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TOPIC: Vascular "Tool" approval to come- Cardiac CMI etc

Vascular "Tool" approval to come- Cardiac CMI etc 05 Feb 2013 11:07 #102

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You might have noticed that the Frontpage has changed somewhat from a design perspective, but also (more importantly) the introduction text on where I believe Cytori "stands" now in its development, which I believe the market highly under-estimates.

Key here is also the forthcoming UK approval on "vascular". I got the impression two weeks ago, that Calhoun does NOT expect CMI no-option approval any longer, but that this milestone is being replaced by the "vascular" Celution claim, to which PRECISE will have contributed substantially too of course.

Going forward- KEY to the short-term are the MARKETING PLANS. Will Cytori want to market the TOOL claims in GENERAL SURGERY (Tissue Ischemia and Skin, Fat, Muscle and Fascia) together with those Vascular claims? Fact is- in 2008 Calhoun couldnt wait to jump into the market with his tool claim on the CRS (=soft tissue) claim, but hardly has a sales force left in Europe.

So the answer to that question is likely -NO- unless a partner deal comes, which could dramatically change the outlook for marketing all these claims (including the THERAPEUTIC claims of course- diabetic foot, radiation wounds etc etc)

The BIG question in my mind is- why this change from no-option to vascular? Are theremaybe more THERAPEUTIC claims in the pipeline from translational work- like PAD? Remember my slide in the other thread- clinics started in 2009 for that indication and diabetic foot links right in there.

Cytori remains a mystery- a GIANT one- but its coming together I believe after all these years.

Like mentioned before- the day comes that Calhoun has to lower his pants and show the real thing!! :evil:
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Vascular "Tool" approval to come- Cardiac CMI etc 05 Feb 2013 13:15 #104

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So Fas, Now that the CMI BS has run its course (assuming your theory is correct) where would this leave Okyanos with their heart treatments ? Are you stating the heart treatments also comes under vascular heading ?

Also...you say UK approval as opposed to EU approval. Is this correct ? If so, why just UK ?

Would appreciate any additional thoughts you would like to throw in.

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Vascular "Tool" approval to come- Cardiac CMI etc 05 Feb 2013 13:35 #105

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One more thought Fas.

The other day I was speculating on the YMB that perhaps the delays in Europe for either CMI approval or vascular approval have been a factor in partnership delays.

Any thought on this possibility ?

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Vascular "Tool" approval to come- Cardiac CMI etc 05 Feb 2013 14:31 #106

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Hedge-
Although Europe is a far cry away from a United States of Europe, the medical compound approval processes are pretty much unified in the EMEA- the device departments however pretty much scattered all over the place and more de-centralized- however- this is key- member countries should adopt the decisions from their colleagues in the other countries. (but could add some more requirements...-sorry to be that vague, but that is how it is)
About Okyanos- Matt told me ages ago, that the Bahama´s approved his procedure already and that he is NOT dependent on CMI approval, although surely he would not mind for marketing purposes, to have some kind of approval on hand.
However- I DO BELIEVE, a vascular claim would allow treatment of cardiac patients too, it would be broader than CMI, but I hesitate at ADOPTION. I simply do not know.

On the delay on closing partner deals. Lets say- that is very well possible in my mind- logic tells me, the most advanced applications are the best candidates for partnering. Cardiac falls in that category. :whistle:
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Vascular "Tool" approval to come- Cardiac CMI etc 25 Feb 2013 09:01 #192

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Here is the approval:

SAN DIEGO--(BUSINESS WIRE)--

Cytori Therapeutics (CYTX) has received a CE Mark in Europe for Intravase®, a reagent intended to be used with Cytori’s Celution® System for preparing safe and optimized adipose-derived stem and regenerative cells (ADRCs) for intravascular delivery into the same patient.

“This approval expands our market access for our cell therapy platform to include intravascular applications,” said Marc Hedrick, President of Cytori Therapeutics. “As a result, this is expected to contribute to revenue growth in 2013 and beyond. We will target select centers to build patient data, which we believe can be used to further expand these claims and increase the adoption of our technology. Furthermore, CE Mark approval of Intravase will allow independent European investigators to conduct their own vascular studies.”

Intravase is a sterile, GMP-grade secondary reagent used with the Celution System to prepare the Celution cell output for safe intravascular delivery. Intravase is currently being used in both our U.S. ATHENA trial in patients with refractory heart failure due to chronic myocardial ischemia and the European ADVANCE trial for acute heart attack patients.
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So Fas, the intravase reagent, is this going to give us our 400% increase in effacacy ?

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Vascular "Tool" approval to come- Cardiac CMI etc 25 Feb 2013 09:06 #193

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Also Fas, this far from a CE claim on a indication approval such as CMI.
If CC has given up on this claim in favor of intrvase as you suggested then I guess we are waiting for Athena and ADVANCE results BEFORE we get any cardiac CE Mark approvals ?????

Thoughts ?

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Vascular "Tool" approval to come- Cardiac CMI etc 25 Feb 2013 09:12 #194

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last point,

Maybe this will jump start the partnership talks again if this indeed what has held them up. Waiting for this approval.

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Vascular "Tool" approval to come- Cardiac CMI etc 25 Feb 2013 10:16 #195

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Hedge-
All I can say at this point in time is that the Intravase approval have been mentioned as "key" for further developments.

My perspective is that it is a "component" of the vascular Celution machine and in view of Hedrick´s statement opens the door for clinics to start work they planned. But has nothing to do with any therapeutic claim on Celution like no-option as you correctly noted.

Maybe - if you go back a little - in August last year- Cytori announced the TOOL approval for TISSUE ISCHEMIA and suddenly I noted that ROBUST and some other trials started recruiting. Combining Intravase with that tool claim will probably result in a tool claim for cardiovascular, which can be expected after this I believe.

What that actually will mean to ADOPTION and REVENUE is something that I stated before in this thread. I simply do not know and its about bloody time Calhoun starts explaining, what the marketing targets are for all these TOOL and THERAPEUTIC claims that we have now.
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Vascular "Tool" approval to come- Cardiac CMI etc 25 Feb 2013 16:08 #199

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After reading the WST article, I am actually totally convinced that Intravase PLUS the Ischemic tool claim = vascular TOOL claim.

WST apparently spoke with Cytori- this sentence is the typical wording you will also find in the 10Q after the 2012 results are out.

Cytori becomes the first cell based company that can market and sell its ADRC platform in Europe for the delivery of regenerative cells into the same patient for the treatment of any vascular related disease.


The red marked text is the usual "EU regulatory wording"

This will start a frenzy of clinics, who have been waiting for this claim- just like in the summer of 2012. Its moving. :vegas:
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Vascular "Tool" approval to come- Cardiac CMI etc 25 Feb 2013 16:12 #200

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And Hedge-

Your favorite subject- ADVANCE.

You will see as a result all the countries where IRB approvals were hard to come by, issue those in no time and will speed up enrollment in ADVANCE SIGNIFICANTLY:
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Vascular "Tool" approval to come- Cardiac CMI etc 25 Feb 2013 16:41 #202

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Thanks Fas....I will be more than happy to drop the (slow) from ADVANCE.
In good time of course...lets get these sites up and running...LOL

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