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TOPIC: Business as usual? - Crohn´s Result Publication

Business as usual? - Crohn´s Result Publication 31 Jan 2019 08:05 #12546

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Jan 31, 2019

80% of Treated Patients with Clinical Response at 48 weeks, Published in Gastroenterology

SAN DIEGO, Jan. 31, 2019 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (NASDAQ: CYTX) announces the publication of results from a pilot investigator-initiated clinical trial of Cytori Cell Therapy™ for the treatment of refractory perianal fistula in patients with Crohn’s Disease. These findings were published online this month in the journal Gastroenterology1, a publication of the American Gastroenterological Association.

Highlighted results from this study:



  • 10 patients were treated with a single administration of Cytori Cell Therapy™. No significant safety concerns were noted as part of the therapy.
    80% of patients exhibited a clinical response at 48 weeks; 60% of patients were deemed in combined remission with no evidence of leakage by clinical examination or MRI.

  • 76% of treated external fistula openings showed complete re-epithelialization or an absence of drainage at week 48

  • >50% decrease in mean Perianal Crohn’s Disease Activity Index (PDAI) 2 at 48 weeks (7.3 points at baseline to 3.4 points at 48 weeks). Mean PDAI score at 12 and 48 weeks after treatment (3.8 points and 3.4 points respectively) was below the threshold score of 4 that indicates active disease, requiring medical or surgical treatment.

  • The treatment approach involved a single administration of an average dose of 23 M freshly prepared autologous adipose-derived regenerative cells (ADRCs) into the fistulous tract in combination with an autologous adipose micrograft. Cytori Cell Therapy™ was prepared using Cytori’s Celution® 800/CRS System, similar to the product that was recently approved as a Class III medical device in Japan.

    Crohn’s Disease (CD) is a rare, chronic idiopathic inflammatory bowel disease condition with no cure that is characterized by flares and remission across the entire gastrointestinal tract from the mouth to the anus. Perianal fistulas are a common in CD (26% of patients within 20 years of CD diagnosis) and typically complex (70-80% of perianal fistulas). These fistulas cause pain, depression, a decreased quality of life, and an increased risk of anal epithelia carcinoma. Management of these fistulas has improved over the last 20 years, but even with the latest combined medical and surgical approaches, healing rates have only approached 50%.

    CD can affect people of all ages, though onset is most common in late adolescence and early adulthood, and has a prevalence of up to 0.2% (201 existing cases per 100,000 population) and incidence of 0.015% (14.6 new cases per 100,000 population) according to the CDC.

    The study was conducted by a team of investigators from the Departments of Gastroenterology, Digestive Surgery, Plastic Surgery, and Cell Therapy of the Assistance Publique Hôpitaux de Marseille (APHM), Aix Marseille University, France. Cytori Cell Therapy has also been evaluated in clinical studies at this Institution for scleroderma and vocal cord scarring. Data from these studies are expected in 2019.

    Cytori’s Cell Therapy products may have broad applicability across a range of diseases and conditions. It has been evaluated in both pre-clinical and clinical research studies and cited in over 65 publications. References to these studies can be found on Cytori’s website.

    1" Long-term safety and efficacy of local microinjection combining autologous microfat and adipose-derived stromal vascular fraction for the treatment of refractory perianal fistula in Crohn's disease” Serrero et al Gastroenterology. 2019 Jan 18. pii: S0016-5085(19)30092-7

    2 The perianal disease activity index (PDAI) score includes the evaluation of 5 elements: fistula discharge, pain and restriction of activities, sexual activity restriction, type of perianal disease, and degree of induration. A PDAI score >4 suggests active fistula drainage or local inflammation, with an accuracy of 87%. This score has been validated in several clinical trials.

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    Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

    Business as usual? - Crohn´s Result Publication 31 Jan 2019 08:09 #12547

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    Rongside will be pleased- at least for patients.
    The following user(s) said Thank You: rongside

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    Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

    Business as usual? - Crohn´s Result Publication 31 Jan 2019 08:51 #12548

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    An allogeneic therapy for the same indication is already available in parts of the world. Interesting study but really meaningless with relation to Cytori's prospects:

    TiGenix and Takeda announce Alofisel® (darvadstrocel) receives approval to treat complex perianal fistulas in Crohn’s disease in Europe
    March 23, 2018 Leuven, Belgium, March 23, 2018 and Osaka, Japan, March 24, 2018, 18:00 CET

    First allogeneic stem cell therapy to receive central marketing authorization approval in Europe
    Alofisel offers a new treatment option for patientswho do not respond to current available therapies and may be subject to numerous invasive surgeries1

    TiGenix NV (Euronext Brussels and NASDAQ: TIG) (“TiGenix”) and Takeda Pharmaceutical Company Limited (TSE: 4502) (“Takeda”) today announced that the European Commission (EC) has approved Alofisel (darvadstrocel), previously Cx601, for the treatment of complex perianal fistulas in adult patients with nonactive/mildly active luminal Crohn’s disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy. Alofisel should be used after conditioning of fistula.1 This marks the first allogeneic stem cell therapy to receive central marketing authorization (MA) approval in Europe.

    The European approval follows a positive opinion by the European Medicines Agency(EMA) Committee for Medicinal Products for Human Use (CHMP), in conjunction with the Committee for Advanced Therapies (CAT), in December 2017. The recommendation was based on results from TiGenix’s Phase III ADMIRE-CD pivotal trial, which showed that Alofisel achieved statistically significant superiority versus the control group in the primary efficacy endpoint of combined remission at 24 weeks,*1 as well as further follow-up data that indicated Alofisel maintained long-term remission of treatment refractory complex perianal fistulas in patients with Crohn’s disease over 52 weeks.2

    “I am extremely excited about this approval, which brings allogeneic stem cell therapy one step closer to patients in Europe,” said Professor Julian Panés, Head of the Gastroenterology Department at the Hospital Clinic of Barcelona (Spain) and President of the European Crohn's and Colitis Organisation (ECCO). “Alofisel offers a novel, minimally invasive and well tolerated alternative treatment option for patients with Crohn’s disease who do not respond to currently available therapies, and who have until now had limited treatment options available.”

    “This approval of Alofisel reflects our deep understanding and recognized leadership in the development of allogeneic stem cells and our firm commitment to developing innovative therapies for medical needs," said Dr. María Pascual, VP Regulatory Affairs and Corporate Quality at TiGenix. "We are pleased to offer the medical community an important new treatment option for patients with Crohn’s disease who do not respond to currently available therapies.”

    Alofisel has been licensed to Takeda for the exclusive development and commercialization outside of the US. Receipt of the MA will trigger a milestone payment from Takeda to TiGenix of €15 million, and initiation of the process of transferring MA from TiGenix to Takeda.

    “Today’s marketing authorization, the first for an allogeneic stem cell therapy, represents a positive advancement in the treatment of patients with complex perianal fistulas in Crohn’s disease,” said Dr. Asit Parikh, Head of Takeda’s Gastroenterology Therapeutic Area Unit. “We look forward to bringing this much needed treatment option to patients across Europe in the coming months.”


    The receipt of MA from the EC is one of the conditions to completion of the tender offer announced by Takeda on January 5, 2018.

    The consummation of the tender offer remains subject to other conditions, including the tender into the offer (in Belgium and the US), in aggregate, of a number of shares, warrants and American Depositary Shares that, together with all shares, warrants and American Depositary Shares owned by Takeda and its affiliates, represents or gives access to 85% or more of the voting rights represented or given access to by all of the outstanding shares, warrants and American Depositary Shares of TiGenix on a fully diluted basis as of the end of the initial acceptance period.

    * Combined remission defined as clinical assessment of closure of all treated external openings draining at baseline, despite gentle finger compression, and absence of collections >2cm confirmed by pelvic MRI

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    Business as usual? - Crohn´s Result Publication 31 Jan 2019 09:07 #12549

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    WST-

    We know that for ages already- we also know that NICE in the UK rejected reimbursement since it is too expensive.

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    Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

    Business as usual? - Crohn´s Result Publication 31 Jan 2019 09:38 #12550

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    fas wrote: Jan 31, 2019

    80% of Treated Patients with Clinical Response at 48 weeks, Published in Gastroenterology

    SAN DIEGO, Jan. 31, 2019 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (NASDAQ: CYTX) announces the publication of results from a pilot investigator-initiated clinical trial of Cytori Cell Therapy™ for the treatment of refractory perianal fistula in patients with Crohn’s Disease. These findings were published online this month in the journal Gastroenterology1, a publication of the American Gastroenterological Association.

    Highlighted results from this study:



  • 10 patients were treated with a single administration of Cytori Cell Therapy™. No significant safety concerns were noted as part of the therapy.
    80% of patients exhibited a clinical response at 48 weeks; 60% of patients were deemed in combined remission with no evidence of leakage by clinical examination or MRI.

  • 76% of treated external fistula openings showed complete re-epithelialization or an absence of drainage at week 48

  • >50% decrease in mean Perianal Crohn’s Disease Activity Index (PDAI) 2 at 48 weeks (7.3 points at baseline to 3.4 points at 48 weeks). Mean PDAI score at 12 and 48 weeks after treatment (3.8 points and 3.4 points respectively) was below the threshold score of 4 that indicates active disease, requiring medical or surgical treatment.

  • The treatment approach involved a single administration of an average dose of 23 M freshly prepared autologous adipose-derived regenerative cells (ADRCs) into the fistulous tract in combination with an autologous adipose micrograft. Cytori Cell Therapy™ was prepared using Cytori’s Celution® 800/CRS System, similar to the product that was recently approved as a Class III medical device in Japan.

    Crohn’s Disease (CD) is a rare, chronic idiopathic inflammatory bowel disease condition with no cure that is characterized by flares and remission across the entire gastrointestinal tract from the mouth to the anus. Perianal fistulas are a common in CD (26% of patients within 20 years of CD diagnosis) and typically complex (70-80% of perianal fistulas). These fistulas cause pain, depression, a decreased quality of life, and an increased risk of anal epithelia carcinoma. Management of these fistulas has improved over the last 20 years, but even with the latest combined medical and surgical approaches, healing rates have only approached 50%.

    CD can affect people of all ages, though onset is most common in late adolescence and early adulthood, and has a prevalence of up to 0.2% (201 existing cases per 100,000 population) and incidence of 0.015% (14.6 new cases per 100,000 population) according to the CDC.

    The study was conducted by a team of investigators from the Departments of Gastroenterology, Digestive Surgery, Plastic Surgery, and Cell Therapy of the Assistance Publique Hôpitaux de Marseille (APHM), Aix Marseille University, France. Cytori Cell Therapy has also been evaluated in clinical studies at this Institution for scleroderma and vocal cord scarring. Data from these studies are expected in 2019.

    Cytori’s Cell Therapy products may have broad applicability across a range of diseases and conditions. It has been evaluated in both pre-clinical and clinical research studies and cited in over 65 publications. References to these studies can be found on Cytori’s website.

    1" Long-term safety and efficacy of local microinjection combining autologous microfat and adipose-derived stromal vascular fraction for the treatment of refractory perianal fistula in Crohn's disease” Serrero et al Gastroenterology. 2019 Jan 18. pii: S0016-5085(19)30092-7

    2 The perianal disease activity index (PDAI) score includes the evaluation of 5 elements: fistula discharge, pain and restriction of activities, sexual activity restriction, type of perianal disease, and degree of induration. A PDAI score >4 suggests active fistula drainage or local inflammation, with an accuracy of 87%. This score has been validated in several clinical trials.

    /

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    Business as usual? - Crohn´s Result Publication 31 Jan 2019 12:11 #12552

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    Just got in....trying to clear may day for tomorrows CYTX action...or lack of it.
    Interesting but not the news we are looking for.
    Tomorrow is another day.....we think !

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    Business as usual? - Crohn´s Result Publication 31 Jan 2019 13:05 #12553

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    myownhedgefund wrote: Just got in....trying to clear may day for tomorrows CYTX action...or lack of it.
    Interesting but not the news we are looking for.
    Tomorrow is another day.....we think !

    /

    HF, think about it - the news coming cannot be too bad, otherwise there is no way that they could release positive Crohn's news today without also disclosing negative debt resolution news (which they would surely know about at this late juncture).

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    Business as usual? - Crohn´s Result Publication 31 Jan 2019 13:55 #12554

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    As written before- there are only 2 indications which indicate a happy ending of this miserable saga-

    1. their cockiness at the last Cc, which however is pretty subjective and open to interpretation.

    2. and for me the only viable reason- the Lincoln Park deal, which clearly would hurt Lincoln in the form written on paper unless they were informed of things we do not know about.....:whistle:

    as usual- time will tell. -that is- if we do not get a filing tonight, than tomorrow most likely and hopefully be smarter.

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    Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

    Business as usual? - Crohn´s Result Publication 31 Jan 2019 19:03 #12557

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    The results validate the use of autologous ADRC in the treatment of Crohn's fistula. Personally I would like to know what price Takeda was demanding for use in the UK which NICE found to be too high. Anone know???.

    I believe that the Celution device can be a very cost effective alternative to Alofisel .

    Here is the question that no one seems to ask: Given the (1) BARDA funding in burn treatment, (2) positive results in diffuse Scleroderma, (3) positive results in pressure/diabetic sores/ulcers etc, (4) SUI , (5) various 3rd party investigator trials (Mayo clinic - osteonecrosis) et al ................. Why has no company made an offer for Cytori? The market cap is ridiculous even when you take into account the debt/loan of approx. $15M and the convertible notes on issue. ANY company making an offer would be buing a technolgy platform with grea potential for a PITTANCE.

    Why has no other Japanese company made an offer (Olympus and Astellas saw something ......... and then didn't ??????? ) Cytori Japan is is probably self sustaining with the cosmetic surgery and independent investigator segments alone ....... with an option for SUI, scleroderma, Crohn's etc, etc

    Also of note is the massive spending to date on this technology. There is a substantial tax benefit for a purchaser , assuming a positive outcome in adoption/sales of the Celution device. Of course this is predicated on their buying CYTX for a relatively low price.

    Also is the short position real ???????? ............... . Hedrick could skewer the shorts in an instant if he sold the company or made a reasonable deal with BP/BB.

    Has CYTX already been sold.???????? Just waiting for the Dear John letter. Hedrick's performance and decisions todate are beyond incompetent: They are deeply suspect. The BoD have a lot to answer for. :evil: :bash: :puke:

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    Business as usual? - Crohn´s Result Publication 31 Jan 2019 19:13 #12558

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    rongside wrote: The results validate the use of autologous ADRC in the treatment of Crohn's fistula. Personally I would like to know what price Takeda was demanding for use in the UK which NICE found to be too high. Anone know???.

    I believe that the Celution device can be a very cost effective alternative to Alofisel .

    Here is the question that no one seems to ask: Given the (1) BARDA funding in burn treatment, (2) positive results in diffuse Scleroderma, (3) positive results in pressure/diabetic sores/ulcers etc, (4) SUI , (5) various 3rd party investigator trials (Mayo clinic - osteonecrosis) et al ................. Why has no company made an offer for Cytori? The market cap is ridiculous even when you take into account the debt/loan of approx. $15M and the convertible notes on issue. ANY company making an offer would be buing a technolgy platform with grea potential for a PITTANCE.

    Why has no other Japanese company made an offer (Olympus and Astellas saw something ......... and then didn't ??????? ) Cytori Japan is is probably self sustaining with the cosmetic surgery and independent investigator segments alone ....... with an option for SUI, scleroderma, Crohn's etc, etc

    Also of note is the massive spending to date on this technology. There is a substantial tax benefit for a purchaser , assuming a positive outcome in adoption/sales of the Celution device. Of course this is predicated on their buying CYTX for a relatively low price.

    Also is the short position real ???????? ............... . Hedrick could skewer the shorts in an instant if he sold the company or made a reasonable deal with BP/BB.

    Has CYTX already been sold.???????? Just waiting for the Dear John letter. Hedrick's performance and decisions todate are beyond incompetent: They are deeply suspect. The BoD have a lot to answer for. :evil: :bash: :puke:


    A really great post - thanks.

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    Business as usual? - Crohn´s Result Publication 31 Jan 2019 19:45 #12560

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    rongside
    1. Small trials don't "PROVE" anything.
    2. CYTX has a poor history with partners and no rush if one wants the BK remains.

    Fas
    Like the Lincoln Park reference as they now need $2 million up from $1.5 million reserve if they are to survive.
    Lets see what fun tomorrow brings.

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    Business as usual? - Crohn´s Result Publication 31 Jan 2019 23:45 #12561

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    Hedge, you are right in that small trials do not prove anything. They do however form the basis and justification for conducting larger trials powered to provide statistical significance. Cytori has an abundance of clinical data that warrants further investigation. In fact it has a trial that is awaiting just that decisive outcome (SUI)

    An additional case in point is Alofisel: Quote ''Alofisel contains the active substance darvadstrocel, which comprises stem cells removed from fat tissue of adult donors. It is a type of advanced therapy medicine called a ‘somatic cell therapy product’. This is a type of medicine that contains cells or tissues that have been modified so that they can be used to cure, diagnose or prevent a disease.''

    ADRC WORK : Autologous or allogeneic.???? Immediate, or expanded and stored????. Inexpensive or outrageous ????? good questions certainly, but not about the efficacy of ADRC !!!!!!! It is hard to believe that there is no interest in pursuing the autologous option for treating Crohn's fistula given the already proven effectiveness of ADRC and high cost of the allogeneic option.

    True, some partners have suffered. But someone who can see the potential and recognize the low cost treatment paradigm can surely pitch an offer for a controlling interest, particularly at this ridiculous share price level ................. unless of course someone else already has that controlling interest ??? In which case an offer would be irrelevant. Is management in place at the sufferance (pun intended) of the real owners ??? WE ARE NOT THE REAL OWNERS. We are however legally entitled to be informed of a change in control, official or defacto.

    Certainly management is obliged to know. I find this consant living/operating on the edge of BK for such a long time to be very suspect given the observations in my previous post about the potential of autologous ADRC.

    As for the purchase of the assets in BK, that is a very risky strategy for someone who truly wants the assets ............. unless of course he already owns them, or has an inside track to their acquisition. That would be a massive obstacle for a new interested party to overcome, particularly with an entrenched management/BoD with their own agenda. I wonder who has kicked the tyres, liked the car but was put off by the salesman. :KO: :cry:

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    Business as usual? - Crohn´s Result Publication 01 Feb 2019 00:22 #12562

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    *** They do however form the basis and justification for conducting larger trials powered to provide statistical significance.***
    100% agree but every real late stage trial has failed. SUI data is a joke imho and even DOV wasn't very impressed as more came out.
    To me, at least right now, the entire stem cell path is broken. Even if it is figured out there is little incentive for cures and the likely biggest beneficiaries besides the patients, governments who would reap the long term savings, have fought it every step of the way. Also IMHO, I am not sure Japan is doing their people any favors with current policy other than admitting patient should have the "informed" right to try. Note the quotes there.

    Also 100% agree on the salesman comments.

    Disagree that a offer in BK couldn't get what one wanted given Cytori has been shunned for so long and Oxford has made it obvious they really don't want it either.
    Personally, at this point, I would prefer a ending but admit another kicking of the can down the road in some form just as likely.
    Good Luck to everyone in the future should this be the end.

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    Business as usual? - Crohn´s Result Publication 01 Feb 2019 06:42 #12563

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    myownhedgefund wrote: *** They do however form the basis and justification for conducting larger trials powered to provide statistical significance.***
    100% agree but every real late stage trial has failed. SUI data is a joke imho and even DOV wasn't very impressed as more came out.
    To me, at least right now, the entire stem cell path is broken. Even if it is figured out there is little incentive for cures and the likely biggest beneficiaries besides the patients, governments who would reap the long term savings, have fought it every step of the way. Also IMHO, I am not sure Japan is doing their people any favors with current policy other than admitting patient should have the "informed" right to try. Note the quotes there.

    Also 100% agree on the salesman comments.

    Disagree that a offer in BK couldn't get what one wanted given Cytori has been shunned for so long and Oxford has made it obvious they really don't want it either.
    Personally, at this point, I would prefer a ending but admit another kicking of the can down the road in some form just as likely.
    Good Luck to everyone in the future should this be the end.

    /

    Trust me, this not the end - at least not yet :yep:

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    Business as usual? - Crohn´s Result Publication 01 Feb 2019 06:47 #12564

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    One thing that should be considered is whether Cytori really has any patent protection. Ingeneron and many others are doing the same thing, extracting stem cells from fat. Tigenix was doing it and switched to allogeneic model. It just may be that Cytori has nothing proprietary to sell.

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    Business as usual? - Crohn´s Result Publication 01 Feb 2019 08:29 #12565

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    We don't need no stinking patents, we have a gimish ...LOL
    Looking like a Friday night filing ???? They're never good.
    Or will it be BUYOUT MONDAY ???

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    Business as usual? - Crohn´s Result Publication 01 Feb 2019 08:46 #12566

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    The Company has many patents, but has not had the funds to defend them over the years - that could change on a buy-out.

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