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TOPIC: Open LabelUrinary Incontinence Trail Gets Approval

Open LabelUrinary Incontinence Trail Gets Approval 30 Jul 2015 07:55 #4907

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SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics, Inc.(CYTX) announced that it has recently been informed that a company-supported trial in Japan has received approval to begin enrollment from Japan MHLW (Ministry of Health, Labor and Welfare).

The ‘ADRESU’ trial is a 1-year open-label, multi-center, single arm trial to evaluate the efficacy and safety of periurethral injection of autologous adipose derived regenerative cells for the treatment of male stress urinary incontinence following prostatectomy for prostate cancer. The goal of the investigator-initiated trial will be to gain product approval for Cytori Cell Therapy technology for this indication.

The trial will be led by both Momokazu Gotoh, MD, Ph.D., Professor and Chairman of the Department of Urology and Tokunori Yamamoto, MD, Ph.D., Associate Professor Department of Urology at Nagoya University Graduate School of Medicine, and is primarily sponsored and funded by the Japanese Government.

The ADRESU trial will enroll 45 patients and the primary endpoint will assess the improvement in urine leakage volume from baseline by 24-hour pad test. Each patient will serve as his own control in the trial. Key secondary endpoints will include: urine leakage volume at each evaluation time point by 24-hour pad test, improvement in the number of incontinence episodes per day with greater than 50% reduction from baseline, number of incontinence episodes per day, number of pads used per day, key quality of life scores, patient overall satisfaction, key urodynamic parameters, blood flow at the injection site measured by transrectal ultrasonography and evaluation of the injection site by pelvic MRI scan.

The lead site of the trial is Nagoya University and enrollment is expected to begin in 2015 at four centers within Japan. The trial is a follow-up trial to an initial clinical study reporting positive benefits in men with urinary incontinence post-prostatectomy performed at Nagoya University (Gotoh et al. Int Journal Urology. 2014;21(3): 294-300).

For more information on the ADRESU trial, please visit:

upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000020539&language=J
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Open LabelUrinary Incontinence Trail Gets Approval 30 Jul 2015 08:40 #4908

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:KO: :KO:

Wow that egg took a long time to produce.



It has been announced in conference calls at least three times and also the new regenerative law did not apparently speed up anything, since the law is there since November 26.... :whistle:

Anyway- as Hedrick indicated at one occasion- Yamamoto and Gotoh continued treating patients with the procedure and tend to be "fast enrollers"..and very competent, if one reads the compliments to have gotten from fellow scientists.

Off we go. :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:

Open LabelUrinary Incontinence Trail Gets Approval 30 Jul 2015 08:47 #4909

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Fas, it will take a year for 45 people... Depending how long it will take to release the results, we will have another trial later... 3-4 years to go... Maybe 5-6 years, since we are looking at safety for now... 7 years ago is now

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Open LabelUrinary Incontinence Trail Gets Approval 30 Jul 2015 09:33 #4910

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Fas, it will take a year for 45 people... Depending how long it will take to release the results, we will have another trial later... 3-4 years to go... Maybe 5-6 years, since we are looking at safety for now... 7 years ago is now


First and "violently" important.. :nice:
The goal of the investigator-initiated trial will be to gain product approval for Cytori Cell Therapy technology for this indication.

I am sure you know what that means- which makes sense under the new law under conditional approval- REIMBURSEMENT- and continued type of Phase IV clinical evidence after the approval.

The fact that the Japanese GOVERNMENT ...that line is more for the US investment public, it does mean the MLHW i.e. the national health authority, SPONSORS the clinic, after looking at it from the back, the front, from above , from below and every angle in between, must mean that chances are good that this will be the real thing about 2 years from now.

As a reminder- enrolling 45 patients should take minimum 3 months at 4 centres and all patients will be followed 12 months......

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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:

Open LabelUrinary Incontinence Trail Gets Approval 30 Jul 2015 10:09 #4912

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Depends on how quickly all 4 centers are up and running.
Giving our history, perhaps longer than 3 months. Lets say 3-6 months. Then the 12 months for collection then another 90 days to analyze and prepare then how long to reimbursement ? The key is the reimbursement green light...how long until they get that ? If it is reasonably quick then 2 years or so is possible....problem is no government entity works very quickly. Lets hope for "year end 2017" Then we will see if we have a large market or not.

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Open LabelUrinary Incontinence Trail Gets Approval 30 Jul 2015 11:44 #4914

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Hard to get excited about this looking at where Cytori stands today. To, me this announcement and the announcement of new legal counsel is typical for Cytori. Just a bit of hype before a CC. Wash rinse repeat. Before we see how large the market is, lers see how much more the company is diluted, and how many more free shares are awarded to the crack management team and BOD at this illustrious company. Not amusing that the gang that could not shoot straight waits until now to get counsel that appears to have a semblance of a clue on how to perhaps get a partnership deal done. All the other potential partnership deals have just evaporated into thin air if they really existed in the first place. Credibility is gone Hedrik and Tiago honeymoon is over as we are now in a worse place when it comes to market cap = shareholder value.
Keeping silent until a week before annual meeting is not my idea of being forthright with shareholders and improved communication. :puke:
How many times do we need to be kicked in the head to get how management tries to manipulate shareholder impressions. Guess they have a new batch of suckers who have bought in at these levels ,long term holder be dammed. Hope your all having a great summer.

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Open LabelUrinary Incontinence Trail Gets Approval 30 Jul 2015 13:45 #4915

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One and three punches: 3 consecutive PRs, one week before earning. Hedrick's favorite pattern, with a prior example earlier this year.

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Open LabelUrinary Incontinence Trail Gets Approval 31 Jul 2015 07:37 #4916

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Fas, you need to read my comments again, instead of telling what Marc - Give me a break - said in some BS release.... care to make a bet on over-under 2 years from the date of announcement, yesterday? You seem to think they can get this done in a few months...

Haven't you been around for the past 10 years? REALLY?!

How about:

The first patient that will pay through his insurance and gets treated - Give me the year for this event... Can you do this?

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