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TOPIC: Investor Relations News & a POV from Leeza R.

Investor Relations News & a POV from Leeza R. 02 Feb 2015 14:02 #3295

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Fas et al,

What are you thoughts around the PS line in Leeza's post below. What do they use at CosmeticSurg?

"May the best device maker win.....p.s. Cytori is not the only game in town :)"

plus.google.com/+LeezaRodriguez/posts/AV9AFx8zcpM

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Investor Relations News & a POV from Leeza R. 02 Feb 2015 14:23 #3297

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I thought I was on every possible distribution list from Cytori- apparently I am not any longer.. :grin: :really:

Anyway- first most important- the communication:

Directly from the Cytori letter to investors...

February 2, 2015

Dear Investors:

In Fall 2014, the Center for Biologics, Evaluation and Research (CBER), a branch of the United States Food and Drug Administration (FDA), issued three draft guidance documents clarifying regulatory issues pertaining to adipose tissue, the manipulation of cells and tissues, and exemptions regarding the use of cell and tissue products in the same surgical procedure.

In 2009, in response to a formal request for designation or ‘RFD’ from the Office of Combination Products at FDA, Cytori received notification that Cytori Cell Therapy would be regulated as a Class III device through CBER (RFD# 090013). The three new guidance documents from FDA relate to the cell therapy field and adipose therapeutics in general, and provide insight into the thinking behind that important designation decision rendered to Cytori.

“We are pleased to see the new FDA draft guidance documents and appreciate the clarity they provide to both physicians and companies developing and using adipose derived therapeutics,” said Dr. Marc Hedrick, President and CEO of Cytori. “The guidelines provide a clear and unambigous path to market for us, which is fully consistent with our current regulatory approach in bringing Cytori Cell Therapy to market here in the US via the PMA (premarket approval) device pathway.”

The draft guidelines contain several points worthy of highlight:

· The clinical use of cells isolated from human tissue, no matter the isolation process, and including cells derived from adipose tissue, will require FDA oversight.

· The process of extracting any cell population or cellular subset from adipose tissue will be considered beyond the technical process of ‘minimum manipulation’. Minimal manipulation means a process that does not change the relevant biological characteristics of a cell or tissue.

· The clinical use of an isolated cell population will not be considered exempt under the technical definition of ‘same surgical procedure’. The same surgical procedure exemption is important because it was the legal mechanism that allowed physicians to legally utilize cell isolates from tissue on the same patient. This exemption has now been redefined to require ‘minimum manipulation’ as a new requirement for the exemption.

· Adipose derived cellular products may be regulated through the investigational drug pathway (as a drug or biological product) or as a PMA device at the discretion of the FDA.

· Any party, in the US, extracting cells from adipose tissue for use as a therapeutic will be required to obtain a biologics license from FDA to commercialize the product or obtain approval for an IND or IDE to pursue a clinical investigation. Products with formal device designation from FDA are eligible to proceed to market through a PMA device pathway where device regulations are applied versus the very different pharmaceutical regulations.

· Physicians can no longer make their own cell therapies from adipose tissue without FDA oversight.

Kenneth Kleinhenz, Cytori’s Vice President, Global Regulatory Affairs offers the following detailed comments on the guidelines.

Same Surgical Procedure Draft Guidance

In the FDA draft guidance document titled, ‘Same Surgical Procedure Exemption under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exemption’, the FDA indicates that it will be applying the scope of the same surgical procedure exemption, listed in 21 CFR 1271.15(b), in a very limited way. Specifically, the guidance document states, ‘FDA’s view is that autologous cells or tissues that are removed from an individual and implanted into the same individual without intervening processing steps beyond rinsing, cleansing, or sizing, or certain manufacturing steps, raises no additional risks of contamination and communicable disease transmission beyond that typically associated with surgery. FDA considers the same surgical procedure exemption to be a narrow exception to regulation under Part 1271.’ Based on the above statement from FDA, it is clear that FDA only considers washing, cutting, and rinsing of tissues to be within the meaning of same surgical procedure. “The guidance document clearly indicates that minimum manipulation will now be an additional criterion, along with existing autologous and same surgical procedure criteria, for physicians to operate outside of FDA oversight,” stated Kenneth Kleinhenz, Vice President of Global Regulatory Affairs.

The draft guidance document can be found at: www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/tissue/ucm419911.htm


Minimum Manipulation Draft Guidance

The FDA draft guidance document titled, ‘Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products: Draft Guidance,’ indicates that cells isolated from adipose tissue are considered drug products. Example number 10 of the guidance document describes a scenario where cells are isolated from structural tissue to produce a cellular therapy product. The guidance document describes manipulations to adipose tissue that would be beyond minimum manipulation due to changes in the ‘original relevant characteristics’ of a structural tissue (adipose) regardless of the mechanisms leading to such changes. Specifically, the draft guidance document indicates that, ‘original relevant characteristics of adipose tissue, a structural tissue, to pad and cushion against shocks generally include its bulk and lipid storage capacity. A manufacturer recovers adipose tissue by tumescent liposuction and processes the adipose tissue to isolate cellular components, commonly referred to as stromal vascular fraction, which is considered a potential source of adipose-derived stromal/stem cells. The HCT/P generally is considered more than minimally manipulated because the processing breaks down and eliminates the structural components that provide cushioning and support, thereby altering the original relevant characteristics of the HCT/P relating to its utility for reconstruction, repair, or replacement.’ Therefore, manufacturing processes that isolate a cellular component from adipose tissue are now considered to be beyond minimum manipulation and will require FDA oversight for clinical use in humans. Furthermore, the guidance document specifically addresses a scenario in which an autologous tissue is processed at the point of care within the same surgical procedure. A scenario is outlined in which, ‘adipose tissue is recovered by tumescent liposuction. Stem cells from the lipoaspirate are then isolated. Cell isolation would typically cause the adipose tissue to no longer be such HCT/P. Thus, even if the processed HCT/P from adipose tissue is injected into the same patient from whom it was removed during the same surgical procedure, the establishment would generally not be considered to qualify for the exception under 21 CFR 1271.15(b).’ FDA has clarified that cell isolation from adipose tissue will now be considered a drug and the ‘establishment’ performing these actions (physician or hospital) will not be exempt from FDA oversight. Practically speaking, physicians and hospitals isolating cells from adipose tissue will be manufacturing a drug product and such activities will require an FDA approval (NDA or BLA) if cells are separated from adipose tissue and used clinically. “Now it is clear that the isolation of cells from adipose tissue will not be viewed as minimum manipulation. This view by FDA affects physicians and industry alike as the physicians will no longer be exempt from FDA oversight through the same surgical procedure exemption because minimum manipulation is a new criteria for such exemptions. Furthermore, the device-based point-of–care industry will require FDA oversight as their devices will be now be producing an FDA regulated drug or biologic that will be regulated no differently than cultured cells. Both cultured cells and isolated cells, at the point-of-care, will have the same regulatory burdens due to the manipulation criteria, which now applies to simple cell isolating techniques from adipose tissue,” stated Kenneth Kleinhenz, Vice President of Global Regulatory Affairs.

The FDA guidance document on minimum manipulation is located at:
www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/cellularandgenetherapy/ucm427692.htm

Adipose Tissue Processing Draft Guidance

The FDA draft guidance document titled, ‘Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations; Draft Guidance’ indicates that stromal vascular cells (SVF) isolated from adipose tissue are considered to be drugs. The guidance document identifies the process of recovering SVF from adipose tissue as being a regulated drug product. The guidance document identifies SVF as a drug product, under any scenario, when it outlines the example of, ‘adipose tissue is recovered by tumescent liposuction. The adipose tissue undergoes processing or manipulation (e.g., enzymatic digestion, mechanical disruption, etc.) to isolate cellular components, commonly referred to as stromal vascular fraction, which is considered a potential source of adipose-derived stromal/stem cells for clinical therapeutic uses. This processing breaks down and eliminates the structural components that function to provide cushioning and support, thereby altering the original relevant characteristics of the HCT/P relating to its utility for reconstruction, repair, or replacement. Therefore, based on the definition of minimal manipulation for structural tissue, this processing would generally be considered more than minimal manipulation.’ Therefore, it is clear that the process of isolating SVF from adipose tissue creates a drug product that will be regulated by FDA, regardless of how the SVF is obtained. “If there was any doubt about the processing of SVF from adipose tissue being beyond minimum manipulation and such SVF products being regulated as a drug, this guidance documents makes it abundantly clear, regardless of the mechanisms to obtain such SVF. This guidance document makes it clear that it is the SVF that is the drug product, and the focus of this determination is based on the SVF product and not the mechanisms by which the SVF was obtained or processed. This view by FDA removes any ambiguity around the question of SVF being a drug and now directs industry and clinicians alike to obtain FDA approval prior to using all and any forms of SVF on humans,” stated Kenneth Kleinhenz, Vice President of Global Regulatory Affairs.

The draft guidance document is located at: www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/tissue/ucm427795.htm


Contact:
Shawn Richardson
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1.858.875.5279


At least in the US- Cytori has a bit of a monopoly position since only Celution has the designation for a device to my knowledge. But it will take time to get to market i.e. 2017 seems right for scleroderma based on the 90 patients pivotal to come.

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Investor Relations News & a POV from Leeza R. 02 Feb 2015 14:34 #3298

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What are you thoughts around the PS line in Leeza's post below. What do they use at CosmeticSurg?

"May the best device maker win.....p.s. Cytori is not the only game in town :)"


5874-

No Celution is not the only game in town - they are about 10 different extraction devices on the market. Some sophisticated, most not or semi-automated.

Leeza is the wife of Ricardo Rodriguez, Cosmetic surgeon (and orthopedic I believe), scientist, President of the ICMS. Both are "soul sisters of mine" i.e. we agree on a lot of things. At CosmeticSurg, I believe they used a manual procedure in the past and Ricardo asked the FDA in 2009 whether what he was doing (same day procedures in the cosmetic field with super charged grafts) was an "unregulated product".

After waiting 2,5 years for an answer- he got one from the FDA- saying his procedure constitutes making a "Drug" of BLA. :whistle:

Celution will be the winner in the pure therapeutic fields, but in soft tissue, you bet they will not use Celution or expensive disposables. Take my word for it. :puke:

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Investor Relations News & a POV from Leeza R. 02 Feb 2015 14:41 #3299

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Thanks Fas. I wasn't aware of the history of CosmeticSurg - great to have some additional info.

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Investor Relations News & a POV from Leeza R. 02 Feb 2015 16:38 #3302

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Fas,

"Celution will be the winner in the pure therapeutic fields, but in soft tissue, you bet they will not use Celution or expensive disposables. Take my word for it"

I can understand your claim considering the widespread use of liposuction in cosmetic surgery, But they still have to separate the stem cells from the "gimish" as you refer to it? Is that not a difficult and time consuming process? Or can a centrifuge or other tool do the job in a timely and efficient matter? I have always worried about that aspect of adipose derived stem cells? Basically defining the value propostion of the Celution System and the claims of Cytori that the product is more than just a "glorified centrifuge".

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Investor Relations News & a POV from Leeza R. 03 Feb 2015 03:49 #3303

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Fatboy-

Let me say, that going forward, manual procedures in separating SVF from fatty tissue will be uneconomical, whatever way you look at it- at least if the number of procedures increase by a significant margin as compared to today. And I believe that will happen in all kind of different applications.

Now- getting a really pure and specialized SVF brew for general surgery or IV treatment Celution stands out a mile- see the article written by Alexey- Comparison of devices.

With soft tissue- not only mine, but also the view of experts like Ricardo Rodriguez, Okyanos and many others is, that the "precision" of Celution , is not required for fat grafts.

See the article of devices available: Devices available on market.

The Lipogems or GID devices do a simple and good job, getting enough relevant cell types, like endothelial cells into their mix to do the job of inducing angiogenesis in the fat structure to maintain the fat tissue.

Even the SUI trial in Moscow used the Puregraft system instead of Celution, which the had available too... :whistle:

Russian SUI study

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Investor Relations News & a POV from Leeza R. 03 Feb 2015 04:41 #3304

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There are other niches to fill ! :grin: :evil:

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Investor Relations News & a POV from Leeza R. 03 Feb 2015 06:54 #3306

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There are other niches to fill !


Totally disagree Hedge- long term, there are heaps of unmet medical needs to tackle and the chance of this actually happening sometimes into the future has increased tremendously in your own backyard.

This legislation is of extreme importance- even more than the development of the XCT-2. :vegas:

Lets say Cytori started developing Celution in earnest in 2002 after the acquisition of StemSource. Ever since than the regulatory pathway was a mess......

I am sure you remember



I wrote my long article on the Celution drama which documented the regulatory struggle (will put it here on the site too today I think) and Centeno commented that this was all facts from his view.

Mind you - what I wrote above with Ricardo Rodriguez submitting a formal request for designation or ‘RFD’ from the Office of Combination Products at FDA for his cosmetic procedure, Chris Centeno did the same for his orthopedic procedure with fat cells.

Of course he got the same answer late 2011 from CBER as Ricardo. Later in 2013 Centeno lost his case with the FDA as could be expected and he did comment that Companies like Cytori would surely benefit from clear rules and regulations. :yep:


That time has come finally- we waited - or had to wait for almost 13 years, but the "fat years" are now bound to come assuming this outfit survives the next two years.....

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Investor Relations News & a POV from Leeza R. 03 Feb 2015 09:19 #3307

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Fas...if you are going to post ***assuming this outfit survives the next two years*** Then I don't think you can "totally" disagree with me because we need those niches before we can ever hope for something to go mainstream. Therefore its still "show me" time imho !

Also of note...the video you posted has a CEO that is out, talking about cardiac, a indication that has had development halted by the company leaving a nich player such as Okyanos to fill the space for now. Yet to be seen what Japan Lorem or the EU can do for this indication...let alone daring again to dream of a partner.

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Investor Relations News & a POV from Leeza R. 04 Feb 2015 10:06 #3315

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Also of note...the video you posted has a CEO that is out, talking about cardiac, a indication that has had development halted by the company leaving a nich player such as Okyanos to fill the space for now. Yet to be seen what Japan Lorem or the EU can do for this indication...let alone daring again to dream of a partner.


Yes- I know that. My thinking is that Daiichi Sankyo in the end balked at the limited data points available. However more should be there now- although Hedrick is hiding it as usual...this is NOT my slide, but a CYTORI slide



We know "cardiovascular" does not have to mean cardiac. More "organ-like" as defined in the Lorem contract. But advanced, hidden for us, but possibly not for a potential suitor. :whistle: :evil:

Anyway- with the regulatory pathway now clear what it was NOT for the past 12 years in the USA, suitors might develop interest again.
Maybe we need some "enforcement" of the regulation on the likes of Cell Surgical Network, who have been crossing the line substantially etc, but I think the signal is on "green" again. The FDA and CBER finally have been providing clarity. :nice:

Mind you- Striker, Zimmer, Medtronic or Baxter might have some interest in the ortho game in the end also, under these conditions.... :whistle: :yep:
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Investor Relations News & a POV from Leeza R. 04 Feb 2015 10:29 #3317

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I didn't get this either and I have always been on the list. Was it just an email or a page on the website?

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Investor Relations News & a POV from Leeza R. 04 Feb 2015 10:40 #3318

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WST-

In the past Cytori presenters at conferences have shown some interesting slides, although they never had time to elaborate on these type of slides during their speeches. I ALWAYS comb thru the slides at Slideshare to see if anything is there what I have not seen. :grin:

One often finds interesting stuff- :vegas:

This one is from an August 2013 presentation.

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Investor Relations News & a POV from Leeza R. 04 Feb 2015 10:52 #3319

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Fas,

"Let me say, that going forward, manual procedures in separating SVF from fatty tissue will be uneconomical, whatever way you look at it- at least if the number of procedures increase by a significant margin as compared to today. And I believe that will happen in all kind of different applications....

With soft tissue- not only mine, but also the view of experts like Ricardo Rodriguez, Okyanos and many others is, that the "precision" of Celution , is not required for fat grafts."

Fas, trying to clarify the issues here.

1)First issue, manual procedures whether economical or not can no longer be done according to the new FDA guidelines assuming the rules are enforced.
2) Whether soft tissue requires a lower level of precision is irrelevant will be irrelevant in the U.S. Again, assuming FDA enforcement, only an FDA approved device can be used to extract SVF or ADRCs.
3)No competitor will be getting 510(k) clearance for the extraction of SVF so the U.S. is closed off (once again assuming FDA cracks down)unless a big investment (both time and money) is made for FDA approval.
4)THIS IS THE KEY QUESTION THAT I DON"T KNOW THE ANSWER TO:
Once Cytori gets its first approval on any indication, be it thermal burn or scleroderma,
>WILL OFF LABEL USE BE ALLOWED? If so the table top, low cost version of the Celution will be the first mover for all applications in the U.S. including fat transfer (although I'm not clear how lipogems fit into the new rules.)

Your thoughts?

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Investor Relations News & a POV from Leeza R. 04 Feb 2015 10:53 #3320

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*** Mind you- Striker, Zimmer, Medtronic or Baxter might have some interest in the ortho game in the end also, under these conditions***

Really ?
I would think the opposite !
Either increases cost or delays usage of their main product.
Also remember the apparent balking of lipo for the Swiss bone study that was given up on.
If we have learned anything is that Cytori is still very early in the game....these slides they post mean next to nothing as a handful of patients has not been able to generate partnerships. Scleroderma is our first real shot at meaningful and that is sometime away let alone it has to be licensed...a reverse partnership if you will. :evil: Otherwise, Cytori has to "show me' and not with talk.

Now that the slide show is over....what does the next raise do to the market cap and PPS ?
Still waiting for what is going to ward off the reverse split as well !
So far, trading volume again at a crawl today.

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Investor Relations News & a POV from Leeza R. 04 Feb 2015 10:54 #3321

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:grin:

Actually it is slide 10 of the Annual Shareholders meeting 2013 :bash:

File Attachment:

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File Size: 847 KB
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Investor Relations News & a POV from Leeza R. 04 Feb 2015 10:57 #3322

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WST...are you suggesting puregraft is toast ?

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Investor Relations News & a POV from Leeza R. 04 Feb 2015 11:15 #3323

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1)First issue, manual procedures whether economical or not can no longer be done according to the new FDA guidelines assuming the rules are enforced.
True- Cytori should still have a patent on manual extraction also. But I believe this relates to extraction of SVF for supercharged grafts only.

2) Whether soft tissue requires a lower level of precision is irrelevant will be irrelevant in the U.S. Again, assuming FDA enforcement, only an FDA approved device can be used to extract SVF or ADRCs.
No- I do not think it is irrelevant. Puregraft has a 510k. And it really only rinses and washes with Ringers solution. There will be plenty of devices suitable for soft tissue that do not involve enzymatic digestion and work for soft tissue procedures.

3)No competitor will be getting 510(k) clearance for the extraction of SVF so the U.S. is closed off (once again assuming FDA cracks down)unless a big investment (both time and money) is made for FDA approval.
Agreed. That is absolutely off the table.

4)THIS IS THE KEY QUESTION THAT I DON"T KNOW THE ANSWER TO:
Once Cytori gets its first approval on any indication, be it thermal burn or scleroderma,
>WILL OFF LABEL USE BE ALLOWED? If so the table top, low cost version of the Celution will be the first mover for all applications in the U.S. including fat transfer (although I'm not clear how lipogems fit into the new rules.)

My understanding was that the FDA was cracking down on off-label use also, like with InFuse of Medtronic, which was only indicated for spine, but was also used in legs and shoulders etc. With medication and drugs, its hard to control off-label use with all the practitioners in medicine and so many different judgments, but with surgeons that should be possible, is my opinion- although some abuse is always possible.

I do not know where to place Lipogems either.. more soft tissue (510k like) but smelling a bit like a Class III device too. :whistle:

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Investor Relations News & a POV from Leeza R. 04 Feb 2015 11:25 #3324

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Really ?
I would think the opposite !
Either increases cost or delays usage of their main product.


I said "might", but was also inspired by an article that I read yesterday written by Chris Centeno.

There is mounting evidence that all those invasive surgical interventions which made the mentioned companies big and rich, have little efficacy i.e. make patients be "worse off".

Any of those tackling regen med will beat the others that dont- would be my guess.... :whistle:

Centeno on an article in the British Medical Journal

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Investor Relations News & a POV from Leeza R. 04 Feb 2015 11:43 #3326

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I am glad you posted the reference article Fas because now I see where you are coming from. When you listed those medical device companies I was thinking the hardware that goes into full knee or hip replacement which indeed has helped people that I know personally...especially the knee replacement. Could it have been put off with ADRC's...unknown.

***It’s hard for patients to believe that procedures like meniscus surgery or arthroscopic surgery to “clean up” a knee have been shown to be ineffective.***
This line in particular caught my interest as I know someone who was told this exact same thing from their doctor.. Bad knees, too young and not ready to accept surgery, but instructed to avoid the "clean-up" type surgeries as they do little if anything positive and could perhaps worsen a issue.

Above said...still would seem strange that if ADRC's have a real and measurable positive impact they would want to promote a procedure that delays their bread and butter products of replacement hardware.

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Investor Relations News & a POV from Leeza R. 04 Feb 2015 11:58 #3327

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I am glad you posted the reference article Fas because now I see where you are coming from. When you listed those medical device companies I was thinking the hardware that goes into full knee or hip replacement which indeed has helped people that I know personally...especially the knee replacement. Could it have been put off with ADRC's...unknown.


Hedge- make sure to get to know what Centeno writes- also on side effects of Celebrex and other NSAIDs (ignore his opinion of fat cells... :grin: - is competitive to his business) and you will agree that regen med the "Cytori way" MUST have a future in orthopedics and as per our former slide- we must also have some data to prove it, which Hedrick is ALSO keeping secret. :winky:


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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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