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TOPIC: Sucessful Adipose phase 2 trial for Fistula

Sucessful Adipose phase 2 trial for Fistula 16 Feb 2013 15:35 #156

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onlinelibrary.wiley.com/doi/10.1002/stem.1357/abstract

82% success rate would make this statistacilly significant. Its proven to work. Why cant the patients get the treatment?

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Sucessful Adipose phase 2 trial for Fistula 16 Feb 2013 17:20 #157

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Good question Joey-

In traditional medicine patients (severe cases) get pumped up with cortico.steriods and anti-bodies with severe side-effects (the so called DNA synthesis), with a success healing rate of 30-35%.

This 80% plus rate is astonishing. CC told me - fresh ADRCs heals at about 65-70%, this is even better, but does NOT surprise me for various reasons.

But we will get into that at a later stage of development of the tech surely. :yep:
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Sucessful Adipose phase 2 trial for Fistula 17 Feb 2013 11:06 #158

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Couple of questions
Could Cytori use this data to run a pivotal trial in the USA for Chrohns for Fistula repair?

If we are approved in Britian for Fistula repair what is stopping us or clinics from advertising this service and charging accordingly?
If its an approved procedure this takes it out of the category of risky stem cell tourism.

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Sucessful Adipose phase 2 trial for Fistula 17 Feb 2013 15:08 #159

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Could Cytori use this data to run a pivotal trial in the USA for Chrohns for Fistula repair?


That is -with the words of Calhoun quoted in another post on this board- the strategy Cytor follows. i.e. to take the therapeutics claims on Celution in the EU (not only Britain) to the FDA and run a pivotal trial in the US with those results as initial evidence of safety and efficacy.
I am not the only one who is pulling his hair out in desperation why this does not happen. Most obviously- since the clinical data belong to others, with whom a deal has to be made first.

If we are approved in Britian for Fistula repair what is stopping us or clinics from advertising this service and charging accordingly?
If its an approved procedure this takes it out of the category of risky stem cell tourism.


There is no reason why this should not be marketed. A therapeutic claim provides that right- but only on an elective basis- reimbursement is the next step, but approval was in July 2010- so something must have been undertaken to get to reimbursement also. These type of questions however are not allowed at Cytori.

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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:

Sucessful Adipose phase 2 trial for Fistula 17 Feb 2013 15:34 #160

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you can ask the questions to cytori but they will go unanswered. cc operates under the premise that if you mention something which does not materialize., then... ignore it pretend it did not happen and people will forget. and so on and so on and so on.

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Sucessful Adipose phase 2 trial for Fistula 17 Feb 2013 15:44 #161

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***These type of questions however are not allowed at Cytori***

You may remember Fas my past complaints of "scripted" calls.

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Sucessful Adipose phase 2 trial for Fistula 17 Feb 2013 15:48 #162

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***If we are approved in Britian for Fistula repair what is stopping us or clinics from advertising this service and charging accordingly?***

No one is going to market this type of procedure in a self pay market.
Quick way to lose money.

They need a deal !!!!!!!!!!!

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Sucessful Adipose phase 2 trial for Fistula 17 Feb 2013 16:22 #163

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Yes Hedge, I know about them "scripted calls". Baker even admitted that at one point in time, which is already a long time ago.

Best one ever -IMHO- was the one in November 2009 or was it November 2010?- do not recall the date exactly, but the "actors"- Brian Gagnon and CC on the "non-binding Letter of Intent" signed. Boy- that was like Bollywood. :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:

Sucessful Adipose phase 2 trial for Fistula 17 Feb 2013 19:07 #164

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Oh yes, I remember...and the changes in 13F's that followed over the years.

Do what I do, not as I say, ...LOL

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Sucessful Adipose phase 2 trial for Fistula 19 Feb 2013 06:16 #165

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Apologies to Joey- I know he made two posts here yesterday- which got wiped out by a renewed re-store.
What can I tell you- only folks that do NOTHING, cannot make mistakes. I do a lot and make a few, but learn from them. I am pretty sure I know why it was these last two times- too many jquery apps running into each other, so will go "soft" on them.

Am also looking at switching to a multi-server solution, where I am more flexible is switching loads to my web sites- and am in control by switching to mirror webs of virtual servers as part of my own dedicated server.

It is fun though- learning and I will keep at it and will become better. :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:

Sucessful Adipose phase 2 trial for Fistula 19 Feb 2013 10:58 #166

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I disagree that know one would market these indications in self pay market. We already have plenty of offshore stem cell clinics making money. These therapies are approved unlike other stem cell clinics.If they could advertise approved treatments that puts them at a big advantage.
It has to be brought to the attention to the public that these therapies are available.This will speed up adoption and promote goverment funding.
I say open a clinic for breast reconstruction,fistula repair and wound repair in Britian. The question I have is would Cytori sell a cellution machine to a clinic and supply consumables?

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Sucessful Adipose phase 2 trial for Fistula 19 Feb 2013 11:48 #167

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Thanks for re-posting Joey.

In general one can say- wound healing of radiation wounds, burn wounds, trauma wounds are all approved already besides fistula types and diabetic foot ulcer. (that is on top of breast augmentation and reconstruction of course)

So- the question is really -what the heck is Cytori´s strategy in marketing those approvals? Waiting for reimbursement? Waiting for partners?

Over the week-end I will write a blog post on the subject, so that anybody can formulate their own questions for the next conference call.

I know- the central wound and burn clinic in Warsaw Poland bought a Celution. To me that cannot be translational since the approvals are already there. Like I wrote before- the silence on marketing plans and path forward is deafening and bugs me more than I can say. :puke:
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Sucessful Adipose phase 2 trial for Fistula 19 Feb 2013 12:16 #168

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Fas
Since we can only speculate due to management silence or comments that turn out to be completely worthless I will speculate on your question
***what the heck is Cytori´s strategy in marketing those approvals?***

Cytori's foremost strategy is to keep the pay checks coming.
Next is...its all appears to be gambled on cardiac, so that is where they put any extra monies. One can insert their own percentages of success and market penetration.
After the two above....WITH WHAT MONEY ??? We have always been 6 months to a year from BK...hence the bi-annual fundings.

As for the Warsaw celution.
I have no idea how things work in Poland but payment in the USA for burn indications is quite a different animal beyond the traditional self-pay and insurance coverage. Burn foundations pay for alot of care. It would certainly be interesting to hear what usage this celution is seeing.

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Sucessful Adipose phase 2 trial for Fistula 19 Feb 2013 12:21 #169

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Joey
We are just going to have to agree to disagree on how wide that self-pay band is and is it worthy of Cytori's always (to date) limited funds.

Also remember, Cytori did support a web site for the cosmetic market to help bring awareness...we know how the cosmetic sales market to date has been.

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Sucessful Adipose phase 2 trial for Fistula 19 Feb 2013 12:52 #170

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Also remember, Cytori did support a web site for the cosmetic market to help bring awareness...we know how the cosmetic sales market to date has been.


Absolutely correct. Cytori spent loads of money on marketing after they received a (general) TOOL CLAIM in late 2007- but by the time they received the THERAPEUTIC CLAIM in 2010, they had dissolved that sales organisation again and have no money to set one up now either, so again are dependent on partners.
I still think the procedure is highly superior to synthetic implants which make boobs look like boxing balls, but it takes more than a dime to spread the word, which is a vicious circle, really. The draw back are the surgeon´s hours in sculpting of course (4 hours minimum), but thats why countries like India and Mexico would be perfect places to go to for women-in-the-know.

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Sucessful Adipose phase 2 trial for Fistula 19 Feb 2013 13:15 #171

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I am not proposing that Cytori use their own money. Personally I would seriously think opening a clinic if I could advertise approved procedures. Hopefully I could get a cellution cheap before the new inexpensive model comes out. I think I will call Cytori now and see what they say.

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Sucessful Adipose phase 2 trial for Fistula 20 Feb 2013 05:53 #172

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Joey - I can't envisage setting up a new clinic from scratch for specific indications in the UK as being either cost effective or feasible. The regulatory requirements alone for establishing such a venture would make this prohibitive.

There are already clinics that offer the Celution system for breast reconstruction in the UK (see below). The question is why has there not been a significant uptake in such procedures given its great effectiveness? This is probably due to most potential practitioners not being trained yet, and most importantly the early adopter surgeons who will be undertaking such procedures are no doubt waiting for reimbursement approval from the UK authorities. Official UK reimbursement approval and establishment of procedures for payment will be a catalyst for not only the public sector but also for the private pay (insurance covered) market. If your private insurance covers you for reconstruction purposes it stands to reason that the private insurers will wait for public sector approval AND reimbursement approval before putting their hands in their pockets. Most doctors are conservative and repeat what they know in terms of treatment paradigms ......... they like all business people react/adapt to competition. Once the early adopters get going so will the rest. Lets not forget also that no one ever got sued for not undertaking a highly innovative treatment.

www.londonplasticsurgerycentre.com/fat-stem-cells/

Once the approvals for reimbursement are in, then we will have a gradual increase in sales and as more doctors are trained and positive word of mouth increases we will have the geometric increase in sales. As the trial (RESTORE) has been completed and is very close to the highly anticipated reimbursement decision I feel that we are very, very close (no joke) to the game changing decision that will make us self funding.

It is unfortunate that CYTX made the premature decison to create a sales organisation and spend so much money needlessly on the self pay market. They were no doubt blinded by their own over enthusiasm for the treatment. A serious error but it does not detract from the effectiveness of the treatment. Hopefully they have progressed along the learning curve and we do not have to experience more such mishaps.

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Sucessful Adipose phase 2 trial for Fistula 20 Feb 2013 09:00 #173

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Yes I agree opening a new clinic would be cost prohibitive. I would like to see a couple of other existing clinics offering procedures that were recently approved though. These procedures seem much less time consuming than breast reconstruction.(As Kas alluded to)

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Sucessful Adipose phase 2 trial for Fistula 20 Feb 2013 15:21 #176

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Joey - the minimum 4 hour procedure Fas alluded to was probably for breast augmentation. It takes a considerable amount of time and skill to build up layer by layer and shape TWO breasts symmetrically. I do not believe this to be the case in breast reconstruction (lumpectomy). It probably takes a lot less time to fill a divot (excised tissue). Given the large number of women who undertake lumpectomies every year and the much larger group of women who have had this procedure in the past, the market is very large. :yep: Everyone is waiting on reimbursement, because apart from the money, it is also effectively an endorsement for the procedure.

As for fistula repair, insurance companies and public hospitals (not to mention the patients) would be only too happy to pay for the Celution procedure in the case of difficult intractable cases. This is not possible though, until the data becomes published, reimbursement is approved, and hospitals are persuaded (allowed) to buy the celution machine.

Billion dollar question: Why isn't the data published?

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