CYTORI GETS EU APPROVAL FOR STEMCELL BREAST RECONSTRUCTION
http://finance.yahoo.com/news/Cytoris-PureGraft-System-bw-2252723998.html?x=0&.v=1
SAN DIEGO--(BUSINESS WIRE)--Cytori Therapeutics (NASDAQ: CYTX - News) has received European (CE Mark) approval for the PureGraftTM 250/PURE System for autologous fat grafting procedures, allowing Cytori to immediately commercialize the PureGraftTM product line to physicians in Europe. PureGraftTM will be sold as both a standalone product and as a complement to Cytori's Celution® 800/CRS System in Europe.
The PureGraftTM System is an optimized tissue processing technology that is positioned at the forefront of the emerging fat grafting trend in the cosmetic and reconstructive surgery market. PureGraftTM replaces current non-standardized methods of graft preparation. Used independently, PureGraftTM rapidly and reliably produces optimal graft tissue for use in autologous fat grafting procedures. In combination with the Celution® 800/CRS, PureGraftTM lowers processing times and increases processing volumes, improving the utility and efficiency of Cytori's core product for soft tissue applications.
"The addition of PureGraftTM to our product portfolio allows us to offer a broad spectrum of autologous fat grafting technologies in Europe. In addition to Celution® System, which enables cell-enriched fat grafting procedures, PureGraftTM fulfills the need for high quality, sterile tissue for fat grafting procedures, including body contouring," said Eric Daniels, M.D., Cytori's Managing Director in Europe and the Middle East.
Cytori will immediately begin commercializing PureGraftTM in Europe, through a combination of direct sales and distributors. In addition to the 27 countries of the EU, the CE Mark is followed by eight other countries and facilitates additional registrations around the world.
The PureGraftTM System sets a new standard for fat graft processing with its membrane-based tissue filtration combined with speed, simplicity, safety and precision. The PureGraftTM technology takes only 15 minutes to purify a fat graft ranging from 50 to 250 mL, removing excess and unwanted fluid, lipid, blood cells and debris in a controllable manner. The consumable-based system, used within the sterile field, "dialyzes" off everything but the purified fat tissue without centrifugation or other methods. The ease of use and simplicity of this innovative system sets it apart from other traditional fat grafting methods.
The PureGraftTM 250/PURE System received 510(k) marketing clearance for aesthetic body contouring from the U.S. FDA in January of this year. The product was formally launched at the meeting of the American Society of Aesthetic Plastic Surgeons in April 2010. In addition, Cytori received a Canadian medical device license for PureGraftTM in March 2010.
For more information, visit http://us.lrd.yahoo.com/SIG=169croqvk/**http%3A//cts.businesswire.com/ct/CT%3Fid=smartlink%26url=http%253A%252F%252Fwww.puregraft.com%26esheet=6377704%26lan=en-US%26anchor=www.puregraft.com%26index=1%26md5=305628161319ced02eaca0e3c0373177.
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® 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. http://us.lrd.yahoo.com/SIG=1686lrfko/**http%3A//cts.businesswire.com/ct/CT%3Fid=smartlink%26url=http%253A%252F%252Fwww.cytori.com%252F%26esheet=6377704%26lan=en-US%26anchor=www.cytori.com%26index=2%26md5=65f2dde5e60a46e26987c4ec1c595e6f
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, including, but not limited to, those regarding the potential market for PureGraftTM in Europe, are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include the challenges inherent in convincing physicians and patients to adopt the new technology, creating and implementing a successful marketing and sales strategy, as well as our history of operating losses, regulatory uncertainties, dependence on third party performance, and other risks and uncertainties described under the "Risk Factors" in Cytori's Securities and Exchange Filings, including its annual report on Form 10-K for the year ended December 31, 2008. Cytori assumes no responsibility to update or revise any forward-looking statements contained in this press release to reflect events, trends or circumstances after the date of this press release.
Contact:
Cytori TherapeuticsTom Baker
tbaker@cytori.com
858.875.5258
Categories
- All Categories
- 679 Advocacy and Fund-Raising
- 289 Advocacy
- 68 I've Donated to Breastcancer.org in honor of....
- Test
- 322 Walks, Runs and Fundraising Events for Breastcancer.org
- 5.6K Community Connections
- 282 Middle Age 40-60(ish) Years Old With Breast Cancer
- 53 Australians and New Zealanders Affected by Breast Cancer
- 208 Black Women or Men With Breast Cancer
- 684 Canadians Affected by Breast Cancer
- 1.5K Caring for Someone with Breast cancer
- 455 Caring for Someone with Stage IV or Mets
- 260 High Risk of Recurrence or Second Breast Cancer
- 22 International, Non-English Speakers With Breast Cancer
- 16 Latinas/Hispanics With Breast Cancer
- 189 LGBTQA+ With Breast Cancer
- 152 May Their Memory Live On
- 85 Member Matchup & Virtual Support Meetups
- 375 Members by Location
- 291 Older Than 60 Years Old With Breast Cancer
- 177 Singles With Breast Cancer
- 869 Young With Breast Cancer
- 50.4K Connecting With Others Who Have a Similar Diagnosis
- 204 Breast Cancer with Another Diagnosis or Comorbidity
- 4K DCIS (Ductal Carcinoma In Situ)
- 79 DCIS plus HER2-positive Microinvasion
- 529 Genetic Testing
- 2.2K HER2+ (Positive) Breast Cancer
- 1.5K IBC (Inflammatory Breast Cancer)
- 3.4K IDC (Invasive Ductal Carcinoma)
- 1.5K ILC (Invasive Lobular Carcinoma)
- 999 Just Diagnosed With a Recurrence or Metastasis
- 652 LCIS (Lobular Carcinoma In Situ)
- 193 Less Common Types of Breast Cancer
- 252 Male Breast Cancer
- 86 Mixed Type Breast Cancer
- 3.1K Not Diagnosed With a Recurrence or Metastases but Concerned
- 189 Palliative Therapy/Hospice Care
- 488 Second or Third Breast Cancer
- 1.2K Stage I Breast Cancer
- 313 Stage II Breast Cancer
- 3.8K Stage III Breast Cancer
- 2.5K Triple-Negative Breast Cancer
- 13.1K Day-to-Day Matters
- 132 All things COVID-19 or coronavirus
- 87 BCO Free-Cycle: Give or Trade Items Related to Breast Cancer
- 5.9K Clinical Trials, Research News, Podcasts, and Study Results
- 86 Coping with Holidays, Special Days and Anniversaries
- 828 Employment, Insurance, and Other Financial Issues
- 101 Family and Family Planning Matters
- Family Issues for Those Who Have Breast Cancer
- 26 Furry friends
- 1.8K Humor and Games
- 1.6K Mental Health: Because Cancer Doesn't Just Affect Your Breasts
- 706 Recipe Swap for Healthy Living
- 704 Recommend Your Resources
- 171 Sex & Relationship Matters
- 9 The Political Corner
- 874 Working on Your Fitness
- 4.5K Moving On & Finding Inspiration After Breast Cancer
- 394 Bonded by Breast Cancer
- 3.1K Life After Breast Cancer
- 806 Prayers and Spiritual Support
- 285 Who or What Inspires You?
- 28.7K Not Diagnosed But Concerned
- 1K Benign Breast Conditions
- 2.3K High Risk for Breast Cancer
- 18K Not Diagnosed But Worried
- 7.4K Waiting for Test Results
- 603 Site News and Announcements
- 560 Comments, Suggestions, Feature Requests
- 39 Mod Announcements, Breastcancer.org News, Blog Entries, Podcasts
- 4 Survey, Interview and Participant Requests: Need your Help!
- 61.9K Tests, Treatments & Side Effects
- 586 Alternative Medicine
- 255 Bone Health and Bone Loss
- 11.4K Breast Reconstruction
- 7.9K Chemotherapy - Before, During, and After
- 2.7K Complementary and Holistic Medicine and Treatment
- 775 Diagnosed and Waiting for Test Results
- 7.8K Hormonal Therapy - Before, During, and After
- 50 Immunotherapy - Before, During, and After
- 7.4K Just Diagnosed
- 1.4K Living Without Reconstruction After a Mastectomy
- 5.2K Lymphedema
- 3.6K Managing Side Effects of Breast Cancer and Its Treatment
- 591 Pain
- 3.9K Radiation Therapy - Before, During, and After
- 8.4K Surgery - Before, During, and After
- 109 Welcome to Breastcancer.org
- 98 Acknowledging and honoring our Community
- 11 Info & Resources for New Patients & Members From the Team