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TOPIC: One Year Follow Up on ED Study

One Year Follow Up on ED Study 10 May 2017 08:12 #9302

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One Year Follow Up of Cytori Cell Therapy™ in Investigator Erectile Dysfunction Trial

May 10, 2017
Data suggests safety and potential sustained efficacy in post prostatectomy patients failing pharmacologic intervention
SAN DIEGO, May 10, 2017 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (NASDAQ:CYTX) announces one year follow up data of ADRCs (Cytori Cell Therapy™) treatment in post prostatectomy erectile dysfunction. The related abstract and presentation will occur at the 2017 American Urological Association Annual Meeting, May 12-16 in Boston. The abstract is currently available in the Journal of Urology (online).
The investigator initiated, open label, Phase I, single arm pilot trial studied 21 men with post prostatectomy erectile dysfunction with insufficient clinical effect after maximal pharmacologic intervention. The abstract reports that following a single administration of Cytori Cell Therapy™, eight of 14 (57%) of subjects with urinary continence at baseline recovered their erectile function and could implement sexual intercourse after 6 months with the effect sustained to 12 months after treatment. This was associated with a modest but statistically significant sustained improvement in the patient’s IIEF-5 score, a widely used measure of male sexual function. Efficacy was solely demonstrated in patients that were continent at inclusion of the trial. No serious adverse events and 8 minor events related to the liposuction were reported.
This data follows previously published six month follow-up from the same trial on a smaller subset of 17 men with erectile dysfunction following radical prostatectomy .
See publication below:

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In addition to this study in erectile dysfunction, Cytori Cell TherapyTM is currently being studied in the ADRESU trial in Japan for male urinary incontinence following prostatic surgery. This investigator initiated, phase III, multicenter, 45 patient trial of Cytori’s ECCI-50 cellular therapeutic is based on promising pilot trial data published in the International Journal of Urology in 2014. Details of the pilot trial can be found on clinicaltrials.gov and the Japanese Ministry of Health Labour and Welfare website.
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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:

One Year Follow Up on ED Study 10 May 2017 08:17 #9303

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Nothing impressive yet again ...

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One Year Follow Up on ED Study 10 May 2017 08:26 #9304

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Wadd...depends if drugs help at all. I would think not but I don't really know. Would have been helpful if they reported what the control group of (7) did. One can assume no return of function but why not state it ?
Otherwise I am sure the 57% of those treated are grateful.

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One Year Follow Up on ED Study 10 May 2017 08:31 #9305

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Thanks FAS.

Tomorrow is the first Q CC and so-called earning release. It is not the most important conference call for the year.

We may have found a platform disease/illness platform to build on: scleroderma. This is only the beginning of a long journey from here. In today's market, the so-called investors are mostly hit-and-run types with no patience. But, I think over time w the value of CYTX will be realized to capture some patient traders/investors here.

ED and OA and others are the other applications for the celution 800 and CTX2. (Great news for sales and marketing overseas.) But, I believe scleroderma may have given us the proof of concept to move on in a focus, particularly in the US and EU.

Look at Botox, it is only barely effective (small improvement from saline injection) in the transient treatment (4 weeks) of the Raynaud's and yet people are using it this and other clinical uses. We have a much stronger case for scleroderma, Raynaud's, ED and OA, among many other uses such as breast reconstruction. There a many, many sex clinics in Asia, particularly in Japan, and I think the celution system will have a market there (just like OA).

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One Year Follow Up on ED Study 10 May 2017 09:05 #9306

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Interesting that the procedure does not work on men who are incontinent after Radical Prostatectomy, which is totally removing the prostate gland and some tissue around it, normally after suffering from prostate cancer.
Most men > 65 (including myself) have BPH (Benign Prostate Hyperplasia) causing urination issues, often followed also by ED.
I have been reading study reports here in Germany about the use of Sildenafil (Viagra) and related compounds, that 66% of men >65 have ED issues and solve it with Sildenafil. My experience is that one can solve this issue with losing weight and increasing your testosterone level with fitness/exercise etc and having sufficient levels of mainly zinc and magnesium in the body. :grin:

Actually the trick is- high insulin comes with low testosterone and vice versa. That is key.

But on the other side - solving such issues with CCT for men after RD makes all sense in the world.

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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:

One Year Follow Up on ED Study 10 May 2017 10:12 #9307

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Fransei --

Would you mind providing some information? When was the last time you heard legitimate mention of Celution 800 and/or CTX2 from a company source? Neither have been mentioned on recent conference calls, etc., despite promises of years ago. Why are you holding on to the concept that these devices are relevant to the future of this company? There's no reason to believe this company is even focusing on device development/sales any longer. Unless, of course, I missed something ...

You're seemingly the only one still mentioning devices ...

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One Year Follow Up on ED Study 10 May 2017 11:41 #9308

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waddlingwillbologni wrote: Fransei --

Would you mind providing some information? When was the last time you heard legitimate mention of Celution 800 and/or CTX2 from a company source? Neither have been mentioned on recent conference calls, etc., despite promises of years ago. Why are you holding on to the concept that these devices are relevant to the future of this company? There's no reason to believe this company is even focusing on device development/sales any longer. Unless, of course, I missed something ...

You're seemingly the only one still mentioning devices ...


I know my user name is not Franshei, but nonetheless would like to respond...


It is clear from the image , that Hedrick desperately wants Cytori to "look like" a DRUG Company if you look at all the designations for the THERAPEUTIC. Still he has no factories spread across the globe, where these therapeutics will be made- that "production" still will take place in the GMP devices, Celution and CTX2, for the foreseeable future and because of that fact, the lucrative regulatory pathway Cytori is following in the US is PMA DEVICE and NOT Drug.
So- the reason why you have not heard about "devices" is strictly political or tactical if you like. With Hedrick though- his tactics are pretty meaningless and useless, as you correctly have preached now for quite some time. :grin:
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One Year Follow Up on ED Study 10 May 2017 12:50 #9309

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Thanks, Fas. CTX2 has just been another milestone over the years that vanished from mention. Cytori seems to be naïve to the negative effects on stock price/investor confidence of such blunders and/or failures to follow projected paths/guidance. What to some is common sense, to others is unknown. It would be nice to know definitively what's going on with CTX2 -- if I'm not mistaken, the last we heard was that it was still in development two years ago ...

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One Year Follow Up on ED Study 11 May 2017 04:27 #9310

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waddlingwillbologni wrote: Thanks, Fas. CTX2 has just been another milestone over the years that vanished from mention. Cytori seems to be naïve to the negative effects on stock price/investor confidence of such blunders and/or failures to follow projected paths/guidance. What to some is common sense, to others is unknown. It would be nice to know definitively what's going on with CTX2 -- if I'm not mistaken, the last we heard was that it was still in development two years ago ...


yes- there are so many things from the past, which are totally unclear and sometimes even scary...for instance like what they told DOV, "that they rounded up the Celutions in Europe. to prevent them from treating Scleroderma patients at lower prices".

I think the device distribution model in Europe and the US will disappear (only will stay in Japan, where folks are a lot more disciplined in following the law), simply due to the plans to charge large sums of money to patient´s insurers for scleroderma. I think that is detrimental to growth and a sign that Hedrick and Cytori never cared for patients, just their own pockets.

This of course- adds other issues- with BARDA- for which CTX2 was planned- and of course we still lease a factory in Wales which is superfluous....:whistle:

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One Year Follow Up on ED Study 11 May 2017 09:47 #9311

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FAS

I think CTX2 is not disappearing. Roth and colleagues met with Hedrick and Girao sometime ago in NYC -Hedrick mentioned that CTX2 is an inexpensive version of celution 800 and it is being held back fro strategic reasons. Celution 800 sells for about $ 200,000 a piece in Japan (of course, there could be discounts and deals in any Asian markets).

I think the BARDA phase 1 will employ the use of CTX2. This phase 1 trial could be very important, as discussed before, because CTX2 and IV dosing can be bridged out to other uses within the so-called Habeo and Cytori Cell Therapy platform illness (scleroderma - such as secondary Raynaud's, where a new IDE is needed if CTX2 and IV dosing are employed). Clinical applications using CTX2 and IV dosing would be lower costs.

I was reading some Johns Hopkins articles re scleroderma and pulmonary fibrosis -some scientists believe that in the sphere of autoimmune illnesses, the origins could very well be malignancy related. You can do a google search. Is Hedrick up to something in this AZA acquisition?

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One Year Follow Up on ED Study 11 May 2017 10:12 #9312

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franshei wrote: FAS

I think CTX2 is not disappearing. Roth and colleagues met with Hedrick and Girao sometime ago in NYC -Hedrick mentioned that CTX2 is an inexpensive version of celution 800 and it is being held back fro strategic reasons. Celution 800 sells for about $ 200,000 a piece in Japan (of course, there could be discounts and deals in any Asian markets).

I think the BARDA phase 1 will employ the use of CTX2. This phase 1 trial could be very important, as discussed before, because CTX2 and IV dosing can be bridged out to other uses within the so-called Habeo and Cytori Cell Therapy platform illness (scleroderma - such as secondary Raynaud's, where a new IDE is needed if CTX2 and IV dosing are employed). Clinical applications using CTX2 and IV dosing would be lower costs.

I was reading some Johns Hopkins articles re scleroderma and pulmonary fibrosis -some scientists believe that in the sphere of autoimmune illnesses, the origins could very well be malignancy related. You can do a google search. Is Hedrick up to something in this AZA acquisition?


I did not write anything which implied that both the 800 machine or CTX2 will be disappearing. No- they cannot disappear since the approved products were or are to be made with them, so they are the GMP environments in which the products are made and are an integral part of the regulatory process.

Just this is what they had in mind in 2009-from the Sharon Begley Article which appeared in WIRED... (and is on this site in Media)

There is one other key feature that the next generation Celution machine shares with a photocopier, as Calhoun demonstrates. Just as the latter has a touch.screen control panel that displays options (paper size, number of copies, magnification), so does the Celution, only here, the options are organs.
See? There's a picture of a breast, a heart, a disc in the back,"he says. "You push that and the machine loads different software, which adds the right drugs, reagents, or other biochemicals to the liposuctioned fat cells. He envisions an iPhone like business model, with individual doctors doing apps to repair different organs with the perfect slurry of adipose regenerative cells. If it works, the breasts on his laptop will have plenty of company.


I know there is diversity in the products, due to different gyrations etc , but at present that is it. For IV just IntraVase is added to the Celase reagent. There are no biochemicals, mechanical force or oxygen or whatever there yet (but will come), to manipulate the cells, so the end-products are too much alike to have a 50.000 $ different price tag for different applications.

This can only work when Cytori remains ownership of the GMP facility i.e. Celution and have Customer Representatives serve the customer base regionally.
I agree also that CTX2 will be used in the BARDA clinic- I guess the chance for abuse for governmental property (if it comes that far) is a bit less...:whistle:

On the primary cause of auto-immune, I will check the web a bit- but my own believe is that aberrations like malignancy are based in our "modern society" and "man-made", but also can be easily prevented.
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One Year Follow Up on ED Study 11 May 2017 22:17 #9316

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Fas, I think your following comments touch on the essence of the problem being faced by Cytori.

''I know there is diversity in the products, due to different gyrations etc , but at present that is it. For IV just IntraVase is added to the Celase reagent. There are no biochemicals, mechanical force or oxygen or whatever there yet (but will come), to manipulate the cells, so the end-products are too much alike to have a 50.000 $ different price tag for different applications.

This can only work when Cytori remains ownership of the GMP facility i.e. Celution and have Customer Representatives serve the customer base regionally.''

and

''yes- there are so many things from the past, which are totally unclear and sometimes even scary...for instance like what they told DOV, "that they rounded up the Celutions in Europe. to prevent them from treating Scleroderma patients at lower prices"

As per the cc the company has stated that they will focus on Centres of Excellence in scleroderma. They will effectively own and operate the devices themselves so as to keep control.

All of the above consolidates in my mind the problem being faced by the company, problems which I had raised in the past. How do you differentiate in price and monitor activity when the device is broadly distributed in the medical community. Of course on top of this, one has to consider that there will be copycat devices as soon as the first approval is given by the FDA.

Anyone who wanted to partner with Cytori would have to have, or been provided wih answers to these questions. I think this is one of the primary reasons that BP partners have been in short supply. Given the above, the all new paradigm the FDA has to deal with along with its fear that if broadly available and without tight regulation then all sorts of cowboys promising treaments for conditions which have not been proven, is a valid fear.

Cytori made some big mistakes but they were to a certain degree understandable given the new paradigm they were confronted with, and in retrospect non of the trials they undertook had negative results. They swung big for a home run but failed. They were truly besotted by the potential but were not up to the task.

We have proof that ADRC work in burn, fistula, ED, lymphedema, wound healing etc, etc. ADRC work !!!!! Wouldn' it be a tragedy (financial and moral) if the delay in its implementation was due to its simplicity and ease of access ?

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One Year Follow Up on ED Study 12 May 2017 06:12 #9320

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rongside wrote: All of the above consolidates in my mind the problem being faced by the company, problems which I had raised in the past. How do you differentiate in price and monitor activity when the device is broadly distributed in the medical community. Of course on top of this, one has to consider that there will be copycat devices as soon as the first approval is given by the FDA.

Anyone who wanted to partner with Cytori would have to have, or been provided with answers to these questions. I think this is one of the primary reasons that BP partners have been in short supply. Given the above, the all new paradigm the FDA has to deal with along with its fear that if broadly available and without tight regulation then all sorts of cowboys promising treatments for conditions which have not been proven, is a valid fear.


Yes- for the US that is a great concern- less for Japan and Europe. Medical folks there are mostly under the socialized medicine umbrella, whilst US clinics/doctors are profit motivated. But all is not lost I think- CBER i.e. the FDA had there new law meeting in September 2016 and should be working on the final concept now. When it becomes law, one should expect efforts for adherence and warning letters and stuff. We will see- at least the law should be there before Scleroderma roll-out in 2018.

In the CC John harris had a lot to say on the marketing plans and what they are preparing for the launch, here is what is in the Seeking Alpha Transcript on it..... HERE

John Harris
As we continue to prepare for the U.S. market launch of Habeo, I will now provide some select detail surrounding these activities and our overall strategy noting that are EU strategy will mirror the U.S. but we will seek a partner there as opposed to a direct business model. Pending STAR data Cytori intends to file for an FDA PMA approval as soon as possible.
Our technology will be regulated as a Class III medical device. This would position Habeo cell therapy as one of the first FDA approved cell therapy and offer healthcare providers with an on-label treatment option to potentially improve hand function in patients with scleroderma.
The EU pilot trial data thus far have shown safety, feasibility and up to three years of clinical benefit and published and presented data. As previously mentioned, we feel the market in the U.S. is comprised of approximately 50,000 patient suffering from scleroderma and over 90% of those patients have hand involvement. There is nothing approved in the U.S. and first and second line therapies to treat scleroderma related hand dysfunction are not effective or well-tolerated.
Third line therapies used off label are very expensive despite being poorly tolerated and provide only limited symptomatic relief. Our market estimations indicate that there is an opportunity to achieve peak annual worldwide sales of $600 million with this product.
Our experience for the STAR trial has confirmed the viability of the procedure in various healthcare facility settings. Habeo is uniquely focused on treating hand dysfunction a major source of disability and socioeconomic impact for these patients.
Pending positive STAR trial data, we anticipate potential approval approximately a year after PMA filing. Our overarching commercial strategy is to take Habeo direct in the U.S. and look for partnerships outside of the U.S.
Market research and validation activities are largely completed. Some of the key completed activities include in-depth interviews with a number of U.S. and EU payers, hospital administrators, physicians, KOLs and patient to analyze and understand the scleroderma patient population, current treatments, unmet needs and the patient journey and of course the reimbursement landscape and potential pathways.
We have further tested with these key stakeholders the Habeo target product profile annual pricing model and market potential product adoption, reimbursement coating strategy and the clinical evidence portfolio in support of coverage.
Habeo cell therapy pricing is anticipated to be similar of those biologic therapies when launched that were targeted to hand dysfunction in rheumatic or inflammatory disease. Working with the STAR principal investigators and specialty societies for plastic surgery rheumatology and hand surgery Cytori has already submitted an application to the AMA for category three CPT codes that would cover the comprehensive procedure.
We anticipate these category three CPT codes may be published in January of 2018 following up CPT coding and activities are also plan post data. The activities that we have planned for Q3 and Q4 include health economics evaluation a burden of illness study, payer budget impact, cost-effectiveness analyses with leading experts, and expansion of our existing relationship with patient and rare disease advocates on national, regional and local levels.
Based on our experience in treating over 100 patients in our pilot and pivotal trials rapid enrollment in our U.S. trial and understanding of the referral pattern, market evaluation results in coupled with our long-standing commercial experience in Japan with this technology.
Our U.S. go-to-market strategy is as follows we anticipate deploying a highly focused specialty sales force in case specialist concentrated in high population centers of the U.S. with immediate coverage of the approximately 40 scleroderma centers of excellence. Note that nearly half of these centers have already successfully used our technology, understand and have established the internal referral process and most importantly have already implemented the simple bedside procedure as a part of the STAR trial. These STAR trial sites will serve as our beachhead for commercialization activities surrounding our planned launch.
Our plan is to place a Celution system at each one of these centers and provide procedural support to the facility. We will be able to broaden our outreach to the remaining centers of excellence in the U.S. and ultimately the EU.
This center of excellence approach which is a manageable number will position Cytori to address the needs of the majority of the market and then we will extend our outreach to the rest of the rheumatology community.

In conclusion, our focus is on preparing for two key product launches one, Habeo with peak worldwide annual revenue estimated to be $600 million we’re on track with the key commercial preparation activities. And two, ATI-0918 via partner in Europe the current annual market for this product is in excess of $300 million and forecasted to grow partner outreach is ongoing in 2017.
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One Year Follow Up on ED Study 12 May 2017 06:27 #9321

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Thanks Fas, that clears up my revenue question I posted on the other thread.

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