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Thursday, June 17, 2010 11:45:18 AM
CYTX News..Fat Grafts Shows Continued High Rates of Physician and Patient Satisfaction at
12 Months
Interim Data Presented at British Oncoplastic Surgery Meeting; Complete
12-Month Results Expected in Early 2011
SAN DIEGO--(BUSINESS WIRE)--June 17, 2010--
Interim results from a breast reconstruction trial show stem and regenerative
cell-enriched fat grafting resulted in a high sustained rate of physician and
patient satisfaction and persistent improvements in overall outcomes of the
procedure at six and 12 months.
Improvements in outcomes previously reported in 30 patients at six months
were confirmed in a larger sample of 51 patients at six months. These
improvements were sustained for the first 30 patients to reach the 12-month
evaluation period.
The European trial, referred to as RESTORE 2, is sponsored by Cytori
Therapeutics (NASDAQ: CYTX) and enrolled a total of 71 patients. The fat grafts
in the study were enriched with stem and regenerative cells using Cytori's
European-approved Celution(R) 800 System. The interim data reported today was
presented at the Fifth Winchester-Jersey Masterclass in Oncoplastic Breast
Surgery at the Royal Hampshire County Hospital.
Interim results from the RESTORE 2 trial demonstrated a high rate of
physician and patient satisfaction at six and 12 months:
-- Overall physician satisfaction with treatment results was 84% at six
months in 51 patients
-- Overall physician satisfaction with treatment results (90%) persisted in
the first 30 patients at 12 months
-- Overall patient satisfaction with treatment results was 73% in 51
patients measured at six months
-- Overall patient satisfaction with treatment results (70%) persisted in
the 30 patients at 12 months
"Medical research has found that untreated partial mastectomy defects
negatively affects patients' psychology and quality of life1," said Dr. Eva
Weiler-Mithoff, M.D., co-principal investigator for RESTORE 2 at the Glasgow
Royal Infirmary. "With reconstruction, patients are less likely to feel
depressed or stigmatized and more likely to appreciate the treatment of breast
cancer."
"A woman is not cured until she is reconstructed. Unfortunately for most
patients, few options are available and there is currently no accepted
standard-of-care for breast reconstruction," added Dr. Rosa Perez Cano,
co-principal investigator for RESTORE 2 and Chief of Plastic Surgery Services
at Hospital Universitario Gregorio Maranon, Madrid, Spain. "These interim
results are encouraging as we see consistent improvements in breast deformity,
breast symmetry and tissue elasticity."
Cell-enriched breast reconstruction is a new procedure that addresses the
unmet need created by partial mastectomy. This approach uses a woman's own fat
tissue combined with her own naturally available adipose-derived stem and
regenerative cells to form a 'cell-enriched' fat graft, which is used to
reconstruct the affected breast.
In RESTORE 2, the cell-enriched graft was prepared by first extracting each
patient's own stem and regenerative cells from their fat tissue using Cytori's
Celution(R) 800/CRS System and then combining these cells with the fat graft,
all in the same surgical procedure. More information on cell-enriched breast
reconstruction and other reconstructive surgery options for breast cancer is
available at www.cellreconstruct.eu.
RESTORE 2 is a post-marketing study primarily intended to measure physician
and patient satisfaction in reconstructing the breast utilizing the Celution
800/CRS System. The study endpoints have been designed, among other things, to
address hospital and physician reimbursement and adoption of the Celution(R)
800/CRS System throughout Europe. The outcomes of the study will be assessed at
12 months, per study design.
For more information, log on to www.cytori.com.
1 "Effect of Esthetic Outcome After Breast-Conserving Surgery on Psychosocial
Functioning and Quality of Life" Journ. Of Clin. Oncology Vol 26 No. Jul 2008
About Cytori
Cytori is a leader in providing patients and physicians around the world with
medical technologies that harness the potential of adult regenerative cells
from adipose tissue. The Celution(R) 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(R) product line is sold globally for cell banking and research
applications. www.cytori.com
Cautionary Statement Regarding Forward-Looking Statements
This communication includes forward-looking statements regarding events,
trends and business prospects, which may affect our future operating results
and financial position. Such statements are subject to risks and uncertainties
that could cause our actual results and financial position to differ
materially. Some of these risks include clinical and regulatory uncertainties,
including risks in the collection and results of clinical data, final clinical
outcomes, dependence on third party performance, and other risks and
uncertainties described under the "Risk Factors" in Cytori's Securities and
Exchange Commission Filings on Form 10-K and Form 10-Q. We assume no
responsibility to update or revise any forward-looking statements to reflect
events, trends or circumstances after the date they are made.
CONTACT: Media Contact:
RLM Public Relations for Cytori
Sharon Nieuwenhuis,
212-741-5106 x237
cytori@RLMpr.com
or
Investor Contact:
Cytori
Tom Baker
858-232-7234
tbaker@cytori.com
SOURCE: Cytori Therapeutics
Copyright Business Wire 2010
Click here to go to Dow Jones NewsPlus, a web front page of today's most
important business and market news, analysis and commentary:
http://www.djnewsplus.com/nae/al?rnd=fK3OT%2BzzxHMGA2%2BJkQ4xgQ%3D%3D. You can
use this link on the day this article is published and the following day.
(END) Dow Jones Newswires
06-17-10 1125ET
11:25 061710
12 Months
Interim Data Presented at British Oncoplastic Surgery Meeting; Complete
12-Month Results Expected in Early 2011
SAN DIEGO--(BUSINESS WIRE)--June 17, 2010--
Interim results from a breast reconstruction trial show stem and regenerative
cell-enriched fat grafting resulted in a high sustained rate of physician and
patient satisfaction and persistent improvements in overall outcomes of the
procedure at six and 12 months.
Improvements in outcomes previously reported in 30 patients at six months
were confirmed in a larger sample of 51 patients at six months. These
improvements were sustained for the first 30 patients to reach the 12-month
evaluation period.
The European trial, referred to as RESTORE 2, is sponsored by Cytori
Therapeutics (NASDAQ: CYTX) and enrolled a total of 71 patients. The fat grafts
in the study were enriched with stem and regenerative cells using Cytori's
European-approved Celution(R) 800 System. The interim data reported today was
presented at the Fifth Winchester-Jersey Masterclass in Oncoplastic Breast
Surgery at the Royal Hampshire County Hospital.
Interim results from the RESTORE 2 trial demonstrated a high rate of
physician and patient satisfaction at six and 12 months:
-- Overall physician satisfaction with treatment results was 84% at six
months in 51 patients
-- Overall physician satisfaction with treatment results (90%) persisted in
the first 30 patients at 12 months
-- Overall patient satisfaction with treatment results was 73% in 51
patients measured at six months
-- Overall patient satisfaction with treatment results (70%) persisted in
the 30 patients at 12 months
"Medical research has found that untreated partial mastectomy defects
negatively affects patients' psychology and quality of life1," said Dr. Eva
Weiler-Mithoff, M.D., co-principal investigator for RESTORE 2 at the Glasgow
Royal Infirmary. "With reconstruction, patients are less likely to feel
depressed or stigmatized and more likely to appreciate the treatment of breast
cancer."
"A woman is not cured until she is reconstructed. Unfortunately for most
patients, few options are available and there is currently no accepted
standard-of-care for breast reconstruction," added Dr. Rosa Perez Cano,
co-principal investigator for RESTORE 2 and Chief of Plastic Surgery Services
at Hospital Universitario Gregorio Maranon, Madrid, Spain. "These interim
results are encouraging as we see consistent improvements in breast deformity,
breast symmetry and tissue elasticity."
Cell-enriched breast reconstruction is a new procedure that addresses the
unmet need created by partial mastectomy. This approach uses a woman's own fat
tissue combined with her own naturally available adipose-derived stem and
regenerative cells to form a 'cell-enriched' fat graft, which is used to
reconstruct the affected breast.
In RESTORE 2, the cell-enriched graft was prepared by first extracting each
patient's own stem and regenerative cells from their fat tissue using Cytori's
Celution(R) 800/CRS System and then combining these cells with the fat graft,
all in the same surgical procedure. More information on cell-enriched breast
reconstruction and other reconstructive surgery options for breast cancer is
available at www.cellreconstruct.eu.
RESTORE 2 is a post-marketing study primarily intended to measure physician
and patient satisfaction in reconstructing the breast utilizing the Celution
800/CRS System. The study endpoints have been designed, among other things, to
address hospital and physician reimbursement and adoption of the Celution(R)
800/CRS System throughout Europe. The outcomes of the study will be assessed at
12 months, per study design.
For more information, log on to www.cytori.com.
1 "Effect of Esthetic Outcome After Breast-Conserving Surgery on Psychosocial
Functioning and Quality of Life" Journ. Of Clin. Oncology Vol 26 No. Jul 2008
About Cytori
Cytori is a leader in providing patients and physicians around the world with
medical technologies that harness the potential of adult regenerative cells
from adipose tissue. The Celution(R) 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(R) product line is sold globally for cell banking and research
applications. www.cytori.com
Cautionary Statement Regarding Forward-Looking Statements
This communication includes forward-looking statements regarding events,
trends and business prospects, which may affect our future operating results
and financial position. Such statements are subject to risks and uncertainties
that could cause our actual results and financial position to differ
materially. Some of these risks include clinical and regulatory uncertainties,
including risks in the collection and results of clinical data, final clinical
outcomes, dependence on third party performance, and other risks and
uncertainties described under the "Risk Factors" in Cytori's Securities and
Exchange Commission Filings on Form 10-K and Form 10-Q. We assume no
responsibility to update or revise any forward-looking statements to reflect
events, trends or circumstances after the date they are made.
CONTACT: Media Contact:
RLM Public Relations for Cytori
Sharon Nieuwenhuis,
212-741-5106 x237
cytori@RLMpr.com
or
Investor Contact:
Cytori
Tom Baker
858-232-7234
tbaker@cytori.com
SOURCE: Cytori Therapeutics
Copyright Business Wire 2010
Click here to go to Dow Jones NewsPlus, a web front page of today's most
important business and market news, analysis and commentary:
http://www.djnewsplus.com/nae/al?rnd=fK3OT%2BzzxHMGA2%2BJkQ4xgQ%3D%3D. You can
use this link on the day this article is published and the following day.
(END) Dow Jones Newswires
06-17-10 1125ET
11:25 061710
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