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TOPIC: Cugat reports ACL 6 month results

Cugat reports ACL 6 month results 21 Nov 2014 09:21 #2752

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SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics, Inc. (NASDAQ: CYTX) today reported positive results from a clinical study of Cytori Cell Therapy™ in anterior cruciate ligament (ACL) reconstruction of patients with ACL tears. The 6 month results from the first 20 patients with combination Cytori Cell Therapy and bone-patellar tendon-bone (BPTB) grafts were presented at the Barcelona Knee Symposium on November 20, 2014.
Dr. Ramon Cugat, co-director of the Orthopedic Institute, Hospital Quiron Barcelona and the lead investigator of the study, performed autologous bone-patellar tendon-bone (BPTB) transplantation to replace damaged ACLs in 20 athletes who had sustained injury. Cytori Cell Therapy utilizing adipose derived regenerative cells (ADRCs™) prepared by the Celution® System from a patient’s own fat was used with the BPTB graft during the transplantation procedure. The cell preparation, injection into the graft and transplantation of the graft were all performed in the same surgical procedure.
“We are extremely encouraged by these results. I have treated thousands of patients with ACL repair and think that Cytori Cell Therapy may have additional benefits over current standard of care. We believe that use of ADRCs processed with Cytori’s Celution System may translate into a more rapid recovery from a potentially career ending sports injury. We are hopeful that this could possibly lead to better quality grafts and improved graft strength,” said Dr. Cugat.
Dr. Cugat discussed the preliminary six month outcomes at the meeting. The procedure was feasible and not associated with safety issues above that seen with a standard small volume liposuction. All patients recovered without any complications. The results were compared to a historical control group of patients who had the same surgical procedure by the same surgical team but without other interventions. Overall, recovery from pain and ability to return to the field appeared to be accelerated as a result of the ADRC enriched BPTB transplant The patient questionnaires and serial magnetic resonance imaging (MRI) scans of the knees following cell therapy were consistent with accelerated healing of the graft.
Dr. Cugat and his team are obtaining one year follow-up information on the treated patients and intend to report and publish these results in the future.
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Cugat reports ACL 6 month results 21 Nov 2014 09:44 #2753

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To bad they couldnt define beyond "accelerated"
What does that mean ? 1 day, 1 week ,1 month ?????
Was the ''appearance" stat sig ?

Another wishy washy release imho with the "appearance" of a positive outcome but no hard numbers in this early trial.

What we DO know is Cytori will not be pursuing further development.

BTW....I believe the tech should work in the indication !

NO SLACK !!!.

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Cugat reports ACL 6 month results 21 Nov 2014 11:06 #2755

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Too bad they couldnt define beyond "accelerated"


Hedge- I am sure they CAN if they have a group which is comparable, but they chose NOT to provide that information.

For those interested in knowledge in respect of the knee and all the agony it can create- this is a good resource: The Knee Guru

It has this description on BPTB -

When the anterior cruciate ligament is ruptured it may be reconstructed using material from the patient himself (an autograft). The most well-known autograft is that of the patellar tendon, the big strong tendon below the kneecap.
The central one third of this tendon can be 'harvested', together with a bone block at each end - the upper block from the patella (kneecap) itself and the lower block from the tibia bone (shin). This harvested tendon is thus 'bone-patellar tendon-bone' in structure.
The bone blocks at each end allow the tendon to be securely anchored once the autograft is threaded through to replace the torn cruciate.
After some years of declaring the B-PT-B the 'gold standard', it became evident that patients often suffered from pain from the donor area, and surgeons started to use hamstrings tendons instead.


If you think about it- all professional sports medicine can benefit of ADRCs. Just think about it- the Oakland A´s lost both AJ Griffin and Jarrod Parker during spring training to Tommy John injury. That is restored with an autograft too. ADRCs just help with the healing process and speed it up and are the natural resources of the body to do that (the pericytes)- again- they get additional help from another part of the body.and Jarrod and AJ could have been ready for 2015 spring training instead of coming back in the summer as is anticipated now, if they would know about this. (or better- their doctor) :whistle: :cool:
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Cugat reports ACL 6 month results 21 Nov 2014 11:53 #2756

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On Ramon Cugat himself.... best to visit his Wikipedia page... CV of Ramon Cugat and be impressed with the VIP names which he has treated already.




On his atroscopiagc,es homepage you can read a lot- has also the Cytori news from today- and is, believe it or not - kept in 10 languages.

Dr. Cugat is on youtube too- here he explains what he does in English ......

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Cugat reports ACL 6 month results 21 Nov 2014 11:53 #2757

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We can change couldnt to wouldnt if you like.

Does change the fact of very limited info on a app we will not be pursuing.

Are these 10 patients enough for a partnership? ...doesnt seem so.

Its just what it has always been...time wasted and money spent on something that went no where !!!!! :puke: :puke:

I want real news with MEANING other than my constant 8 years of dilution !!! :evil: :evil:

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Cugat reports ACL 6 month results 21 Nov 2014 12:38 #2758

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Hedge,

Got to agree with you that there was very little to hang our hats on in this press release.

The big news right now for Cytori is related to Okyanos. From what I've heard they are doing very well. However, Okyanos alone is not enough for Cytori. What I find exciting is if Okyanos is really catching fire and when we extrapolate this Okyanos success to Asia and KT Lim's efforts. The China application is set to be submitted soon and approval should be a formality from what I understand as it is based upon EU approval. Approval triggers a US5,000,000 order and, if KT has orders ready to be filled, a real revenue ramp-up could be with us shortly. The caveat of course is that between now and then we need more capital or a restructuring of the debt.

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Cugat reports ACL 6 month results 21 Nov 2014 15:08 #2759

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Regardless of what we think....gains did not hold...only a $ 0.008 gain.

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Cugat reports ACL 6 month results 22 Nov 2014 01:02 #2760

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This is Dr. Cugat's study, not Cytori's. As far as I can tell, Cytori was only involved to the extent of giving/selling the cells / machines and then getting back the publicity.

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Cugat reports ACL 6 month results 22 Nov 2014 08:53 #2761

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I want real news with MEANING other than my constant 8 years of dilution !!!


Hedge-

Of course we all want "real news" - when possible "money news" that settles the Oxford "hang-them-high" loan, the preferred stock crap and a few years of operation, all at the same time.

However that does NOT mean that they should forsake on news on the technology at the same time. :bash: :bash:

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Cugat reports ACL 6 month results 22 Nov 2014 08:58 #2762

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Very true indeed. I think Calhoun and Hedrick started CYTX a sales and marketing company. I think CYTX has given away celution to thought leaders in exchange of doing market awareness studies or pilot trials. When the study results mean something for follow up, CYTX may proceed to do confirmatory and even pivotal trials. This way of doing business keeps developmental cost down considerably. All big pharmas do this. When I started my career at Bristol Myers (Bristol Oncology) over 30 years ago, we had a least 30 to 40 non company sponsored cancer trials, in additional to another 30 to 40 NCI trials. Bristol supplied all the drugs free in return of clinical safety and efficacy data (universal experiences), which were used in registrations (supplementary to company sponsored trials). Registrations always started overseas, before the US. I think CYTX has been doing the right things.

I think the some of recent problems with CYTX has to do with Japan. For a least 2 years, the Japanese revenue has been very dry. Japan revenue used to be 70% of the company's total. Now with the new Japanese stem cells regs, things may change.

The other problems may have to do with the unrealized expectation that a big pharma such as Astellas would partner to do phase 3 trials in chronic MI due to ischemia. Maybe things have changed, but Astellas/Fujisawa is not the kind of companies with a great track record doing business with cardiac diseases and medical devices. However, CYTX has been so sure that the cardiac data is so compelling that a big pharma would knock at the door (people like DOV and his crew had actually asked the company to guard this crown jewel). Yet, no big pharma come to give us hundreds of million dollars. And yet, Calhoun and Saad kept on spending big money with the cardiac trophy in mind. I think the company woke up from this dream this time last year. I think early last year (maybe this year), Hedrick was presenting the company in NYC and he mentioned very briefly that he did not think big pharmas are ready to jump into this type of big ventures in the US. Saad had also said in his last company outreach conference that CYTX needed a big pharma to do big cardiac trials in the US.

By sidelining the big expectation of a phase 3 CMI trial in the US, does not mean this program is dead. Okyanos and maybe Lorem Vascular are still very important overseas. There maybe a big future catalyst which would turn our fortune around. Celution the technology probably works in acute and chronic CMI due to ischemia and it is always a hidden treasure till the time comes to shine in the sun.
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