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TOPIC: Cytori Trial Summary

Cytori Trial Summary 16 Dec 2014 20:09 #2920

  • DOV
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I am sending this summary out to my distribution list. Not much new information, but I do feel the pieces of the puzzle are starting to come together. Let's hope the stock price begins to recover in response to the FDA granting Cytori a phase III pivotal trial. For the first time, we can calculate a US approval timetable. That is a major development. Enjoy!


The Star Trial – The most important aspect of this FDA approval is the fact that the FDA recognized the results of the French SCLERADEC-I trial and waived the typical requirement for a Phase I and Phase II trial prior to a Phase III pivotal trial. The STAR Trial will treat 80 patients with the primary end-points being at 6 months and 12 months. After the data is compiled and presented to an FDA panel, it will likely take another year for the FDA to approve the therapy. The trial will be randomized, blinded and placebo controlled with a one to one randomization (40 patients will receive the cells and 40 will receive a placebo). The Cochin hand score will be used to measure effectiveness.

As published, the SCLERADEC-1 trial was an open label trial meaning all 12 patients were treated with the ADRCs isolated and prepared by Cytori’s Celution 800 device. On average, these patients experienced a 50% improvement in hand function at six months. These results are considered to be very promising and encouraging. The 12-month data should be published in the near future. If you are not familiar with scleroderma, I suggest watching this video.



Per the press release, Cytori will engage up to 12 sites for the trial. Dr Kesten acknowledged that some sites will be more active than others, but on average each site will treat seven patients. The procedure will take a little over two hours to perform the liposuction and process the cells from the patient’s body fat. Each finger will receive four injections of ADRCs in a process that takes about 20 minutes. Each patient will be injected with the ADRCs only once, but will be examined at one week, four weeks, twelve weeks, 24 weeks, 36 weeks and 48 weeks.

Those patients receiving the placebo will be permitted to “crossover” and receive the cell injections after all patients have completed their 12 month examination and the trial is complete. An important point is that there are no effective treatments for advanced scleroderma. The drugs used to treat the symptoms can have nasty side effects. Fortunately, scleroderma patients have a very strong support system from the Scleroderma Foundation. A google search will take you to Medifocus Guidebook on Scleroderma. Within this guidebook is a directory of “Centers of Research” within the United States as well as other countries. Because scleroderma is fairly rare, medical expertise is found in these specialty centers.

The company has not released specifics about the trial’s timetable except to say they expect the trial to begin in mid 2015. A reliable source within the company told me they are operating a full speed ahead and that money was not a problem. Putting everything together from all sources, MY timetable would be as follows:

Start date: August 2015
End Date: July 2016
FDA Review: September 2016 to August 2017
Revenue from patient treatments: October 2017

In other words, Cytori should have a $ 500 million available market of scleroderma patients starting in late 2017 based on a single treatment per patient. It is too early to speculate on how fast this patient backlog can be treated and revenue recognized, but this patient population is desperate for treatment options. The FDA is cooperating on a shortened timetable approval and I believe this is incredibly positive. After all these years, Cytori has a well-defined pathway to approval and commercialization in the United States for a single cell therapy using the Celution system.

The ACT-OA Trial – Cytori has received FDA approval to begin a U.S. based trial on patients with knee osteoarthritis. This trial will have up to 15 participating sites. There will be before and after MRI scans of each patient’s knee. The primary end-point will be pain reduction while walking with a secondary “hope” of detecting a measureable regeneration of the cartilage as a result of the differentiation properties in the ADRC mix. The overall goal of the trial is to delay or remove the need for joint replacement surgery. Here is a link to a similar procedure done by Dr Christopher Centeno, who is a real stem cell pioneer and a target of the FDA because trials have not been done according to the FDA’s self imposed authority to govern stem cells as if they are drugs. The main difference in the Regenexx procedure is that they use bone marrow stem cells, which is a much more expensive source of stem cells. In addition, adipose tissue contains 300x more stem cells as does the bone marrow aspirate. There are two videos within this link. The second is best.

www.regenexx.com/the-regenexx-procedures/knee-surgery-alternative/?utm_source=SheinkopREPS&utm_medium=ppc&utm_campaign=sheinkop&gclid=CLXx44WRxsICFaZDMgodg1oAXQ

Through discussions with Cytori employees and outside physicians I have been led to believe companies like Zimmer or Striker are interested in starting biological divisions within their own companies. They are seen more as likely partners than competitors.

The trial procedure will be very similar to the Scleroderma trial in that each patient will undergo a small liposuction with the Celution system processing the cells in about two hours and then a single injection of the cells into the knee. This trial should begin enrolling patients prior to the STAR Trial and should take about the same time to complete. It is important to note that the OA trial is NOT a pivotal trial, but is a phase I/II trial. Therefore, approval to treat patients will come after a larger phase III pivotal trial.


The Athena Trial – Although the company has received FDA approval to re-start the ATHENA trial, a decision has been made to “unblind” the trial and evaluate the six-month results. The last patient treated in the trial completed their six-month testing in November. Dr Kesten said Cytori would have the data scrubbed by February. Based on these results, the company will make decisions about the future of the trial. But, with limited cash resources, it is likely the Athena trial will not commence without a partner to pay the cost to finish the phase II as well as phase III plans. The cost per patient is close to ,000.


The BARDA Trial – Once the government funded research & development has been completed, the company expects Barda to fund a clinical trial on humans with thermal burns. This trial will be conducted at specialty burn wards throughout the country. The trial design is still being determined so there is little to report at this time.

Alopecia – You may recall Cytori sold the PureGraft product line to Bimini for use in cosmetic fat grafting applications. I think you will find this article and web site to be very interesting. I intend to follow the progress of this application very closely. The early results are very encouraging, but more patients need to be treated to prove out the effectiveness. Insurance companies do not reimburse cosmetic applications, but there is no shortage of money being spent on restoring hair growth for men and women.

www.cytx-investor.com/forum/7-its-application-platform/530-hair-growth-with-supercharged-fat-graft

In summary, investors in Cytori have suffered an enormous paper loss over the years and especially in 2014. I find it odd that the stock price would tumble right before the company’s outlook began to improve. The change in management and another change in strategy has caused uncertainty, but for the first time, Cytori has FDA approval for a pivotal trial. In fact, there are four FDA approved trials if you include the BARDA thermal burn trial. The Japanese government has approved a pivotal trial for Stress Urinary Incontinence and new legislation has become law in Japan that puts Cytori’s Celution system in the safest category with the lowest amount of regulation. Okyanos Heart Institute is Cytori’s first customer to begin treating patients for Cardiac Ischemia and a host of other autoimmune diseases. I hear business is very strong and there is a good likelihood Okyanos will purchase close to $4 million in 2015 from Cytori. Lorem Vascular should gain Chinese approval to market the Celution system in 2015, which will trigger an order for $5 million from Cytori. Adding in roughly $12 million in revenue from the BARDA contract and Cytori will likely have revenues of $27 million in 2015 versus about $11 million in 2014. This will not be enough to reach break-even, but the loss should be only $16 million down from $34 million in 2014.

Cytori will need additional funds to complete the Star Trial and the ACT-OA trial. The BARDA trial will be 100% funded by the U.S. Government and the SUI trial will be 100% funded by the Japanese government. I expect more dilutive financing, but I am hopeful that some day a strategic partner will emerge to speed along the approvals and the revenue ramp that would follow. Cytori has huge long-term potential and we can begin to see the pieces of the puzzle coming together. Patience continues to be the word of the day.

NEW ADDITION TO POST: Hedge, I remember Cytori saying the application for Chinese approval would be submitted in December with approval in 2015. I also heard a rumor (which never are true) that KT Lim expects approval to follow in two days after the application. I guess if he has bribed all of the right people that could happen :winky: :really:

Also, I have started to build a financial forecast through 2020 (like John Putnam and Jason Kolbert have done). I will share as an Excel file attachment shortly. I will do this in an attempt to create a "working document" subject to change as news might influence projections. I don't want this to be MY document, but OUR document. Is that something that works for interested posters?
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Cytori Trial Summary 17 Dec 2014 04:30 #2921

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Excellent summation concerning the Scleroderma STAR trial. Lets not forget that more or less concurrently with the US trial we will also have the Scleredac II trial being undertaken in Europe (France). Positive data in both trials may/will provide early reimbursement decisions in Europe also (subject to bureaucracy). :yep:

The implications of a successful treatment for Scleroderma will have VERY positive implications for other autoimmune diseases. Lets hope that the data arising from the patients treated for autoimmune diseases by Okyanos is made available to the relevant regulatory authorities and to CYTX ............ and by extension to us the shareholders.

Unwarranted dilution is/was a manifestation of incompetence. Lets hope that the future funding mix better reflects the potential that this technology has, and the new focus of management !!! Patience is a given, hopefully CYTX will prove to be a thoroughbred and not a nag that ends up in the knackers yard.

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Cytori Trial Summary 17 Dec 2014 10:05 #2924

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Thanks a lot Lewis- really nice summary. :yep:

It came right on time- last night I was thinking about next steps. That always happen to me, when I reach milestones like turning 65 or like yesterday - having been married for 30 years with my adored wife Antje.

Thereby I tend to drink a glass (or two) of my Dornfelder red wine too much and more or less decided to close all my web pages, since also this one is more of a one man show than compared to a platform where folks exchange opinions.

Your post made me change my mind for the time being. So thanks- much appreciated :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 Trial Summary 17 Dec 2014 10:37 #2925

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Dov,
Good to see your post. So what are your expectations financially from Cytori. I would assume $500 per share is out of the question. I would be happy with $5 so i could recoup some of my losses. Can't begin to describe what a disater my investment in Cytori has been and the financial hard ship it has caused. Have you bought at these levels? Not sure why one would with more dilution sure to come and i am not even allowed to mention Cytori in my home.

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Cytori Trial Summary 17 Dec 2014 13:03 #2926

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Hello DOV,

Agree that while we will have reduced expenses...several years of funding still needed !
A change from your last post is you didn't mention a reverse split and 175 million shares guestimate...curious if you still expect these ?
Also noticed the 2015 call for Chinese approval...which if true...would be another miss on a Cytori management timeline as they have even very recently repeated Dec/2014 approval.
On Scleroderma while you approval timeline may prove correct it takes a bit further for insurance adoption..so I am not expecting a immediate ramp late 2017.
If you get the chance correcting the missing data points due to use of a $ would be helpful. I also hope this post breaks the sad trend of bad news shortly following one of your updates :cry:
Since you post rarely...I'll take this opportunity to wish you and your family a safe and Happy Holiday Season !!!!

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Cytori Trial Summary 17 Dec 2014 13:12 #2927

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Happy Birthday! Merry Christmas and a safe, prosperous and joyous New Year.


Lab Rat Wall-e, aka, Mtpinman

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Cytori Trial Summary 17 Dec 2014 14:29 #2928

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Saw this finance.yahoo.com/news/the-worst-ceos-of-2014-191156277.html and was surprised not to see Marc and Chris sharing honors for 2014 as by far they have to top the list..

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Cytori Trial Summary 17 Dec 2014 15:12 #2929

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A lot of numbers here seem truncated. The forum code needs fixing...

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Cytori Trial Summary 17 Dec 2014 15:49 #2930

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Aga-

The existence of the truncated numbers issues are known. Also by the poster, but we do not know its cause- it is assumed its a code issue.

I have looked at the php code of Kunena, the best forum code for Joomla CMS. That is way beyond my capabilities and knowledge. And the culprit seems to be the BB-code which the Kunena team use as a "standard tool" for Kunena..... :really:

If you are in programming (I think you are) - any help is appreciated... :winky:

and $200.000

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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 Trial Summary 17 Dec 2014 16:44 #2932

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I can try to hunt for the particular issue, but perhaps you can consider a different forum system within Joomla, or migrating it to phpbb or something else...

Edit: I see that a lot of your libraries in use are severely outdated... like jquery 1.x which is several years old. Mootools is also a little old.. you have 1.4.5 and latest is 1.5.1... bootstrap too... a lot of old stuff. But that may all just come with the forum software version. Are you upgraded to Kunena 3.0.6?

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Cytori Trial Summary 18 Dec 2014 05:31 #2933

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Aga-

From a software perspective, I always use the latest stuff- so yes Kunena is 3.0.6 and Joomla itself is 3.3.6. The related library tools I leave to the developers of that software. I might install a software that stops unwanted tools from loading- than again my hoster Siteground is so good with their Varnish reverse proxy caching tools, that optimization hardly has impact.

Anyway- I think I found the issue. Kunena requires Mootools to load before Jquery and other stuff and I had a tool running which kind of took priority in determining loading sequences.

So -had nothing to do with code - just loading pages.... :evil: :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:

Cytori Trial Summary 18 Dec 2014 05:35 #2934

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Lewis-

Can you please edit the summary part of your post- delete whats there and copy-paste your draft-


WITHOUT CHANGING ANYTHING!!

I think the $ issue is solved. :nice:

$2.00 $2,15 $215,15 $215.000

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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 Trial Summary 18 Dec 2014 11:11 #2935

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Fas, looks like you fixed the problem. I added a paragraph to my original post.

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Cytori Trial Summary 18 Dec 2014 11:18 #2936

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Hedge, I built in a full year for the FDA to approve the therapy for scleroderma once they have received all of the trial data. Hopefully, they can do it sooner. France may do it sooner as they will be doing trials at the same time. Scleroderma has a strong support group in the Scleroderma Foundation. I would anticipate a strong lobby for insurance reimbursement, but frankly, I have no experience in this area.

Off to get a root canal.

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Cytori Trial Summary 18 Dec 2014 11:35 #2937

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Thanks for the update DOV.

On China approval, Yes I have heard "submitted" and "approval" used for Dec 2014....they seem to use the words interchangeably !

On scleroderma...a 1 year wait for approval is quite normal. I have not heard anything from Cytori about fast tract status. Agree, France should be much further along but they seemed to drag their feet on starting the expansion...so who knows.

Okyanos indication expansion a real plus. I guess we will see if the indication usage numbers gets fleshed out or not.

Root Canal: Ahhhh...but when its over you'll feel much better. Way back when I really thought the gum disease indication for Cytori was interesting...especially when you consider the links of gum disease to cardiac disease. Amazing what a well funded, well run Cytori could have accomplished...sigh !

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Cytori Trial Summary 18 Dec 2014 13:17 #2941

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Also, I have started to build a financial forecast through 2020 (like John Putnam and Jason Kolbert have done). I will share as an Excel file attachment shortly. I will do this in an attempt to create a "working document" subject to change as news might influence projections. I don't want this to be MY document, but OUR document. Is that something that works for interested posters?


Good idea Lewis.

I do recall that I promised myself to never ever get engaged in forecasting for Cytori ever in my life, since I went public with a forecast for 2008, which simply was a more conservative version of a spreadsheet that Brian Gagnon mailed me after the StemSource SC banking deal in 2007.

I just found it again at Investor Village- Msg 34 of 270 at 10/2/2007 1:55:09 PM by sheepshead :evil: :bang: :bash:

Anyway- web technology has improved tremendously since than and Google Sheets offer exactly what might be wanted here- access to a spreadsheet that anybody can change (assuming its saved under a different name) and can be exported to something like this board or web page.

Maybe the time has come to start this all over yes. Marc Hedrick appears totally allergic to commit to any number at this point in time.. so maybe we should help... :grin: :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:

Cytori Trial Summary 18 Dec 2014 14:26 #2943

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Thanks for the fix, Fas.

As far as numbers go, I think the only question is whether this projected $16 million cash burn is enough to cover the perceived value created in the company from the trials. Without immediate profitability from a big partnership deal, Cytori needs to rely on financing. (Let's not call it "dilutive financing" cause that's has a bad connotation... call it investment. :-))

To that end, I am happy to see the level of engagement, with an investor chat this month and another presentation next month... do you guys see the level of engagement from Hedrick with investors as more, compared to when Calhoun was CEO?

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