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The Biological Goldmine Confirmed

Written by  Fas Kuiters

On January 8 2013 our beloved CEO Chris Calhoun made his "usual (?)" presentation at the Biotech Showcase conference in San Francisco. "Usual" since one could read afterwards from expert investors, that they did not hear anything new or special after listening to the webcast of the conference. To me this presentation- and primarily the Q&A session AFTER the presentation were of absolutely HIGHEST interest.

Basically Calhoun (finally) confirmed what I have been writing on this investors page now for 3-4 years and confirmed the BIOLOGICAL GOLDMINE that Cytori -its investors-and its non-executing management is sitting on!!! 

Let me explain (again). But first, understanding the remainder of this article would be a bit easier if you simply re-visit the spoken word for about the last 11 minutes, which includes for the more short-term oriented financial investor 4 minutes of explanation on the progress in revenue growth in the 4th quarter 2012 and what Calhoun describes as a "Step shift in Revenue going forward in 2013, which together with expense reimbursement from BARDA should result in a considerable cash burn reduction". The 11 minute audio therefore you will find first. From the presentation slides I would like to draw your pipeline-chartattention to one slide, which also (finally) confirmed what I have been writing for years and that is, that some of the UNDISCLOSED third party clinical investigations- i.e. the famous 40 plus translational investigations ARE CLOSER TO MARKET REIMBURSEMENT than Cytori´s own breast reconstruction application, if the image on the left tells the truth!!! (which I am sure it does)

 

Now isnt that something? Surprised? 

Not for me- the IR policy of Cytori has been desastrous for years and will continue to be so until the partner deals, which are supposed to be still on the table are "in the bag"- and I do expect some to close for exactly that reason- the apps are already DEVELOPED in

some parts of the world and ready for prime-time. 

NICE-but much more relevance from a future development perspective were Calhoun´s statements in the Q&A session.


He answered (good) questions from the audience about regulatory issues, cell population and mechanisms, cell manipulation and programming and lastly, but most important- aging of ADRCs. These topics I have discussed on this page for several years, but besides the regulatory issues, were NEVER really expressed clearly by a leading Cytori representative. Even if those statements came from Calhoun, who has zero credibility left- the statements were extremely important, because they obviously come from "the scientific base" of Cytori and CC is just "echoing" their bts12 logoresults, which surely must have been the basis of Dean´s 10XWD. CC is more responsible for investor "expectations" in which he simply has done a lousy job. But going down the REVERSE order of those Q&A questions. 

Aging of Cells from Adipose.

Or better- the acceptance by CC&Co that ADRCs dont age or hardly do age, was absolutely new. Of course to protect from material impact to the banking business of which Cytori always have been wanting to pick-up a piece. Well- there never was a business, despite the announcement in 2007 of 250 banks to be sold in Japan alone by 2012. Believe me- the best storage facility is your own belly and ADRCs are un-matched from a quality perspective to other stem cell sources, especially for elder folks. Calhoun´s statement- The ideal cell for the aging population- I believe to be absolutely correct and storing fat or cells make sense only for cosmetic surgeons, where you do a lipo for other reasons than cells anyway. 

Programming fresh cells for optimal therapeutic efficacy.


Probably even more important than the "aging issue" is the fact that the therapeutic performance of the fresh cells can be improved by a short exposure (10-15 minutes) to a growth factor, small molecule compound or other means before administration to the patient. CC indicated that scientists at Cytori already discovered in the pre-clinical setting a 400% improvement (against present conditions, I presume) of blood flow. This is also what I have been writing about for ages- Eckhardt precise-bloodflowAlt and Kai Pinkernell already wrote about that in 2006 for the cardiac indication (VGEF growth factor exposure for blood flow AND the myocardium i.e transdifferentiation into cardiomyocytes) and Marco Helder uses BMP-2 as stimulator for bone growth. CC mentioned Vitamin D himself for that purpose, which is certainly not unknown either. Of course- doing "more manipulation" changes the regulatory pathway, but KEY here is that is right up the alleyway of BIG PHARMA. You can patent the process of CELLS WITH AN ADDITIVE and have a protected monopoly for a long time. Just ask yourself the question- if I as a large pharmaceutical Company see a STAIR STEP improvement in EFFICACY in apps for unmet needs, which wipes out any pill-competition. Wouldnt you start clinical trials ASAP? Than- how many of the 40 plus investigator trials are doing "fresh cells plus additives" do you think????? Definitely something to think about-

just think of what a 400% blood flow improvement would do to a PRECISE patient- right- not status quo holding and keeping from sliding into heart failure, but re-modeling of the heart- see picture. Cool

 

Composition of the Celution Cell Population for therapeutic Dosing 

Maybe not so interesting for most of you, but personally very "stimulating" for myself and my conviction of the versatility and capabilities of the GIMISH in respect of other mechanisms than just angionesis or blood flow, was CC´s discussion on the composition of the Celution output. He (and therefore Cytori IR) is "swinging" more to the immune-modulation and anti-inflammatory virtues of the gimish, which I described in detail in my HARDCORE article. Actually in the past year I have read so many scientific papers, which have confirmed my viewshardcore on this issue, which probably means that a HARDCORE II is not far away in the future. I also strongly believe that the immune-modulation virtues will be the driving force for Astellas to work with Cytori. Transplantation is the core business of Astellas and ADRCs are very potent in respect of helping to protect immune response directed issues with organ transplants. This will be core ahead of liver.

 

Finally- Regulatory Pathway- FDA and DEVICE business model.

In view of the complexity of the device regulatory pathway- which I am very familiar with and have discussed many times- many investors still do not grasp its gory details. Therefore it was good for most folks to hear it confirmed again- that the relation with the FDA and particularly CBER, appears to be very good (thanks to Dean and Thompson probably- since that wasnt the case- lets say 3 years ago). Key to know is simple- Device PMA means 2 stages- pilot and pivotal compared to IND, three stages plus clinics which tend to be much smaller in size. But readers from this page know that already for ages too.

 

deanTO CONCLUDE

Yes- I believe 2013 will be Cytori year- all we need is execution by management and EXECUTION by Lloyd Dean (picture) to make the changes, he NEEDS to make from a corporate governance perspective. Lets cross our fingers.

 

 

 

 

 

 

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  • Global Healthcare and Cytori

    On August 8 2013 Cytori reported its results on Q2 and held its usual Conference Call to discuss business developments. Some folks stamped it as being the worst call made since 7 years and the ensuing market reaction the next day more or less confirmed that view. I would not deny that or try to argue otherwise. It probably was the worst call for a very long time, but on the other hand it provided also a lot of clarity, which surely was difficult to discover, for which reason this article. Lets start with this- the most important statement:

    "We're creating an autologous point-of-care system. We're not manipulating cells. The business model really works. It's affordable. These aren't $xxx,000 therapies. They're a few thousand dollars to maybe ,000 or ,000 for vascular, very affordable" continued

People in this conversation

    • Guest - rsc

      Your article/comments are excellent, as your usual work consistently is. First and foremost thank you for your dedication and your willingness to share with us over the years. Before I read your article, early this morning (1.9.2013) I listened to the January 8th, 2013 presentation and found too the Q&A fascinating and insightful. It addressed areas that I had never heard before (I have been long w 6 digits number of shares for approximately 4 years). After I hear the comments in the Q&A I felt as strong and as good about the future of Cytori as I have since owning Cytori shares. Thank you again.

      0Like
    • Guest - niorthe

      Thanks Fas for the article. In the last few days, I have increased my number of CYTX shares by 15%. In the past, i was waiting for some kind of positive trend/hype on the yahoo message board before buying (i.e. resulting in "overpaying" some shares), now when the yahoo message board is dead (this is the case now), this is when I am buying. A few well rounded investors assessed the BARDA deal at 4$ per share. If you discount it for the secondary i believe that the current share price is a good deal. Regarding the recent conference in San Francisco, i believe that CYTX will not meet their revenue target for FY 2012 due to cut-off issues (products shipped but revenue can not be recognized yet; same deal as Q3) but i believe that if you do not look at the revenue but at the shipments, they will exceed the FY 2012 target. The key will be the shipments, not the revenues, and I believe that the shipments will evidence that activity is picking up. During the conference, I believe that CC used the word "incubation" to qualify the situation on the potential partnership(s) side. I interpret this word as a set back versus the "contract phase" expression used previously. Wait and see and accumulating at a depressed and depressing levels, Yves

      0Like

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