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TOPIC: Questons on Cytori for Thursday

Questons on Cytori for Thursday 28 Jul 2014 11:27 #1909

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I am running behind in producing this list- partially eye issues- partially "motivation"-

I will post the introduction first- and after that- the issues and 5 questions at the time- just shoot any feedback to make it "teamwork" like it should be- :grin:

Resolving ISSUES and perceived QUESTIONS from LT shareholders in respect of the "Mystery Company- Cytori Therapeutics Inc".

To most of the long-term holders of Cytori stock, the Company has been and still is a mystery in respect of its regulatory pathway, science and clinical achievements. The only clear fact about the Company however has always been that the empty bottom of their virtual money coffer has always been clearly visible by all market participants on a perpetual basis, which explains the constant pressure on PPS and the relatively large short position.

We have heard that there is a "renewed willingness" for openness and information sharing, however we realize that 14 years of Cytori with extremely poor investor relations has created a gigantic gap in knowledge and facts, which gaps are in need for "high level" closure, in order for those shareholders to regain the confidence in the ability of present management and board to move this company forward and achieve the financial success that all of us seek, based on what we believe is the ability of the science to help patients with a multitude of disorders.

We also feel that we should convey our ISSUES to Dr. Hedrick together with the descriptions of the "perceived knowledge voids" (i.e. QUESTIONS) to re-invigorate the shareholders confidence in Cytori. These descriptions we accumulated by creating a list of the most relevant questions we have on the past in respect of the knowledge voids mentioned and also on the present and future in respect of the status quo as described by Dr. Hedrick in the most recent shareholders letter.

We have a chance to clear the air and set a new base for shareholder expectations. We hope that Dr. Hedrick and the organization embraces this opportunity to create a renewed confidence in the ability of Cytori to achieve the great things her investors have envisioned in the future.

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Questons on Cytori for Thursday 28 Jul 2014 11:32 #1910

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Following the 3 "advice" type things- i.e. no questions- I think the first one is critical and vital. If Hedrick does not embrace this- he can pack his bags soon (IMHO)

The Three Perceived ISSUES

1. Financing the Company.
The latest shareholder letter contains the following quotation:
While we remain focused on clinical development and commercial success , equally important to many of our shareholders with whom I have spoken, is to ensure that Cytori grows in financial strength and is able to take full advantage of its technology. I wholeheartedly concur. As CEO, I will personally do all I can to ensure we wisely invest our resources and focus the use of those resources on only those projects most likely to bring the highest return on investment
We believe this statement contains a "contradictio in terminis"- that is - only selecting projects with the highest return simply EXCLUDES the opportunity to take FULL advantage of the technology. Cytori needs therapeutic development partners as long as it is not a commercial company. We all know the promises from the past, starting in November 2006 and continued until recently. Fact is, it STILL should be the highest priority objective for management to find financially potent development partners, without promising anything, but at least with general explanations why success remains futile. If such explanations make sense, shareholders´buyin to dilution will be assured.

2. The Regulatory Pathway.
The global regulatory device pathway is generally poorly understood by shareholders. Some efforts have been made in the past at conference calls to explain, but the most obvious places to look- the Corporate Homepage as well as the Annual Report are mainly devoid of explanations. It is suggested to use the EU regulatory framework as the benchmark by defining the "broad device claims" for this "extended" region and later assign "specific therapeutic device claims" to these broad claims. Regulatory achievements in other global territories than could be related and compared to these descriptions. At present- when Celution achieves an approval in a non-EU country nobody really knows what the approval represents and what treatments can be performed with Celution.

3. Business Risk- Device Competition
The Annual Report focuses mainly on competition in the application space regardless of cell source i.e. cardiac cell therapy etc. At present the scientific publications using adipose tissue as a cell source are increasing exponentially. Thereby it does not go unnoticed that, despite the current IP position, that many new devices (we know 10 by now) are developed for cell extraction from fat. Consideration and a some guidance would be welcome in that new "commercial space".

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Questons on Cytori for Thursday 28 Jul 2014 11:42 #1911

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The Questions to fill "knowledge voids" from the past

Science
1. The past few years Cytori as a Company has contributed very little to the scientific community in respect of published basic- AND applied research on MSCs and SVF in particular. Can we assume that Cytori agrees to the publications of Dr. Arnold Caplan in this field and is it "safe" to assume that ADRCs "behave" according to his teachings?

2. Congruent to 1. Cytori has contributed very little as a leader in the field of ADRCs to IFATS, the overruling scientific organisation, although at least in 2012 three papers were presented. Can you explain your hesitation in contributing more freely, which possibly relate to past events?

3. Independent research from the Basel Saxer group and Amsterdam Helder group in recent years came to different conclusions than Cytori "related" research on osteogenic potential of ADRCs with the periodental clinic in Amsterdam and ROBUST in Basel as exciting results. Both clinics are using Celution as source for clinical grade cells. What is Cytori doing to stimulate global interest and further development of this exciting opportunity in a major application market?

Cytori clinical development
1. The ADVANCE clinic
You have conveyed to us in 2013 that you enrolled the last patient in September. From that perspective at least 6 months data should be available now for a population which is almost double the size of APOLLO. How about a heads up? Are there European clinics pickung up on the application and were any registry entries made since than?

2. The BARDA Primate study
"I think it would be remissive for us to design experimental studies which irradiated animals and did not look at some of the other organ systems that would be damaged by radiation". Was a statement by John Fraser in 2012. One can presume this was done. Can there anything be said as a result of the potential for ADRCs in ARS?

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Questons on Cytori for Thursday 28 Jul 2014 14:41 #1913

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so the next 5- continuation of the third post-

3. BARDA next phase
In the published studies from Akita on radiation wounds, which we assume was the basis of BARDA´s interest, a combination of SVF, FGF growth factor and collagen matrix was used. Is this anticipated for any new pivotal burn study also? and to what extent do you see a possibility (since the treatment already has proven to be very effective) of fast tracking the study by the FDA?

Cytori´s collaborations and potential therapeutic partnerships
1. Fraunhofer- Stroke research,
In 2008 you announced a small collaboration with the largest research institute on the globe- Germany´s Fraunhofer- on ischemic stroke. In view of the fact that Cytori has indicated that the German "government" is about to sponsor a clinical study, the question obviously is- Is there a connection?

2. Astellas
Is Astellas still privy to the developments at CYTX i.e. do they send a non-voting Director to BOD meetings? Astellas has stated (after their re-organization 2013) that they would adopt somatic cell technology. Are they still conducting research and is CYTX being kept up to date of R&D findings i.e. how is your relationship?

3. All those other therapeutic partner discussions from the past
There is a huge range of applications for ADRC. Whatever happened to all the potential partners that were in discussions with CYTX over the years?

4. Lorem Vascular
The recently published Investor Note updating on Lorem was highly appreciated! This is the way to go!
From this Note- "our application for Class 1 approval in China will be filed before year-end". You have explained in the past that Class 1 approval in Japan is similar to a 510k tool device approval in the US, which is followed than by specific clinics on applications for which a specific therapeutic device claim is desired. Can we assume that a. Class 1 approval in China is similar as in Japan and b. that Lorem will act as the sponsor of "cardiovascular, renal and diabetes" studies in China i.e. in the beginning phase will be more a application development partner as compared to a commercial partner?

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Questons on Cytori for Thursday 28 Jul 2014 16:23 #1915

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Lot's of great questions. I "d appreciate some honest,candid,factual answers. I have yet to hear one that has actually lead to a result as advertised.

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Questons on Cytori for Thursday 29 Jul 2014 05:33 #1916

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****I "d appreciate some honest,candid,factual answers.****

Now that would be something rothco and a welcome change.

Fas...nice list of questions. While not really the past a update on how they plan to proceed in Japan would be nice. I am hoping we hear something on the subject very soon but one never knows with Cytori !

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Questons on Cytori for Thursday 29 Jul 2014 06:58 #1917

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While not really the past a update on how they plan to proceed in Japan would be nice. I am hoping we hear something on the subject very soon but one never knows with Cytori !


Yes- Hedge- surely we will cover that-

Here´s the next five

5. Apollo Hospitals and India
In September 2011 you closed an initial alliance with Apollo Hospitals on soft tissue applications. With the available hospital infrastructure, the specific Indian cardiac issues, the potential for adoption and growth looked enormous. So, what happened?

6. Lorem Vascular- all other licenced territories
Developments in China and the rest of the franchise countries are not mutually exclusive or contingent on one another. What is happening in Australia, Hong Kong, Malaysia and Singapore? Australia and Singapore already have device approval of "some sort".

additional Q in Science
4. (high level only) In the past Dr. Hedrick has stated that the drawback of autologous fresh cells is mainly the variability in patient samples and with allogeneic mass cultured cells the drawback being the reduction in potency of the cells. Many clinical studies have confirmed the last issue. Has Cytori been able to solve the variability issue with incorporation of the Sistemic miRNA quality control system in clinical studies like ATHENA?

Translational clinical development
Japan
1. In November 2013 Dr. Hedrick stated in a discussion with Dave Musket, that there are about 9 clinical studies ongoing in Japan, which will lead to our own approved and reimbursed technology for specific indications, OUTSIDE of whatever benefit the new law may have. Specifically he referred to the multi-centre SUI clinic led by Nagoya as a prime example.
In May 2014 Dr. Hedrick however indicated, that all parties involved are still working on a clinical timeline, implying that the study did not even begin. You have us confused and somewhat frustrated. Please explain.

2. In September 2012 Cytori announced the start of a 40 patient multi-centre (3) study led by Nagoya on PAD/CLI. Members of our group noted on Japanese language websites indications that this study was completed in Q1 2014, which we believe Dave Musket also referred to in November 2013. In view of your excellent relationship with Nagoya, can you elaborate and share early conclusions?

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Questons on Cytori for Thursday 29 Jul 2014 09:49 #1918

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Fas, Have you sent these questions to Megan or anyone at Cytori so that perhaps they will be addressed ? One other comment , the analysts who have out price targets of $8 -10 by year end, must be privy to information that we don't have , are being paid by Cytori for bogus analysis, or are working in concert with the shorts. D day is 2 days away as far as i'm concerned :bang:
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Questons on Cytori for Thursday 29 Jul 2014 09:55 #1919

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No Michael- I have not send them to Megan- nor will I send them.

Every Board member will get his copy of the document early on Thursday morning during breakfast.

"Our man" will also have the digital version for any takers and shareholders at the venue.
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Questons on Cytori for Thursday 29 Jul 2014 10:26 #1920

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No surprise for me on India Fas as we had our disagreements as to where that one would go anytime soon but the answer should be interesting.

Really liked this Q
***4. (high level only) In the past Dr. Hedrick has stated that the drawback of autologous fresh cells is mainly the variability in patient samples and with allogeneic mass cultured cells the drawback being the reduction in potency of the cells. Many clinical studies have confirmed the last issue. Has Cytori been able to solve the variability issue with incorporation of the Sistemic miRNA quality control system in clinical studies like ATHENA?***

Hoping for serious and responsive action from management and the BOD !

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Questons on Cytori for Thursday 29 Jul 2014 11:13 #1921

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My questions:

1)What are Cytori's most immediate revenue opportunities and how large are they?
2)How are you going to recapitalize the balance sheet?
3) Cytori's Celution cannot be marketed in the U.S. for clinical applications yet hundreds of SVF clinics are opening up throughout the U.S. using competing systems. How do you reconcile this and are Cytori patents being violated?

WST
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Questons on Cytori for Thursday 29 Jul 2014 11:53 #1922

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Street, you should send thee questions as well. It will be interesting to see if they will even acknowledge receipt of the questions,and heaven forbid actually answer them with true color. As one poster on the yahoo board continues to post, perhaps it really just is a centrifuge. He has always received numerous thumbs down but perhaps he has been right all along. PPS says he is, as does your comment.

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Questons on Cytori for Thursday 29 Jul 2014 13:21 #1923

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Hi Ray- thanks for chipping in- 1 and 2 are somewhat too obvious, where you will not get any answer- so I will pass on those. I like your third question and will include that one.

Below- some repetitive stuff- but gives the whole translational chapter

Translational clinical development
Japan
Ongoing clinical studies
1. In November 2013 Dr. Hedrick stated in a discussion with Dave Musket, that there are about 9 clinical studies ongoing in Japan, which will lead to our own approved and reimbursed technology for specific indications, OUTSIDE of whatever benefit the new law may have. Specifically he referred to the multi-centre SUI clinic led by Nagoya as a prime example.
In May 2014 Dr. Hedrick however indicated, that all parties involved are still working on a clinical timeline, implying that the study did not even begin. You have us confused and somewhat frustrated. Please explain.

Pheripheral Artery Disease/Critical Limb Ischemia
2. In September 2012 Cytori announced the start of a 40 patient multi-centre (3) study led by Nagoya on PAD/CLI. Members of our group noted on Japanese language websites indications that this study was completed in Q1 2014, which we believe Dave Musket also referred to in November 2013. In view of your excellent relationship with Nagoya, can you elaborate and share early conclusions?

The investor note on the new Japanese Regenerative Law.
3. Now that the feedback period has started and it looks like that in November 2014 the new law comes into force, maybe the time has come now, to based on efficacy signals seen around the globe on the use of ADRCs and status of the ongoing clinical work to round up the SPECIFIC applications, which Cytori plans to introduce in Japan WITH and WITHOUT the new law in the coming two years and whether this is planned WITH or WITHOUT a Japanese partner.

Europe/France
4. Scleroderma- Second Stage
Several Cytori representatives spoke at the Scleradec Workshop in April 2014 in Marseille, to discuss next steps after the highly succesful feasibility pilot on Scleroderma of the hands and the face. Could you provide a status report on the STAR registry and next steps?

Europe/Russia
5. Feasibility Glaucomatous Neurodegeneration
The Moscow centre is quite reputable according to some sources and embraced Celution for several investigations. This one appears very interesting since SVF is used for the first time (to our knowledge) for a neuronal disorder. Pre-clinical studies (Gimble et al) in spinal cord injury has proven SVF more efficaceous compared to cultured AD stromal cells. Are there any other neuronal feasibility clinics that you are aware of?

Europe
6. All other 30/40 translational clinics past, present and planned
With all due respect, it defeats your loyal (but critical) LT shareholders common sense, more than they can express, what the purpose is to withhold "non-confidential or non-sensitive" information from your information-hungry LT shareholders (all >10 years) on the studies performed or in process.
Especially - in absence of therapeutic partner deals from which the value of the technology can be derived from deal construction- adoption by governmental health authorities of the technology through sponsoring of clinical studies normally should be the next best indication of technology value. Since Cytori claims more than a dozen of such sponsorships- at least your international shareholders (of which there should be quite a few) value G5 and other sponsorship highly and crave for detailed information in this regard.

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Questons on Cytori for Thursday 29 Jul 2014 13:27 #1924

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Roth my comment about competing systems is not any indication of support for the "just a centrifuge" theory. In an article I wrote here: seekingalpha.com/article/2011181-cytori-therapeutics-global-patient-stem-cell-demand-builds-important-short-term-catalysts-ahead , I pointed to a study on the superiority of the Cytori system. My comment is more about an acknowledgement of a regulatory system that seemingly allows potentially inferior, non-FDA approved stem cell extraction systems to be used in clinical settings in violation of the "more than minimally manipulated" threshold stipulated by the FDA. The proliferation of these clinics, in what is still a private pay system, is a testament to the public's growing interest in autologous stem cell treatments. The irony is that the FDA's position on Cytori's regulatory path combined with their lack of action in enforcing their own rules has set up situation where patients have no way to ascertain the quality and quantity of the autologous mixture going back into their bodies. Its not Cytori's role to regulate stem cell clinics but the question of Cytori's IP is an interesting one but I certainly can see why they sit on the sidelines at this stage.

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Questons on Cytori for Thursday 29 Jul 2014 14:03 #1925

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Fas,

You're welcome. Whether they answer them or not, #1 & 2 are the most important questions from a shareholder's perspective.

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Questons on Cytori for Thursday 29 Jul 2014 14:46 #1926

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Fas, what do you mean by "our man"?

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Questons on Cytori for Thursday 29 Jul 2014 15:13 #1927

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Whether they answer them or not, #1 & 2 are the most important questions from a shareholder's perspective.


Sure- I agree. But I would prefer the German Lotto numbers of next Saturday instead. Pays off better.
Just kidding- I do see serious improvement in "corporate governance" in the days "after Chris Calhoun". It should stay that way.

what do you mean by "our man"?


A friend of Cytori who is at the meeting, of course. And a friend of mine too. You surely are not asking for names in a public board, do you????????????????????????????????????????

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Questons on Cytori for Thursday 29 Jul 2014 17:17 #1928

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Not at all. just did not understand the reference. Someone I know?

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Questons on Cytori for Thursday 30 Jul 2014 07:49 #1929

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This is the last bit- John, can you look over to see if I forgot anything important???

I think I will put the end product in a blog entry and keep track of answers there. Of course a PDF version will be in this thread and going accross to my partner and probably Megan also (contrary to earlier statement) I think thats only fair.

Main Question
Regulatory and reimbursement efforts in Europe
European Specific Claims (CE Mark) On Celution
1. You have conveyed to us how you went through the reimbursement process motions in the UK on Breast Reconstruction and ended up with the request for more data from NICE and an uneconomical DRG rate. However you also have reported several other specific therapeutic claims on Fistulae after Crohn´s and several other wound healing claims. Since these other indications covered many serious unmet needs, the question arises of course- what have you done since approval to get these procedures reimbursed by G5 health authorities. To our knowledge- this process works very well in Germany and other G countries, where authorities are rather receptive for new technology, which can save money for the countries health care system. Actually- we would expect in view of the time passed since approval, that you would be actively marketing reimbursed procedures by now. What happened????

Canadian approval for Celution
2. At several points in time in the past, Cytori conveyed the forth coming approval (assumed soft tissue procedures) of Celution in Canada, which might be favorable for US customers to "reach". Can you elaborate what the issues are, which most apparently have cropped up?

Approvals for New Generation Celution Device
3. Present CE mark, Class 1 and other country approvals are for mainly Celution 800/CRS or Celution One.
Is the new desktop device "substancially equivalent" to the other ones to achieve the same approvals as the 800 device and what kind of timeframe do you think is required to complete the "change processes" so that the new device can be marketed globally?

Mixed bag- current developments in the US
1. Cytori's Celution cannot be marketed in the U.S. for clinical applications yet hundreds of SVF clinics are opening up throughout the U.S. using competing systems. Chains of primarily cosmetic surgeons offer a three day introduction course in stem cell technolgy and promptly you are part of a franchise like the "Cell Surgical Network". There are a few other chains to- like the one from Dr. Purita. How do you reconcile this with your FDA & BARDA interface and are Cytori patents being violated?

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Questons on Cytori for Thursday 30 Jul 2014 08:17 #1930

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Totally forgot about Canada...LOL ! Another failure to date :cry:

Otherwise...really like the lis...Thank you so much for your effort fas !!!! :nice:

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