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To: tnsaf who wrote (220)12/14/2009 9:09:34 PM
From: tnsaf
   of 251
 
Cytori’s RESTORE 2 Interim Data Demonstrate High Level of Patient and Physician Satisfaction

* Press Release
* Source: Cytori Therapeutics
* On 8:01 am EST, Saturday December 12, 2009

SAN ANTONIO--(BUSINESS WIRE)--Interim results from a European clinical trial, RESTORE 2, demonstrate that cell-enriched breast reconstruction achieved a high rate of patient and physician satisfaction and improvements in overall breast deformity in lumpectomy patients. These results are based on six-month follow up from the first 32 women enrolled and treated. The results were presented at the 32nd Annual CTRC-AACR San Antonio Breast Cancer Symposium (Poster #4123) by Dr. Eva Weiler-Mithoff, M.D., co-principal investigator for the Restore 2 Trial at the Glasgow Royal Infirmary.
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CYTX 5.94 -0.51

The highlights from the interim data of Cytori Therapeutics’ (NASDAQ: CYTX - News) RESTORE 2 clinical trial include:

* A high rate of patient satisfaction (73%) and physician satisfaction (82%) with the overall outcome after a single treatment was reported in difficult to treat breast cancer patients
* Mean patient and physician satisfaction scores dramatically improved for breast symmetry, scarring and deformity from baseline to six month follow-up
* Qualitative analyses of imaging data confirmed clinical improvement in both breast defect and overall breast shape

Breast conserving therapy (BCT) or partial mastectomy for breast cancer is a surgical technique that preserves as much native tissue as possible, focusing tissue removal on the target area affected by cancer plus some surrounding tissue for margin. The majority of patients treated with breast cancer today receive BCT. Although the goal is to protect as much of the patient’s own tissue as possible, the procedure can create a deformity that can be extremely difficult to repair. In patients with severe deformities, a tissue flap may be taken from the back and used to reconstruct the defect, but requires at least one additional surgery, creates another defect and scar at the donor site and can be a long and expensive procedure. For most patients however, there are no good reconstructive options.

Cell-enriched breast reconstruction is a new procedure which addresses this unmet need created by BCT. In this approach, a woman’s own fat tissue is combined with her own naturally available adipose-derived regenerative cells (ADRCs). The ‘cell-enriched’ fat graft is then injected into and around the defect area. In RESTORE 2, the ADRCs were extracted from the patient’s own fat tissue using Cytori’s Celution® 800/CRS System. The Celution® 800/CRS System was CE Marked in 2007 and is commercially available in Europe and certain other markets. More information on cell-enriched breast reconstruction and other reconstructive surgery options for breast cancer may be found at www.cellreconstruction.eu.

"These patients really suffer from these deformities because they interfere with their choice of clothing, lifestyle, confidence, and body image,” commented Dr. Weiler-Mithoff. “We now have a way of treating these patients without major surgery and major additional scarring. Half my patients are at the 12 month stage and I have found a continued improvement of the skin, the tissues, how the breast feels, how it moves on the chest wall and in particular in the pain the patients often describe pre-operatively over the second six months. We are expecting even more improvement to happen in the latter part of the observation period. Considering that defects after breast conservation and radio-therapy are very difficult to correct and quite often only 50% can be improved with secondary treatment, the RESTORE 2 study outcome is a very good result."

RESTORE 2 is a post-marketing study primarily intended to measure patient and physician satisfaction in reconstructing the breast utilizing the Celution® 800/CRS System. The goal is to support hospital and physician reimbursement and adoption of the Celution® 800/CRS System throughout Europe. The outcomes of the study will be assessed at 12 months, per study design. The co-principal investigators for RESTORE 2 are Dr. Weiler-Mithoff, Consultant Plastic Surgeon at the Canniesburn Plastic Surgery Unit at the Glasgow Royal Infirmary and Dr. Rosa Pérez Cano, Chief of Plastic Surgery Services at Hospital Universitario Gregorio Marañón in Madrid, Spain.

“Breast cancer treatment is not complete until after reconstruction,” said Marc Hedrick, M.D., president of Cytori. “Going into this study, we knew the technology both worked and made patients look and feel better. Now we have strong supporting data such as MRI and photographic evidence and formal physician questionnaires to complete the reimbursement dossier on our products. Our goal is to make the Celution®-based procedure the gold standard treatment for reconstruction of defects following breast conserving therapy.”

Clinical Results: The study reported a high degree of patient (73%) and physician (82%) satisfaction at the interim six-month observation period with the overall outcome after a single treatment in difficult to treat breast reconstruction patients. On a scale of zero to five (five is extremely satisfied and zero is extremely dissatisfied), mean patient satisfaction scores improved from 2.8 at baseline to 3.9 at six-month follow up. Mean physician satisfaction scores improved from 3.1 to 4.1. For the 32 patients, there was a mean age of 52 years and a mean defect volume estimated by the investigators of 106 milliliters in 33 treated breasts (one patient had both breasts treated).

General anesthesia was used in most patients (32 out of 33 during liposuction and 20 of 33 for re-injection). In 24 patients, a single donor site was used, in eight patients two sites, and in one patient, three sites were used for liposuction. The abdomen was the preferred site for harvest of the graft (28 of the total 43 harvest sites). One operative complication was reported. A patient on anticoagulation therapy had a postoperative hematoma that resolved without continuing harm to the patient. Patient and physician satisfaction scores are based on pre-operative versus post operative assessment of symmetry, scarring, pigmentation, and overall breast deformity.

Imaging Results: All MRIs were evaluated by an independent blinded core lab to avoid assessment bias. Qualitative assessments of MRI for changes in breast shape and defect shape were included in the abstract. Of the 31 patients with imaging data reviewed at the time of publication, 19 had defects assessable by MRI. The remaining 12 patients either had defects not assessable by MRI, such as in the extreme upper lateral quadrant, or presented mostly with breast asymmetry. One of 31 patients developed an asymptomatic lipid cyst that was observed on MRI; no treatment was required.

The shape of the breast improved (58%), significantly improved (13%), or remained stable (29%) in all of the 31 cases assessed (100%). None of the patients had negative changes in the overall shape of their breasts. The shape of the defect improved (47%), significantly improved (11%), or remained stable (31%) in 17 of the 19 cases (89%).

Breast Cancer and BCT: More than one million women worldwide are diagnosed with breast cancer annually. The reported number of new cases is about equally spread geographically between the Americas, Europe and Asia. The U.S. has the highest incidence rate of any country in the world where breast cancer will be diagnosed in approximately 1 in 8 women during their lifetime. According to the American Cancer Society, the U.S. also reports the greatest number of cases with an estimated 190,000 new diagnoses per year. The increased emphasis on early detection means that a growing percentage of women are discovering the cancer earlier in the disease progression, receiving earlier and better care with corresponding improvement in survival. Earlier detection means more patients are eligible for BCT versus a full mastectomy, with the majority of breast cancer patients now eligible for BCT.

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To: SnowShredder who wrote (215)1/8/2010 10:50:59 AM
From: SnowShredder
   of 251
 
FDA Grants 510(k) Marketing Clearance for Cytori's PureGraft System; First & Only Device on Market for Aesthetic Body Contouring using Autologous Fat Grafts

finance.yahoo.com 

Best of Luck,

SS

>>>>>>>>
FDA Grants 510(k) Marketing Clearance for Cytori's PureGraft System; First & Only Device on Market for Aesthetic Body Contouring using Autologous Fat Grafts


Press Release Source: Cytori Therapeutics On Friday January 8, 2010, 8:00 am EST
SAN DIEGO--(BUSINESS WIRE)--The FDA has granted Cytori Therapeutics (NASDAQ: CYTX - News) 510(k) marketing clearance for its PureGraft™ System. Cytori will now launch the first and only device in the United States cleared for aesthetic body contouring using autologous fat. PureGraft™ allows a patient’s own fat tissue to rapidly be prepared in approximately 15 minutes for re-injection back into the same patient for aesthetic contouring.

PureGraft™ is able to prepare both small and large volumes of fat grafting tissue ranging from 50 mL to 250 mL. Puregraft™ maintains sterility while optimizing the yield of tissue to be grafted, which provides significant utility to physicians. In contrast to traditional methods of graft preparation, PureGraft™ washes the graft and drains the tumescent fluid, free lipid and debris in a closed sterile system, allowing for a cleaner graft in less time than it would take to prepare a comparable volume of graft tissue traditionally.

“FDA clearance provides us with a strategically important product in addition to the CelBrush™ to help establish our brand and build relationships with U.S. plastic and reconstructive surgeons,” said Marc H. Hedrick, M.D., President of Cytori Therapeutics. “There are several advantages this product offers physicians performing autologous fat grafts, which can improve efficiencies in the operating room, decrease surgery time and, by being able to process greater volumes, to include large defects.”

PureGraft™ will be sold in the United States directly by Cytori as well as through select distribution partners on a non-exclusive basis. The product will be available in the first quarter of 2010 and will be formally launched at the American Society of Aesthetic Plastic Surgeons in May 2010.

Cytori is also seeking marketing approval (CE Mark certification) for PureGraft™ in Europe, which is expected in the first half of 2010. In Europe, PureGraft™, in addition to being sold as a standalone product, will be used to complement Cytori’s currently available autologous tissue processing system as a means to expand the potential number of clinical applications.

According to the American Society of Plastic Surgeons’ most recent report of plastic surgery statistics, over 46,000 fat grafting procedures were performed in the United States in 2008. Currently, over 5,000 plastic surgeons are registered with the American Society of Plastic Surgeons.

About Cytori

Cytori is an emerging leader in providing patients and physicians around the world with medical technologies, which harness the potential of adult regenerative cells from adipose tissue. The Celution® System family of medical devices and instruments is being sold into the European and Asian cosmetic and reconstructive surgery markets but is not yet available in the United States. Our StemSource® product line is sold globally for cell banking and research applications.

<snip>

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From: SnowShredder1/13/2010 11:17:21 AM
   of 251
 
Cytori has couple interesting videos posted on its home page.

cytoritx.com 

One from a NBC special...

cytoritx.com 

An interview from a Dr. from Japan on his clinical use...

cytoritx.com 

Best of Luck,

SS

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To: SnowShredder who wrote (223)1/19/2010 4:20:10 PM
From: SnowShredder
   of 251
 
Another video clip of a Dr. & the patient in Japan who was treated for urinary incontinence...

cytoritx.com 

Best of Luck,

SS

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From: tnsaf1/25/2010 1:42:33 PM
   of 251
 
Cell-Enriched Fat Grafts Improve Long Term Graft Retention in Preclinical Study

Press Release Source: Cytori Therapeutics On Monday January 25, 2010, 7:00 am EST

SAN DIEGO--(BUSINESS WIRE)--Results from Cytori Therapeutics’ (NASDAQ: CYTX - News) preclinical fat grafting study have been published in the February issue of the Annals of Plastic Surgery. This article, entitled “Supplementation of Fat Grafts with Adipose-Derived Regenerative Cells (ADRCs) Improves Long-Term Graft Retention,” examines the science behind cell-enriched autologous fat grafting and its application to cosmetic and reconstructive surgery. The results demonstrate a doubling in graft retention in cell-enriched grafts and provide insight into the mechanisms behind this improvement. The results reinforce both commercial observations and interim data from the RESTORE 2 clinical study that was presented at the San Antonio Breast Cancer Symposium in December.

The preclinical results described in the paper support the potential clinical utility for cell-enriched fat grafts in cosmetic and reconstructive surgery. The key results include:

Long term retention of cell-enriched autologous fat grafts was increased two-fold over controls
Quality of the cell-enriched grafts was significantly higher than controls with an increased number of healthy fat cells and reduced formation of cysts
Improved blood vessel density in ADRC-enriched grafts
Demonstration of several critical growth factors expressed by ADRCs
In this study, a mouse model of autologous fat grafting was used to compare graft retention of cell-enriched fat grafts with traditional fat grafts. Retention was evaluated six and nine months after implantation. Supplemental in vitro and in vivo studies provide evidence that ADRC-enrichment improved graft retention and quality by promoting cell survival and the rapid formation of blood vessels within the graft through expression of growth factors known to promote vessel formation and prevent cell death.

The February issue of Annals of Plastic Surgery is currently available online at www.annalsplasticsurgery.com

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From: tnsaf2/9/2010 9:27:52 PM
   of 251
 
The company must think the share price hit its low. Friday they gave four officers a few hundred thousand options at $6.71

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To: SnowShredder who wrote (224)2/19/2010 12:52:38 AM
From: SnowShredder
   of 251
 
Periurethral injection of autologous adipose-derived stem cells for the treatment of stress urinary incontinence in patients undergoing radical prostatectomy: Report of two initial cases

fwiw...

urotoday.com 

Best of Luck,

SS

>>>>>>>>


Periurethral injection of autologous adipose-derived stem cells for the treatment of stress urinary incontinence in patients undergoing radical prostatectomy: Report of two initial cases - Abstract


Wednesday, 27 January 2010
Department of Urology, Nagoya University Graduate School of Medicine, Nagoya, Aichi, Japan.

To report a novel cell therapy using autologous adipose tissue-derived stem cells (ADSC) for stress urinary incontinence caused by urethral sphincteric deficiency and the outcomes in two initial cases undergoing periurethral injection of stem cells for the treatment of urinary incontinence after radical prostatectomy.

Two patients with moderate stress incontinence after radical prostatectomy were enrolled. After liposuction of 250 mL of adipose tissue from the abdomen, we isolated ADSC from this tissue by using the Celution system. Subsequently, the isolated ADSC and a mixture of stem cells and adipose tissue were transurethrally injected into the rhabdosphincter and submucosal space of the urethra, respectively. Short-term outcomes during a 12-week follow-up were assessed by a 24-h pad test, a validated patient questionnaire, urethral pressure profile, transrectal ultrasonography, and magnetic resonance imaging.

Urinary incontinence progressively improved after 2 weeks of injection up to 12 weeks in terms of decreased leakage volume in a 24-h pad test, decreased frequency and amount of incontinence, and improved quality of life as per the questionnaire. In urethral pressure profile, both maximum urethral closing pressure and functional profile length increased. Ultrasonography and magnetic resonance imaging showed sustained presence of the injected adipose tissue. Enhanced ultrasonography showed a progressive increase in the blood flow to the injected area. No significant adverse events were observed peri- and postoperatively.

This preliminary study showed that periurethral injection of the autologous ADSC is a safe and feasible treatment modality for stress urinary incontinence.

Written by:
Yamamoto T, Gotoh M, Hattori R, Toriyama K, Kamei Y, Iwaguro H, Matsukawa Y, Funahashi Y. Are you the author?

Reference:
Int J Urol. Epub ahead of print.

PubMed Abstract
PMID:20002225

UroToday.com Stress Urinary Incontinence Section

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To: tnsaf who wrote (226)2/19/2010 12:59:15 AM
From: SnowShredder
   of 251
 
FDA decision due soon, Apollo trial abstract at ACC in March...should be interesting...bwdik?

Best of Luck,

SS

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To: SnowShredder who wrote (228)3/12/2010 3:38:06 AM
From: SnowShredder
   of 251
 
Duckers et al (ACC poster title)...

"First-in-Man Experience of Adipose-Derived Stem Cell Transplantation in the Treatment of Patients with an Acute STElevation Myocardial Infarction (APOLLO Trial)"


Best of Luck,

SS

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To: SnowShredder who wrote (229)3/12/2010 1:37:38 PM
From: tuck
   of 251
 
Cytori firesaling on greater than expected expenses. I don't follow the company, but this would seem like an over reaction unless it actually crimps their operating ability and/or requires dilution way ahead of the previous schedule. Thoughts?

Cheer, Tuck

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