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TOPIC: Cytori’s Celution® System Approved in Australia

Cytori’s Celution® System Approved in Australia 07 Aug 2013 07:21 #717

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Cytori Therapeutics (CYTX) has received notice from the Australian Therapeutic Goods Administration (TGA) that the Celution® System is approved for commercial use through inclusion on the Australian Registry of Therapeutic Goods for autologous re-implantation or re-infusion of a patient’s adipose-derived regenerative cells (ADRCs). The Celution® System produces autologous (a patient’s own) ADRCs at the point-of-care which may then be used for a range of injuries or conditions.

“Following an intensive two year review by the TGA, hospitals and physicians in Australia will have full commercial access to the only closed-system, point-of-care device which produces clinical-grade ADRCs for re-implantation or re-infusion into the patient,” said David C. Oxley, Vice President Emerging Markets for Cytori Therapeutics. “This approval establishes the foundation for enabling treatment of critical unmet medical needs across a variety of indications for patients in Australia.”

During the past two years, Dr. David Chin, MCh, PhD (Plast), FRCS, FRACS (Plast) of Queensland, Australia worked with Cytori under a TGA Authorized Prescriber Approval to treat a variety of conditions, particularly in the area of soft tissue injury and limited blood flow.

“We have had very favourable outcomes in the 80 plus patients treated using the Celution® System. Cases include breast reconstruction and patients who no longer wish to have silicone breast implants. Additional medical conditions, such as rheumatoid arthritis and soft tissue sports medicine related injuries are included,” commented Dr. Chin. “I can attest to the healing power of these cells based on the positive outcomes in my own clinical practice. In total, my experience includes a variety of presenting conditions over two years. Being able to access the patient’s own adipose derived regenerative cells during a single procedure opens up a whole dimension of acute and chronic medical conditions that may be addressed, including some previously considered untreatable under conventional treatment modalities.”

Adipose tissue is considered the richest source of regenerative cells in the body. These cells are comprised of a heterogeneous population of cells which are collectively referred to as ADRCs. The heterogeneous nature of ADRCs are believed to contribute to the healing process via multiple mechanisms, which include cell-to-cell signaling, supporting improved blood flow and regulation of the inflammatory response.

About Cytori

Cytori Therapeutics is developing cell therapies based on autologous adipose-derived regenerative cells (ADRCs) to treat cardiovascular disease and other medical conditions. Our scientific data suggest ADRCs improve blood flow, moderate the inflammatory response and keep tissue at risk of dying alive. As a result, we believe these cells can be applied across multiple “ischemic” conditions. These therapies are made available to the physician and patient at the point-of-care by Cytori’s proprietary technologies and products, including the Celution System product family. www.cytori.com

Cautionary Statement Regarding Forward-Looking Statements

This communication includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include the challenges inherent in convincing physicians and patients to adopt the new technology as well as our history of operating losses, regulatory uncertainties, dependence on third party performance, and other risks and uncertainties described under the "Risk Factors" section in Cytori's Securities and Exchange Commission Filings on Form 10-K and Form 10-Q. Cytori assumes no responsibility to update or revise any forward-looking statements contained in this press release to reflect events, trends or circumstances after the date of this press release.


.Cytori Therapeutics
Cytori Therapeutics, Australia
David Oxley
This email address is being protected from spambots. You need JavaScript enabled to view it.
+1-858-337-3565

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Cytori’s Celution® System Approved in Australia 07 Aug 2013 08:00 #718

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Wow- this is pretty HOT stuff.

Re-implantation or re-infusion to me also indicates intravenous or intramuscular delivery, so established Medical practitioners can use for virtually anything. I knew that the Aussies are "advanced" in the practice of medicine but not to that extent.

Now Dr. Chin can continue the work that Dr. Mitsuo was doing in Japan before they stopped him in 2010. :vegas:

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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:

Cytori’s Celution® System Approved in Australia 07 Aug 2013 08:12 #719

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I did shoot off an email to David Oxley- will post the reply here when I get one- :write:

Hallo David,

Congrats on the wonderful news on the TGA approval- this reads like the Celution system will generally be available for the practice of medicine without requiring specific approvals for intended therapeutic use. Re-infusion would also imply intravenous delivery i.e. systemic apps?
If so -that is great stuff for advancing the science!
Any impact you see for emerging nations like India etc in respect of this approval?
Thanks and congrats again
Fas Kuiters
Editor of cytx-investor.com

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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:

Cytori’s Celution® System Approved in Australia 07 Aug 2013 08:21 #720

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Excellent news,thanks for the post.

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Cytori’s Celution® System Approved in Australia 07 Aug 2013 08:40 #721

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Hi Fas, do you think the 80 cases that lead to approval will be available for review?

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Cytori’s Celution® System Approved in Australia 07 Aug 2013 08:43 #722

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Thank you keysman, Australia has been in the mix for quite some time, a very pleasant surprise. I wonder if we will hear about reimbursement codes in the near future, as off the cuff, it looks like self pay at this point?? Oh yes, welcome. :grin: :vegas:

d9

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Cytori’s Celution® System Approved in Australia 07 Aug 2013 09:07 #723

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Let there be no mistake- this is all private pleasure of course.

But next step could be to leverage already available clinical data from Europe and some supplemental stuff done locally.

There should be plenty around for breast reconstruction and the different surgical apps approved there of which we do not even know the clinical data.
But I guess if he had good results on rheumatoid arthritis (which is well known from medical tourism in Japan/Mexico etc) surely some clinics will pick this up and do a clinic on that. I expect one in Japan in the coming weeks also. :grin:

The website of Dr. Chin indicates he did mainly soft tissue stuff - Dr. Chin in Aussieland

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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:

Cytori’s Celution® System Approved in Australia 07 Aug 2013 15:51 #724

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Since David Oxley did not respond I sent the same mail to Tom who responded as follows:

Fas,

This approval is similar to the CE Mark indications with the exception that we do not have approval on intravase, which is something we’re pursuing. I’m not sure this will have an impact on other emerging markets.

But what we want to do is amass country approvals where we think it makes sense to do so, get the system into the hands of early adopters and docs familiar with cell therapy, have them expand the overall clinical experience and in so doing, build toward specific therapeutic claims and reimbursement.

David has a strategy for Australia that includes using a distributor to target select private hospitals starting with the current approval and eventually progressing to cardiac/vascular over time. Dr. Chin who was quoted in the release has had promising results across a variety of conditions outside of classic plastic surgery (breast reconstruction, augmentation, facial rejuvenation, etc), including elite sports, osteoarthritis, erectile dysfunction, and male pattern baldness (having used the device under a provision that allows doctors in Australia to access new technology). These are examples of one can be accomplished in just one center and we expect to bring more docs like this onboard over time.

Thanks,

Tom


This makes all the sense in the world to me- you can translate this as -LOCALIZED TREATMENT WITH CELUTION FOR EVERYTHING- except intravascular/intravenous i.e. organ etc. I like this very much- this is to me (from a patient perspective) what it should be for a safe treatment with ADRCs all across the globe.

The Aussies are not dumb- :nice:

(some of my best friends are from down under :really: )

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Cytori’s Celution® System Approved in Australia 07 Aug 2013 17:53 #725

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***I like this very much- this is to me (from a patient perspective) what it should be for a safe treatment with ADRCs all across the globe.***

The Cytori strategy appears to "circumnavigate" the globe with celutions, and getting them into the proper hands as well. These independent clinical treatments and trials will exponentiate with viable data that cannot be overlooked. A country with many similarities to Australia that comes to mind, that might be near to approval, would be Canada. Could they be the next domino to fall? :cool:

d9

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Cytori’s Celution® System Approved in Australia 08 Aug 2013 08:44 #727

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Fas through the years ,I've been unable to get a response from Tom Baker. His response to you was very informative and to the point.
Needless to say I was very disappointed with the price performance. I really don't think you obtain CE Status every day. Many steps have occur before total success. My program shows deliberate share dumping (shorting). I'm now here for the long haul. Congratulations on getting Tom to answer you.

keysman

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Cytori’s Celution® System Approved in Australia 08 Aug 2013 09:47 #728

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Keysman-

The price performance to me is no issue. I have come to accept that investors - including Wallstreet and some fund managers, simply do not understand the beauty of the business model. Tom´s answer-

get the system into the hands of early adopters and docs familiar with cell therapy, have them expand the overall clinical experience and in so doing, build toward specific therapeutic claims and reimbursement.


Is what I am trying to explain now for a few years with the evidence of regulatory pathway included. As we all know- we already HAVE therapeutic claims from studies of early adopters- those claims surely are on their way through the reimbursement process, which takes three years or there about. What is missing to "exploit" this enormous value already have been created is simply a sales and marketing organisation.

That requires a partner and to me the timing is about right that these folks come on board too. :yawn:

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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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