Cytori Therapeutics
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interessant
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witzig
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gut analysiert
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informativ
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Der versprochene Thread :-) Die letzten Presseveröffentlichungen Sechsmonats-Chart Zwei Jahre Komplett seit Börsengang(damals noch unter dem Namen Macropore)
Cytori Therapeutics Inc. Registered Shares DL -,001
12.09.07 16:45 Uhr
4,00 EUR
-4,31 % [-0,18]
KGVe:
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DIVe:
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Typ: Aktie WKN: A0ETV6
Börse: XETRA
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Unternehmensbericht | Neuemissionsbericht | ||
Kontakt | Cytori Therapeutics, Inc. Top Gun Street 6740 CA-92121 San Diego | |||
Telefon | +1 (0) 858-458-0900 | |||
Fax | +1 (0) 858-458-0994 | |||
ir@cytoritx.com | ||||
Internet | www.cytoritx.com |
Erforschung von biologisch abbaubaren Implantaten und zellbasierter Therapeutika Die Cytori Therapeutics, Inc. (zuvor MacroPore Biosurgery, Inc.) bezeichnet sich als Technologieführer in der Entwicklung und Produktion bioresorbierbarer Implantate zur Behandlung von Knochendefekten. Die Implantate der Gesellschaft zeichnen sich u.a. dadurch aus, dass sie sich nach der Regeneration rückstandslos im Körper auflösen. So könnten Operationen zur Entfernung von Metallteilen (z.B. Schrauben und Platten) entfallen und Entzündungen und Abstoßreaktionen vermieden werden. Zudem fokussiert das Unternehmen auf die Forschung und Entwicklung patentierter zellbasierter Therapeutika, die aus dem Fettgewebe adulter Stammzellen gewonnen werden. Eingesetzt werden diese Behandlungsweisen bei Herz-Kreislauf- sowie Magen- und Darm- oder auch orthopädischen Erkrankungen und der plastischen Chirurgie. Cytori hat ein eigentumsrechtlich geschütztes System entwickelt, das so genannte Celution-System, mit dem adipöse Stammzellen von Patienten entnommen und innerhalb einer Stunde isoliert und konzentriert werden können. Dieses System ermöglicht somit die beschleunigte Bereitstellung individuell abgestimmter zellbasierter Therapeutika. Das Unternehmen beabsichtigt, sich die Rechte auf die Therapieentwicklung seiner Stammzellen zur Behandlung von Myokardininfarkten und weiteren Herz-Kreislauf-Krankheiten vorzubehalten. Für weitere Indikationen sollen strategische Bündnisse mit Firmen aus dem Bereich der Biotechnologie, medizinischer Geräte und der Pharmazie eingegangen werden. Die kommerzielle Verwendung dieser Behandlungsweise hänge vom Verkauf des Systems und den damit verbundenen Verbrauchsgütern an Pflegeeinrichtungen ab, so das Unternehmen. Es biete jedoch ein praktisches Geschäftsmodell für den Einsatz therapeutisch genutzter Stammzellen. Als Meilenstein gilt hierbei die Komplettübernahme der StemSource, Inc. im November 2002. Diese Gesellschaft ist mit de r Extrahierung, Kältekonservierung und klinischen Anwendung von Stammzellen befasst, wobei die Stammzellen aus adultem Fettgewebe gewonnen werden und nicht auf embryonale Stammzellen zurückgegriffen werde, wie hervorgehoben wird. Ziel ist es, mit diesen Stammzellen Nerven, Muskeln oder Knorpel zu "produzieren" und damit Krankheiten zu behandeln. Die bioresorbierbaren chirurgischen Implantate, die im Geschäftsbereich MacroPore Biosurgery hergestellt werden, basieren auf Milchsäureverbindungen, so erklärt das Unternehmen. Milchsäure ist ein natürlicher Stoff, der vom menschlichen Körper durch die normale Muskelarbeit permanent produziert und zu Kohlendioxid und Wasser wieder abgebaut wird. Der Ausgangsstoff ist bei führenden Pharmaherstellern erhältlich und wurde auf seine Verträglichkeit und toxischen Eigenschaften hinreichend geprüft, heißt es. Cytori kombiniert die Erkenntnisse aus langjähriger Forschung mit dem Einsatz von High-TechVerfahren und ist so in der Lage, Implantate in verschiedensten Designs und mechanischen Eigenschaften für eine Vielzahl von Anwendungen herzustellen. Die Kompetenz von Cytori zeige sich entlang der gesamten Wertschöpfungskette. Entwicklung, Design, Zulassung, Herstellung, Branding und Vermarktung liegen in einer Hand. Der Vertrieb in den USA stützt sich vor allem auf den Partner Medtronic, Inc.. Daneben, insbesondere in den anderen Regionen der Erde, ist Cytori auch mit einer eigenen Vertriebsmannschaft aktiv. Eingesetzt werden die Implantate von Cytori in den Bereichen Wirbelsäure und Neurologie sowie bei chirurgischen Eingriffen in das Muskel-Skelett-System. Das Produktspektrum für den Schädel- und Gesichtsbereich wurde im September 2002 inklusive der zugrunde liegenden Rechte und Assets für 16 Mill. US-Dollar an Medtronic verkauft. Cytori behielt jedoch die Rechte zur Nutzung der Basistechnologie in anderen Körperteilen. Parallel zur Verkaufsvereinbarung wurde die Zusammenarbeit auf dem Gebiet der Wirbelsäulenimplantate mit Medtronic bis 2012 verlängert. Noch recht jung im Produktportfolio von Cytori ist ein vielseitig verwendbarer bioresorbierbarer Film. Eingesetzt unter den Bezeichnungen SurgiWrap und CardioWrap könne dieser sowohl zur Verstärkung weichen Gewebes im Körper als auch zur Vermeidung von postoperativen Verklebungen verwendet werden, so wird erklärt. Für die erstgenannte Anwendung erhielt Cytori Ende 2001 die Zulassung in den USA. Im März 2003 wurde ein entsprechendes US-Patent mit Laufzeit bis 2021 erteilt. Für die zweitgenannte Anwendung erhielt MacroPore 2002 die Zulassung in Europa, Kanada, Thailand, Korea und Australien. Am 13. Dezember 2003 wurde eine Vereinbarung mit Medicis Ventures Management GmbH bzw. MAST Biosurgery AG über den Verkauf geschlossen. Zunächst erhielt Cytori 7,0 Mill. US-Dollar in bar sowie eine Schuldverschreibung über 5,0 Mill. US-Dollar und eine 0,2 Mill. US-Dollar Meilensteinzahlung. Darüber hinaus bestand Aussicht auf regelmäßige Zahlungen (z.B. Lizenzen). Thin-Film-Implantate werden von MacroPore Biosurgery auch exklusiv für Senko Medical Trading Co. entwickelt, die ein Alleinvertretungsrecht in Japan besitzt. Weiter im Minus Cytori erwirtschaftete auch im Geschäftsjahr 2004 Verluste. Die Umsatzerlöse ermäßigten sich auf 6,82 (i.V. 14,09) Mill. US-Dollar. Die Forschungs- und Entwicklungskosten erhöhten sich auf 11,01 (9,07) Mill. US-Dollar. Vor diesem Hintergrund verschlechterte sich das operative Ergebnis auf minus 16,06 (minus 9,66) Mill. US-Dollar. Doch konnte durch den Verkauf von Aktiva ein Gewinn von 13,88 (0,0) Mill. US-Dollar vereinnahmt werden. Davon entfielen 7,00 Mill. US-Dollar auf eine erstmalige Zahlung, die aus dem Verkauf eines signifikanten Anteils des so genannten Thin Film Geschäfts im zweiten Quartal an die MAST Biosurgery AG resultiert. Trotz dieser anderen Einkünfte von 13,97 (0,38) Mill. US-Dollar verzeichnete Cytori unter dem Strich für 2004 einen Jahresüberschuss von minus 2,15 (minus 9,42) Mill. Euro. Der operative Cashflow stellte sich auf minus 12,57 (minus 7,25) Mill. Euro. |
Aktionärsstruktur
Streubesitz
73,64%
Neil Gagnon
8,72%
Olympus Corporation, Tokyo, Ja..
6,10%
Management
6,00%
Medtronic Asset Management, In..
5,54%
Leitende Positionen
Name | Position | ||
Vorstand (Management) | |||
Bruce Reuter | Mitglied | ||
Mark E. Saad | Mitglied | ||
Charles E. Galetto | Mitglied | ||
Aufsichtsrat (Directors) | |||
Christopher C. Calho.. | Vorstandsv.. | ||
Marshall G. Cox | Vorsitzend.. | ||
Paul W. Hawran | Mitglied | ||
David Rickey | Mitglied | ||
Ronald D. Henriksen | Mitglied | ||
MD E. Carmack Holmes | Mitglied | ||
MD Marc H. Hedrick | Mitglied |
Beteiligungen
(an anderen Unternehmen)
Unternehmen | Bet. | ||
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Cytori Expands Asia Pacific Celution System Distribution Network - Quick Facts
(RTTNews) - Cytori Therapeutics (CYTX) revealed the expansion of its Asia Pacific distribution network for the Celution System in reconstructive surgery.
The company said that for Korea and China, additional distributors would cover through Olympus Digital Networks Korea, or ODNK, and Shanghai Cosmo Medical Products, or SCMP, respectively.
Cytori stated that in their respective territories, distributors would help in regulatory clearances, take care of product sales and provide physician education and training.
Christopher Calhoun, Chief Executive Officer of Cytori Therapeutics, commented, "Asia-Pacific represents an important and growing reconstructive surgery market for Cytori. Aligning ourselves with ODNK expands upon, and reflects the growth in, our partnership with Olympus Corporation. In addition, we look forward to benefiting from SCMP's existing leadership in the reconstructive surgery market in China."
The company added that Celution System is a medical device that removes a patient's own regenerative cells from their adipose, or fat, tissue in about an hour. The cells can then be delivered to the same patient at the bedside in the same surgical procedure.
For comments and feedback: contact editorial@rttnews.com
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Cytori Awarded NIH Grant to Develop Cell-Based Treatments for Vascular Disease |
15:15 19.09.07 |
SAN DIEGO--(BUSINESS WIRE)--Cytori Therapeutics (NASDAQ:CYTX) was awarded a $250,000 NIH (National Institutes of Health) Grant to develop adipose-derived regenerative cells as a treatment for vascular disease. Regenerative cells within adipose (fat) tissue include adult stem cells and other cell types that have been shown to increase blood flow in and around damaged and oxygen deprived tissues. As a result, these cells hold exciting potential for the treatment of vascular conditions such as peripheral arterial disease, atherosclerosis, and critical limb ischemia, which impact millions of patients each year worldwide. This grant allows Cytori to expand the number of therapeutic applications for adipose-derived regenerative cells, said Marc H. Hedrick, M.D., President, Cytori Therapeutics. Due to the shared mechanism of these cells in vascular and heart disease, this research will complement and provide valuable insight into our clinical-stage development of treatments for cardiovascular disease. The grant work will study adipose-derived regenerative cells in preclinical vascular disease models. This will involve looking into which cells within adipose tissue are optimal for remodeling and promoting growth of both small and larger blood vessels. In addition, the research will explore the capacity of adipose-derived regenerative cells in patients with a history of smoking, hypertension, and diabetes. <!-- Template Id = 1 Template Name = Banner Creative (Flash) --><!-- Copyright 2002 DoubleClick Inc., All rights reserved. --> We look forward to this grant building on the success of our earlier NIH grant, said John K. Fraser, Principal Scientist, Cytori Therapeutics. That research led to the clinical trials we are now performing in cardiovascular disease. Successful completion of the new grant may potentially qualify us for additional funding at a higher level that we believe will lead to similar clinical opportunities in other disease states. Cytori Therapeutics Cytori Therapeutics is a global leader in the development and commercialization of regenerative medicine products. The company is developing therapeutic applications for its Celution System to enable real-time regenerative cell therapy in conjunction with breast reconstruction surgery, cardiovascular disease, and other unmet medical needs. The Company's StemSource Cell Bank, which is based on Cytori's innovative Celution System, is being commercialized in Japan to hospitals and clinics to enable regenerative cell banking. 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. |
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Keine Ahnung warum das so abgeht. Vielleicht hat jetzt endlich jemand kapiert, dass ab 2008 bei Cytori wirklich Umsatz gemacht werden soll.......
Übrigens: Ab morgen kein xetrahandel mehr und cytori stellt die Berichtspflicht nach deutschen Börsenregeln ein. Ist dann also ein normaler Nasi-wert, der auch im deutschen Freiverkehr gehandelt wird. Könnte natürlich zu Aufweitungen des spreads führen. Bin mal gespannt, wie das in D aussieht. Aber Kurse werden eh an der Nasi gemacht.
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Reflections from a veteran investor
This a really more a reply to a remark that David Chang made, alleging that investors that went into the stock years ago, simply were way too early (Olympus thread)
I think differently, since I believe that the stock is severely undervalued at present and a lot of the reasons why this is the case are pretty much home-made. There are a lot of prior events and facts about Cytori that apparently are not known generally in the US- for good and bad reasons.
The early days.
What one should realize for instance there has been a past before the Cytori stem cell days: a MacroPore past, which from a stock perspective only took place in Germany, where it was listed after the IPO in October 2000.
I took for instance a larger position in the company in early 2004 at prices which were even substantially lower than the present ones. The deciding fundamental factors at the time were:
1. realized sales of about 10 Mio in H2 of 2003 with 70% margins.
2. pick up of a nice bunch of cash of 15 Mio or so from the sale of SurgiWrap
3. forecast of 18 Mio for revenue in 2004 with further growth likely in future years and break-even for 2004 a distinct possibility.
4. added bonus for the then “interesting looking” stem cell development
The early investors were counting on the implants business- nothing to do with stem cells. What actually happened is known- many promises, but only non-delivery of promises due to a horrible contract with Medtronic. The time span of about 8-9 years which is normally required to develop a mature company business came to a conclusion this summer with the HydroSorb sale to Kensey Nash for 3.4 Mio.
It was somewhat macabre to read in Schedule 14A for 2004 that the compensation committee (Rickey!) awarded all employees the same (full company) bonus for that disaster year in order to keep up moral. Of course there was no interest in the moral of the shareholder.
Talking about shareholders- in those disaster days, Calhoun, Cox and Rickey had awarded each other 200k, 135k & 50k annually in options, which was at the time, each year approx. 2,5-3% of outstanding float and of course, all at low prices because of non-performance.
Normally these options would be rendered worthless, because of bankruptcy of MacroPore. The in 2002 acquired company StemSource and Marc Hedrick have blown “new life” in the future value of these options, which in my mind are worth a gigantic fortune.
No surprise therefore that Calhoun & Cox were selling some shares occasionally in case the bottom of their wallets was visible- they have “earned” plenty of them in the past.
Concluding remarks on the “pre-Cytori” days option policy- this was changed for management in 2004 from intergalactic- to more worldly and acceptable proportions. The Board however collected for another 3 years, up to 2007, cyberspace option rewards for meeting 4-5x a year. Again hardly any incentive for those guys to buy on the market now like has been demanded by other users in this board- they got plenty for free.
As an add-on, a real “veteran-investor”, that is a guy that bought 750 shares at an over 18$ price at the IPO and who is still holding those shares today, mailed me an IPO summary powerpoint . Looking it the projected profits 2001-2004 compared to the actual achievements in the following years, I am not surprised that Marshall Cox dumped all the 2 Mio shares of his VC organization (Saratoga Boys Club) and part of his own, within 6 months after the IPO. This person who was also employed as a full time “Board director” (have never come across any situation like that) and gave Calhoun “valuable” advice over 7 years, including 3 major strategic directions over the course of only 2 years, thank god retired in April this year. Part of the advice surely was to reduce risk- Calhoun took good note of that and reduced his ownership as co-founder of the company also from 731k (post-IPO still 5%) to 120K at present or 0,5%. No further comment appears required.
No surprise therefore that I had only a token number of MacroPore shares left in my portfolio going into 2005. That changed later on though.
Why this should be a 15-20$ stock right now
Just one single event brought me and several of my fellow international investors back or new into the stock. That event was the summer 2005 pick up of 1,1 mio shares by Olympus at 10$ although the share price was 3$ at the time and stayed on the same level for a long time thereafter.
I never assumed Olympus was a charitable foundation, so the incredible premium must have had solid value reasons- certainly after doing due diligence for almost a year and closing the hardware deal a couple of months later.
Olympus´ due diligence inspired me to do my own and I spent at least 5-6 man months in the past 2 years looking at stem cell science in general, IP issues, everything available on the web on ADSC´s and evaluating the business models of Cytori and all known present and future competitors. The result of that due diligence is simply, that in my mind there is no other business model in the stem cell sector and all other biologics spaces known to me, which is as compellingly simple, efficient and cost effective and at the same time addressing major markets for unmet needs with a strong (but not perfect) IP- portfolio. One cannot at the present time estimate its true value in 10 years time, other than saying, it could be gigantic, if the company is managed in the proper fashion. One can only applaud the thinking and execution of the employees at Cytori so far of the Celution based model using fresh autologous cells, whose plasticity and potency, based on the evidence available to me, are beyond any doubt.
Coming back to Olympus ; even if they didn’t exercise their option to buy more shares after the first round, which need if you like was negated by picking up 2 Mio shares from the summer 2006 share issue, the prices paid were still at a high premium over market, but at the same time more in line with sector development. If you take a look at the sector, STEM, ASTM, GERN, OSIR etc you will notice that the "hype and hope" valuation of 2 years ago, at the time of the Olympus equity deal, was roughly 200% higher for all players compared to the present one, is gone and has turned into "prove it to me" wait and see approach by the market, despite encouraging clinical progress by all sector participants.
Now on top of that premium paid by Olympus for equity, one has heard thru-out the years that Olympus is spending 7-10 Mio a year on salaries of their employees in developing the technology and is probably laying out somewhere between 30 and 50 Mio for construction of a building or building-extension in Nagano, together with putting together a assembly line, moulds for parts etc. All value created, that at a minimum benefits CYTX for 50%.
Again, Olympus is not a charitable foundation and looks to optimise value for stakeholders (whether Cytori pursues that goal is very questionable when reading their mission & values) and cannot achieve a meaningful contribution for its stakeholders by spending much money (read above) and only producing hardware i.e. Celution for Cytori, which is meant to be the razor in the razor-razorblade concept for marketing of the therapies. Meaning the return thereof will be minimal if any.
What is obviously much, much more important is the complementary synergy of stem cell technology to the business of Olympus itself. Next to the camera business, the endoscope business is the biggest revenue driver at Olympus (70% world market share) and obviously the fit is right there to deliver Celution cells with Olympus engineered delivery systems into the intestinal tract of patients to sites of injury or disease.
This is going to be huge, no doubt about it. On top of the “undisclosed” application (fistula), which should have been tested in the clinic by now, other (much smaller) companies like Cellerix in Spain have already proven the efficacy of treatment of fistula problems with and without Crohns disease with cultured ADSC´s through the IND pathway (>70% healing rate compared to 20% with standard of care), which also applies to the therapies of French Celogos with myoblasts for urinary incontinence. These tiny outfits obviously have a head start, but the favourable regulatory pathway (certainly in Europe) together with the Olympus delivery competence and marketing clout will certainly make them irrelevant.
This brings me to the next vastly underrated key aspect of the Cytori technology. That ADSC´s work extremely well for reperfusion of ischemic tissue, as pre-clinical results on large animals have delivered compelling evidence, which were much better than competing marrow sourced cells have ever delivered in similar settings. This is known and hard fact for heart, legs and neo-vascularisation of fat issue, basically useful in all parts of the body.
But the versatility is a lot more widespread in respect of wound healing (intestinal, body surface and infections of the mouth or lungs), orthopaedic applications for bone-and disk regeneration, immune system disorders (of which there are about 60) and organ regeneration, kidney, liver and yes even endocrine therapies look feasible, probably on a more attractive timeline compared to (partial) resolving of neurological disorders.
Basically an immensely broad platform technology is visible for the investors that want to see it. Several of those opportunities have apparently been tackled, but are kept “undisclosed” and basically are “waiting” for development with partners. We have been told that a few potential partners already have been turned down by Cytori for lack of “total” commitment for the technology. That certainly did not please anybody, but apparently we got the Green Hospital banking deal instead to keep the stakeholders happy.
Obviously in view of the preceding comments on platform technology, this appears to make sense to start building up the infrastructure for banking now. To do so without explaining why appears a totally different story.
Nonetheless, with the fact that CYTX will be the first stem cell player that will make good revenue from their technology already next year (I expect 30-50 Mio from breast and banking and 10 Mio development revenues) and has an incredibly broad pipeline on products, this stock under “present normal” conditions already should have a $15-20 price ticket right now (multiple of 7-8 for next year).
“Present normal” circumstances would entail several factors that are not there and which I anticipated to be there for which reason this stock is still creeping around at the 5-6$ level. Absolutely appalling if you ask me and I will give my views on the “reasons why” in the next posting-
Reasons why the stock is at 5-6 and not 20 $.
There are many reasons in my mind; however which all centre on two things, communication to the street and management attitudes and capabilities. I will split my subjective key reasons up in those two major areas:
Content of communication:
1. The main drawback for management of course is, having to do a balancing act between the interests of the publicity shy Japanese, confidentiality agreements with this partner and SEC reporting responsibilities. My legal friends tell me that the disclosures of the JV deal and following first right of negotiation deal in February 2006 of an undisclosed indication are waterproof. Common sense tells me that the communication to stakeholders other than insiders, as to the real INTENT, ECONOMICS AND PURPOSE of those two deals are closely interconnected and intertwined and therefore could be severely misleading to the general public. Future transactions and events will provide us with the answer to that question and will govern upcoming actions.
2. The company is extremely un-precise and vague about its regulatory success in Europe. In February Cytori announced going to market early with its breast application and was planning to perform a “post-market” pivotal trial in 2007. This announcement was accompanied by the following statement : “This accelerated product launch is primarily the result of Cytori's receipt of a favorable regulatory notice regarding the Celution™ System by the Competent Authority, a European medical device governing body”. What the added claims for Celution really represented has never been conveyed, despite several requests for explanation. It could very well be that the notice also covers a range of other applications, like GI, PAD etc which would upgrade the value of the technology tremendously. Than again it doesn’t have to be- remains a mystery, which is never good.
3. This of course also ties into the virtual omittance of data and information on pre-clinical progress in developing the PLATFORM technology, which in my mind is critical in order to assess the technology value of the company. A visitor to the Companies website would find absolutely nothing on this theme. Information wise this page is in general in extremely poor condition, one gets the impression the web developer has been paid by the number of words. Examples of how to do it properly, can be found at the Aastrom- or even the CellCyte website- the last company having a present market cap of >350 Mio without having any substance at all- but the marketing is good, which I would like to see at Cytori also.
4. In my opinion the recent announcement of the Green Hospital deal was timed very poorly and looked like emergency news to coincide with the release of the Q2 financials. The lack of common knowledge of the potential applications for the future plus the lack of a financial short term plan (2008/2009) of installations from both partners gave this show more the impression of wishful thinking instead of a solid business opportunity, which it most likely is. The adverse market reaction was therefore really not a big surprise.
Addressees of communication
Cytori tends to issue announcements, which are difficult to understand by the Street- the “phase” 510k US approvals are perfect examples of that or the above referenced February news of the early breast application launch in Europe, however I think that is the lesser problem- the main communication is done in the quarterly conference calls, however this reaches only the hard-core Cytx-investors who hardly need convincing. Max 100 people?
On top of that management has been pounding the pavements of national- and international streets on its way to hundreds of investment conferences. Apparently without any visible result, which to me is largely due to the issues in the communicated content listed above, which are misguiding the value of the Olympus partnership, regulatory success and platform technology.
This probably wont change until the therapeutic partner deal is closed and Olympus will have picked up their last portion of cheap Cytx shares at 5-7$ or something. But I really do expect for them to finally step up after these events have occurred and the confidentiality chains are removed, to take up a leadership role in the stem cell industry by being the voice and frontrunner in the media to influence public opinion. I hope they have the capabilities to step up to the plate to carry out this responsible task, since you cannot leave this to the Okarma´s and West´s of this world, who will be playing around with their rat models for the foreseeable future.
Next to communication, management attitudes and capabilities have played a major role in keeping this stock down- the points below are just a short list thereof:
1. Credibility and reliability- you should not ask a German former MacroPore shareholder to rate the credibility virtues of management. He/she would tell you there are none in view of broken promises of the past. Hopes were high that such would improve due to new “blood” in management and the name change to Cytori i.e. stem cell business. Hopes were shattered again when one listens to a public statement in the fall of 2006 announcing 20 to 30 Mio $ from the sale of none-core business soon. Part of that business fetched less than 3,5 Mio much later and for the other one (SurgiWrap) a Phase IV clinical trial has been started in March in LA with completion target February 2009. Don’t count on cash before 2010 please. The estimating of start dates of key clinical trials have not been better- APOLLO was due to start either late Q4 06 or early Q1 2007, we are still waiting.
2. Unnecessary dilution- obviously the cash inflow of the sale of non-core business was planned and did not occur so was substituted by the second placement of shares in February. The first one in 2006 was fine- the shares went virtually all to Olympus and other friendly addresses. The second one was pretty lousy with a half warrant attached. If one than later hears that partner deals with a few potential partners have been abandoned due to lack of “total commitment”, one wonders in who´s interest such decisions are made- it certainly cannot be the shareholder. Losing 25% of all future profits surely has been more painful than having to alleviate the hurt of partners being slow in adapting the technology.
3. “Bad luck picking” and past history- financial management selected Piper Jaffray to lead the placing of the (first and) second share placement. “They were worth every penny they earned” was the message shortly after the issue. In hindsight it is easy to criticise of course, but noticing sell-out of “known pipers” like Sandell and RG Capital within 4 months after placement, speaks a totally different language, with surely more selling to report in the third quarter. Both buy- and sell side Jaffray are for the birds. Its that simple. Together with the inheritance of MacroPore days of Medtronic as an investor, who´s shares most likely will have been sold on the market by now- 1 Mio - and the cashing of dismissed former employees of options from the “golden” options days, a total of over 3 Mio shares must have hit the market in the last 6 months. A big number with the present turnover.
4. Egocentric attitudes of top management- insider sales of stock are always a drain on the stock price, but especially with development outfits with low volumes on the market. The insider sales of Cox and Calhoun of over 200k end 2005, early 2006 did its thing to drive the stock down with average daily volumes under 15k. The 50k stock sale of Calhoun in August is relatively fresh on our minds. Horrible timing with logical consequences for prices. Since one can reasonably assume, that the sale has no fundamental reasons or expectations of lower prices in the future, it can only be for private cash needs. If somebody is not in control of his finances with a CEO salary, one wonders if he should oversee the same of an emerging company. Anyway, do expect a repeat performance next year same time, since 53k options with a strike price of 15 cents will expire 01/01/09. Deserved compensation for major personal financial sacrifices from the founding days, as Cytori would qualify this.
The above I consider the major reasons why Cytori is not the 15-20$ stock that it should be. Those reasons have nothing to do with technology or development issues- simple management communication and workings incl. neglect in my subjective opinion. Of course there are other issues, like uncommitted board, a buy-side analyst from Piper Jaffray (Ted Tenthoff, who has 1 Mio $ revenue for 2008 in his analysis even after the company has announced an early therapy launch and closed a banking deal, talk about disconnect) and a few other things that however are not under direct control of management.
Conclusion- great technology, huge potential and most likely a great future, but with a leadership that puts up smoke screens, which investors should try to see through, but is the reason why we are where we are. Probably also to provide strategic investors (Olympus and others) more cheap entry points. Nevertheless highly recommended to stick with and try to visualize those objects that fly below the radar screens.
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Kopiert von shapekop auf WO.
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Irgendwann klappts.
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Mit Stammzellen zu natürlichem Brustaufbau
Wiener Mediziner traf Stammzell-Experten in Japan
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Wien (pts/16.10.2007/14:44) - Der Wiener Schönheitschirurg DDr. Karl-Georg Heinrich besuchte den Japaner Dr. Kotaro Yoshimura in Tokio. Der Wiener Spezialist für kosmetische Chirurgie und sein japanischer Kollege von der medizinischen Universität Tokyo sind derzeit weltweit führend in einer neuen Methode der Körperformung mit Eigenfett tätig. Beide bemühen sich um eine Verbesserung der bekannten Eigenfett-Verfahren für den Brustaufbau durch den Einsatz von Stammzellen.
Bei der klassischen Methode des Eigenfetttransfers (Lipofilling, Lipostructure ®) wird das von Bauch oder Po sehr schonend abgesaugte Eigenfett nach spezieller Aufbereitung zum Auffüllen an anderer Stelle verwendet. Cell assisted Lipotransfer - der stammzellen-unterstützte Fetttransfer - erhöht die Überlebensfähigkeit von körpereigenem Fett, das für den Brustaufbau verwendet wird.
Der stammzellen-unterstützte Fetttransfer braucht, wie auch die klassische Methode, chirurgisches Feingefühl: Das Fettgewebe muss mit einer speziellen Kanüle schonend aus Po oder Oberschenkel entnommen werden. Und zwar doppelt so viel, wie später der Brust zugeführt wird. Aus einer Hälfte des Materials werden nun in einem mehrstufigen Prozess die Bindegewebsstammzellen herausgefiltert. Die wertvollen Zellen dürfen dabei nicht zerstört werden. Sie werden nicht manipuliert, nicht verändert. Die entnommenen Zellen werden bereits ein bis zwei Stunden später dem Fettgewebe zugeführt, das nun in vielen kleinen Injektionen nach dem "Reiskornprinzip" bei örtlicher Betäubung der Patientin in die Brüste gespritzt wird. Das Ergebnis ist ein Volumenszuwachs der Brust um ein bis zwei Cupgrößen.
Das Verfahren zum "cell assisted lipotransfer" oder stammzellen-unterstützten Fetttransfer wurde vor allem in den USA und in Japan entwickelt. Professor Kotaro Yoshimura ist ein Pionier auf diesem Gebiet. Er hat in der "Cellport-Clinic" in Yokohama seit 2003 bereits hunderte Patientinnen erfolgreich mit "cell assisted lipotransfer" behandelt. DDr. Karl-Georg Heinrich ist der erste Mediziner in Europa, der dieses Verfahren in seiner Ordination anbietet.
Gegenüber seinem Gast aus Wien betonte Professor Yoshimura die Vorteile dieser Methode im Vergleich zu Silikon-Implantaten. Viele der Frauen, die sich an die "Cellport-Clinic" wenden, wollen keine sichtbaren Narben und sind sich unsicher in Bezug auf mögliche langfristige Nebenwirkungen von Silikon. "Dr. Yoshimura erzählte mir sogar, dass sich in Japan viele Frauen ihre Silikonimplantate entfernen lassen, um sich danach mit stammzellen-unterstütztem Fetttransfer behandeln zu lassen", erzählt DDr. Heinrich. "Es ist uns beiden ein Anliegen, den Frauen eine natürliche und haltbare Alternative zu Silikon bieten zu können", so der Wiener Mediziner.
Für DDr. Heinrich ist wissenschaftlicher Austausch mit Kollegen aus aller Welt selbstverständlich und er reist dazu regelmäßig ins Ausland. So war er im Sommer auf Einladung der US-Firma "Cytori Therapeutics" in San Diego, um sich über den Stand einer Celution(R) genannten Technologie zu informieren, die gegenwärtig in klinischer Erprobung ist und mit der möglicherweise in Zukunft die Stammzellgewinnung aus dem abgesaugten Fett vereinfacht werden kann. Zur Zeit ist für die Gewinnung der Stammzellen aus dem Fett nämlich komplexe und zeitaufwändige Laborarbeit unter speziellen, hochsterilen Bedingungen erforderlich.
(Ende)
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Cytori Receives European Approval for 2nd Generation Celution Stem & Regenerative Cell Processing System |
13:10 01.11.07 |
SAN DIEGO--(BUSINESS WIRE)--Cytori Therapeutics, Inc. (NASDAQ:CYTX) received European approval - CE Mark - for the second generation Celution stem and regenerative cell processing system. The Celution System is the only device approved in Europe to extract and concentrate a patients own stem and regenerative cells from within fat tissue in order to be delivered back to the same patient in the same procedure. Fat tissue, known medically as adipose, is a rich, accessible, and non-embryonic source of stem and regenerative cells. With this approval, Cytori can begin targeted commercial introduction of the Celution System next year to select reconstructive surgeons in Europe, said Christopher J. Calhoun, chief executive officer, Cytori Therapeutics. In parallel, we will conduct our planned post-market studies of the Celution System for use in breast cancer reconstruction in order to drive market adoption and reimbursement. The Celution System was evaluated in an 11-patient investigator-initiated safety and feasibility study, designated as RESTORE I, conducted in Japan. This study investigated adipose-derived stem and regenerative cells extracted and processed with the Celution System to treat the complications of surgery and radiation damage following partial mastectomy for the treatment of breast cancer. Study results will be presented at the San Antonio Breast Cancer Symposium on December 15, 2007. Based on preliminary results, Cytori is planning two clinical studies, designated as the RESTORE II and VENUS studies, which will further evaluate the use of adipose-derived stem and regenerative cells in breast reconstruction following partial mastectomy for the purpose of offering optimal reimbursement in Europe. RESTORE II will evaluate up to 70 patients at multiple European trial sites. VENUS will be a 20 patient single center study, adjunct to RESTORE II, in patients with more severe radiation damage and contour defects resulting from a partial mastectomy.
Zitat shapekop auf WO: Noch was zum Thema .... |
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und nicht nur nach Krebsoperationen. Auch da ist bestimmt Umsatz abzugreifen. Und Eigengewebeaufbau ist sicher besser als der Silikonzirkus.....
Cytoris Celution System Under Evaluation for Breast Augmentation as Part of Investigator-Initiated Study |
14:20 06.11.07 |
SAN DIEGO--(BUSINESS WIRE)--A new study underway in Japan will examine the effect of adult stem and regenerative cells derived from adipose tissue in breast augmentation. In this investigational procedure, a patients breast is augmented with her own liposuctioned fat, which has been combined and enhanced with her own adipose-derived stem and regenerative cells. These cells are made available at the time of surgery using the Celution System - an investigational device developed by Cytori Therapeutics (NASDAQ:CYTX) of San Diego, CA. This independent, investigator-initiated study is being sponsored by Tatsuro Kamakura, M.D., Chief Medical Officer of Cosmetic Surgery Seishin in Japan. Fat, known medically as adipose tissue, is one of the bodys richest and most accessible sources 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 graph retention when applied to cosmetic and reconstructive surgery. This study further demonstrates the breadth of potential applications for the Celution System, said Marc H. Hedrick, M.D., president for Cytori Therapeutics. A number of physicians like Dr. Kamakura are interested in exploring new applications for the Celution System through investigator-initiated studies. These studies will help accelerate and broaden the number of potential uses of the device and allow us in parallel to maintain our focus on the medical need of breast reconstruction in partial mastectomy patients. The study will enroll 20 patients, all of whom will undergo a standardized cell enhanced fat tissue transplantation procedure, whereby the cells are processed with Cytoris Celution System. The primary endpoints will be cosmetic improvement volume retention at nine months. The study is being sponsored by Dr. Kamakura. Clinical research is ongoing for breast reconstruction in partial mastectomy patients. The Celution System was evaluated in an 11-patient investigator-initiated safety and feasibility study, designated as RESTORE I, conducted in Japan. This study evaluated adipose-derived stem and regenerative cells extracted and processed with the Celution System to treat the complications of surgery and radiation damage following partial mastectomy. Results will be reported at the San Antonio Breast Cancer Symposium on December 15, 2007. Based on preliminary findings and other data, Cytori is sponsoring two post-marketing studies, designated as the RESTORE II and VENUS studies, which will further evaluate the use of adipose-derived stem and regenerative cells for reconstruction of breast tissue following a partial mastectomy. RESTORE II will evaluate up to 70 patients at multiple European trial sites. VENUS will be a 20-patient single center adjunct to RESTORE II in patients with more severe damage and contour defects resulting from a partial mastectomy. |
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http://www.cosmetic-medicine.jp/english/result/mmshichu/index.html
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Adipose-Derived Stem & Regenerative Cells Improve Fat Graft Retention in Preclinical Study |
13:55 15.12.07 |
SAN ANTONIO--(BUSINESS WIRE)--Cytori Therapeutics, Inc. (NASDAQ:CYTX) reported positive preclinical results demonstrating adipose-derived stem and regenerative cells improved the quality and long-term retention of a fat graft, representing a potential new approach in reconstructive surgery. The benefit of adipose-derived stem and regenerative cells was observed at six months and was retained through the end of the study at nine months. Results were presented at the 30th annual San Antonio Breast Cancer Symposium. (Poster #4072) Fat tissue transfers enhanced with adipose tissue-derived stem and regenerative cells can provide a novel option for reconstructive surgery, said Marc H. Hedrick, M.D., president of Cytori Therapeutics. Using Cytoris Celution System to provide stem and regenerative cells would simplify, standardize and improve the predictability of shape and volume outcomes for fat transfer procedures, including breast reconstruction following partial mastectomy. In the preclinical rodent study, donor adipose-derived stem and regenerative cells, or saline, was combined with donor adipose tissue and then transplanted onto recipient skulls. After six and nine months, grafts were harvested and weighed. The mean weight of cell-enhanced grafts at six and nine months was two times greater than grafts with saline (p = 0.019 at six months; p=0.034 at nine months). Histological analysis revealed the cell-enhanced grafts contained less fibrous tissue, suggesting improved graft quality. Additionally, donor stem and regenerative cells were present within grafted adipose tissue and were incorporated into blood vessel walls within the fat graft.
...... |
http://www.ariva.de/...tion_in_Preclinical_Study_n2460492?secu=801441
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http://www.ariva.de/..._in_Breast_Reconstruction_n2460494?secu=801441
Adipose-Derived Stem Cells Show Promise in Breast Reconstruction |
14:05 15.12.07 |
Results Reported at the 30th San Antonio Breast Cancer Symposium SAN DIEGO--(BUSINESS WIRE)--Cytori Therapeutics (NASDAQ:CYTX) received results from an independent, investigator-sponsored study in Japan in which adipose tissue-derived stem and regenerative cells were used for breast reconstruction following partial mastectomy. The study data were presented today at the 30th San Antonio Breast Cancer Symposium (Poster #4071). The novel procedure evaluated 21 women with no metastases or recurrence at least one year after partial mastectomy. Among key findings: The procedure was reported safe and well tolerated in all women No rejection or immune response was observed Patient satisfaction of the outcome was 79 percent, with a mean follow up period of 7.7 months There was a statistically significant improvement in average breast tissue thickness at one month following treatment and at final assessment compared to baseline There was no significant loss of tissue thickness between one month and the final assessment In the study, tissue loss resulting from partial mastectomy was reconstructed with each patients 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 Cytoris investigational device, the Celution System. This clinical series is an exciting, early development for women with breast cancer who undergo partial mastectomy, said Marc H. Hedrick, M.D., president for Cytori Therapeutics. The reported data suggest this novel procedure can be safely performed, is clinically practical for surgeons to implement, and confirms Cytoris decision to initiate clinical trials intended to establish efficacy, ascertain volume retention, and measure the magnitude of aesthetic and functional improvement. Reconstructive options have not kept pace with the development of new cancer therapies and existing reconstructive options for women are either ineffective, impractical or both. Until now, partial mastectomy patients have had little hope other than to live with tissue loss. This procedure holds the potential to offer women the opportunity to restore the contour, volume and function lost during cancer treatment. Two clinical studies will be initiated next year in Europe by Cytori to further evaluate adipose-derived stem and regenerative cells, processed with the Celution 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. Fat, known medically as adipose tissue, is one of the bodys richest and most accessible sources 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 volume retention and graft persistence. For this reason, these cells potentially may improve and simplify traditionally complex fat transfer procedures as well as enable more predictable outcomes when applied to cosmetic and reconstructive surgery. More than one million women worldwide are diagnosed with breast cancer annually, including more than 370,000 women in Europe and more than 240,000 in the United States. Due to continual advancements in cancer detection, a growing percentage of women are eligible for partial versus full mastectomies. Unfortunately, partial mastectomy often results in significant skin damage, tissue loss, pain, and reduction or loss of motion. Women who undergo such procedures have limited reconstructive options to potentially reduce associated pain, reverse loss of motion, and restore breast volume and contour. |
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Tolle Ergebnisse für die erste Studie im Menschen.
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hast du da auch ein paar?
Langfristig bestimmt lohnen, vor allem wenn die Infarktgeschichte ins Rollen kommt.
"Die NPD ist braunes Pack und eine Verbrecherbande"
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Auch noch auf deutsch Stammzellen aus Fettgewebe vielversprechend bei der Brust-Rekonstruktion |
11:45 17.12.07 |
Resultate wurden beim 30. Brustkrebs-Symposion in San Antonio bekannt gegeben SAN DIEGO--(BUSINESS WIRE)--Cytori Therapeutics (NASDAQ: CYTX) erhielt Resultate von einer unabhängigen, Prüfer gesponsorten Studie in Japan, in welcher Stammzellen und regenerative Zellen aus Fettgewebe für Brustrekonstruktionen nach teilweiser Brustamputation benutzt wurden. Die Daten aus der Studie wurden beim 30. Brustkrebs-Symposion in San Antonio bekannt gegeben (Poster Nr. 4071). Das neue Verfahren wurde an 21 Frauen untersucht, die innerhalb von mindestens einem Jahr nach teilweiser Amputation weder Metastasen noch erneutes Auftreten des Krebses hatten. Schlüsselbefunde waren unter anderem: Die Prozedur erwies sich bei allen Frauen als sicher und gut verträglich Keine Abstoßung oder Reaktion des Immunsystems wurde beobachtet Die Patientenzufriedenheit mit dem Resultat betrug 79 %, bei einer mittleren Nachsorgeperiode von 7,7 Monaten Es gab, verglichen mit der Baseline, eine statistisch signifikante Verbesserung in der durchschnittlichen Dicke des Brustgewebes einen Monat nach der Behandlung und bei der Schlussbewertung Es gab keinen signifikanten Verlust an Brustgewebe zwischen dem 1-Monats-Zeitpunkt und der Schlussbewertung In der Studie wurde der Gewebeverlust, der aus der partiellen Brustamputation resultierte, mittels des eigenen abgesaugten Fetts der Patientin rekonstruiert, das mit ihrem eigenen Stammzellen und regenerativen Zellen aus dem Fettgewebe kombiniert und verbessert wurde. Diese Zellen wurden zum Zeitpunkt der Operation durch ein Instrument von Cytori, das sich in der Erprobung befindente Celution-System, zugänglich gemacht. Diese klinische Erprobungsreihe ist eine faszinierende neue Entwicklung für Frauen mit Brustkrebs, die sich einer partiellen Brustamputation unterziehen müssen, sagte Marc H. Hedrick, M.D., Präsident von Cytori Therapeutics. Die vorliegenden Daten legen nahe, dass die Prozedur sicher durchgeführt werden kann, für den Chirurgen klinisch praktisch einsetzbar ist und sie bestätigt die Entscheidung von Cytori, klinische Erprobungen zu starten, mit dem Ziel, Wirksamkeit nachzuweisen, die Volumenretention zu bestätigen und das Ausmaß der ästhetischen und funktionellen Verbesserung zu messen. Die Möglichkeiten zur Rekonstruktion haben nicht mit der Entwicklung neuer Krebstherapien Schritt gehalten und die existierenden Möglichkeiten der Rekonstruktion für Frauen sind entweder unpraktisch oder untauglich oder beides. Bis jetzt hatten Patientinnen mit teilweiser Brustamputation wenig andere Aussichten als mit dem Gewebeverlust zu leben. Diese Prozedur verfügt über das Potenzial, Frauen die Möglichkeit zu geben, Kontur, Volumen und Funktion, die im Zuge der Krebsbehandlung verloren gingen, wieder herzustellen. Im nächsten Jahr wird Cytori in Europa zwei klinische Studien starten um Stammzellen und regenerative Zellen aus Fettgewebe, die mit dem Celution-System bei Brustrekonstruktion nach teilweiser Brustamputation bearbeitet wurden, weiter zu untersuchen. Eine der Studien, RESTORE II, wird bis zu 70 Patientinnen an mehreren Versuchsstandorten bewerten. Eine zweite Studie, VENUS, wird 20 Patienten in einem einzelnen Studienzentrum umfassen, die unter schwereren Strahlungsschäden und Konturdefekten leiden. Fett, medizinisch als Adipositasgewebe bezeichnet, ist eine der reichsten und am besten erreichbaren Quellen des Körpers für regenerative Zellen. Regenerative Zellen aus Fettgewebe schließen Stammzellen ein, zusätzlich zu anderen wichtigen Zelltypen, welche präklinisch demonstriert haben, dass sie Volumenretention und Transplantathaltbarkeit verbessern. Darum könnten diese Zellen potenziell traditionell schwierige Prozeduren der Fettverpflanzung vereinfachen und verbessern, so wie auch besser vorhersagbare Resultate in der kosmetischen und rekonstruierenden Chirurgie ermöglichen. Weltweit werden jährlich mehr als eine Million Frauen mit Brustkrebs diagnostiziert, darunter mehr als 370.000 Frauen in Europa und mehr als 240.000 Frauen in den Vereinigten Staaten. Durch den kontinuierlichen Fortschritt in der Krebserkennung kommt eine wachsende Zahl von Frauen für eine partielle, im Gegensatz zu einer vollständigen, Amputation in Frage. Teilweise Amputation führt bedauerlicherweise oftmals zu signifikanten Hautschäden, Gewebeverlusten, Schmerzen und Reduktion oder Verlust der Beweglichkeit. Frauen, die sich einer solchen Prozedur unterziehen, haben nur begrenzte Möglichkeiten der Rekonstruktion, um potenziell den damit einhergehenden Schmerz zu reduzieren, dem Verlust von Beweglichkeit entgegenzusteuern und das Volumen und die Form der Brust wiederherzustellen. Cytori Therapeutics Das Ziel von Cytori Therapeutics (NASDAQ: CYTX) ist es, weltweit führend in der regenerativen Medizin zu sein. Das Unternehmen widmet sich der Versorgung von Patienten mit neuen Optionen für die rekonstruktive Chirurgie, entwickelt Behandlungen für Herz-Kreislauf-Erkrankungen und besitzt eine Zellenbank für erwachsene Stammzellen und regenerative Zellen von Patienten. Um sein Ziel zu erreichen, entwickelt Cytori sein innovatives Celution-System, um bei Patienten eigene Stammzellen und regenerative Zellen aus Fettgewebe zu separieren und zu konzentrieren und die Zellen dann via derselben chirurgischen Prozedur wieder in den Patienten zu implantieren. Das Celution-System wird 2008 in Europa für die rekonstruktive Chirurgie eingeführt werden und es startet in Japan um Patienten eigene Stammzellen und regenerative Zellen tiefgekühlt zu konservieren. Klinische Versuche laufen oder sind geplant für Herz-Kreislauf-Erkrankung, Bandscheibendegeneration, gastrointestinale Krankheiten und andere Felder, auf denen der medizinische Bedarf nicht gedeckt ist. www.cytoritx.com |
Sarahspatz, ich verstehe deine Ängste vor Übergewichtung gut.
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Cytori Therapeutics (NASDAQ: CYTX) enrolled the first two patients in a clinical trial using adipose-derived stem and regenerative cells in the treatment of heart attack. In this trial, patients' cells are made available using Cytori's Celution? System, a real-time cell processing device. One patient has been enrolled in each trial center, Hospital Universitario Gregorio Marañón in Madrid, Spain, and Thoraxcenter, Erasmus Medical Center, The Netherlands.
For more details, please view the attached documents.
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First Patients Treated in Cytori's Stem & Regenerative Cell Heart Attack Study
January 30, San Diego, Calif -- Cytori Therapeutics (NASDAQ: CYTX) enrolled the first two patients in a clinical trial using adipose-derived stem and regenerative cells in the treatment of heart attack. In this trial, patients' cells are made available using Cytori's Celution™ System, a real-time cell processing device. One patient has been enrolled in each trial center, Hospital Universitario Gregorio Marañón in Madrid, Spain, and Thoraxcenter, Erasmus Medical Center in Rotterdam, The Netherlands.
Fat, known medically as adipose tissue, is one of the body's richest known sources of regenerative cells. Adipose-derived regenerative cells include adult stem cells in addition to other important cell types that have been shown to increase blood flow in and around damaged and oxygen deprived tissues. As a result, these cells hold exciting potential to revolutionize the treatment of heart disease, which affects millions of patients worldwide each year.
"Time is of the essence in the treatment of patients with heart attacks," said Prof. PW. Serruys, M.D., Ph.D., principal investigator for the trial and Head of the Department of Interventional Cardiology at the Thoraxcenter, Erasmus Medical Center. "The Celution™ System makes adipose-derived regenerative cells available in real-time and enables early treatment. For this reason, adipose-derived regenerative cells processed by the Celution™ System could play a critical role in limiting or reversing heart damage caused by a heart attack."
"A major challenge in cardiovascular cell therapy is having a meaningful number of stem and regenerative cells," said Francisco J. Fernández-Avilés, Chief of Department of Cardiology at Hospital Universitario Gregorio Marañón and an investigator for this APOLLO trial. "To date, we have treated a number of patients with chronic ischemia in Cytori's PRECISE trial, and we are pleased that the Celution™ device has enabled us to administer a meaningful dose of their own cells in real-time."
The APOLLO trial is a 48-patient, randomized, placebo-controlled, dose escalation, safety and feasibility multi-center study. A dose of adipose-derived regenerative cells, or a placebo, will be delivered through an intracoronary catheter within 36 hours following the onset of a heart attack. The trial will involve four groups of 12 patients each. In each group, nine patients will receive cells and three will receive the placebo control. Cytori is the sole sponsor of the APOLLO clinical trial.
"The Celution™ System is unique in its ability to potentially address acute and chronic heart conditions using a patient's own cells," said Alex Milstein, M.D., Vice President, Clinical Development, Cytori Therapeutics. "Cytori's comprehensive clinical development program for the Celution system addresses chronic ischemic heart disease as well as in acute heart attack. The initiation of the APOLLO trial is an important milestone that has a potential of bringing innovative treatment options for patients with acute heart attack."
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Dear Friends and Investors,
Cytori Therapeutics, Inc. (NASDAQ: CYTX) entered into a strategic equity agreement with Green Hospital Supply, Inc. (Tokyo: 3360). Green Hospital Supply, Cytori's StemSource(TM) commercialization partner for Japan, will purchase 2.0 million shares of unregistered Cytori common stock at $6.00 per share and be granted a non-voting observer seat on Cytori's board of directors. The transaction will close on or before February 28, 2008, subject to satisfaction of customary closing conditions. Following the transaction, Green Hospital Supply's ownership in Cytori will increase to 3.0 million shares, representing 11.5% of Cytori's total shares outstanding. For more details, we invite you to read the attached document.
Regards,
Tom Baker
xxxxx
Und der cash in Richtung Kommerzialisierung reicht nun auch noch besser. Mit Olympus und Green Hospital haben 2 große Investoren ihre Pakete, das sichert unabhängigkeit, bzw. treibt die Preise, wenn einer übernehmen will. :-)
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