Anyway- beyond what has been written in The Mystery unraveled- the Fistula after Crohn´s application

I think, the key is that Calhoun told me last year that the closing rate of fistula´s not closing with standard of care is approx. 65 to 70%.
This more than double what standard of care apparently.

So- if you do have this capability- is it not immoral towards patients not to pursue marketing thereof and deprive them of a possible medical solution of their problem?

I think this is key and the most pressing issue. I think as long as Cytori has the claim, they should be able to market regardless of their former partner. Time to reimbursement normally is 3/4 years (see image). That time frame has past and time has come that action is under taken
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Take-One Specific EU claim (2010) for fistulae 14 Apr 2014 13:46 #1547

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In respect of Olympus-

As I have mentioned before. I have not given up on them, but am somewhat skeptical now.

Key is- in 2009 a deal with them blew up just like Daiichi did. But than again the players- top management Olympus and Calhoun, are no longer with us now.

Calhoun told me twice- that the manufacturing deal still existing with Olympus (in the time that it did- things are arranged now) was no issue for other partners. I do not know- but as far as I can see they are pursuing development of regenerative medicine STILL and their chances to become successful would increase with Cytori technology- I strongly believe. :really:

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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:

Take-One Specific EU claim (2010) for fistulae 15 Apr 2014 02:38 #1548

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rongside

I lean toward your suggestion that fistula was tied up in a deal and we have no control over the application.

Just one bungle in a long serious of bungles.

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Take-One Specific EU claim (2010) for fistulae 15 Apr 2014 08:43 #1549

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***I lean toward your suggestion that fistula was tied up in a deal and we have no control over the application***

hedge, make one wonder how many more applications they have no control over?? It would certainly explain the non-partnering up to this point. Do the Olympus built Celutions come into play here, and is that what led to the new tabletop Celutions not being manufactured by Olympus?
:bash:
d9

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Take-One Specific EU claim (2010) for fistulae 15 Apr 2014 09:38 #1550

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Well I sent this to IR in order to illicit some kind of response

Megan,
Treatment of Fistulae has been approved in UK since 2010 but it has not been offered as a treatment modality. This is immoral and has been a hindrance to Cytori.
Currently we are gathering together a large number of shareholder that want answers to these questions.
Expect a letter to the BOD within 10 days. This formal letter will be endorsed by a significant percent of the shareholders.
Regards Joe C.XXXX

From: Megan McCormick
Sent: Monday, April 14, 2014 4:23 PM
To:
Subject: RE: pipeline

Hi Joe –



We don’t tend to have a lot of visibility into these independent research studies as they are truly run by the physicians. We’ll provide updates when there are material developments in these areas.



Thanks,

Megan



.
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Take-One Specific EU claim (2010) for fistulae 15 Apr 2014 12:26 #1551

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Joey, the reply you received was very much the standard response received in the past. It does not address the question.

Although I appreciate Megan's preemptive promptness, ............ perhaps she can advise us to how it is possible for Cytori to have received CE approval (MHRA -UK) without "visibility" of the independent research studies. Of course it may well be that the researchers submitted the application for review on our behalf without making the data known to us ......... which is absurd.

The only rational reason for the delay in progressing this indication and seeking reimbursement is that a PARTNER who has the power of VETO has chosen not to proceed. Perhaps they were not in a financial position to do so or management inertia (paralysis due to the reporting scandal) did not allow them to proceed. I find it very difficult to believe that left to its own devices CYTX management could not find funding for an approved indication for which there is a clear and pressing need.

Perhaps the trade off for this delay on the part of Olympus was the writing off of CYTX's share in the CelutionOne development cost?

The only conceivable business imperative that requires continued secrecy after 3.5 years is one of avoiding embarrasment. :bash: :KO: :puke:

If so, management needs to get this deal on track quickly as the questions will NOT GO AWAY.

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Take-One Specific EU claim (2010) for fistulae 16 Apr 2014 10:54 #1552

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Some additional questions for Megan :

Two years after the Crohn's fistula CE approval we gained an expanded approval for cryptoglandular fistulae.

ir.cytori.com/investor-relations/News/news-details/2012/Cytori-Expands-European-Approval-for-CelutionR-System-for-New-Indications-Including-Intractable-Cryptoglandular-Fistulae-Inve/default.aspx

"Since 2009, we have treated seven patients with quite challenging cryptograndular fistulae-in-ano as part of an approved feasibility study," said Dr. David Borowski , Consultant General and Colorectal Surgeon at the University Hospital of North Tees, UK. "Five of the seven patients had the fistulae for a long time and failed prior treatment; of these, four were treated successfully. All seven patients underwent an advancement flap procedure in combination with adipose-derived regenerative cells, which were prepared at the point-of-care using the Celution® System. Five of the seven patients had initial healing after a single procedure and there were no adverse events. Of the three successfully treated patients with more than two-year follow-up, none had a recurrence to-date. Based on the feasibility study and the new indications for Celution®, we are planning a larger, controlled, multi-center study in the UK to investigate the benefit of the addition of adipose derived regenerative cells. Furthermore, this new labeling should facilitate our ability to use Celution in the treatment patients with complex or recalcitrant cryptoglandular fistulae-in-ano."

It would appear that not all researchers are so reticent about publishing their findings. Now to the questions:

- Has there been any progress on expanding this trial given the very positive outcomes from the initial findings???
- If not, why not???
- Can we assume that this trial has been undertaken by a different group than that which undertook the Crohn's indication given the publication of the data???
- Are both indications covered by a single partnership/marketing/product development agreement???
- If not why doesn't CYTX proceed to partner the cryptoglandular fistula indication independently of Crohn's fistula???
- How could this be done given that both indications appear quite similar (to a layman)??? (off label issues)

Any bets on whether we get a reply? :KO:

Perhaps Olympus has decided to focus on the Japanese trials in these indications. The new Japanese regulations may facilitate approval and reimbursement more easily than in the UK/Europe. Lets hope so! :winky:
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Take-One Specific EU claim (2010) for fistulae 17 Apr 2014 08:54 #1557

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Thanks John for the research work.

The work of Borowski is basically independent too, but than again Cytori apparently had all access to the data, since they brought the Gary story in 2012.
From those days I remember that they still had a Celution at Hartlepool, since Pud Baskar was part of the RESTORE trial and even did a 22 patient independent breast reconstruction study.

Anyway- the fact that another type fistulae (after gastro-surgery) is mentioned in the slide of the first post, which never was disclosed before, I am hopeful that the development continued after 2012.

I did write a mail to somebody who has continuous access to Board members and will ask for "satisfaction" on the issue.

This "satisfaction" means that development IS ongoing and work is done towards reimbursement. In case this is NOT- one can speak of non-fulfillment of duties assigned to management by shareholders, which the BOD is responsible for to check on a continuous basis on our behalf.

I will report back if there is some printable news- in the mean time anybody can work through Megan or anybody... personally I think you simply get the "corporate answers" which are plain lies and deception.

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Take-One Specific EU claim (2010) for fistulae 17 Apr 2014 10:53 #1558

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Fas, Do you believe that Cytori is actually going to make it as an independant company ? Do you feel there would be life if BARDA milestone is not achieved ? I know you don't read the YM message board but I have suggested some possible scenarios un the heanding MY Thoughts. I am having such a difficult time remaining positive and to keep from being completely cynical,however, nothing has changed in some 4 + years of ownership other then the size of my significant losses. I have no doubt that STEM CELLS are the future, I have major doubt that CYTORI as we know it will be a major factor. As has been quoted on numerous ocasions " the definition of insanity is doing the same thing over and over and expecting a differnt outcome " Your thoughts, please :bash:

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Take-One Specific EU claim (2010) for fistulae 17 Apr 2014 11:41 #1559

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Michael- first- I still do read whats written on the YB. Just not daily, but I inform myself several times per week on the more interesting topics.

Yes- I did read your comments under that heading and thought they were quite interesting and certainly not to be dismissed as impossible, since of course- a take-over is possible anytime, despite the best defenses and poison-pill constructs, that a Company and its BOD puts up.

I do want to remind you of Rickey´s statement when he took over in September last year:

“Cytori’s cell therapy platform has the potential to bring about an entirely new class of therapeutics that are innovative and cost-effective,” said Mr. Rickey. “In the role as chair, my priorities will be to represent the interests of our shareholders and to help guide Cytori’s growth as it aims to become a leading independent global biotechnology organization.”


As I have mentioned on this Board- Rickey has gained the respect of the largest shareholders in Cytori and worked diligently to get rid of CC despite the fact that they have known each other for that long. I think more actions will come from him in the next months and they will most likely determine if Cytori can make it on its own.

At present- in my view- NO WAY can they make it on their own. Their is no talent or money to do so. I think Hedrick is even worse than CC- not to speak of Saad. They really have nothing except for a wealth of technology know-how developed in Europe and Asia.

To monetize that expertise as I said we need MONEY and TALENT.

To me BARDA is for the birds (at least for a few years) and the corporate image simply in shambles i.e. requires restoration, a partner or a miracle.

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Take-One Specific EU claim (2010) for fistulae 17 Apr 2014 11:57 #1560

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Thanks Fas, unfortunately I am in agreement and feel this is going to be one costly mistake I have made.

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Take-One Specific EU claim (2010) for fistulae 17 Apr 2014 14:02 #1561

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Fas....you seem at a new low in your outlook.

Certainly, you must feel my call of single digits for all of 2014 must seem realistic at this point and my views on cash levels over the years a big issue.
I do disagree that BARDA today (should it advance) does have some value even though the real pay-off would be years away.
I still think the biggest worry is ATHENA...I never was satisfied with the reasons for the need for ATHENA 2. Recent long term cardiac data from PRECISE a yawner ...rehash of what we have known for a long time.
We are still light years away from the tens of thousands of patients needed annually to make this company work. Rickey needs to rent a chainsaw to cut out all the dead wood found at Cytori !!! Even then it is unknown if it will be too little too late in the end.
A buyout may not be so bad ....oh but what could have been...should have been. :cry:
Its not over yet though. So we shall see if Rickey saves the day :really:

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Take-One Specific EU claim (2010) for fistulae 18 Apr 2014 11:20 #1566

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Hedge- I do not feel myself to be "low" in my outlook.

This discussion started when I listed NINE forthcoming events and accomplishments of the past and present in the thread-

This is NOT the Company I know.

To me they all represent opportunities for marketing and partnering ASSUMING the Callan Road gang has done the job they were supposed to be doing.

Now BARDA is distilled as a life-saving event, although it is a PLAIN RECOGNITION by a part of the US system recognizing the relevance of Cytori technology. The REVENUES resulting from approval for the next phase is still 4-6 years out. The government is just paying for the development cost in the mean time.

At present we have already > a DOZEN - governments (if you believe CC- "only 8 if you believe Saad") who are already DOING EXACTLY that- RECOGNIZING the value of Cytori technology and sponsoring its development-
Only difference is that BARDA will reimburse the cost to Cytori who orders the PI´s and CRO´s and pays them.
The other governments sponsor their own PI´s and CRO´s directly- whats the difference????????????????????????????

I think Cytori is lying to us on the developments and mishandled that part of the business completely.

Something has to happen - coming from these developments- either work with governments directly or deals with POC suppliers like Smith & Nephew are urgently needed. :bang:
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Take-One Specific EU claim (2010) for fistulae 18 Apr 2014 11:36 #1567

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Fas

I think the BARDA value is it will be the US government...a narrow minded view I admit...but some US money managers may put value to this.
Do I think it can push the PPS significantly ? not really..but it may provide some support.

Curious if you also view BARDA as being mismanaged as other government programs ?

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Take-One Specific EU claim (2010) for fistulae 18 Apr 2014 11:49 #1568

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Fas do you think we should put together 5 or 6 questions addressed to the BOD?
Perhaps have shareholders sign it.Personally I dont think it would hurt at all

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Take-One Specific EU claim (2010) for fistulae 18 Apr 2014 12:23 #1570

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Hedge-

I understand patriotism- thats all fine, but one should present the complete picture I believe

On government programs "mismanagement"- I purposely avoid knowing ANYTHING on that subject in order to avoid making political statements. LOL :yep: You know how Dutch liberals react- I am a very typical one.

Joey- I believe- we, that is myself and the folks that write here- are the vocal "thinking" minority. A lot of other folks are a lot less critical and believe what comes out of Callan Road. I just believe scientific papers and prefer to take the "back-route" for the time being. (which can be effective at times)

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