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TOPIC: Cytori releases Cugat News

Cytori releases Cugat News 24 Mar 2014 08:42 #1439

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Independent Sports Medicine Study Using Cytori Cell Therapy to Treat ACL Injury Underway in Spain

SAN DIEGO, March 24, 2014 – Cytori Therapeutics (NASDAQ: CYTX) today announces the first investigator initiated study evaluating Cytori Cell Therapy as a potential concomitant treatment for Anterior-cruciate ligament (ACL) injury. The study is led by Ramon Cugat, M.D. PhD. Dr. Cugat is President of the Medical Council for the Catalan Soccer Delegation's Health Insurance Company under the Spanish Soccer Federation, President of the Board of Directors of the Council of the Garcia Cugat Foundation for Regenerative Medicine Research, Professor of the Chair of the Garcia Cugat Foundation at CEU Cardenal Herrera University, Director of the Orthopaedic Surgical Department in Hospital Quiron, Barcelona, Spain and Head of Trauma and Orthopaedic Surgery in Mutua Patronal Montañesa.

Dr. Cugat presented at the Football Medicine Strategies for Joint & Ligament Injuries, 23rd International Conference on Sports Rehabilitation and Traumatology on March 22 and commented on an ongoing investigator-initiated, open-label pilot study in Spain in patients undergoing ACL reconstruction for sports-related injuries using Cytori Cell Therapy. “We are encouraged by the clinical data we have observed in our first series of patients treated with Cytori Cell Therapy in conjunction with our ACL reconstruction procedure,” said Dr. Cugat. “We will continue to evaluate more patients and look forward to presenting our final results of this important study in the near future.”

The study is an investigator initiated study to determine the feasibility of using Cytori Cell Therapy on patients undergoing complete ACL reconstruction. The study is approved to treat 20 patients who will be followed by both clinical and imaging end points. Thirteen patients have been treated thus far, full enrollment is expected this year and data is being evaluated on a rolling basis. The study was initiated in 2013 under an approval from the Spain Ministry of Health, Social Services and Equality (Ministerio de Sanidad, Servicios Sociales e Igualdad). It was organized by a multidisciplinary team of researchers at Hospital Quiron. The researchers include Dr. Ramon Cugat, Dr. Josep Maria Serra Renom, Dr. Pedro Álvarez, Dr. Javier Cuscó, Dr. Roberto Seijas, Dr. Montserrat Garcia Balletbó, Dr. Gilbert Steinbacher, Dr. Betina Nishishinya, Dr. Oscar Ares, Dr. Juan José Bofa, Dr. Marta Rius, Dr. Ester Sala, and Dr. Jordi Català.

Internationally, Cytori Cell Therapy has been evaluated in several investigator-initiated pilot studies during the past two years involving professional and amateur athletes with acute and chronic muscle injuries. The goal of these studies is to further the understanding of the potential utility of adipose-derived regenerative cells (ADRCs) in sports and orthopedic conditions.

“We are encouraged by the preliminary data from these pilots and as a result, we have initiated two multi-center registries for related indications in countries where the Celution® System is available for commercial use,” said Christopher J. Calhoun, Cytori’s Chief Executive Officer. “The ACHILLES Registry will collect data from patients with muscle and ligament injuries treated with Cytori Cell Therapy and the RELIEVE Registry will collect data from patients with osteoarthritis. In the United States, the Company has initiated an FDA approved trial, RECOVER, for hamstring injury.”

The annual incidence of Anterior Cruciate Ligament (ACL) reconstruction is more than 250,000 in Europe and the United States. ACL injury is often accompanied with a popping noise and a giving out of the knee, which leads to ongoing pain, swelling, loss of range of motion and joint instability.

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Cytori releases Cugat News 25 Mar 2014 07:49 #1442

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Why do you suppose they released this info when they did? It wasn't when the study started, or when it finished.

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Cytori releases Cugat News 25 Mar 2014 09:53 #1443

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Why do you suppose they released this info when they did? It wasn't when the study started, or when it finished.


Good question.

As a general rule- in view of the regulatory "advance" that Europe has in respect of Cytori Cell Therapy applications development, it always was planned by Cytori (info Calhoun in yours truly ´s ears) to leverage successful apps to the US from there. Mind you- I am sure he was thinking at the time he would have some financial support from partners by that time.

The simple fact that they started preparations for a hamstring clinic in the US - although they are not finished in Europe yet and as usual, do not have any "extra dollar" to spend- means to me that something is up, which drives the "sense of urgency" and prepare shareholders for things to come. i.e. educate them a bit before the event comes.

That event can only be a partner deal in sports medicine which deal has been in the grapevine rumours for a while. :yawn:
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Cytori releases Cugat News 26 Mar 2014 20:23 #1453

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The knee appears to be very much in the news of late. Even bigger than ACL, osteoarthritis is a huge indication being researched by the Europeans using ADRC . They appear to have treated a number of patients already, apparently with success and plan to expand the trial.

This group appears to use autologous ADRC which are centrally processed. Apparently they had problems with some bacterial contamination initially, and the logistics must also be a concern. The Celution device must surely be a superior form of treatment as it does not require a cGMP facility nor the tricky logistics. Once the CYTX sponsored Relief Registry is established one would hope that the comparison with the ADIPOA trial would lead the EU sponsors to adopt the Celution device. I believe that it would simplify and standardise the whole trial in an effective manner. :yep:

wwwold.chu-montpellier.fr/fr/ADIPOA/
wwwold.chu-montpellier.fr/publication/inter_pub/R811/A15530/index.html

cordis.europa.eu/result/brief/rcn/9939_en.html

cordis.europa.eu/result/report/rcn/57529_en.html

Admittedly Celution is not part of this trial, but it is not too difficult to appreciate that it is the only device that can provide treatment to hundreds of thousands if not millions of patients with autologous cells in an efficient, timely and standardised manner .............. Dean is right about 10XWD.............. I can only hope that it will be in my lifetime ..........

Fas, I agree, it would appear that all these independent translational studies are totally ignored by the market. The researchers, even when they have stunning data are not linked to a commercial enterprise (read Cytori) so that the market can become excited about the commercial ramifications of the research. It would appear that as CYTX is not paying for the research "ipso facto" the market believes it cannot benefit from it !!! :bash:

BARDA may well be the catalyst we require to awaken the market to the benefit of the translational research being undertaken by others!!
Hopefully once the US government approves the next stages of the agreement and proceeds to fund the Burn trial the markets will wake up to the fact that ADRC work, and that the government is prepared to pay to see them deployed. Once that happens they will then actively look at and appreciate the value of the translational research being undertaken. :nice:

As regards a deal in sports medicine that is very interesting and God knows I want to see a partnership deal signed ASAP but lets not forget that this treatment does not only treat sports injuries but potentially all the aging senior citizens of the world plus the hordes of baby boomers, both sedentary and active who will be suffering from arthritic knees, ankles, shoulders and backs. Interesting to see how such a deal is structured???? :KO:
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Cytori releases Cugat News 27 Mar 2014 09:46 #1454

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Calhoun did mention the potential for a sports medicine deal potential after the 10 patient trial in the US. We shall see.

rongside: As far as potential market size ...I agree that this can be absolutely HUGE when adding in the osteoarthritis aspect.

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Cytori releases Cugat News 27 Mar 2014 10:41 #1455

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Fas, I agree, it would appear that all these independent translational studies are totally ignored by the market. The researchers, even when they have stunning data are not linked to a commercial enterprise (read Cytori) so that the market can become excited about the commercial ramifications of the research. It would appear that as CYTX is not paying for the research "ipso facto" the market believes it cannot benefit from it !!! BARDA may well be the catalyst we require to awaken the market to the benefit of the translational research being undertaken by others!!


Sigh...you probably are right- the market does not recognize the value of all the translational stuff. Question is though: who is to blame for that- who should educate and teach?

The last 24 hours I have been reading a lot of very very depressing stuff in respect of Cytori and Calhoun in particular- I simply cannot comprehend why CC & Co are acting like they do.. I just do not grasp it without wanting to go in great detail here.

Anyway- my simple logic is -yes BARDA will involve 100 Mio of research money not to be paid by Cytori- but on the other hand is still 4-5 years away. Question - whats the value of all the translational work- somewhere between 500 Mio and 1 Billion maybe????

And how far away to market????????????????????????????



More than 100 patients with Fistula treated- good results- CC told me approx. 70% healing- this was approved 4 years ago-

WHY IS THIS NOT BEING MARKETED AND WHY DOES IT NOT HAVE REIMBURSEMENT?????????????

We both have 10-15 more examples like that....it is beyond my comprehension... :bash: :KO: :bash:
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Cytori releases Cugat News 27 Mar 2014 11:02 #1456

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*** The last 24 hours I have been reading a lot of very very depressing stuff in respect of Cytori and Calhoun in particular- I simply cannot comprehend why CC & Co are acting like they do.. I just do not grasp it without wanting to go in great detail here***

The bigger question imho is why has he been allowed to stay ?

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Cytori releases Cugat News 27 Mar 2014 12:34 #1457

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The bigger question imho is why has he been allowed to stay ?


Yes- there are no known reasons to deny this, except maybe "disruptive technology".

Even this can hardly be an excuse.. :cry:

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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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