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TOPIC: Poll on China

Poll on China 12 Feb 2014 09:15 #1320

  • fas
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With "mixed feelings" I see all those new analysis´come out from presumed professionals and amateurs (seeking alpha) alike.

All basing their work on "official Cytori announcements" and re-chewing the stuff Cytori management has "taught" them.

In principal this is virtually only US stuff- BARDA and ATHENA- which is coming in the only global territory where no regulatory achievements have been made (see -The Cytori Saga) due to vehement resistance by the FDA.

The KT Lim deal has been ridiculed by Feuerstein and others and the Cytori "brew" does not do anything.

The major market that Lim will be "working on" China is expected to provide approval for Celution to treat major "internal organ" disorders like, cardiac, renal, stroke and diabetes i.e. the "riskiest" procedures possible in the human body-

my question to all of you- thats why a poll, to make this easy to participate :grin: :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:

Poll on China 12 Feb 2014 11:45 #1321

  • myownhedgefund
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Few care yet Fas !
Stem Cells are still a backwater and all the companies burn lots of cash.
To date, Big Pharma avoiding Cytori in all regions.
CEO carries credibility baggage.
Visibility to profits still not clear and has left many institutional investors in a wait and see mode imho

This has left retail and fee seeking analyst to offer opinions.

BTW...took the survey but would have liked to be able to select more than one choice.

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Poll on China 12 Feb 2014 11:53 #1322

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Hedge-

If I recall correctly- the settings of the poll are- you can vote up to 100 times but with an interval of 10 minutes. :joy: :joy:

so- take your time and adjust your vote- if you think their should be another option - tell me - maybe I can add.

Normally webmaster can do everything except for reading personal data. :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:

Poll on China 13 Feb 2014 10:59 #1323

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Very nice article by Ray/WST yesterday- really enjoyed that.

Besides the fact that he does not know how to spell my name- the only major problem is that he still does not understand the regulatory picture. If WST still does not- I bet 90% of shareholders also do not grasp.

This piece is totally wrong:

However, the FDA stance is that since Cytori uses an enzyme to release the chemical bonds that bind ADRCs to adipose (Cytori uses Celase® and Intravase® for intravascular delivery), its cell output is considered to be more than "minimally manipulated" and is thus defined by the FDA as a biologic drug that requires extensive FDA-approved clinical trials.


It basically took Cytori 3 years to convince CBER that Celution "minimally manipulates"- otherwise all clinics would NOT be device regulated- i.e PMA but instead be IND type studies, which they arent.

Interesting the interview with the EA man:

WST: Hello Dr. Dizon, can you tell me a little about EA Regenerative Medicine?

Dr. Dizon: The center was just launched last December 7, 2013. All our treatments will be in a form of a Global Registry. These are multi-center, world-wide clinical registries using Cytori Therapeutics sponsored protocols. A Registry is a form of a clinical study but instead of it being investigative, it is observational and assess a technology's ability to achieve its intended use in the real world. As of the moment, we are still waiting for the ethical and technical review of our protocols by an accredited IRB. We will be doing clinical studies in heart diseases, osteoarthritis, muscle and ligament injuries, and scleroderma initially.

WST: …and when do you expect to achieve IRB approvals?

Dr Dizon: Depending on how smoothly the Registries will pass through the IRB but we may see this at least within 2 months minimum.

WST: How did you come to choose Cytori Cell Therapy as the basis for your practice?

Dr. Dizon: We definitely did our research and we went for the best technology available. We are the exclusive licensee of Cytori Therapeutics here in the Philippines. We made sure we got the exclusivity since we anticipated that once we start marketing this, a lot of interested parties will start knocking on Cytori's doors and we were correct. A lot of other groups have started to talk to us already for possible partnerships.

WST: Are you also planning to offer cell banking?

Dr. Dizon: We offer both adipose tissue and ADRC banking using the StemSource Cell and Tissue Bank installed and certified by Cytori Therapeutics.

WST: Could you explain the regulatory framework in the Philippines that allows you to use the Cytori Celution? Do the Philippines follow the EU with regard the CE Mark?

Dr. Dizon: Stem cell and other cell therapy regulation in the Philippines is still in its infancy. Actually, the Philippine FDA and DOH doesn't even have the guidelines yet for the registration of medical devices for said therapies hence we got an exemption for the Celution pending the issuance of the new medical device registration guidelines. Unfortunately, Philippines pattern most of its regulations after the USFDA but they give credence if a device has approvals from other countries also like CE, Australian TGA, Singapore HSA and Japan MHLW. What we aim is to set the standards and contribute in setting the guidelines for the regulations of these devices by providing them all the documents they are requiring in the application of our facility for accreditation as well as the clinical registries we will be conducting.


The interest in the Far East in Cytori Cell Therapy is obviously on the rise. Here is where the money will come from in the next few years- and sooner than people think. :vegas: :cool:
The following user(s) said Thank You: rothco619, myownhedgefund, keysman

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Poll on China 14 Feb 2014 09:03 #1324

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The above I just saw has created some "commotion" :joy: :joy:

Actually the article that WST linked tells the whole story, but just to indicate that it conforms Cytori understanding- see this announcement from 2009- this again lead to legal fight - is Celution low risk 510K or high risk (class 3 device- requiring PMA studies).

Cytori's Celution(R) 700 System to be Regulated as a Medical Device by U.S. FDA
07/17/2009
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SAN DIEGO, Jul 17, 2009 (BUSINESS WIRE) -- Cytori Therapeutics (NASDAQ:CYTX) was informed by the U.S. Food and Drug Administration (FDA) that the Celution(R) 700 System will be regulated as a medical device under the Federal Food, Drug, and Cosmetic Act. This determination, in response to Cytori's Request for Designation, clears the way for Cytori to compile and submit a marketing application to the FDA for the Celution(R) 700 System for use as a medical device in aesthetic body contouring and/or filling of soft tissue voids.

"This important decision provides greater clarity of our regulatory path in the U.S. and is consistent with our interpretation of current device regulations," said Christopher J. Calhoun, chief executive officer for Cytori. "We are preparing for the next steps in the process of working with the FDA to determine the specific device marketing application to submit, including whether clinical evaluations will be necessary."

Based on the jurisdictional determination from the FDA, marketing applications for the Celution(R) 700 device will be reviewed by the FDA's Center for Biologics Evaluation and Research under the law applicable to medical devices. Clinical investigations, if required, would be conducted in accordance with the Investigational Device Exemption (IDE) regulations, not the Investigational New Drug regulations applicable to drugs and biologics.

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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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