Welcome, Guest
Username: Password: Remember me
Cytori´s Platform applications
  • Page:
  • 1

TOPIC: Approval trial at Ariake

Approval trial at Ariake 12 Nov 2016 11:55 #8006

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3332
  • Thank you received: 1114
Listening to Hedrick brings back my good ol´burn-out, so it took some re-newed attempts to listen to parts of the CC, but anyway- half is done now- the Breast Reconstruction app after Lumpectomy. In view of experiences with RESTORE I and II, this is obviously a very very low risk trial. We know what comes out - its just a matter of time and being patient. :yep:

What was said:

Now let me discuss a potential new trial & application to our pipeline. First the background.
Breast cancer is increasing in Japan like it is all around the world. In fact and look back to 2010, there were approximately 50,000 patients diagnosed with breast cancer and this has been growing year-over-year and about 60% of those patients receive breast conservation therapy and are treated with concomitant radiation,which is a partial mastectomy and radiation. Many sequelae (=following issues and complications) result from the radiation. This globally is an unmet need and there are currently no approved therapies in Japan to treat this population of patients.

Shareholders who known us for a while, know that we have completed two trials in this area and actually Cytori has been working on an approval trial in Japan for some time quietly behind the scenes. (typical )
Now, we were informed in the Q3 that Cancer Center Ariake in Tokyo (to put this in perspective for those, who are familiar with the hospitals in Japan, Ariake is a sister hospital to M.D. Anderson here in Japan) They have received both internal IRB and Japanese government approval to begin an approval trial for Cytori Cell Therapy for breast reconstruction after partial mastectomy.
The principal investigator will be Dr. Masayuki Sawaizumi- link to his department- HERE who is the Chief of Reconstructive Surgery at Cancer Centers Ariake and an important leader in the field in Japan and a member of the reimbursement committee at MHLW in Japan and I want to congratulate and thank him for all his hard work behind the scenes and helping to drive this through. The trial as I mentioned is based on the previously reported RESTORE I trial from Japan and the RESTORE II trial in Europe both of which have been published.

So what we're waiting on with respect to this trial, is the final administrative protocol approval from MHLW and PMDA and at that point, we can further discuss the details of the trial and the time line. And right now we more or less anticipate enrollment beginning next year. Regarding the funding of the trial, it will be internally funded, but will receive logistical support from Cytori, no direct cash support at this time and actually maybe associated with consumable revenue to Cytori, more on that later.



I have all the write -up´s on RESTORE I and II still on my hard drive and will put them on fat-cell.com one of these days.
Attachments:
The following user(s) said Thank You: Old Young Fox

Please Log in or Create an account to join the conversation.

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:

Approval trial at Ariake 14 Nov 2016 08:37 #8013

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3332
  • Thank you received: 1114
One of the more interesting comments from the last call was the understanding I got, that Cytori can decide in EU and Japanese markets which pathway to follow in respect of an application. Lets say- both IND and IDE- drug and device therefore.

For Europe- in the past only the device pathway was followed which did not bring the Company any further, with the result that only 1,5 FTE´s (employees) are working there and revenues are low.

With the success of the AMTP pathway for scleroderma, SME status, regulatory connections to the EMA and some work being done in Denmark-

i.e. the stuff Rongside came up with in June- Treatment of Breast Cancer Related Lymphedema With Cell-assisted Lipotransfer

The above Phase II trial was a follow on from the single patient trial that had very positive results. stemcellstm.alphamedpress.org/content/early/2016/05/03/sctm.2015-0357.abstract

The odds are getting better that breast reconstruction and "treatment of its sequelae" will get a fast AMTP pathway in view of available clinical data of RESTORE II.

Something to keep in the back of our minds. :yep:

Please Log in or Create an account to join the conversation.

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:

Approval trial at Ariake 14 Nov 2016 19:52 #8022

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2820
  • Thank you received: 201
Fas
I was always disappointed with the patient satisfaction response in this app compared to what seemed to be incredible before/after pictures.
Thoughts ?

Please Log in or Create an account to join the conversation.

Approval trial at Ariake 15 Nov 2016 04:58 #8025

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3332
  • Thank you received: 1114

myownhedgefund wrote: Fas
I was always disappointed with the patient satisfaction response in this app compared to what seemed to be incredible before/after pictures.
Thoughts ?


I checked back in Eva Weiler-Mithoff´s video on numbers of RESTORE II and the "satisfied with procedure" numbers were 82% for physicians and 73% with patients, which I think was decent if you consider the complexity of some of these reconstruction cases.

That the patients number is somewhat lower, is just human in my view- some people expect miracles from stem cells and are "thinking "BB" or "MM" boobs", but afterall- it is just fat and doctors tend to be somewhat more realistic there.

Please Log in or Create an account to join the conversation.

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:
  • Page:
  • 1
Time to create page: 0.497 seconds

Copyright Information

Copyright Fas Kuiters © 2016 young-foxes.com. All Rights Reserved.
This page is made with Joomla CMS and its various templates designed by Fas Kuiters with the excellent Themler tool.

 

 

Shared Spreadsheet Links

DOV´s Revised Projections for the Periods 2017 until 2020

Shareble link : HERE

Fas Kuiters Websites