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TOPIC: A great ECCS-50 application

A great ECCS-50 application 14 Jan 2015 10:32 #3191

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How does this announcement sound???

22 December, 2014 –Cytori Therapeutics (Nasdaq: CYTX), an advanced biopharmaceutical company focused on developing and commercialising novel therapeutics from its proprietary platform of autologous, adipose-derived stem cells, or ADRC´s, in inflammatory and autoimmune diseases, announced today that it has submitted to the Food and Drug Administration (FDA) the required documentation for a Investigational Device Exemption (IDE) to begin a pivotal trial in the treatment of complex perianal fistulas in patients with Crohn’s disease in the United States. Agreement with the FDA on the IDE will ensure that the trial design is aligned with the FDA’s requirements for the future approval of ECCS-50.


Actually I made this one up. Its fake, but the MAIN mechanism of therapeutic action for treatment of rectal- and vaginal fistulae after Crohn´s is auto-immune and anti-inflammatory. Just as the Celution product ECCS-50.

Chris Calhoun told me personally one time that they had a healing rate of 70% (meaning closing the fistula completely and no remission after a year)



Cytori also has SPECIFIC approval (i.e. CE mark for the application as claim on Celution) for this in Europe. Never went into the US with it or tried to get reimbursement in Europe.

Marc Hedrick apparently does not want to tell us what happened, but I SURELY WILL NOT FORGET. :winky: :yep:

This is the real announcement from Belgian Company TiGenix.... we will be looking at TiGenix a lot going forward- I also hold some shares of the Company.... :yawn:

Leuven (BELGIUM) – 22 December, 2014 –TiGenix NV (Euronext Brussels: TIG), an advanced biopharmaceutical company focused on developing and commercialising novel therapeutics from its proprietary platform of allogeneic, expanded adipose-derived stem cells, or eASC’s, in inflammatory and autoimmune diseases, announced today that it has submitted to the Food and Drug Administration (FDA) the required documentation for a Special Protocol Assessment (SPA) of its pivotal Phase III trial design for Cx601 in the treatment of complex perianal fistulas in patients with Crohn’s disease in the United States. Agreement with the FDA on the SPA will ensure that the trial design is aligned with the FDA’s requirements for the future approval of Cx601.

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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:

A great ECCS-50 application 14 Jan 2015 11:10 #3192

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Fas,
Why would you ever believe anything that Chrisa calhoun told you ? :puke:

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A great ECCS-50 application 14 Jan 2015 12:11 #3196

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Given the former CEO's history of destroying everything he touches....it seems possible that this app was encumbered some how and no longer avail to Cytori for development.
Of course they really never had money for anything and constantly changed direction so just as easily they simply shelved it.

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A great ECCS-50 application 14 Jan 2015 13:56 #3198

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myownhedgefund wrote: Given the former CEO's history of destroying everything he touches....it seems possible that this app was encumbered some how and no longer avail to Cytori for development.
Of course they really never had money for anything and constantly changed direction so just as easily they simply shelved it.


FAS / Hedge -

This kind of news is disconcerting to say the least.

My understanding is that Cytori holds the intellectual patent on the process of extracting stem cells from adipose fat for use in treating fistula? Am I wrong?

That being said, is it bad strategically to allow another company to spend their capital commercializing this process for Fistula ? Can it not be construed as letting someone else do the dirty work and Cytori hits them with a legal notice of infringement once all the approvals are in place? Cytori can piggyback on this. ALbeit celution uses an enzyme solution. This solution has always worried me because Cytori does not own this enzyme.

Looking forward to your replies.

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A great ECCS-50 application 14 Jan 2015 14:24 #3199

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My understanding is that Cytori holds the intellectual patent on the process of extracting stem cells from adipose fat for use in treating fistula? Am I wrong?


No- Cytori does not hold ANY patent in respect of cells extracted from adipose and cultured i.e. stromal cells from fat, be they autologous (own) or allogeneic (from somebody else). It could be that the patent licensed to Cytori from Thomas Ichim has some applicability- not sure and not so relevant.

The patent on stromal cells is owned by Artecel- the infamous patent 231 story- available on this site :grin: :vegas:

Cytori is auto and fresh..CCDG. You should know :winky:

Mind you- auto and fresh, I think will prove to be more effective.... but who am I ????? :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:

A great ECCS-50 application 14 Jan 2015 21:24 #3200

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@ fas

So basically Hedrick was part of the UCLA team that are trying to prove in the courts that stem cells from fat are different than other stem cells.

But that aside, cytori still has the other patents for application of the adipose stem cells. Wound healing alone is incredible. If any other company comes up with their own machine to use adipose stem cells to treat wounds, then cytori can cry infringement.

I still think Hedrick can appeal the 231 decision once research documentation matures.

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A great ECCS-50 application 15 Jan 2015 06:37 #3201

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CCDG-

Of course the bulk of patents relate to METHODS of treatment of disorders with cells from Celution and patents on the machine itself.

Only with fat grafts and wound healing I think its broader.

Composition of matter patents have globally less relevance (231 is one of those) since matter from one´s own body cannot be claimed as an invention internationally. The US is the only exception I believe, where the Regents of UCLA does hold a patent of the heterogenous population of fat cells as it comes out of Celution.

As said- cultured -plastic adherent- stromal cells not, which is covered by 231.

So basically Hedrick was part of the UCLA team that are trying to prove in the courts that stem cells from fat are different than other stem cells.


No- its just the other way around. The lawyers were in my view so dumb to try to prove that the cells were very equal to MSC´s from bone marrow and UCLA lost the case since the others could produce a "lab-docs" which "mesenchymal stem cells?" written on it.
If they would have tried to prove that it is a totally different and UNIQUE mix of cells- the verdict probably would have been the other way round. :bash:

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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:

A great ECCS-50 application 15 Jan 2015 14:27 #3202

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This is really a first to market race with application methods for adipose derived stem cells.

Wound healing is pretty broad and this has a considerable market cap.

PPS is on life support. We need an event for BARDA to press FDA for an approval for radiation burns.

You'd think that in the world today this would be a priority.


While it would certainly be nice to have the 231 patent in our pockets....the reality is there are 6 billion other people in the world to treat in countries that wont even recognize this patent.

However, methods of application are integral. Me thinks scientists are not savvy business men. Time for Lorem to bring in a hired gun and demote Hedrick.

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