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TOPIC: Takafumi Hirakana

Takafumi Hirakana 04 Nov 2017 08:09 #10416

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A few days ago, I noted a facebook entry from Cytori IR floating by. It shared the page of Takafumi Hirakana - HERE , who apparently is a new install in Osaka at the Takatsuki General Hospital, where he is orthopedic surgeon.

The install was on Juli 21 when he wrote: Today, in the takatsuki hospital, the authorization for the rehabilitation of the medical clinic is officially thick!

For Treatment using fat stem cells, it is also possible to have a sports fracture, a sports or a laceration, or a nán zhì fracture. A Fat Suction and separation the cells and can be port on the same day.

He says somewhere -After returning from England in 5 and half a year ago, I came to know this treatment and continued to work for the introduction, but I finally arrived at the end of a lot of great cooperation So learned about in the UK.

First two images-



Interestingly- this looks like a Celution 800 and not the CTX2 although it was a new install.


Takafumi also visited Cugat in Barcelona to pick up knowledge on sports injuries.



I visited Dr. Cugat hospital in Barcelona, Spain. The Passion for soccer injury was great, and I had a lot of ideas for rehabilitation in this temple.

The discussions he has with patients are interesting - (for the ambitious folks)- just click the translations.

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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:

Takafumi Hirakana 04 Nov 2017 20:04 #10417

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Even if Cytori misses the Q3 est. of $2.5 million how can Tiago dare to lower guidance with a raise about to happen ?
Analyst are already estimating Fiscal 2017 as a greater than 19% decline from last years sales as it is.

They always associated the CTX2 with the start of the next BARDA trial so maybe next Q ?
Of course "next year" will be the break out year for sales LOL...always just over the horizon.
JK will be glowing no matter what the results !

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Takafumi Hirakana 05 Nov 2017 11:24 #10418

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myownhedgefund wrote: Even if Cytori misses the Q3 est. of $2.5 million how can Tiago dare to lower guidance with a raise about to happen ?
Analyst are already estimating Fiscal 2017 as a greater than 19% decline from last years sales as it is.

They always associated the CTX2 with the start of the next BARDA trial so maybe next Q ?
Of course "next year" will be the break out year for sales LOL...always just over the horizon.
JK will be glowing no matter what the results !


Hedge- I do not remember that Girao has been reiniterating revenue projections for 2017- just cash burn. But also- I hold nothing of analyst projection, who get their (wrong) numbers from Girao anyway.

CTX2 was mentioned - actually it was an announcement I think- ready for roll-out. I kind of lost faith in that message- we will know soon.

Anyway- I glanced at the Q2 numbers from the Q2 10Q this afternoon-



The Americas revenue surely was only Okyanos- that is gone now.

EMEA has diminished to a trickle- only cosmetic and plastic surgery surely, but nothing and unlikely to pick up. Unless....the Dutch can sell scleroderma as MAP.

Japan needs to show a gigantic leap in order to get anywhere near 2,5 Mio (without BARDA) so, from the looks of it, you can forget the forthcoming call and chances that it will excite me are in the 1-2% range.

Chances are therefore at 98-99% that I will surrender too- i.e. capitulation like Rongside and maybe will pick up some shares at the 15-20 cents range where Sabby et al will push it to.
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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:

Takafumi Hirakana 05 Nov 2017 15:20 #10419

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Oh I agree Fas...they will miss.
Their only hope was they expected some installations in Q2 that got pushed out and if the sale was able to be made in Q3 then maybe they show some sort of improved growth Q over Q. Celution used to sell for around 250K BEFORE discount...who knows what they go for today.

Growth remains at a abysmal rate and why I disagree so strongly on the present value of Japan that franshei seems to see.

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Takafumi Hirakana 06 Nov 2017 08:45 #10421

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FAS and Rodney

As I have commented that cell therapy does well in relative small clinical trials (with experienced physicians treating patients who would benefit from this kind of treatment), rushing through a large clinical trial may not generate expected results.

I have another followup observation, in the hands of physicians outside of CYTX, celution system works very well. I think we may be very lucky that the next wave of pivotal phase 3 trials they are all run by outsiders and mostly paid by other people: sclerodec 2in France, SUI , breast reconstruction and phase 3 scleroderma in Japan. Physicians outside of CYTX know what they are doing.
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Takafumi Hirakana 06 Nov 2017 09:52 #10422

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As I have commented that cell therapy does well in relative small clinical trials (with experienced physicians treating patients who would benefit from this kind of treatment), rushing through a large clinical trial may not generate expected results.


I would argue that any therapy does better when there is no placebo control but if you can't beat the placebo you haven't proven anything.

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Takafumi Hirakana 06 Nov 2017 10:33 #10423

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Wall Street Titan wrote:

As I have commented that cell therapy does well in relative small clinical trials (with experienced physicians treating patients who would benefit from this kind of treatment), rushing through a large clinical trial may not generate expected results.


I would argue that any therapy does better when there is no placebo control but if you can't beat the placebo you haven't proven anything.


We will see- Scleradec II is randomized and placebo controlled. ANDRESU not- open, but with a clear objective- and measurable target - reduction of leakage with 50%. So no- subjective patient opinion. Patient selection and n- determination - I tend to think- is key- and Cytori has not performed well on these matters, including primary endpoints.

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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:

Takafumi Hirakana 06 Nov 2017 14:08 #10424

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In general Fas, we agree. However, in OA of the knee, as an example, since ADRCs did work better than the placebo the dosage or delivery method could have been a factor too. The other option is that it just does not work well on chronic conditions. So far it's been lose lose with only Tigenix clearly beating the placebo and they used allogeneic fat derived cells.

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Takafumi Hirakana 06 Nov 2017 16:56 #10425

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We are witnessing an ever increasing expansion of Celution device installations in Japan for an ever increasing range of use: eg sports injury. This will eventually translate into increased unit sales of disposables I would love to know the price per unit and whether there is any differentiaton between indications treated?

Tigenix bet the placebo, but CYTX data in fistula have also been very good. The question is whether the body of evidence from global trials is sufficient along with Japanese trial data to get some sort of approval for fistula in Japan. ?????

Also i would like to ask what people think is the probability of the FDA approving scleroderma for diffuse patients with a post approval study in the USA?

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Takafumi Hirakana 06 Nov 2017 17:14 #10426

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rongside wrote: We are witnessing an ever increasing expansion of Celution device installations in Japan for an ever increasing range of use: eg sports injury. This will eventually translate into increased unit sales of disposables I would love to know the price per unit and whether there is any differentiaton between indications treated?

Tigenix bet the placebo, but CYTX data in fistula have also been very good. The question is whether the body of evidence from global trials is sufficient along with Japanese trial data to get some sort of approval for fistula in Japan. ?????

Also i would like to ask what people think is the probability of the FDA approving scleroderma for diffuse patients with a post approval study in the USA?




Does not seem that there has been capitulation by Rongside. LOL.

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Takafumi Hirakana 06 Nov 2017 19:35 #10427

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***Also i would like to ask what people think is the probability of the FDA approving scleroderma for diffuse patients with a post approval study in the USA? ***

Zero

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Takafumi Hirakana 06 Nov 2017 21:44 #10428

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My capitulation is with regard to investing any more money in this company via the purchase of shares in the market or investing via capital offerings/rights issues. Management have been bad stewards of shareholder capital and I can no longer give them the benefit of the doubt.

Perhaps I should sell off my holdings for a pittance, and never visit this board again? However I am too emotionally involved to do so. I still believe in the technology and efficacy of ADRC, and as such would like to see how this plays out.

As always I remain ''rongside'', invesment wise, and maintain the monicker.

However, the questions I raise are valid. Particularly the pricing in Japan of disposables as per type of indication. This is a self pay market where I believe they (CYTX management) may have had a problem wih differential pricing endeavours. If this is the case in Japan it may wll hold true elsewhere. If this affects BP/BB decision making then it begs the question how does one address the issue?

As for the likelihood of a post approval study for scleroderma I recognise that the likelihood is quite small, but I do not believe it to be zero. There is substantial data that shows Celution ADRC output is safe and that there is substantial/quantifiable positive data in the case of diffuse patients, ie. those with greatest need. Also let us not forget that there is no alternative treatment available !!!

www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/PostApprovaStudies/default.htm

www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm393994.pdf

The FDA has to get ahead of the trend for individual States to (de)regulate the use of SVF in a huge range of indications by inappropriate actors/players using INAPPROPRIATE systems/protocols/devices that do not conform to CGMP regulations. Approving Celution sets the bar defining minimum standards, outside of a cGMP approved hospital facility. It also provides an oulet for researchers/doctors to use APPROVED standardised systems for broader based studies (IND) that will follow predetermined approved protocols.

Lots of questions ........ any answers ........... ?????????

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Takafumi Hirakana 07 Nov 2017 05:38 #10429

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rongside wrote: My capitulation is with regard to investing any more money in this company via the purchase of shares in the market or investing via capital offerings/rights issues. Management have been bad stewards of shareholder capital and I can no longer give them the benefit of the doubt.

Perhaps I should sell off my holdings for a pittance, and never visit this board again? However I am too emotionally involved to do so. I still believe in the technology and efficacy of ADRC, and as such would like to see how this plays out.

As always I remain ''rongside'', invesment wise, and maintain the monicker.


Rongside, you are certainly one of the most knowledgeable posters on this MB - unfortunately, CYTX has not performed as had been expected over the years and many of us have huge losses - I certainly understand why many in that group are not willing to participate in the RO - I also totally understand why it makes little sense to those in that group to sell what they already have at this horrendous SP - it is obvious that you still believe that CYTX has an outside chance of success - when and if that happens, make sure that you change your moniker to "rightside" - the best of luck to you!

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