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Advance trial data 02 May 2015 06:06 #4395

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Is the title for our chronic heart trial ''ADVANCE'' a misnomer?

Management needs to disclose this data!! The data has matured and cured (pun?) for longer than necessary. What gives? .... any ideas anyone....

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Advance trial data 02 May 2015 06:54 #4396

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ADVANCE was the European acute MI clinic, which had 23 patients when it was stopped.

Eric Duckers reported upon that clinic in November 2014 at the AHA Scientific Sessions.

Just safety data though.... :cry: :cry: :puke: :puke: :evil: :evil: :bash: :bash: :bang: :bang:

ATHENA the chronic clinic in the US is pending yes- if I recall right Hedrick indicated last time that "they" = Cytori wanted to sort and analyse the data themselves before publication, which is idiotic to say the least. Data gathered for 31 patients is what it is as assembled by the PIs and CROs.... :puke: :puke: :bang: :bang:

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Advance trial data 03 May 2015 05:26 #4397

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Fas, your sentiment icons truly reflect my view of the situation concerning the non disclosure of ADVANCE efficacy data.

There are any number of variables that may determine the optimal use of ADRC in the treatment of acute heart disease. Perhaps the current trial construct is not optimal. Regardless of whether the current construct is optimal or not we deserve to know what the EFFICACY data shows. More than sufficient time has elapsed for the data to mature. I find it very hard to believe that the incremental cost of the data analysis is such that it restricts our access to it.

I want to know the data. I am a shareholder. I paid for that data, and I want it. They should provide it to us. Its non provision is suspect in the extreme.

As a company we may well not be in a position to take heart disease indications further by ourselves. That is understandable. But as a shareholder I want to know what I have invested in ............ and that includes the clinical data arising from trials I HAVE PAID FOR !!!!!!!!!

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Advance trial data 03 May 2015 07:16 #4398

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John-

I cannot agree more with you, that Cytori OWES US the data.

And NOT in 5 years when they finally have found a partner in Qatar or the United Arab Emirates, but NOW. It would be nice if the regulars with some clout in respect of share ownership get active here and raise some questions on the data in SD. :yep:

In my view the acute case of cardiac is still the most promising therapy of all "blood flow" dominated apps. (so NOT considering auto-immune here :grin: ) The APOLLO study with only 13 patients showed very promising reductions in the infarct size and the perfusion defect. See the study attached- only a few pages.

Arnold Caplan theories beg for picking up the app again at some point in time when the Company and science have "grown" :really:


File Attachment:

File Name: 2012-apollo-results.pdf
File Size: 281 KB
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Advance trial data 03 May 2015 11:22 #4400

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From the looks of it, Okyanos personnel keep an eye on what is going on on this page too, since the tweet that you see on the right hand side if you visit the "recent" tab ( like I always do) , features an article from a Canadian news site on the presentation by Duckers of the APOLLO result in Chicago back in 2010 (AHA Scientific Sessions).


CTV News on the APOLLO study

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Advance trial data 04 May 2015 05:34 #4402

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While I would like to see the ATHENA data ASAP, I don't think it will change much in market cap valuation at this stage. :evil:

Other than perhaps saving a few bucks has Cytori ever given a reason for wanting to do the final analysis in house....I personally don't think it gives a professional impression.

How about a plan for Japan...now that would be progress that might effect the near term. !!! :KO:

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Advance trial data 05 May 2015 06:22 #4408

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I don't think it will change much in market cap valuation at this stage


Absolutely agree. Big yawn as usual.

Would be different if there is a partner to develop cardiac for 10% what Daichii Sankyo was prepared to pay as upfront and THAN publish the results. :nice:

No- I will not say.. :grin:

Anyway- for all who care about finding a potential venue: this site is good and has most events of the AHA (American Heart Association) and ACC (American Chamber of Cardiology) together with TCT- interventionist arm thereof. :

Events Calendar- Cardiology
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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:

Advance trial data 20 Jan 2016 06:16 #6056

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Its been a long time since we addressed this issue. We got confirmation of positive safety data but none concerning efficacy, even though the data has matured ages ago :bash:

Still it appears that there is some proof of efficacy available if one looks. :winky:

www.iccti.eu/file/5th-iccti-conference-abstract-book/

On page 14 there is a synopsis of a presentation by Druckers concerning ADRC. He makes specific reference to the ADVANCE trial data
in which he states :

The APOLLO was the first-in-men multi center, randomized placebo-controlled clinical study
of ASC in the treatment of patients with a ST-elevation myocardial infarction (STEMI). STEMI
patients treated with ASC, showed a significant reduction of infarct size (-51,3%) with improved
myocardial perfusion, resulting in a improved cardiac contractility (+5.7% LVEF) and reduced
adverse cardiac remodeling on long term follow-up. The ADVANCE was a phase IIb, multi center
placebo-controlled trial in 275 STEMI patients. In the first STEMI patients, ASC therapy showed
a significant reduction in infarct size.


It would appear that the 23 patients showed results that confirmed the original APOLLO trial. :woohoo: :joy: :happy:

Two independent trials that provide corroborating data, PARTICULARLY when they are of small sample size is HUGE.

Admittedly given the SP malaise and mistakes made to date this data is unlikely to positively affect the shares price.

Still, I thought you guys might like to know about it. Who knows maybe one day management may deign to to give us specific data. :KO: :evil: :cry:

Could this data be the reason Duckers is associated with CELACTIVE and CC.???????

Hey Guys (ie. management), have you shopped the data around or is this going to be a closed round of bidding with a single participant? :puke:

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Advance trial data 21 Jan 2016 04:15 #6067

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Perin is also trying to keep a finger on the pulse of the cardiac indication at Celactive. This must be his wife I believe.

www.linkedin.com/in/jacqueline-grant-perin-7ba0515?authType=name&authToken=aCmX&trk=Skyline_click_NPS&sl=NPS%3B1534417931453370412196%3B1%3B1534417931453370412196%3B

The positive data from the ADVANCE trial confirms the APOLLO trial data. Reducing the the infarct size is huge.

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Advance trial data 21 Jan 2016 07:55 #6070

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Yes Jacky Perin is Emerson´s wife.



She preceded Steve Kesten as Director of Clinical Development, but ATHENA went way over her head i.e was too much for her.

This comment I made 8 months ago in this thread unexpectedly gets some "present actuality" in view of most likely Celactive sponsorship.... :whistle:

John, I cannot agree more with you, that Cytori OWES US the data.

And NOT in 5 years when they finally have found a partner in Qatar or the United Arab Emirates, but NOW.


It is a known fact that Arab countries have an even bigger issue with the consequences of the metabolic syndrome than the US ... :whistle:

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Advance trial data 21 Jan 2016 08:50 #6073

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this conversation is turning too positive. i'm unaccustomed to such optimism. it's obviously been a while.

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Advance trial data 21 Jan 2016 19:53 #6077

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Just before Joe Feshbach passed away, he called me and expressed his excitement about cardiac applications with Cytx tech......he believed it would be huge. Forgot

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Advance trial data 24 Jan 2016 05:31 #6090

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forgotmorthanuno wrote: Just before Joe Feshbach passed away, he called me and expressed his excitement about cardiac applications with Cytx tech......he believed it would be huge. Forgot


I still believe that too.

As I have written several times on this board in the past- I believe the therapy will most likely not be in its present form as we know it- i.e. cells extracted by Celution and UNCHANGED delivered into the heart with the help of the NOGA system and the Bioheart catheter.

A major change will be delivery- as discussed before, Okyanos are using the C-cath from cardio3, but might have changed to Biocardia´s Helix, but than again - there is still room for improvement there. But really this to me is all of second relevance or importance.

THE major change and HUGE impact on efficacy will be the conditioning of the cells with growth factors or other means. What Vitamine D will be for bone growth, directly and indirectly, some type of VEGF growth factor will be for blood flow.

Remember- Calhoun confirmed to me personally a few years back that studies at Callan Road improved angiogenesis with 3-400% with conditioning versus no conditioning in preclinical models. Having gone through the change processes myself from being virtually a cripple with limited mobility to somebody who can move freely now, makes it easy to understand how this will effect the health of the global population going forward.

Anyway- here I go again- showing unbridled optimism again. The catch though is- that the therapy will be a DRUG and not will follow DEVICE regulation since the cells will be more than minimally manipulated. So- yes- let the experts develop that in the background, as long as Cytori shareholders remain to have a majority stake in this thing :KO: :bye:

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Advance trial data 24 Jan 2016 09:05 #6091

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A lot of the confidence in writing the posting before this one, is coming from knowing the research work of Professor Eckhardt Alt and Dr. Kai Pinkernell- both Germans, pretty well.

Kai is a former Cytori employee- actually another one, who left on his own, since his wife wanted to go home to Germany (something I really understand well- I had the same living in SF) and Prof Alt´s Bio you can read here.. by the way- Kai just got promoted into the top management (Science Director) at Medigene- a Münich outfit- with a market cap way bigger than CYTX... :whistle:

File Attachment:

File Name: CV-Alt-EN_230215.pdf
File Size: 69 KB


So- in order to look at their COMBINED research work- just go to PubMed and use Pinkernell, Alt, as query title and you will get 7 papers which are relevant to the subject. :grin:

For the not so ambitious readers of the site - I suggest looking at a recent video from Professor Alt called -The Future of Stem Cells- he is doing at houston apparently what Okyanos does in the Bahama´s....and shows a lot of images of patients healed with ADRCs-

Inclusive OA patients and evidence of hyaline cartilage growth and a video of a dog treated on his spinal cord....amazing.. :vegas: :nice:

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Advance trial data 24 Jan 2016 10:04 #6092

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Sure, the video confirms what many of us saw as the wide potential.

When and who will develop it ?

If I have time, I'll try to check out the papers you refer to tonight.

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Advance trial data 24 Jan 2016 11:43 #6093

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To take the cardio indication through the FDA will not be easy - a long time, a lot of patients and money (at least $ 100 million). CYTX will not be able to do it.

On a different note, re the January 21 NASDAQ hearing, it looks like CYTX has used a third party to present the company's case. It may take up to a month for a decision (per Girao, who was present at the hearing together with other CYTX executives).

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Advance trial data 24 Jan 2016 13:16 #6094

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***To take the cardio indication through the FDA will not be easy - a long time, a lot of patients and money (at least $ 100 million). CYTX will not be able to do it.***

Exactly !!!!
Everything has to be redesigned. Do we really want to trust that to CC ?
Besides, if someone wanted to open the UAE to Cytori's products....why do they need Celactive ? Just go to Cytori.

We need OA and scleroderma up and running first...then we can dream again. :yep:

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Advance trial data 24 Jan 2016 15:05 #6095

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Sadly, all old articles on PubMed, Fas.

We need fresh data for the public to absorb and get excited.

What's the cardiac application rate at Okyanos ? With DOV only calling for 1 million in annual sales it cant be much. Less than 100, of course I always thought it would be a limited pool of self payers despite all the hoopla on the YMB of posters saying they would pay up no questions asked. India, China, Japan, Philippines ...cardiac snoozeville !!!! It needs development and reimbursement. Just too long a road to get excited again for me unless they finally sell the app. with a decent long term return structure.

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Advance trial data 25 Jan 2016 06:35 #6097

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Sadly, all old articles on PubMed, Fas.


Hedge- that is a quality statement. :grin: In my view, timestamps or age do not protect from quality science and valuable discovery. :bye:

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Advance trial data 25 Jan 2016 07:08 #6098

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franshei wrote: To take the cardio indication through the FDA will not be easy - a long time, a lot of patients and money (at least $ 100 million). CYTX will not be able to do it.

On a different note, re the January 21 NASDAQ hearing, it looks like CYTX has used a third party to present the company's case. It may take up to a month for a decision (per Girao, who was present at the hearing together with other CYTX executives).


That CYTX cannot do it- is rather clear and something we all agree on. Celactive has a lot of SC cardiac expertise assembled and concentrated, which should stand a chance after initial introduction in "low regulatory barrier" countries followed by applying the know-how and expertise gained in the clinical setting in the US. At least that would make sense to me. :yep:

That Cytori not only spends 10.000$ for the hearing, but also the fees from (I assume) expert consultants to do the presentation makes a statement and means that they are serious about the mid cap listing. Wonder why. Maybe because of the additional listing in Europe? Or possibly future listings elsewhere like Japan? Very interesting.. :cool:

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