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TOPIC: Hedrick note on first STAR patient treated

Hedrick note on first STAR patient treated 25 Aug 2015 08:47 #5028

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Cytori recently treated our first patient in our STAR trial for scleroderma related hand dysfunction. I was fortunate to be involved in the procedure (as an observer only), and I would like to highlight to our investors several aspects of the case and this trial.

First, let me give a brief overview of the case. The procedure was performed at Baptist Medical Center in Little Rock, Arkansas. Baptist Health has a very active clinical research group led by Dr. Clint W. Abner and a statewide referral network of scleroderma patients. The patient had longstanding scleroderma and significant hand involvement.

The patient first underwent a small abdominal fat harvest similar to a cosmetic liposuction using surgical equipment from Cytori. The patient was awake during the procedure and received a mix of intravenous sedation and local anesthesia in the procedure room to provide analgesia during the small volume fat harvest procedure.

Immediately following the harvest, the patient left the procedure room for recovery. While the patient recovered, the fat tissue was placed into the Celution 800 system embedded with a new software version designed to improve the cellular manufacturing process for the STAR trial and these patients.

Approximately 90 minutes later a dose of 40 million cells was prepared along with a placebo dose containing blood-tinged saline indistinguishable from the syringe containing the active therapeutic, ECCS-50.

After randomization, the selected syringe was emptied into ten 1mL syringes each containing approximately 4 million cells. The surgeon, in the recovery room, prior to discharge of the patient to her home, delivered the syringe contents, one syringe to each finger through two, small, 25 gauge needle sticks per finger. The patient had received a small dose of IV analgesia, but no other specific anesthesia in the extremities and required no bandaging after injection. She left the hospital soon thereafter. The cell injection procedure took approximately a half hour and there were no periprocedural complications.

“Scleroderma is a multifaceted disease with hand disability being a severe problem for patients and currently there are no solutions that provide significant relief,” said Dr. Clint W. Abner, Director of Operations and Business Development, Baptist Health Center for Clinical Research. “The Cytori procedure was well tolerated in our first enrolled patient and our team here is very excited about the procedure and we are dedicated to the STAR clinical trial”.

So what’s relevant about this first case to investors:

Cytori has successfully and uneventfully begun its first ever U.S. approval trial.
Consistent with our experience in treating scleroderma in Europe, this patient tolerated the procedure well.
Although the scleroderma patient population tends to be thin, the fat harvest procedure and injection can be performed in a straightforward fashion and was well tolerated.
Cytori’s new software code and Celution 800 configuration functioned admirably in the production of the ECCS-50 cellular therapeutic.
Our Cytori team would like to thank the team and Baptist Hospital for the wonderful care given to this patient, the meticulous attention to detail in the execution of the trial and congratulate them on treating the first patient in the United States with this innovative technology.

STAR is an eighty patient randomized, double blinded controlled trial of a single dose of the ECCS-50 therapeutic compared to placebo in up to 20 centers in the United States. Details of the trial including inclusion and exclusion criteria can be found at the following links: clinicaltrials.gov/ct2/show/NCT02396238?term=Cytori&rank=5 and www.startrial-us.com/

The STAR trial was predicated on promising data from the European phase II/pilot trial named SCLERADEC which was published in 2014 (Granel et al. Annals of Rheumatic Diseases) and reported data suggesting that the treatment was safe and potentially effective in improving certain hand symptoms in patients with scleroderma. The data canbe found at the following link:

ard.bmj.com/content/early/2014/08/10/annrheumdis-2014-205681.full .

Subsequent follow up of the SCLERADEC patients at 12 months revealed that the beneficial effect of Cytori’s ECCS-50 therapy in scleroderma persisted at least to 12 months and that data has been accepted for publication and is currently in the press.

Sincerely,

Dr. Marc H. Hedrick, President and Chief Executive Officer
The following user(s) said Thank You: forgotmorthanuno, d9dozrman

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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:

Hedrick note on first STAR patient treated 25 Aug 2015 13:32 #5030

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I wonder how long he will sit on these results :yep:

Any ETA on Athena? :bye:

But I bet, he will pump out the results like a $&$%&( in a $&$%*( party...

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Hedrick note on first STAR patient treated 25 Aug 2015 18:38 #5036

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My house is just a few miles from this hospital. Bough more cytx today.F

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Hedrick note on first STAR patient treated 25 Aug 2015 20:25 #5038

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FAS, this is a good write up. In the world of clinical r/d, this is a trip report. Usually, a man like Hedrick or Kristen would be present at the study site, when the first patient is dosed, particularly in a pivotal trial.

In this trial, they are using Celution system 800. When would the smaller but newer version CX-2 (?) be available? The US alopecia trial will be started later on this year, are they waiting for the availability of CX-2 at that time? Regardless the type of machines which would be used, CYTX would probably make some research sales for both the machines and reagents.

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