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TOPIC: Cugat presents 12 months ACL data

Cugat presents 12 months ACL data 08 Jun 2016 06:51 #7184

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It has been rather quiet around Ramon Cugat- but he is still going strong apparently...

Jun 08, 2016
SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today Dr. Ramón Cugat MD, Ph.D. will present 12-month follow-up results from a 20-patient, single arm, open label pilot study on the use of Cytori Cell Therapy in anterior cruciate ligament (ACL) reconstruction. The presentation is titled ‘Biological Augmentation of ACL Reconstruction’ and will be made to The Orthobiologic Institute (TOBI) 7th Annual PRP and Regenerative Medicine Symposium in Las Vegas on June 10, 2016.
Patients in the study had sports-related injuries leading to complete rupture of their ACL, a relatively common sports injury that can impact the long-term careers of professional athletes as well as the ability of non-professional athletes to participate in active lifestyles. All patients in the study received Cytori Cell Therapy as an adjunct to bone-patellar tendon-bone grafting to reconstruct the ACL. Data to be presented include safety, feasibility, patient-reported outcomes related to activity levels and pain as well as serial magnetic resonance imaging (MRI) of the knee through one year. Data have been compared to a historical control group of similar patients treated at the same center by the same surgical team using the same procedure without supplementation with Cytori Cell Therapy.
Dr. Ramón Cugat is internationally-recognized for his expertise in orthopedics, sports medicine and the treatment of orthopedic trauma in elite soccer players. He is currently President of the Medical Council at the Catalan Mutual Insurance of Football under the Royal Spanish Football Federation and a recent inductee as a full academician into the Royal European Academy of Doctors. In addition, he is currentlyCo-Director of the Department of Orthopaedic Surgery and Traumatology at the Hospital Quiron in Barcelona, Spain and on the faculty of the Department of Surgery and Regenerative Medicine at the Universidad CEU Cardenal Herrera in Valencia, Spain. He has published more than 100 papers and multiple book chapters.

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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:

Cugat presents 12 months ACL data 08 Jun 2016 12:17 #7189

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Dr Cugat will travel 5,600 miles to present the 12 month results on his ACL study. We should expect good results, but tempered by the usual choice of words such as "may" or "perhaps". Although we did get a "remarkable" out of Dr. Martha Haahr!

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Cugat presents 12 months ACL data 08 Jun 2016 21:40 #7191

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Dr Cugat could very well bring data to the table that will have a significant impact on the market's perception of the efficacy of ADRC. As per the announcement:

"Data to be presented include safety, feasibility, patient-reported outcomes related to activity levels and pain as well as serial magnetic resonance imaging (MRI) of the knee through one year."

MRI data over the course of a year compared to standard of care is very significant. If it shows a visual correlation/response that is commensurate with a positive response in the other outcomes vis a vis SOC, one would wonder whether there may not be a similar response in the OA trial being conducted by Cytori?

Dov, the "remarkable" Erectile Dysfunction indication is very interesting and has gone totally unnoticed. What is also of great interest is the statement by Dr Haahr : "We are already planning a double-blind randomized follow-up study.”

ADRC are being tested in a huge number of indications many of which could be life changing for both patients and us as investors. I would hope that after the rights issue the investigator led trials will receive greater visibility from the company..

When the first data from the French investigator led trial for a small number of scleroderma patients was published I immediately saw that it was low hanging fruit, and said as much on this message board vociferously . The other indication which bedevils me is the cryptoglandula fistula and fistula in general indications. A huge medical need for which we have a treatment. Why the delay?????

In all honesty we should not be in this situation. This platform can revolutionize the treatment of a multitude of indications.

Many suggest that we will need to go back to the markets for capital due to the to the 48 week analysis of the scleroderma (STAR) trial data and subsequent submission to the FDA with the commensurate wait. I would point out that the primary indication is the 24 week Cochin score with key secondary indications being 1. Raynaud's Condition Score and 2. Scleroderma Health Assessment Questionnaire (SHAQ), both are 24 week data sets. This data will be available a lot SOONER than 48 weeks. If it tracks like the previous trials the probability of success rises geometrically ......... and so do the suitors.
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Cugat presents 12 months ACL data 09 Jun 2016 09:09 #7193

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For me, it's all about MRI in terms of efficacity !!!
Let's hope an image will tell more than a thousand words....as usual :grin:

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Cugat presents 12 months ACL data 09 Jun 2016 11:03 #7196

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****In all honesty we should not be in this situation.****
You are correct rongside...but we all know the missteps and some of us tried to point them out as we went along. The key was limiting exposure during the EXTREME Bozo years !

The erectile dysfunction indication doesn't get me pumped up at all....you might as well be pumping cardiac again. Too far away to have any impact on value.
As I said some time ago only scleroderma and OA matter (imho) and right now OA is hanging by a ligament.
This means scleroderma has a lot of heavy lifting to do the next few years. If real cash from the EU starts to roll in as we wait for the US trial result then we may get some PPS stability. Its a big "if" no matter what Hedrick says and obviously some are betting against it. Debt remains the biggest threat ! Ca-Ca-CALHOUN !!!!

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Cugat presents 12 months ACL data 09 Jun 2016 19:11 #7201

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Hedge, I wish that I had traded CYTX instead of constantly averaging in for what has been an investment that is currently worth considerably less than 10% of my invested capital. Woulda, coulda, shoulda . With hind site everything is simple ......... plus, I should have known better having lived through some other biotech catastrophes in the past. Still, I persevere and take comfort from Kipling's poem "IF" . Big boys don't cry.

www.kiplingsociety.co.uk/poems_if.htm

The reason I highlight the ED study is that they have identified the subgroup that can be CURED by the treatment: men who are not incontinent. Identifying which patients are likely to be treatable is one of the key purposes of phases 1& 2. This has already been done with a 20 person trial and has cost CYTX ...........NIL, NADA, ZERO, TIPOTA (Greek).

The researchers are already planning a double blind randomized study which will probably cost CYTX ......NIL, NADA, ZERO, TIPOTA.

How long will such a trial take to enrol? I don't know but I think it compares more closely to scleroderma rather than CHF.

If by some chance we get approval for scleroderma and the proof of concept ie. "ADRC work to repair the body" is validated how do you think the market will value the Celution device for the incontinence indication going forward? :winky: I get a hard on just thinking about it....... spontaneity is very important in sex .........one time injection instead of ... hey darling should I take a pill.? :bash:

How many other investigator led trials are there ongoing? :winky:

The FDA is not about "method of action". Admittedly it is great to have a deep and comprehensive understanding of how and why a drug works but it is not the major determinant for approval.
The FDA is about EFFICACY and SAFETY. One approval is all I want............ I know what follows after that . :vegas:

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Cugat presents 12 months ACL data 13 Jun 2016 06:17 #7218

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No press release?

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Cugat presents 12 months ACL data 22 Jun 2016 04:26 #7281

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rongside wrote: Dr Cugat could very well bring data to the table that will have a significant impact on the market's perception of the efficacy of ADRC. As per the announcement:

"Data to be presented include safety, feasibility, patient-reported outcomes related to activity levels and pain as well as serial magnetic resonance imaging (MRI) of the knee through one year."

MRI data over the course of a year compared to standard of care is very significant. If it shows a visual correlation/response that is commensurate with a positive response in the other outcomes vis a vis SOC, one would wonder whether there may not be a similar response in the OA trial being conducted by Cytori?


I would absolutely agree, that outcomes would be indicative of the future potential of the technology, which we now see confirmed already in various ortho patients at Okyanos with wonderful outcomes for the patients.

I simply cannot believe Hedrick et al would simply "ignore" this data presentation like they did with the ADVANCE data, which I believe were extremely important too.

Do remember- Celactive was first to be marketing "the Cugat technology", before cardiac received focus again. The scleroderma results and the French pig study in urethral fibrosis will be the katalysators for katapulting Cytori in the hands of Astellas and others I believe and OA and Cugat the same with an US ortho player.

The key being- finally we will have clinical results.... :grin:

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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:

Cugat presents 12 months ACL data 22 Jun 2016 13:30 #7291

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Hedrick told me there will be an abstract published in 4 to 6 weeks after the meeting so roughly a month from now. The data belongs to Dr. Cugat not Cytori.

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Cugat presents 12 months ACL data 23 Jun 2016 07:20 #7296

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DOV wrote: Hedrick told me there will be an abstract published in 4 to 6 weeks after the meeting so roughly a month from now. The data belongs to Dr. Cugat not Cytori.


Thanks DOV - that makes sense. It makes the announcement of the presentation however, a pretty superfluous piece of information. Not surprising with the chaotic management - including announcements, with the 24 weeks OA data as the summon of incompetent news delivery. :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:

Cugat presents 12 months ACL data 23 Jun 2016 07:33 #7298

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At the time they were desperate for any snippet of news to hold the PPS and get the rights offering done.

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Cugat presents 12 months ACL data 23 Jun 2016 07:35 #7299

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Forgot to add...shouldn't CC company be called Cel(in)active. since they keep pumping claims of where they are going and do nothing.
The ever changing strategies of CC

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Cugat presents 12 months ACL data 23 Jun 2016 17:24 #7303

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The findings of Dr Cugat's 12 month study were very good - data to follow! This will be just another data set proving the cells work. Cytori would not fund a clinical trial for this indication because this type of trial is expensive and the returns are not as high as other low hanging fruit (and there is no extra money). The fact that one of the world's most famous and influential orthopedic surgeons in sports medicine (especially soccer) is this interested in the Cytori cell therapy is what is interesting. This is how procedures become "standard of care." KOLs basically spread the word with their peer reviewed data through medical journals and meetings. The medical community pushes for reimbursement because the procedure should be covered simply because it is very beneficial to the patient.

I am adding ACL as a therapy along with (aesthetics, OA, IBD) under the general therapies category, but I am not going to change the numbers in any of the years covered by the spreadsheet. Numerically, it is a non event for now, but I think Dr. Cugat's work creates awareness about stem cell therapies and that is good for the entire industry.

The same type of exposure should come out of the fistula studies and the ED studies.
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Cugat presents 12 months ACL data 24 Jun 2016 06:56 #7306

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DOV wrote: The findings of Dr Cugat's 12 month study were very good - data to follow! This will be just another data set proving the cells work. Cytori would not fund a clinical trial for this indication because this type of trial is expensive and the returns are not as high as other low hanging fruit (and there is no extra money). The fact that one of the world's most famous and influential orthopedic surgeons in sports medicine (especially soccer) is this interested in the Cytori cell therapy is what is interesting. This is how procedures become "standard of care." KOLs basically spread the word with their peer reviewed data through medical journals and meetings. The medical community pushes for reimbursement because the procedure should be covered simply because it is very beneficial to the patient.

I am adding ACL as a therapy along with (aesthetics, OA, IBD) under the general therapies category, but I am not going to change the numbers in any of the years covered by the spreadsheet. Numerically, it is a non event for now, but I think Dr. Cugat's work creates awareness about stem cell therapies and that is good for the entire industry.

The same type of exposure should come out of the fistula studies and the ED studies.


I spent half an hour - a few weeks ago- on flipping through the presentations and abstracts of the Las Vegas conference. What I recall is that 99% of the studies presented related to PRP procedures, which the FDA in its great wisdom announced to be a 361 cellular product i.e. was one of the few exceptions together with the fertilization of women procedure, which were NOT to be regulated. The above (that only PRP abstracts were presented) is logical since that was what the Conference was all about- The Orthobiologic Institute (TOBI) 7th Annual PRP and Regenerative Medicine Symposium.
The real question therefore which need to be answered is to what extent Cytori Cell Therapy is superior- also related to treatment cost- as the market for "free" development (without regulatory FDA costs) of these Platelet-Rich-Plasma therapies, Arthrex located in Naples Florida, captured a big piece of the PRP market pie and is also well positioned. Surely they watched Cugat´s presentation with interest. :whistle:

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Cugat presents 12 months ACL data 24 Jun 2016 07:42 #7307

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Question to Paul-

Could you explain a bit to what extent PRP has found a place in the ortho practices in the US?

And whether ACL is being treated with PRP. I think Purina did Bartolo Colon with a combination of cells and prp.

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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:

Cugat presents 12 months ACL data 24 Jun 2016 09:46 #7308

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Here is a link to the symposium agenda. Seems like a there was an abundance of information presented by the elite scientists in the field.

www.prpseminar.com/tobi-2016/agenda-2/
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Cugat presents 12 months ACL data 24 Jun 2016 13:34 #7309

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thx tesla

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holdi

Cugat presents 12 months ACL data 27 Jun 2016 14:54 #7332

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Interesting presentation: www.tctmd.com/privateAssets/0/114/818912/820562/0d630a68-59c9-4f75-98ed-bbcd48baf070.pdf

It's old news...from 2013. obsolete

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