Cytori Therapeutics

Aber die Oberkante sollte jetzt mal wieder drin sein....  

Cytori Receives First Celution 800 System Orders in Europe and Asia; Begins Commercialization into the Reconstructive Surgery Market

13:50 13.02.08

SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics (NASDAQ:CYTX) received its first orders from Europe and Asia for Celution® 800 Systems. The devices are now being sold into the growing international reconstructive surgery market. Eleven Celution 800 Systems and related CT-805 single-use consumables were ordered by Cytoris distributors MBA Grupo, who covers Spain, Italy, and Portugal, and Astrea International, who covers Singapore. The first devices are expected to be delivered in the first quarter of 2008. These opening orders mark a key transition for the company and its products, said Christopher J. Calhoun, chief executive officer for Cytori. We achieved our stated goal from last year, which was to accelerate our product introduction to early 2008 by bringing an innovative reconstructive surgery product to physicians and their patients. Cytori has regulatory approval for the Celution 800 System in Europe, is seeking clearances in Asia-Pacific, and has forged commercialization partnerships with distributors in these markets. Cytori is working with its distribution partners and physicians to educate the market about this technology in order to extend its penetration. Clinical trials are ongoing with Celution 800 to broaden its utility for multiple applications. The products are being manufactured at Cytoris headquarters in San Diego, CA. There is strong receptivity among oncologic and reconstructive surgeons for Cytoris Celution 800 System, and we are now moving forward with targeted sales, said Paul Griffin, vice president of international sales and new business development for MBA Grupo. This growing demand is due in part to recent reports from successful clinical reconstructive surgery cases. This product line has the potential for significant growth as it is addressing an important, unmet medical market. The Celution 800 System provides physicians with a rich source of a patients own adipose tissue-derived stem and regenerative cells at the bedside. When these cells are re-combined with more of a patients own adipose (fat) tissue in the same surgical procedure, it is referred to as cell-enhanced reconstruction. Cytori Therapeutics Cytori Therapeutics (NASDAQ:CYTX) goal is to be the global leader in regenerative medicine. The company is dedicated to providing patients with new options for reconstructive surgery, developing treatments for cardiovascular disease, and banking patients adult stem and regenerative cells. The Celution 800 System is being introduced in Europe into the reconstructive surgery market while the Celution 900 System will be launched in Japan for cryopreserving a patients own stem and regenerative cells. Clinical trials are ongoing in cardiovascular disease and planned for spinal disc degeneration, gastrointestinal disorders, and other unmet medical needs. www.cytoritx.com

 

Jetzt geht der Kurs kräftig hoch!

Bei 6.50 USD wird es sich entscheiden, ob die beginnende Kommerzialisierung endlich vom Markt anerkannt wird.  

Leider nix entschieden....  

Endgültig?  

Press Release Source: Cytori Therapeutics


Cell-Enhanced Breast Reconstruction Study Shows Sustained Improvement at 12-Months
Friday February 22, 8:00 am ET


SAN DIEGO--(BUSINESS WIRE)--Cytori Therapeutics (NASDAQ:CYTX - News) was informed that positive longer-term follow-up data were presented today from an independent, investigator-sponsored breast reconstruction study in Japan. As part of the study, adipose tissue-derived stem and regenerative cells, processed with Cytori’s Celution™ 600 System, were used to reconstruct breast tissue following partial mastectomy. New data from the study showed:
Patient satisfaction remained at 79 percent, with a mean follow-up of 12-months
The procedure remains safe and well tolerated
There was no significant loss of breast tissue thickness from one month to a mean follow up of 12-months
The procedure reconstructed partial mastectomy defects in 21 women with no metastases or recurrence at least one year after tumor resection. A statistically significant improvement in average breast tissue thickness at one month following treatment was reported in December at the San Antonio Breast Cancer Symposium.

The results were presented at the 9th Japan-Korea Congress of Plastic and Reconstructive Surgery by Kaoru Kitamura, M.D., Ph.D., Department of Breast Surgery, Kyushu Central Hospital, Fukuoka, Japan. Dr. Kitamura is a co-investigator of the study with Dr. Keizo Sugimachi, M.D., Ph.D. of Kyushu Central Hospital and Masaki Mori, M.D., Ph.D., of Kyushu University.

“The investigational procedure offers hope to partial-mastectomy patients who have limited options,” said Dr. Kitamura. “Unfortunately the concept of ‘breast conserving therapy’ can often times be misleading, as even minimally invasive resections can result in defects that leave patients dissatisfied with the cosmetic outcome.”

In the study, tissue loss resulting from partial mastectomy was reconstructed with each patient's own liposuctioned fat, which was combined and enhanced with her own adipose-derived stem and regenerative cells. These cells were made available at the time of surgery using Cytori's device, the Celution™ 600 System.

Two clinical studies will be initiated this year in Europe by Cytori to further evaluate adipose-derived stem and regenerative cells, processed with the Celution™ 800 System, in breast reconstruction following partial mastectomy. One study, RESTORE II, will evaluate up to 70 patients at multiple trial sites. A second study, VENUS, will be a 20-patient single center study in patients with more severe radiation damage and contour defects.

Cytori Therapeutics

Cytori Therapeutics’ (NASDAQ:CYTX) goal is to be the global leader in regenerative medicine. The company is dedicated to providing patients with new options for reconstructive surgery, developing treatments for cardiovascular disease, and banking patients’ adult stem and regenerative cells. The Celution™ 800 System is being introduced in Europe into the reconstructive surgery market while the Celution™ 900 System will be launched in Japan for cryopreserving a patient’s own stem and regenerative cells. Clinical trials are ongoing in cardiovascular disease and planned for spinal disc degeneration, gastrointestinal disorders, and other unmet medical needs. (www.cytoritx.com)

Cautionary Statement Regarding Forward-Looking Statements


This press release includes forward-looking statements regarding events, trends and prospects of our business, 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 and uncertainties include our history of operating losses, the need for further financing, regulatory uncertainties, dependence on performance of third parties, and other risks and uncertainties described (under the heading "Risk Factors") in Cytori Therapeutics' Form 10-K annual report for the year ended December 31, 2006. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.

 

zu kaufen..... Jetzt 6,20. :-)

http://de.advfn.com/...chart&s=cytx&p=0&t=17&dm=0&vol=1&cb=1136389482  

Oberkante war wie angekündigt drin und jetzt ist akut Ausbruchsgefahr gegeben, allerdings natürlich gibts natürlich auch trader mit Gewinnmitnahmeambitionen.....

Ich hoffe das cytx jetzt nicht die Puste ausgeht und genügend Nachkäufer die Ausbruchschance wahrnehmen. Ein Ausbruch dürfte zügig auf 8,50 bis 9 USD führen.  

 

Und im Eurochart ists eh kein Seitwärts sondern ein Downtrend.....  

12.03.2008 13:19

Cytori Reports 4th Quarter and Year End Results; Provides Update on Commercialization Progress

Cytori Therapeutics (News) (NASDAQ:CYTX) reports financial results for the year and quarter ended December 31, 2007, reviews 2007 highlights, and provides update on Celution™ System commercialization progress. “In 2007, we established the foundation for the commercial introduction of the Celution™ System family of products which was our largest priority for the year,“ said Christopher J. Calhoun, chief executive officer for Cytori. “As a result, we received our first orders for the Celution™ 800 CRS into the European reconstructive surgery market and commercialization efforts are well underway in Japan for StemSource™ Cell Banks. “For 2008 we look forward to expanding adoption of the Celution™ 800 and initiating breast reconstruction studies for partial mastectomy defects; receiving the first of multiple StemSource™ orders in Japan by Green Hospital Supply; and advancing our product pipeline. Based on anticipated product orders, we are maintaining our 2008 revenue guidance of $10 million to $12 million.“ Reconstructive Surgery Market Introduction Cytori received orders for 11 Celution™ 800 Systems in the first quarter of 2008. The Company's goal for 2008 is to introduce the device to select surgeons and hospitals in Europe and Asia-Pacific to build familiarity with the device ahead of the broader market launch anticipated to follow the completion of the planned clinical studies. Current efforts are being supported by a training facility in Europe, where physicians can observe live cases utilizing the Celution™ 800. Cytori is planning two European clinical studies for partial mastectomy defect reconstruction. One study, RESTORE II, will take place at multiple centers. The other, VENUS, will be at a single center in patients with more severe damage from radiation therapy. Trial designs have been completed and Cytori is currently working through final, customary details with participating hospitals and country-specific review process. Positive results from an investigator initiated study in Japan on partial mastectomy defect reconstruction using the Celution™ System were reported in December 2007. Key findings showed safety, a statistically significant increase in tissue thickness, and 79% patient satisfaction. More importantly, the reported clinical results suggest this novel product is easy to use for surgeons. StemSource™ Launch The StemSource™ Cell Bank commercialization efforts are ongoing by Green Hospital Supply, our exclusive cell bank distribution partner in Japan. Green Hospital Supply, with the support of Cytori, is working closely with a targeted selection of large private and academic hospitals to receive the first StemSource™ orders. Regulatory clearance for use of the Celution™ 900 for cell banking was achieved in the fourth quarter of 2007; commercial-scale manufacturing process has been validated; the software application and patient database has been developed; and supply agreements for Cytori-sourced equipment have been finalized. Product Pipeline Cytori's most advanced pipeline product is in cardiovascular disease, for which two double-blind, randomized, dose-escalating, placebo controlled clinical trials are underway in Europe. Our PRECISE trial in patients with chronic heart disease was initiated in the first quarter of 2007 and enrollment is now well into the second of three 12-patient cohorts. The APOLLO trial in heart attack patients was initiated in the fourth quarter of 2007 and enrollment is now well into the first of four 12-patient cohorts. Preclinical progress has been made in other therapeutic applications, including spinal disc disease, and we expect to advance one or more applications into clinical trials in the next six to 18 months. 2007 Financials Development revenues for the quarter and year ended December 31, 2007 were $25,000 and $5.3 million, respectively, compared to $5.2 million and $6.5 million, respectively, for the same periods in 2006. The majority of these revenues were recognized as performance milestones linked to the Olympus-Cytori Joint Venture were met. 2007 milestones included completion of a pre-clinical study in the second quarter and achieving a development milestone in the third quarter. Development revenues will fluctuate until the remaining $18.7 million in deferred revenue, related party stemming from the Olympus-Cytori Joint Venture is recognized. Product revenues for the year ended December 31, 2007 were $792,000, compared to $1.5 million for 2006. All of the 2006 and 2007 product revenues came from Cytori's non-core HYDROSORB™ surgical implant product line, which the Company sold to Kensey Nash Corporation in May 2007 for $3.2 million. Research and development expenses for the quarter and year ended December 31, 2007 were $5.4 million and $20.0 million, respectively, compared to $5.2 million and $22.0 million, respectively, in the same periods in 2006. Sales and marketing expenses for the quarter and year ended December 31, 2007 were $1.0 million and $2.7 million, respectively, compared to $0.5 million and $2.0 million, respectively, for the same periods in 2006. General and administrative expenses for the quarter and year ended December 31, 2007 were $4.4 million and $14.2 million, respectively, compared to $2.5 million and $12.5 million, respectively, for the same periods in 2006. Total operating expenses for the year and quarter ended December 31, 2007 increased over the same periods in 2006 due in part to expenses associated with initial setup for Celution™ System manufacturing, accounting and legal expenses, clinical trial costs, and sales and marketing expenses for increased commercialization activities. This was partially offset by a decline in expenses for preclinical studies. Net loss for the quarter and year ended December 31, 2007 was $10.7 million, or $(0.44) per common share, and $28.7 million, or $(1.25) per common share, respectively, compared to a net loss of $1.9 million, or $(0.10) per common share, and $25.4 million or $(1.53) per common share, respectively, for the same periods in 2006. Cash, cash equivalents and short term investments were $11.5 million as of December 31, 2007, compared to $12.9 million at the end of 2006. Subsequent to the end of the year, Cytori entered into an equity agreement with Green Hospital Supply, who purchased 2.0 million shares of unregistered Cytori common stock at $6.00 per share. Cytori received a $6.0 million payment for the first million shares on February 29, 2008 and will receive a $6.0 million payment for the second million shares on or before April 30, 2008. 2008 Financial Projections For 2008, Cytori currently anticipates the following: $10-$12 million in total product revenues; $1.5 million in development revenues; $22-$24 million in research and development expenses; greater sales and marketing expenses compared to 2007 primarily to expanding commercialization activities; and a reduction in general administrative expenses to $10-$12 million. Management Discussion Cytori's management will host a conference call at 10:00 a.m. Eastern Standard Time today to discuss these results and the Company's outlook for 2008. The audio webcast of the conference call may be accessed under “Events &Webcasts“ in the Investor Relations section of the Company's website at www.cytoritx.com. The webcast will be available live and by replay two hours after the call on the company's website and archived for 90 days. A telephone replay will be available for one week. To access the replay, please call +1 (303) 590-3000 (PIN: 11109084#). Cytori Therapeutics Cytori Therapeutics' (NASDAQ:CYTX) goal is to be the global leader in regenerative medicine. The company is dedicated to providing patients with new options for reconstructive surgery, developing treatments for cardiovascular disease, and banking patients' adult stem and regenerative cells. The Celution(TM) 800 System is being introduced in Europe into the reconstructive surgery market while the Celution(TM) 900 System will be launched in Japan for cryopreserving a patient's own stem and regenerative cells. Clinical trials are ongoing in cardiovascular disease and planned for spinal disc degeneration, gastrointestinal disorders, and other unmet medical needs. www.cytoritx.com Cautionary Statement Regarding Forward-Looking Statements This press release 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 and uncertainties include our history of operating losses, the need for further financing, regulatory uncertainties regarding the collection and results of, clinical data, dependence on third party performance, and other risks and uncertainties described under the "Risk Factors" in Cytori Therapeutics' Securities and Exchange Commission Filings. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made. Unaudited Consolidated Statements of Operations and Comprehensive Loss               Three Months Ended December 31,     For the Years Ended December 31,       2007       2006       2007       2006                           Product revenues, related party $ “”     $ 363,000     $ 792,000     $ 1,451,000                           Cost of product revenues   “”       293,000       422,000       1,634,000                           Gross profit (loss)   “”       70,000       370,000       (183,000 )                         Development revenues:                       Development, related party   “”       5,222,000       5,158,000       5,905,000   Development   “”       3,000       10,000       152,000   Research grants and other   25,000       7,000       89,000       419,000                               25,000       5,232,000       5,257,000       6,476,000   Operating expenses:                       Research and development   5,438,000       5,228,000       20,020,000       21,977,000   Sales and marketing   995,000       471,000       2,673,000       2,055,000   General and administrative   4,408,000       2,542,000       14,184,000       12,547,000   Change in fair value of option liabilities   “”       (917,000 )     100,000       (4,431,000 )                         Total operating expenses   10,841,000       7,324,000       36,977,000       32,148,000                           Operating loss   (10,816,000 )     (2,022,000 )     (31,350,000 )     (25,855,000 )                         Other income (expense):                       Gain on sale of assets   “”       “”       1,858,000       “”   Interest income   181,000       170,000       1,028,000       708,000   Interest expense   (27,000 )     (41,000 )     (155,000 )     (199,000 ) Other expense, net   (8,000 )     (13,000 )     (46,000 )     (27,000 ) Equity loss from investment in joint venture   (9,000 )     (5,000 )     (7,000 )     (74,000 )                         Total other income   137,000       111,000       2,678,000       408,000                           Net loss   (10,679,000 )     (1,911,000 )     (28,672,000 )     (25,447,000 )                         Other comprehensive income (loss) - unrealized holding income (loss)   “”       35,000       (1,000 )     17,000                           Comprehensive loss $ (10,679,000 )   $ (1,876,000 )   $ (28,673,000 )   $ (25,430,000 )                         Basic and diluted net loss per common share $ (0.44 )   $ (0.10 )   $ (1.25 )   $ (1.53 )                         Basic and diluted weighted average common shares   24,037,980       18,715,967       22,889,250       16,603,550             http://www.finanznachrichten.de/...chten-2008-03/artikel-10327074.asp

 

 

Behandlung von Herzinfarkten mit Stammzellen aus körpereigenem Fett
Hohes therapeutisches Potenzial von Körperfett

Wien (pts/27.03.2008/10:55) - Wurde abgesaugtes Fett bisher achtlos weggeworfen, ist das immense therapeutische Potenzial von aus dem Fettgewebe gewonnenen Stammzellen im Moment Gegenstand mehrerer klinischer Studien. DDr. Karl-Georg Heinrich, Experte für Ästhetische Medizin und Anti-Aging aus Wien: "Wir setzen körpereigene Stammzellen, gewonnen durch Fettabsaugungen mit Mikrokanülen, bereits jetzt erfolgreich zur Behandlung von Gewebsdefekten, bei der Brustvergrößerung und zur Hautverjüngung ein."

Fett ist eine der reichsten Quellen an regenerativen Zellen im Körper. Es enthält neben adulten Stammzellen auch andere wichtige Zelltypen, von denen sich zeigte, dass sie die Durchblutung in geschädigtem Herz-Muskel-Gewebe erhöhen.

"Eine große Herausforderung bei kardiovaskulärer Zelltherapie ist, über eine ausreichende Zahl an Stammzellen und regenerativen Zellen zu verfügen", sagte Francisco J. Fernández-Avilés, Leiter des Department of Cardiology am Hospital Universitario Gregorio Marañón und einer der Forscher am APOLLO-Versuch. "Bis jetzt haben wir mehrere Patienten mit chronischer Ischämie behandelt und wir konnten eine ausreichende Menge an körpereigenen Zellen in Echtzeit vorbereiten".

Beim APOLLO-Versuch handelt es sich um einen randomisierten, Placebo-gesicherten Versuch mit 48 Patienten, der bei Steigerung der Dosis Sicherheit und Machbarkeit der Behandlung von Herzinfarkten mit körpereigenen Stammzellen untersuchen soll. Der Versuch wird an mehreren Zentren durchgeführt.

Stammzellen, die bei kosmetischen Fettabsaugungen aus dem körpereigenen Fett des Patienten gewonnen wurden, könnten für eine breite Palette von akuten und chronischen Organerkrankungen eingesetzt werden.  

http://www.n-tv.de/941817.html?310320081524

Montag, 31. März 2008
Therapie nach Herzinfarkt
Stammzellen enttäuschen

Bei der Behandlung von Herzinfarkt-Patienten mit Stammzellen ist nach Experteneinschätzung eine gewisse Ernüchterung eingekehrt. Einige Studien konnten keine deutlichen Verbesserungen nachweisen, berichtete der Kardiologe Prof. Johann Bauersachs von der Universität Würzburg beim Internistenkongress in Wiesbaden. Außerdem gebe es Untersuchungen, nach denen nur 0,5 Prozent oder weniger der aus dem Knochenmark gewonnenen Zellen auch Herzmuskelzellen bildeten. Hinzu komme, dass sich Knochenmarkszellen von älteren Patienten nicht so gut umbildeten wie erwartet.

Allerdings wird laut Bauersachs an Verfahren gearbeitet, die Regenerationsfähigkeit solcher Stammzellen zu verbessern. Andere Untersuchungen hatten gezeigt, dass die Pumpleistung des Herzens nach einem Infarkt mit Hilfe von Stammzellen aus Knochenmark deutlich besser wird. Infarkte führen zum Absterben von Herzmuskelzellen, so dass sich eine Herzschwäche einstellt.

Studien weiterführen

Bevor sich die Therapie mit Stammzellen etablieren kann, sind nach Ansicht von Bauersachs größere klinische Studien nötig, um etwa den optimalen Zelltyp und den besten Zeitpunkt der Transplantation nach einem Infarkt herauszufinden. Die Medizin setze weiterhin auf Stammzellen gegen Herzkrankheiten.


Zum 114. Kongress der Deutschen Gesellschaft für Innere Medizin (DGIM) von Sonntag bis Mittwoch haben sich mehr als 8000 Mediziner angekündigt. Bei dem Treffen geht es nicht nur um neue Forschungen und Behandlungsmöglichkeiten, sondern unter anderem auch um die optimale Versorgung Kranker und die damit verbundenen Kosten.
 

k (osaka) wird das Verfahren einsetzen!

TOKYO, Apr 03, 2008 (BUSINESS WIRE) -- Enrollment was completed in a 20 patient investigator-initiated study in Japan using adipose-derived stem and regenerative cells in breast augmentation procedures. The study, which began November 2007, is evaluating a procedure whereby a woman's fat tissue is enriched with her own adipose derived stem and regenerative cells to create a natural filler. This technique is referred to as 'cell-enhanced reconstruction.'

The stem and regenerative cells in the study were made available at the time of surgery using the Celution(R) 800 System, an investigational device from Cytori Therapeutics (NASDAQ: CYTX). This independent, investigator-initiated study is being sponsored by Tatsuro Kamakura, M.D., Chief Medical Officer of Cosmetic Surgery Seishin in Japan. Results of the study will be available following a nine month assessment of the primary endpoints of cosmetic improvement and volume retention.

"Our clinic's goal for this study was to learn if cell-enhanced reconstruction is feasible for bilateral cosmetic breast augmentation as an alternative to implants," said Dr. Kamakura. "We look forward to assessing the procedure's effect on volume retention following the nine-month follow-up period as we believe that cell-enhanced reconstruction could overcome the challenges often associated with conventional, non-cell-enhanced fat grafting. We plan to continue offering cell-enhanced reconstruction to our patients in Tokyo and expand it to patients in our Osaka clinic as well."

Fat, known medically as adipose tissue, is the body's richest known source of regenerative cells. Adipose-derived regenerative cells include adult stem cells in addition to other important cell types that have been shown pre-clinically to improve tissue retention compared to non- 'cell enhanced' tissue transfers. For this reason, these cells potentially may improve and simplify traditionally complex fat transfer procedures as well as enable more predictable outcomes and graft retention when applied to cosmetic and reconstructive surgery.

Cytori Therapeutics

 

 

Nagasaki University Awarded Clinical Research Grant to Study Cell-Enhanced Reconstruction in HIV Therapy-Induced Facial Atrophy Using Celution® 800 System

SAN DIEGO & NAGASAKI, Japan, Apr 09, 2008 (BUSINESS WIRE) -- Nagasaki University will sponsor and perform a clinical study on the use of cell-enhanced reconstruction in HIV therapy-induced facial atrophy, a condition where adipose (fat) tissue becomes unevenly lost, leaving patients with a gaunt appearance. The study will be funded through a three year, 58.5 million yen grant (approx. U.S. $600,000), which was awarded to Nagasaki University by the Japanese Ministry of Health, Labour and Welfare. Cytori's research team will collaborate with Nagasaki University to optimize the treatment formulation prior to commencement of clinical research.

The need for this research is based upon increasing demand by patients with HIV seeking new options to restore their facial appearance after long-term use of potent protease inhibitor drugs. This represents an important unmet medical need, for which cell-enhanced reconstruction may provide a potential solution. Cell-enhanced reconstruction combines a patient's own stem and regenerative cells with their own fat tissue as a matrix. It has been used on many patients for the restoration and reconstruction of soft tissue loss. The stem and regenerative cell will be made available in real-time from the patient's own adipose tissue using the Celution® 800 System from Cytori Therapeutics (NASDAQ: CYTX).

"The treatment of facial wasting in patients with HIV who have undergone protease inhibitor therapy represents another potential medical application within the field of reconstructive surgery for adipose-derived stem and regenerative cells and our Celution® 800 System," said Marc H. Hedrick, M.D., president, Cytori. "The goal of this study will be to show cell-enhanced reconstruction in HIV-induced facial wasting is clinically feasible and effective."

Adipose tissue is a rich source of regenerative cells that have been shown pre-clinically to improve volume retention and graft persistence as part of a cell-enhanced reconstruction. These adipose-derived regenerative cells include adult stem cells in addition to other important cell types. To facilitate a cell-enhanced reconstruction, Cytori developed its European-approved Celution® 800/CRS System to automate and standardize the process by which physicians can access their patient's adipose-derived stem and regenerative cells at the bedside.

Cytori

Cytori's (NASDAQ:CYTX) goal is to be the global leader in regenerative medicine. The company is dedicated to providing patients with new options for reconstructive surgery, developing treatments for cardiovascular disease, and banking patients' adult stem and regenerative cells. The Celution® 800 System is being introduced in Europe into the reconstructive surgery market while the Celution® 900 System will be launched in Japan for cryopreserving a patient's own stem and regenerative cells. Clinical trials are ongoing in cardiovascular disease and planned for spinal disc degeneration, gastrointestinal disorders, and other unmet medical needs. www.cytoritx.com

Cautionary Statement Regarding Forward-Looking Statements

This press release 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 and uncertainties include our history of operating losses, the need for further financing, regulatory uncertainties regarding the collection and results of, clinical data, dependence on third party performance, and other risks and uncertainties described under the "Risk Factors" in Cytori's Securities and Exchange Commission Filings. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.

SOURCE: Cytori

Cytori
Tom Baker, 858-875-5258
tbaker@cytoritx.com

Copyright Business Wire 2008

 

 

 

Gähn  

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17.04.2008 11:05

pressetext.de: Busenwunder ohne Silikon - mit Stammzell-angereichertem Eigenfett

DJ pressetext.de: Busenwunder ohne Silikon - mit Stammzell-angereichertem Eigenfett Wien (pts/17.04.2008/10:00) - Dauerhafte, natürliche Brustvergrößerung mit körpereigenen Stammzellen ohne Skalpell, Narben und Silikon statt "Fußballbrüsten". Kürzlich ging ein Bericht über die Silikon-Brustvergrößerung der Freundin eines Ex-Fußballers durch die Medien. Solche Berichte über Brustvergrößerungen mit Silikon an Prominenten bewirken, dass Patientinnen Silikon irrtümlich als die aktuelle und optimale Methode zur Brustvergrößerung wahrnehmen. Dank aktueller Erkenntnisse auf dem Gebiet der Stammzellen und moderner medizinischer Technologie sind Frauen nun nicht mehr auf Kunststoff-Kissen angewiesen, wenn sie ihre Brüste vergrößern lassen möchten. So können kleine oder schlaffe Brüste nun schonend und natürlich mit Stammzell-angereichertem Eigenfett vergrößert werden. DDr. Karl-Georg Heinrich, Experte für Ästhetische Medizin und Anti-Aging aus Wien, bietet diese Methode als erster Mediziner Europas in der "Clinic DDr. Heinrich" an: "Die Brustvergrößerung mit Stammzellen ermöglicht vielen Frauen eine nachhaltige, natürliche Brustvergrößerung ohne Implantate und Operationsnarben", so DDr. Heinrich. Mehrere klinische Studien aus Japan und den USA haben mittlerweile klargestellt, dass Stammzell-angereichertes Eigenfett ein ideales, haltbares und ungefährliches Füllmaterial für Brustrekonstruktionen nach Operationen aber auch zur kosmetischen Brustvergrößerung ist. Da die entnommenen Stammzellen nicht künstlich verändert oder vermehrt werden sind sich führende Experten der Stammzell-Forschung, wie Prof. Donnenberg, Universität Pittsburgh sicher, dass bei Implantation kein Risiko von Zellentartungen besteht. Zunächst wird Körperfett schonend mit speziellen, patentierten Mikrokanülen entnommen. Nach Anreicherung des Fettes mit körpereigenen Stammzellen wird das Fett mit ästhetischem Feingefühl in die Brüste injiziert. Die Einstichstellen der Injektionsnadeln verheilen - wie bei einer Blutabnahme - rasch und ohne Narbenbildung. Die Brustvergrößerung mit Stammzell-angereichertem Eigenfett erfolgt unter örtlicher Betäubung bzw. Dämmerschlaf ohne Vollnarkose. Der Nachsorgeaufwand ist gering, die Patientin wird nach dem Eingriff nach Hause entlassen und ist voll mobil. Typischerweise kann im Rahmen eines Eingriffs eine Brustvergrößerung um 1 bis 2 Körbchengrößen, das sind 50-300 ccm pro Seite, erzielt werden. Das transplantierte Volumen an Stammzell-angereichertem Körperfett bleibt zu fast 100 % erhalten. Im Vergleich dazu überdauern bei klassischer Eigenfett-Transplantation nur etwa 60-70 % des transplantierten Volumens langfristig. Die vergrößerte Brust fühlt sich völlig natürlich an und sieht auch in jeder Position "echt" aus, da das gewonnene Volumen nicht aus Silikon, sondern aus lebendigem, körpereigenem Fettgewebe besteht. Zu Einwänden von plastischen Chirurgen, dass Fetteinspritzung die Röntgen-Diagnose von Krebs erschweren könne meint DDr. Heinrich: "Jeder Eingriff an der Brust kann minimale Verkalkungen hervorrufen, die mit Krebs verwechselt werden können. Dies gilt ebenso für Silikonimplantate. Gute Röntgenologen können im Mammogramm erkennen, ob es sich um eine harmlose Verkalkung durch einen Eingriff oder um die Vorstufe von Krebs handelt. Im Zweifel klärt es die Magnetresonanzmethode". Da die Stammzellen aus körpereigenem Fett extrahiert und nicht aus Embryonen gewonnen werden, ist die Methode ethisch unbedenklich. Die zur Brustvergrößerung eingesetzten Stammzellen können in ausreichender Menge aus schonend abgesaugtem Fett entnommen werden und müssen vor der therapeutischen Anwendung - im Gegensatz zu Stammzellen aus Haut und Knochenmark - nicht künstlich zur Vermehrung angeregt werden. Zu welcher Art von Zellen (Haut-, Fett- und Muskelzellen etc.) sich die Stammzellen bei der Ausdifferenzierung zu erwachsenen Zellen entwickeln, wird durch das umgebende Gewebe gesteuert. DDr. Heinrich setzt Stammzell-angereichertes Eigenfett auch zum natürlichen Body-Forming an anderen Körperregionen wie Po, Hüften, Oberschenkel, Waden etc. sowie zur Dellenkorrektur und Hautverjüngung an Gesicht, Dekollete und Händen ein. "Stammzellen aus Fett besitzen eine besondere biologische Potenz, die Anwendungen weit über die Ästhetik hinaus, etwa zur Organverjüngung, nahe legen", sagt DDr. Heinrich. Wer also in Zukunft nicht unbedingt Wert auf "Fußball-Brüste" legt, die in Bewegung wie Bälle hin und her tanzen, wird sich wohl gerne die Brüste mit Stammzell-angereichertem Fett aus Po und Bauch natürlich und formschön vergrößern lassen. Weitere Informationen unter http://www.liposkulptur.at (Ende) Aussender: Clinic DDr. Heinrich Ansprechpartner: Mag. Thorwald Fastner Email: kunden@ddr-heinrich.at Tel.: +43 1 532 18 01, +43 664 458 05 36 Quelle: http://pressetext.com/pte.mc?pte=080417013 Dr. Heinrich der Stammzellen-Pionier arbeitet ab April 2008 mit Celution von Cytori!

 

Cytori ist mal wieder weit unten in der Range.
Wie oft das Spielchen noch geht? Keine Ahnung.  

Cytori Begins Breast Reconstruction Study in Europe

14:15 01.05.08

SAN DIEGO--(BUSINESS WIRE)-- Cytori (NASDAQ:CYTX) received approval to begin its European stem and regenerative cell-enhanced breast reconstruction study in breast cancer patients who have undergone partial mastectomy. This is a post-market study designated as RESTORE II. Currently, there is no generally accepted reconstructive technique for partial mastectomy patients despite the fact that breast conserving therapy is standard practice in the treatment of women with breast cancer worldwide. In this study, tissue loss resulting from partial mastectomy will be reconstructed with the patients own fat tissue (adipose), which will be enhanced with their adipose-derived stem and regenerative cells. This procedure is referred to as cell-enhanced reconstruction. The cells in RESTORE II will be made available at the time of surgery using Cytori's Celution® 800 System. The primary goal is to obtain European reimbursement for cell-enhanced reconstruction using the Celution® 800 System by measuring key quality of life improvements in breast cancer patients desiring reconstruction. Up to 70 women will be enrolled at six clinical centers in the U.K., Italy, Spain, and France. Primary endpoints will be patient and physician satisfaction with functional and cosmetic outcomes at six and 12 months after surgery. Cytoris goal is to complete enrollment before the end of March 2009. RESTORE II is important for advancing reconstructive options for women with breast cancer, said Professor Emmanuel Delay, the studys principal investigator and Chief of Plastic and Reconstructive Surgery at The Leon Bérard Cancer Center in Lyon France. A successful study should broaden availability of this therapy to partial mastectomy patients in Europe. Unfortunately fewer options are available to women desperate for reconstructive surgery following partial mastectomy due to the effects of the adjuvant radiotherapy, said Mrs. Eva Weiler-Mithoff, surgeon at the Glasgow Royal Infirmary, and lead investigator for the U.K. study site. Adipose tissue enriched with stem and regenerative cells represents a new approach that we believe allows for predictable graft retention. My ongoing clinical experience using Cytoris Celution® 800 System in breast reconstruction has been very encouraging, said Professor Claudio Calabrese, Associate Professor of Surgery and lead investigator at University of Florence Hospital. The preliminary results warrant further investigation as part of the broader, post-market RESTORE II study. Secondary endpoints include six and 12-month assessments of breast volume and shape via magnetic resonance imaging (MRI) and improvement in skin pigmentation. The study will evaluate patients who have undergone their last breast treatment at least 12-months prior and are recurrence free. The Celution® 800 System is what makes this an effective, reproducible, bedside procedure, said Dr. Marc H. Hedrick, president of Cytori. Cytori has customized this system to provide a cell output specific to breast reconstruction, to be easy to use for doctors and hospitals, and to be affordable. We believe this mix of attributes combined with our goal of reimbursement could fill a tremendous patient and market need. Fat, known medically as adipose tissue, is the body's richest known source of regenerative cells. Adipose-derived regenerative cells include adult stem cells in addition to other important cell types that have been shown pre-clinically to improve tissue retention compared to non-cell-enhanced tissue transfers. These results have been confirmed in physician-initiated clinical studies.

......

 

SAN DIEGO, May 09, 2008 (BUSINESS WIRE) -- Cytori Therapeutics (NASDAQ:CYTX) achieves first Celution(R) System revenues in the quarter ended March 31, 2008.

"Demand for the Celution 800 System has been very encouraging within the European and Asian reconstructive surgery market," said Christopher J. Calhoun, chief executive officer of Cytori. "Commercialization of our Celution System-based StemSource(R) Cell Bank also began during the quarter, generating significant interest among multiple hospitals in Japan, Asia and Europe. The depth and level of discussions with prospective customers gives us confidence that our full year product revenue projections remain on track for $10 to $12 million."

Reconstructive Surgery Market Introduction

Cytori received orders for 13 Celution 800 Systems during the first quarter of 2008 for customers and distributors in both Europe and Asia. This represents $954,000 in product that was shipped during the quarter, of which $801,000 will be recognized in the second quarter in accordance with the appropriate revenue recognition accounting policy. Additional orders have been received and are being filled during the second quarter.

The Company's goal for 2008 is to introduce the device to select surgeons and hospitals in Europe and Asia-Pacific to build familiarity with the device ahead of the broader market launch anticipated to follow the completion of the planned clinical studies.

Cytori recently announced that the RESTORE II post-marketing breast reconstruction study has begun. This study has been designed to support reimbursement and market adoption of the Celution 800 System for use in this application. The study will evaluate up to 70 partial mastectomy patients undergoing reconstructive surgery to restore the volume and contour lost from removal of breast tissue associated with tumor removal.

StemSource(R) Launch

The StemSource Cell Bank commercialization efforts are ongoing by Green Hospital Supply, our exclusive cell bank distribution partner in Japan. Green Hospital Supply, with the support of Cytori, is working closely with a targeted selection of large private and academic hospitals to receive the first StemSource Cell Bank orders in Japan. Additionally, Cytori is working directly with potential StemSource Cell Bank customers in Asia and Europe to expand the market for its fully developed cell banking products and systems.

Product Pipeline

Cytori's most advanced pipeline product is in cardiovascular disease, for which two double-blind, randomized, dose-escalating, placebo controlled clinical trials are underway in Europe. The PRECISE trial is in patients with chronic heart disease and enrollment is now well into the second of three 12-patient cohorts. The APOLLO trial is in heart attack patients and enrollment is well into the first of four 12-patient cohorts. Preclinical progress has been made in other therapeutic applications, including spinal disc disease, and we expect to advance one or more of these applications into clinical trials in the next six to 18 months.

Financials

Product revenue for the first quarter of 2008 was $153,000. Because this is the first time Cytori recognized Celution System-based product revenues, the first quarter of 2007 is not a comparable period. During the quarter, Cytori received orders for 13 Celution Systems plus consumables, amounting to $954,000 in shipped product into the European and Asian reconstructive surgery market. In the second quarter of 2008, Cytori will recognize $801,000 from the systems that were shipped in the first quarter.

Development revenue for the first quarter 2008 was $811,000 compared to $45,000 for the same period in 2007. The majority of this revenue was recognized by achieving performance milestones linked to the Olympus-Cytori Joint Venture.

Research and development expenses for the quarter ended March 31, 2008 were $5.0 million compared to $5.0 million in the same period in 2007. Sales and marketing expenses for the first quarter of 2008 were $958,000, compared to $546,000 for the same period in 2007. General and administrative expenses for the first quarter were $3.1 million, compared to $3.2 million for the same period in 2007. Net loss for the first quarter was $8.3 million, or $(0.34) per common share, compared to a net loss of $8.7 million, or $(0.43) per common share, for the same period in 2007.

Cash, cash equivalents and short term investments were $8.0 million as of March 31, 2007. After the end of the quarter, Cytori received $6.0 million from the sale of 1.0 million shares to Green Hospital Supply, Inc. This was the second payment as part of an agreement entered into in the first quarter of 2008 to sell 2.0 million shares at $6 per share.

Management Discussion

Cytori's management will host a conference call at 10:00 a.m. Eastern Daylight Time today to discuss these results and the Company's outlook for 2008. The audio webcast of the conference call may be accessed under "Events & Webcasts" in the Investor Relations section of the Company's website at www.cytoritx.com. The webcast will be available live and by replay two hours after the call on the company's website and archived for 90 days. A telephone replay will be available for one week. To access the replay, please call +1 (303) 590-3000 (PIN: 11113064#).

About Cytori

Cytori's (NASDAQ:CYTX) goal is to be the global leader in regenerative medicine. The company is dedicated to providing patients with new options for reconstructive surgery, developing treatments for cardiovascular disease, and banking patients' adult stem and regenerative cells. The Celution(R) 800 System is being introduced in Europe into the reconstructive surgery market while the Celution(R) 900 System will be launched in Asia-Pacific for cryopreserving a patient's own stem and regenerative cells. Clinical trials are ongoing in cardiovascular disease and planned for spinal disc degeneration, gastrointestinal disorders, and other unmet medical needs. www.cytoritx.com

Cautionary Statement Regarding Forward-Looking Statements

This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. These statements include, without limitation, statements about our anticipated revenue projections, expenditures and progress related to clinical studies, and future expansion of our product launches in the reconstructive surgery and stem cell banking market. Such forward-looking statements are not guarantees of future performance and actual results will likely differ, perhaps materially, from those anticipated in these forward-looking statements as a result of various factors, including: changes in laws or regulatory requirements, market conditions, product performance, unforeseen litigation, and competition within the regenerative medicine field. These and other risks and uncertainties are described under the "Risk Factors" section in our annual and quarterly reports filed with the Securities and Exchange Commission, and we encourage you to read our Risk Factors descriptions carefully. These statements, like all statements in this press release, speak only as of the date of this release (unless an earlier date is indicated) and we undertake no obligation to update or revise the statements except as required by law.



Consolidated Condensed Balance Sheets
(Unaudited)

As of As of
March 31, 2008 December 31, 2007
-------------- -----------------
Assets
Current assets:
Cash and cash equivalents $ 8,010,000 $ 11,465,000
Accounts receivable, net of
allowance for doubtful accounts
of $8,000 and $1,000 in 2008 and
2007, respectively 146,000 9,000
Inventories, net 360,000 --
Other current assets 782,000 764,000
-------------- -----------------

Total current assets 9,298,000 12,238,000

Property and equipment, net 3,270,000 3,432,000
Investment in joint venture 360,000 369,000
Other assets 507,000 468,000
Intangibles, net 1,023,000 1,078,000
Goodwill 3,922,000 3,922,000
-------------- -----------------

Total assets $ 18,380,000 $ 21,507,000
============== =================

Liabilities and Stockholders' Deficit
Current liabilities:
Accounts payable and accrued
expenses $ 6,707,000 $ 7,349,000
Current portion of long-term
obligations 601,000 721,000
-------------- -----------------

Total current liabilities 7,308,000 8,070,000

Deferred revenues, related party 17,974,000 18,748,000
Deferred revenues 2,379,000 2,379,000
Option liability 1,200,000 1,000,000
Long-term deferred rent 399,000 473,000
Long-term obligations, less current
portion 184,000 237,000
-------------- -----------------

Total liabilities 29,444,000 30,907,000

Commitments and contingencies
Stockholders' deficit:
Preferred stock, $0.001 par value;
5,000,000 shares authorized;
shares issued and outstanding in
2008 and 2007 -- --
Common stock, $0.001 par value;
95,000,000 shares authorized;
26,976,732 and 25,962,222 shares
issued and 25,103,898 and
24,089,388 shares outstanding in
2008 and 2007, respectively 27,000 26,000
Additional paid-in capital 136,108,000 129,504,000
Accumulated deficit (140,405,000) (132,132,000)
Treasury stock, at cost (6,794,000) (6,794,000)
Amount due from exercises of stock
options -- (4,000)
-------------- -----------------

Total stockholders' deficit (11,064,000) (9,400,000)
-------------- -----------------

Total liabilities and
stockholders' deficit $ 18,380,000 $ 21,507,000
============== =================





Consolidated Condensed Statements of Operations and Comprehensive Loss
(Unaudited)

For the Three Months
Ended March 31,
2008 2007
------------ ------------
Product revenues:
Related party $ -- $ 280,000
Third party 153,000 --
------------ ------------
153,000 280,000
------------ ------------


Cost of product revenues 60,000 225,000
------------ ------------

Gross profit 93,000 55,000
------------ ------------

Development revenues:
Development, related party 774,000 --
Research grants and other 37,000 45,000
------------ ------------
811,000 45,000
------------ ------------

Operating expenses:
Research and development 4,963,000 4,996,000
Sales and marketing 958,000 546,000
General and administrative 3,111,000 3,166,000
Change in fair value of option
liabilities 200,000 200,000
------------ ------------

Total operating expenses 9,232,000 8,908,000
------------ ------------

Operating loss (8,328,000) (8,808,000)
------------ ------------

Other income (expense):
Interest income 76,000 197,000
Interest expense (23,000) (52,000)
Other income (expense), net 11,000 (4,000)
Equity loss from investment in joint
venture (9,000) (2,000)
------------ ------------

Total other income, net 55,000 139,000
------------ ------------

Net loss (8,273,000) (8,669,000)
------------ ------------

Other comprehensive loss - unrealized loss -- (1,000)
------------ ------------

Comprehensive loss $(8,273,000) $(8,670,000)
============ ============

Basic and diluted net loss per common share $ (0.34) $ (0.43)
============ ============

Basic and diluted weighted average common
shares 24,442,655 20,063,750
============ ============



SOURCE: Cytori Therapeutics

Cytori Therapeutics
Tom Baker, 858-875-5258
tbaker@cytoritx.com

 

Fraglich nur, ob jetzt der Vielfachwiderstand im Bereich jenseits 6 USD endlich geknackt werden kann.