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TOPIC: Japan working hard on RegenMed

Japan working hard on RegenMed 05 Dec 2015 06:49 #5597

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On my travels through the web, I came across a Dutch government publication written in July 2015 by a staff member of the local Japanese Embassy in Holland- Noriko Ogawa.

The 3,5 pages contain high level information, which is very interesting to read. I -again- came away with the notion that regen med is really something for the Japanese themselves, which THEY want to develop, on a corporate level as well as a central governmental level.

From this perspective, I think you will see take-overs in the future of technology THEY find interesting- after ATCT, BioTime has been mentioned a few times. Whether Cytori is "save"? I dont think so, we are surely as much in danger as anybody who has a viable model and technology. :cry: :whistle:

The paper contains the line... Olympus and Mitsubishi Chemical HD also established regenerative medicine units within the organization to expand the opportunities (3).

I have not been able to find anything much on this activity as of yet... any one else with more luck.. please shout. :grin:

The Dutch paper below-

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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:

Japan working hard on RegenMed 05 Dec 2015 07:07 #5598

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But I did run down the list of Olympus Companies in Asia on their corporate website and that´s where I noted this:






Since December 2008 a joint venture named Olympus-RMS exists. RMS is short for Regenerative Medicine Systems, which was just moved from Kobe to Tokyo this year. The venture was with Korean Sewon Cellontech of which I have never heard before.

Anyway- the venture researches cultured cells and specializes on cartilage... :grin: :grin: which should have given them enough issues, since cells are very stubborn in respect of cartilage. :bye:

Olympus- Terumo still exists, but Terumo is no longer major shareholder of Olympus. It is possible that Calhoun had his fateful meeting with Kikukawa in late 2008 early 2009 and found his Waterloo as a result f this venture.... :whistle: :puke: :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:

Japan working hard on RegenMed 05 Dec 2015 19:55 #5600

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Some companies may sell early....in a recent trip to Fantasy Land earlier this year when I was speculating in the Cytori numbers game and various other Cytori thoughts I considered it may not be a bad time for a sale in the 2020-2022 timeframe depending on developments.

Hostile take overs do happen but less often these days as the poison pill helps management to make sure they are NOT completely cut out....contrary to popular belief that anything is really in place to protect the little guy :grin:

I think the recent institutional ownership numbers also hints that few are seriously sniffing around here for a take over play anytime soon.

Now lets see some OA data and STAR enrollment numbers !!!!!!!!!! :nice:

BTW...interesting find Fas. Focus still seems to point that most players really want the expanded cell route to work.

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Japan working hard on RegenMed 06 Dec 2015 06:53 #5601

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interesting find Fas. Focus still seems to point that most players really want the expanded cell route to work.


Yes- the route which surely can be patented, but I believe the Cytori Celution process too... :yep:

Whilst visiting the Terumo business too ...surprise surprise, they already have a conditional approval according to the new law (Sept 18 2015 !!)- the path is very interesting - so is the product- I thought myoblasts from a leg muscle could not beat into sync with cardiac myoblasts :whistle:

September 18, 2015
Terumo Receives Approval for the Manufacturer and Sale of its HeartSheet Autologous Skeletal Myoblast Sheets in Japan
Terumo Corporation (Headquarters: Shibuya-ku, Tokyo, Japan. President: Yutaro Shintaku) announced today that it has received conditional approval for manufacturing and selling its HeartSheet autologous skeletal myoblast sheets as a cellular or tissue-based products in Japan.
HeartSheet is cultured autologous skeletal myoblast sheets from a patient own muscle of thigh and transplanted to patients heart under the open chest surgery. This transplantation is expected to improve the patients heart condition significantly. A strong point of the therapy is the absence of any adverse reaction to the cells, since they are harvested from the patients own body.





The conditional approval requires:
I. 60 HeartSheet cases, showing efficacy of the product and treatment
II. Superiority compared to current existing treatment to 120 cases
III. Application for official approval within 5 years
Additional information:
1. Terumo began developing cell sheets in 2007 as part of its R&D on cardiac regenerative therapy. It commenced a clinical trial at three medical institutions in Japan in 2012 and completed the study in 2014. On October 30, 2014, Terumo applied to Japans Ministry of Health, Labour and Welfare for approval to produce and market its skeletal myoblast sheets as a regenerative medicinal therapy for treating severe heart failure caused by chronic ischemic heart disease.
2. Terumo has been promoting joint research with Osaka University, where clinical research on skeletal myoblast sheets is being carried out by Professor Yoshiki Sawa as part of a project sponsored by the New Energy and Industrial Technology Development Organization (NEDO). Terumo has also participated in a research project on regenerative medicine using cell sheets. It is led by Professor Teruo Okano of Tokyo Womens Medical University, which is part of a special consortia involved in developing advanced medical care in Japan.


Actually- come to think of it- the 40 patients study on PAD in Japan with Celution should qualify for conditional approval too....if wanted.. :whistle: :really:

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Japan working hard on RegenMed 06 Dec 2015 10:49 #5604

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fas

the phase 2 data from OA are enough to qualify for conditional approval in Japan?

Could Japan the stategy for faster market introduction?

Is Harris the man of the match for Japan?

Could the preffered partner for OA come from Japan?

Is that the possible strategie for 2016/2017?

regards holdi

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holdi

Japan working hard on RegenMed 06 Dec 2015 11:52 #5606

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Holdi- I will keep this telegramm style also, and simply will present my gut feeling on the different questions.. :bye:

the phase 2 data from OA are enough to qualify for conditional approval in Japan?

No- one has to have data on JAPANESE patients- that is key

Could Japan the stategy for faster market introduction?


Clearly, the Japanese way is the fastest and most revolutionary. Cytori needs a partner in Japan for OA too and will get one if the pilot delivers good results-

Is Harris the man of the match for Japan?


Probably..my hope is that he will be. Time will tell- we need partners and money as we all know. :evil:

Could the preffered partner for OA come from Japan?


Unlikely for the US market, my bet is still the Naples outfit. :cool:

Is that the possible strategy for 2016/2017?


I see local players for the different markets- i.e. Japanese Company for that market. European partner for scleroderma etc etc
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Japan working hard on RegenMed 08 Dec 2015 12:47 #5621

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Actually the reimbursement calculation provided by the agency is now available too on the Terumo therapy....



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Japan working hard on RegenMed 08 Dec 2015 12:56 #5622

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Quite a bit more than what JVC got for the TEMCELL product.... :grin:

Since Terumo is a Japanese company? Or since its autologous? i.e. more expensive to culture...Probably. :write:

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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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