The page where you can find all relevant information about Cytori Therapeutics Inc, listed on Nasdaq- Symbol-CYTX. You can learn about its history, the people at Cytori and its disruptive technology, which prepares a cellular product as remedy against many disorders from your own tissue with the aid of an extraction device, called Celution.
First, there is inflammation. Second, there is an immune response. Third, a lack of blood flow (ischemia) or vascular dysfunction. Fourth, there is scarring and tissue degeneration. The foregoing describes the pathophysiology of a typical chronic disorder, to which one can add apoptosis or cell death for most acute disorders. The cells extracted, named ADRCs, which is short for- Adipose Derived Regenerative Cells- have mechanisms of therapeutic action, which address all those debilitating factors. Absolutely magic.
In early 2010, the FDA shocked investors in Cytori by refusing to grant a 510K on the Celution 800 device. A 510K approval would have granted Cytori the right to market the Celution system to doctors and hospitals as a device capable of providing a clinical grade dose of stem and regenerative cells for use in the practice of medicine (for use in any application the doctors felt was appropriate). By Congressional Charter, the FDA does not have authority over the practice of medicine. So, why was it a shock that the FDA refused to grant Cytori’s Celution System a 510K? The reason was because the medical device produced stem cells that were highly effective and therefore was worried the cells would be used too widely. As a precaution, the FDA wanted to regulate the Celution System as a biologic rather than a medical device. Safety is the responsibility of the FDA and because these stem cells had been demonstrated to be highly effective, the FDA ruled that each application must be approved based on clinical trial data.
Fast forward to the present; Cytori is in an advanced stage of drug development trials with the FDA and with the European Medicines Agency. It is an advantage to the company and stockholders that the drug is regulated as a device instead of a biologic. That is a benefit in terms of time and investment dollars needed to gain approval. From here, I will discuss each trial, its timeline, and when the company should begin to receive revenues from the drug’s approval and insurance reimbursement.
Long term investors into this exciting technology, of which most at least got third degree financial burns in their wallets and some might even have incurred heavier losses, certainly will remember the speech Marc Hedrick gave in the November 2009 Conference Call.
The title of this little speech was- We can "smell the Inflection Point" - the roadmap he saw at the time to a break-even situation, which would occur some UNDEFINED time in the future, which was explained in some more detail in the image which Mark Saad at the time (2009) had shown (see image below). This predicted Inflection Point -as we know- never came and Marc must have smelled something different. The mystery is still, what did he smell? Anyway-keys to this failure was mainly, that the marketing pull from surgeons and consumers, which never came as predicted, since not having any specific indications approved or supported by adequate clinical data and the fact that device 510K was never realized in the US.
Recently the question was raised whether anybody ever had encountered a negative scientific -peer reviewed- study involving Cytori´s processing device Celution, which had been-as written- unfavorable i.e. negative in its conclusions.
In order to be able to give a substantiated answer to this question, one really has to know first which scientific- peer reviewed- papers do exist on the subject, so since I have been rather involved with the art of interrogating databases, I did so with the pretty substantial- and complete PubMed database. Off late the DB has been returning more and more publications from Private Investigator clinics and it is very likely that the funnel of these investigations has been growing and growing and beats the quality of Cytori´s past own investigations by many many miles. But also, that funnel will also "spit out" more results in the near future- Cugat -as an example- is expected any day now with his ACL results.
So- it starts to be interesting to put FOCUS on what is being issued in the various scientific journals of the globe, in order to be able to glimps at Cytori´s platform future.