Cytori Therapeutics
Ob es die CE für EU schon gibt, weiß ich nicht, aber eines habe ich in den letzten Tagen erkannt:
Ich muss mich mal hinsetzen und die Fakten aus diversen Quellen zusammentragen und aufbereiten.
Meine beiden Zwillinge haben übrigens jeweils 200 Stück seit einer Woche im Depot und die verkaufe ich erst, wenn die beiden Kleinen Führerschein machen. Also in ca. 17 Jahren :-)
Wenn Du Dich einliest, stolperst Du eventuell über die Zulassungsprozeduren der Pharmaindustrie, i.e. Phase I, II und III. Das ist bei der FDA in diesem Falle anders: es kommt direkt Phase III und das nennen die dann Pivot-Trial. Das Erstaunliche ist, dass dies nach so wenigen Patienten der Fall ist, was wiederum bedeutet, dass bei Phase II die Ergebnisse exzellent waren. Aber lies Dich in Ruhe ein, es ist ziemlich kompliziert.
Zur Zeit ist Short-Festival, aber das geht vorbei. Die Kern-Story ist einfach zu gut!
.... gleich mal eine kleine vorsichtige Position. Ich denke die neutrale Zone (gibts sowas überhaupt?) liegt zwischen Anfang 2007 und Mitte 2008. Also Kurse zwischen ca. 4,80€ und 6,30€. Genau da sind wir heute wieder angekommen.
Mal angenommen, jemand hat die Chance genutzt und hat sich ein richtiges fettes Paket zusammengekauft, wie hätte er das in normalen Zeiten jemals machen können, ohne den Preis in astronomische Höhen zu treiben? 1:0 für die Herren Shorties!
Zwischen 4,32 und 4,74 sollte es spätestens drehen, für eine technische Reaktion. Das war meine Vermutung. Diese Zone wurde mit einem Tief von 4,66 bereits erreicht.
Im Laufe der nächsten Woche wird sich zeigen, ob gegen diese massive Abwärtsdynamik ein Boden eingezogen werden kann, oder ob der Kurs weit in die Unterstüzungszone eindringen kann.
Der Aufwärtstrend seit ATL ist bereits angeschlagen und wird nicht halten können.
Im Moment wäre es wohl als positives Szenario zu sehen, wenn CYTX es schafft sich zwischen 4,50 und 6,50 einzupendeln, um auf die Herzdaten im Mai zu warten.
Kann cytori jetzt den Boden ausbilden?
Könnte mir vorstellen, dass jetzt eine gute Zone zum kaufen wäre mit Risikopuffer bis hochstens 3 hinunter.
Aber klar: Nur mit guten Nerven und nicht zu hohem Einsatz.
Die Aktie hat Potential bis 30 oder 50 in wenigen Jahren, wenn sie nicht eingehen....
Press Release Source: Cytori On Thursday April 22, 2010, 8:30 am
SAN DIEGO--(BUSINESS WIRE)--Cytori announces the product launch of PureGraft 250, a revolutionary fat grafting technology that standardizes the graft preparation process for use in aesthetic body contouring at the American Society of Aesthetic Plastic Surgeons (ASAPS) meeting.
“PureGraft is a game-changer in the world of fat grafting,” says San Diego-based plastic surgeon Steven Cohen, MD. “The system offers high speed and sterile preparation of a viable and functional fat graft that is ready to inject, and takes a third of the time to prepare three times the graft.”
According to the American Society of Aesthetic Plastic Surgeons, over 46,000 autologous fat injection procedures were performed in the US in 2008. These procedures include adding volume to facial areas such as cheeks, tear troughs, chin and jowls, as well as reshaping the breasts and enhancing the buttocks during aesthetic body contouring. Up until now, fat grafting methods and results varied widely among practitioners. Common complications included skin irregularities, contour defects, prolonged bruising and swelling, excessive resorption as well as inconsistent outcomes.
The PureGraft System sets a new standard for fat graft processing due to its speed, simplicity, safety and precision. The ease of use and simplicity of this innovative system sets it apart from other fat grafting methods. As a result, processing takes only 15 minutes from fat extraction to delivery, irrespective of volume. The volumes that can be processed range from 50 to 250 mL.
The PureGraft technology enables the physician to purify a fat graft and remove excess ‘graft fluid’ in a controllable manner on the sterile field. This is accomplished without centrifugation or other motorized methods. The fat is added to the system and 15 minutes later, free lipid, blood cells, infusion chemicals and excess fluid are removed. PureGraft technology ‘dialyzes’ off everything but the pure fat tissue.
“PureGraft is an FDA-cleared device that is indicated for cosmetic ‘body contouring’ procedures using autologous fat grafts,” stated Marc H. Hedrick, M.D., President of Cytori. “Although PureGraft is simple to use, the technology behind it is unique. PureGraft selectively filters the graft using dialysis membranes in a process best called lipodialysis. We believe lipodialysis will be the new standard in fat graft preparation.”
About Cytori
.....
http://finance.yahoo.com/news/...arket-bw-214046259.html?x=0&.v=1
Aber Quartalszahlen und Studiendaten in Spanien sollten den Aufmerksamkeitsschub bringen können im Mai.
Oberhalb kommt schnell der nächste Angriff auf die 9.
ich bin jetzt auch mit 1000 Stück in Cytori eingestiegen, aus eigenen Fett Stammzellen zu gewinnen die dann Brustreparaturen bei Brustkrebs zum Ziel haben ist eine tolle Sache und zudem die gewonnenen Stammzellen bei Herzkrankheiten einzusetzen ....
Schaun mer mal was die Ergebnisse der Trials am 7.5.2010 bringen!
Die Stammzellen bekämpfen den Brustkrebs nicht. Mit Hilfe der Stammzellenangereicherten Fettzellen kann man nach Total- oder Teilweiser Entfernung der Brust wieder Gewebe aufbauen.
Was aber auch geht ist Brustvergrößerung (statt Silikon).
Es gibt aber eine Viezahl laufender Studien neben den kosmetischen Anwendungen die gerade ins rollen kommen:
Herzinfarkt, Inkontinenz, Bandscheibenschäden, Leberschaden usw. usf.....
Hier kann mit langem Atem ein Verfielfacher blühen.
ich hab mich schlampig ausgdrückt! Ein Artikel macht ja nicht allzu viel Hoffnung auf die Herzstudie, oder:
Cytori Stem Cell Cardiac Data Preview
By Adam Feuerstein 05/05/10 - 11:48 AM EDT 4 Comments Loading Comments... Add Comment
Stock quotes in this article: CYTX
SAN DIEGO (TheStreet) -- Cytori Therapeutics(CYTX) is hoping to demonstrate that adult stem cells harvested from belly fat can repair damaged heart tissue. Towards this goal, Cytori on Friday will release updated results from a couple of small (and perhaps controversial) mid-stage studies of its Celution System in heart disease patients.
More from Adam Feuerstein The InterMune Debacle Post-ScriptInterMune Lung Drug Rejected by FDANew Cancer Vaccine the Next Dendreon? Market Activity Cytori Therapeutics Incorporated| CYTX DOWNThe Celution System is an experimental device in the U.S. that harvests and enriches adult stem cells derived from a patient's abdominal fat collected by a surgeon through a standard liposuction procedure. In two, phase II studies, Cytori is infusing those fat-derived adult stem cells back into the hearts of patients who either suffered a heart attack (the Apollo study) or have a diagnosis of advanced coronary artery disease (the Precise study.)
The primary objective of both the Apollo and Precise studies are to determine whether the entire procedure -- the liposuction of fat, the harvesting of adult stem cells and the re-infusion of those stem cells back into the patient's heart -- is safe. Secondarily, Cytori will use various measures to determine if the adult stem cells are having any effect on damaged heart tissue.
If my email inbox and Twitter feed are any guides, investors are eagerly anticipating the new data from the Cytori cardiac studies. Cytori shares, at around $6, are up about 30% from the stock's recent lows.
A few things to note about the Cytori cardiac studies in advance of the data presentation on Friday, May 7 at the Stem Cell Therapy & Cardiovascular Innovation meeting in Madrid, Spain:
Both Apollo and Precise enrolled a small number of patients, which might make it difficult to extrapolate anything definitive about the efficacy of adult stems and heart tissue repair. In fact, both studies were significantly downsized. The Apollo study, for example, was designed originally to enroll about 48 patients treated in four cohorts, each treated with an escalating volume of adult stem cells. Cytori, however, enrolled just 12 patients (nine patients receiving stem cells, three patients receiving placebo) using a single dose volume of stem cells.
In March 2009, Cytori said a steering committee and independent safety monitors concluded that the safety and feasibility goal in the Apollo trial was met at the initial dose, therefore enrolling additional patients at higher doses wasn't necessary. [The Precise study, similarly, enrolled a smaller number of patients than originally intended.]
Cytori executives told me in a recent phone interview that the Apollo study was not powered for efficacy. If that's true, it will be interesting to see what Cytori and its researchers say Friday about the clinical effect these stem cells are having on damaged heart tissue.
A key question moving forward will be whether Cytori can get regulators either in the U.S. or in Europe to sign off on larger, phase III studies of the Celution System in cardiac repair based on data from a handful of patients treated at a single dose. If not, will regulators require Cytori to conduct additional phase II studies? Cytori sells the Celution System in Europe already although the company can't make any therapeutics claims about the stem cells harvested from the device. Doctors in Europe use Celution primarily for breast reconstruction or enhancement procedures, despite the lack of data from controlled studies showing that stem cell-enriched fat is any better than "ordinary" fat.
In the U.S., Cytori suffered a setback in March when the U.S Food and Drug Administration said additional, larger studies would be required before the company could seek approval here for the Celution System.
It's been little publicized, but safety data from the Apollo study was presented already in March at the American College of Cardiology (ACC) conference. (Cytori did not issue a press release or otherwise announce the safety data presentation.) According to the Apollo safety data presentation at the ACC meeting, two patients suffered bleeding complications during liposuction, after which blood-clotting procedures used in the study were changed.
In the six-month follow-up period of the study, two patients reported complications -- one episode of unstable angina requiring hospitalization and another patient with a new blockage in a coronary artery requiring treatment.
Echoing Cytori's statement from March 2009, the Apollo safety poster at ACC says data monitors and independent safety inspectors deemed the study complete and the stem cell infusion procedure safe and feasible in patients with heart damage.
-- Reported by Adam Feuerstein in Boston.
Follow Adam Feuerstein on Twitter.
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Cytori Therapeutics (NASDAQ:CYTX) will present and provide a webcast of its corporate presentations at three upcoming investor conferences.