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TOPIC: Past communication on Nagoya´s SUI clinic

Past communication on Nagoya´s SUI clinic 02 Mar 2015 06:46 #3601

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I presume this should be close to publication also, like scleroderma and OA.
I never understood why this took so long- it might be that possibly Astellas had to get involved, since they are market leader globally in Urology, so you would get something like cells+drug.
Anyway- there should also be at least sufficient data in Japanese MEN to apply for conditional approval with the pivotal starting at the same time and switching to women at a later date. :write:

So here the past statements from Hedrick (some are really old and stale :grin: )

Q4 2012- March 7 2013 Transcript
Now we can announce that our early feasibility study on both men and women with urinary incontinence has been expanded to a larger multi-center trial funded by the Japanese government. Nagoya University has received a grant in the amount of JPY 500 million or approximately $5 million to fund the clinical trial, amend the labeling for this indication and establish reimbursement. We intend to provide more detail on this trial throughout the year.

Q1 2013 May 9 2013 Transcript
More recently, an early feasibility study in urinary incontinence in Japan has expanded to a larger multi-center trial funded by the Japanese government. Nagoya University has received a grant in the amount of ¥500 million, or approximately $5 million, to fund the clinical trial, amend the labeling for this indication, and establish reimbursement. We anticipate that these investigator-led studies will be a growing aspect of our business strategy.

Q3 2013 November 7 2013 Transcript
As part of the Musket discussion on Japan
And then in the background, we have things that are going on irrespective of this new law, for example, as you know, we have a urology trial that's going, it's multi-center led by Nagoya, which would be geared towards not just early approval, but approval and reimbursement.

Q1 2014 May 12 2014 Transcript
Dr. Gotoh from Nagoya has studied ADRCs with stress urinary incontinence. We originally had positive results from 11 male patients published in the International Journal of Urology in 2013, and more patients have also been treated beyond this.
So MHLW, an arm of the Japanese government, has agreed to fund that study, which should be a pivotal trial in Japan going forward, and we're currently under negotiations regarding the details of that trial with Nagoya University, MHLW and ourselves.

Q3 2014 November 6 2014 Transcript
And let me switch to urinary incontinence. This is another area that we’ve mentioned briefly on previous calls, but this trial is beginning to take shape in Japan. We, along with Nagoya University and the Japanese Ministry of Health, Labor and Welfare, are in late-stage discussions regarding the trial that we’ve mentioned before.
It’s based on the positive results from 11 male patients published in the International Journal of Urology back in 2013. As a reminder, the data showed that Cytori felt therapy led to improvements in leakage, urethral closure and patient quality of life. The team at Nagoya is actually continuing to treat patients with urinary incontinence, including some women, subsequent to publication under the old stem cell guidelines approved by MHLW, which are now passed away. MHLW has agreed to fund a pivotal trial in Japan which is anticipated to be a multi-center approval trial led by Nagoya, using Cytori cell therapy for the treatment of male urinary incontinence, at least at first.
While the incontinence market in men is much smaller than it is in women, it is a very important lifestyle concern and limitation to the affected patients, and there’s no good treatment. And there’s obvious investigator and governmental interest in Japan. If the trial is successful, a very well may provide a path to approval in reimbursement in Japan and potentially expand the opportunity to move into the broader market in women with some more feasibility data.
And we anticipate meeting with the Japanese regulatory authorities as a follow up to several other meetings we’ve had in the past on the final trial design timeline in Q4. But this has been a slow process amongst these three entities working together.

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Past communication on Nagoya´s SUI clinic 02 Mar 2015 07:34 #3603

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Great compilation. You would think CYTX should have announced a positive development in Japan before ATHX.

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Past communication on Nagoya´s SUI clinic 04 Mar 2015 08:23 #3645

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In order not to forget and record when its fresh on the mind... :cool:

During his Cowen presentation on March 4th, Hedrick mentioned that this indication has data now on about 30 patients instead of only the referenced 11 patients. (By the way- there were several very small studies under the former regulations)

Anyway- 30-50 patients- appears enough for asking for conditional approval in my mind- other indications that fit that bill in Japan are PAD and Breast reconstruction. :bye: :yep:
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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:
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