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TOPIC: New CYTX Publication re Long-Term Followup for Breast Reconstruction

New CYTX Publication re Long-Term Followup for Breast Reconstruction 08 Jun 2017 07:02 #9440

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New PR re Japanese safety data for almost 9 years.

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New CYTX Publication re Long-Term Followup for Breast Reconstruction 08 Jun 2017 08:20 #9441

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The text of the announcement-

Jun 08, 2017
SAN DIEGO, June 08, 2017 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (NASDAQ:CYTX) (“Cytori” or the “Company”) today announced the publication of long-term follow-up data reporting patient satisfaction and surveillance for cancer recurrences following use of Cytori Cell Therapy™ for breast reconstruction following partial mastectomy and radiation for breast cancer treatment.
This Cytori-supported, investigator-initiated study, which was peer-reviewed and published in June 2017 edition of Surgery Today, followed ten patients treated with a single therapeutic administration of Cytori Cell Therapy at Kyushu University. None of the ten patients experienced cancer recurrence or new cancer formation through a median of 8.5 years of follow up (range 5.1-8.9 years; mean 7.8±1.5 years).

Scarring and tissue volume loss, particularly following extirpative surgery and adjuvant radiation therapy remains a significant reconstructive problem for survivors of breast cancer. Cytori’s technology is available to doctors in Japan under the new regenerative medicine regulations for reconstructive purposes. Several pre-clinical and clinical studies suggest that Cytori Cell Therapy has potential to help alter markers and outcomes related to fibrosis characterized by tissue fibrosis (scar), irrespective of the etiology of the fibrosis.
Currently, there are three ongoing clinical trials involving Cytori Cell Therapy in which fibrosis is an important pathophysiologic feature of the primary disease: (1) Cytori’s Phase III STAR trial for hand manifestations of systemic scleroderma, (2) the investigator-initiated ADRESU trial in Japan for post-prostatectomy urinary incontinence and (3) Cytori’s RELIEF trial for thermal burns. The published report can be found at the following link: Ito et al, Surg Today (2017) DOI 10.1007/s00595-017-1544-4.

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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:

New CYTX Publication re Long-Term Followup for Breast Reconstruction 08 Jun 2017 08:36 #9444

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Remind me, what were sales in Japan last Q ?
Zzzzzzz.
Meanwhile ISRG with their razor/blade PPS is closing in on $1,000/share...$936.70

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New CYTX Publication re Long-Term Followup for Breast Reconstruction 08 Jun 2017 08:57 #9445

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myownhedgefund wrote: Remind me, what were sales in Japan last Q ?
Zzzzzzz.
Meanwhile ISRG with their razor/blade PPS is closing in on $1,000/share...$936.70


The Gagnon funds were one of the early birds in ISRG- however they sold early at 110$.

That wont happen to me with CYTX- :yawn:

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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:

New CYTX Publication re Long-Term Followup for Breast Reconstruction 08 Jun 2017 10:31 #9446

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Wow FAS, at a $110 pps I sure would be thinking about taking some profits off the table on this. No denying the potential of this with good data next month but a five year outlook on this seems very optimistic to be above 110.

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New CYTX Publication re Long-Term Followup for Breast Reconstruction 08 Jun 2017 12:32 #9447

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b7-

110$ is less than 10$ pre-split. I agree with DOV- there will be re-valuations of regenerative med companies once the first approvals are there and market demand is strong. Mind you- that does not apply to re-furbished Genzyme junk from Vericell of course. That is antique.

Anyway- the data from the paper come from the RESTORE I clinic, which was NOT a Cytori clinic, but a PI done at Kyushu by Kitamura and Sugimachi- in the research section I put up an old write up on the subject (not yet corrected or edited)- link- HERE

An abstract was presented in December 2007 at the San Antonio Breast Cancer conference, which paper I attach-

File Attachment:

File Name: poster4071.pdf
File Size: 88 KB


From this paper-

This investigator-initiated study was approved by the Institutional Review Boards of the Kyushu Central Hospital and the Kyushu University, and all patients were appropriately consented. Twenty-one (21) female patients aged from 29 to 59 (mean 46.9) years underwent 25 stem cell augmented reconstructions at the Department of Breast Surgery, Kyushu Central Hospital, Fukuoka, Japan. All patients previously received BCT, for small BRCA. Subsequent to the surgical treatment, 19 patients also received radiation therapy in doses ranging between 50 - 60 Gy (mean 53 Gy). All patients were deemed free of any local recurrence or distant metastasis for ≥ 13 months following BCT. The volume of autologous ADRC-enhanced fat transplant for each patient was determined by clinical evaluation including assessment of the volume defect at the time of screening, the severity of radiation damage present and an assessment of residual scarring and fibrosis in the affected breast.

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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:

New CYTX Publication re Long-Term Followup for Breast Reconstruction 08 Jun 2017 13:21 #9448

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Certainly the sooner the better for that reevaluation but I am still stuck at:
200 million post positive STAR data
400 million post FDA approval, pre major earnings.
I believe these to be fair market caps with discounts for the debt and such as mitigating factors.
Plug in what you believe the outstanding share count will be by then to get a idea on price.
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New CYTX Publication re Long-Term Followup for Breast Reconstruction 08 Jun 2017 13:46 #9449

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myownhedgefund wrote: Certainly the sooner the better for that reevaluation but I am still stuck at:
200 million post positive STAR data
400 million post FDA approval, pre major earnings.
I believe these to be fair market caps with discounts for the debt and such as mitigating factors.
Plug in what you believe the outstanding share count will be by then to get a idea on price.


We all have taken note Hedge. Not only this time. And given the reputation of the soon to be "Lusk Boulevard" crooks, that is certainly not unfair. I do expect a snowball effect on Raynaud´s and many other things which will present themselves in due course.
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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:

New CYTX Publication re Long-Term Followup for Breast Reconstruction 08 Jun 2017 14:34 #9450

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Hedge, curious what variables you plugged in to come up with a 200m market cap post STAR results. Seems to me that if STAR data is strong and a European Sclero partnership comes through shortly after, forward PE ratios should push us closer to the 400-500m range. FDA approval would be largely expected by the market if data is as strong as many of us feel that it will be.
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New CYTX Publication re Long-Term Followup for Breast Reconstruction 08 Jun 2017 14:40 #9451

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Thanks FAS,
I hope you're right about this turning into another Microsoft but at 110 per share, I will be smiling all the way to the bank. Above that, I could be doing back flips to the bank.

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New CYTX Publication re Long-Term Followup for Breast Reconstruction 08 Jun 2017 14:45 #9452

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irrationalexuberance wrote: Hedge, curious what variables you plugged in to come up with a 200m market cap post STAR results. Seems to me that if STAR data is strong and a European Sclero partnership comes through shortly after, forward PE ratios should push us closer to the 400-500m range. FDA approval would be largely expected by the market if data is as strong as many of us feel that it will be.


Hoping the data will be good enough for accelerated FDA approval.

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New CYTX Publication re Long-Term Followup for Breast Reconstruction 08 Jun 2017 17:41 #9453

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***We all have taken note Hedge. Not only this time.***
I know, I know Fas. LOL
I just never know when new eyes may be looking in the lodge.
I'm gonna take a break until July when we are closer to data and we will see if anticipation has begun to build in the PPS.

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New CYTX Publication re Long-Term Followup for Breast Reconstruction 09 Jun 2017 02:06 #9454

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I am thinking the only USA produced machine manufactured by a USA company that set all the standards for this new technology should be approved.
Bottom line is the device needs to be approved for reimbursement. FDA is loosing control of clinics. We need standardized results. Cytori is proven best in the world. (comparison of 4 cell machines )
Force the clinics to use Cytoris machine if they want reimbursement

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New CYTX Publication re Long-Term Followup for Breast Reconstruction 09 Jun 2017 09:15 #9455

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Hedge Have a great vacation break!

Look like you have made enough money over time and have bought enough shares at these gutter prices and not to be bothered by all these small fluctuations.

You are a strong believer in gaps and there is a small gap around 1.03 yet to be filled.

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New CYTX Publication re Long-Term Followup for Breast Reconstruction 09 Jun 2017 09:42 #9456

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joeycav11 wrote: I am thinking the only USA produced machine manufactured by a USA company that set all the standards for this new technology should be approved.
Bottom line is the device needs to be approved for reimbursement. FDA is loosing control of clinics. We need standardized results. Cytori is proven best in the world. (comparison of 4 cell machines )
Force the clinics to use Cytoris machine if they want reimbursement


Hi Joey-

Unfortunately, this is not the way it works.
The PMA approval that Cytori hopefully will get from the FDA in 2018 will be for the device in connection with the application- scleroderma only. Not for all other disorders that those "wild west clinics" are treating. My hope is that CBER (i.e the Biologics arm of the FDA) will come in 2017 with the final version of the new legislation and become active in closing those 500+ clinics breaking the law at present.

But than again- with the way Wallstreet seems to work and evil folks all over the place, who´s only incentive is money and are devoid of morals, the same could apply to regenerative medicine. :whistle:

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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:

New CYTX Publication re Long-Term Followup for Breast Reconstruction 09 Jun 2017 19:25 #9457

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FAS

I think we are very fortunate to have rather convincing clinical applications in scleroderma, secondary Raynaud's, breast reconstructions and several other medical conditions.

In the case of alopecia (Kerastem), I am not fully convinced that for treatment of male pattern baldness, our celution system is really ideal. In a patient dialogue website, one patient indicates the cost for one treatment is $ 8000.00 and the success rate is over 60%. This particularly patient indicates that it is rather painful going through the scalp injections (with residual pain lasting a few days). 3 months after the treatment, hair growth appears to be lower than expected. Of course this is only one case.

It appears to me that the alopecia indication (which is available/approved in EU and Japan) may have a small market size.

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New CYTX Publication re Long-Term Followup for Breast Reconstruction 12 Jun 2017 20:27 #9459

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Interesting info on alopecia. Thanks franshei. I was told a couple of years ago that Kerastem wanted to go for volume instead of margins. They were thinking $1500 to $1700 for a single treatment. Since Cytori would be paid by consumable and a small royalty, we were thought to get roughly $900 of the total cost. At $8,000, few people will pay so it will be a very small market. My guess is they will start there and drop the price as needed to stimulate revenue and a larger data base. These guys are basically private equity and are out to make money... period.

I am not sure what 60% success rate means. Any more clarification?

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New CYTX Publication re Long-Term Followup for Breast Reconstruction 13 Jun 2017 06:38 #9460

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I know nothing about treating baldness, since I never bothered with the issue, despite my gigantic bald spot, which I however cannot see when I look into the mirror, which is my most important criteria, but did have a look at the web page of the Dutch Hair Foundation.

I presume the Kerastem app competes with hair transplants and here you have different methods- they list the FUE (Follicle Unit Extraction) and FUT (Follicle Unit Transplant) methods, also use PRP and other stuff. All in all the price ranges seem to be right there- 8- to 12K Euro for a complete treatment with about 1000 transplant units, which does not seem much (the units) and surely isnt a painless affair.

That 8K $ sounds about right to me - surely only folks that care about their looks would be interested and should have the money and the willingness to pay for this.

Actually I wear my hair very short nowadays and my son who is my barber claims my hair is getting fuller again. maybe thats because my testosterone levels are decent again due to the fitness centre and I take totally natural Saw Palmetto, which inhibits the synthesis of T into DHT (Dehydrotestosterone), of which high levels seem to be a main cause of alopecia.

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New CYTX Publication re Long-Term Followup for Breast Reconstruction 13 Jun 2017 07:25 #9461

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DOV

From what I read, the chance of hair regrowth is 60 to 80 %, as told by the Kerastem doctors. The post from this particular patient indicates 2 impression: pains for a few days after topical injection and very limited hair growth on the scalp after 3 months (except the eye brows, which are not injected - but, in my opinion, the stem cells therapy works).

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