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April 13 2016 is the date of the public hearing, which is of extreme importance for the future of Cytori as a Company. It will likely also determine whether Cytori is "partnerable" or not.
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TOPIC: History water under the bridge.

History water under the bridge. 30 Jun 2017 18:55 #9513

  • rongside
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Found this attachment relating to the predicate device application. It shows how CYTX was so close to getting aproval in the USA (in fact it did) and how the FDA has been moving the goal posts.


As a result a totally new regulatory pathway opened for Cytori ie. AUTOLOGOUS CELLS ARE DRUGS. This change was driven by the FDA. In retrospect that may well have been for the good, but it wasted a lot of time and capital (suing the FDA)

Geting a drug/device approved is no easy thing especially when confroned wih a paradigm changing approach for which here is no roadmap for either the regulaor or the company.

Management's failing was in (1) not capitalising itself better and not getting partners on board earlier. I undersand the desire to succeed on ones own and reap all the rewards, as I also understand that a bad deal can be just as bad as no deal (Macropore/Medronic). (2) Assuming cosmetic breast reconstruction was huge wihout adequately factoring in cosmetic suregeons and hospitals cost benefit analysis.

I can only hope that management is a bit more careful as to who they get into bed wih on the finance side (invesment banks- Maxim ) and that they remember that there are some of us here who have supported them over the long term, and who subscribed to the share capital increase to shareholders of record. That was a seminal event which I have not seen done by any other biotech company in the USA.

There are still a huge number of questions wih regard partnering, pricing and off label use that I have regarding ADRC and Celution. I can only hope that management has a WELL THOUGHOUT PLAN ?? for dealing wih the myriad issues that will inevitably arise if successful wih scleroderma. Management with their poison pill defences, and constant option allocations (while being paid) hink they can be complacent. THEY CAN'T, if for no other reason that its not fair to all the patients that can be successfully treated ......... and aren't.

Its been a long haul. Time to get the ball over the try line. GO THE ALL BLACKS (playing the Briish Lions tonight- 2nd test)

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History water under the bridge. 01 Jul 2017 13:54 #9515

  • fas
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Wow- Rugby is an amazing sport with superior athleticism and skill.

Yes- I do remember this announcement from October 2 2006-

San Diego, CA, October 2, 2006 - Cytori Therapeutics, Inc., (NASDAQ: CYTX; Frankfurt: XMPA) was awarded 510(k) clearance from the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) for the Celution™ Cell Concentration System as a cell saver device. The system is cleared for the collection, concentration, washing and re-infusion of a patient's own cells for applications that may include, but are not limited to, cardiovascular, plastic and reconstructive, orthopedic, vascular, and urological surgeries and procedures.
"This is our first U.S. clearance of a fully automated cell processing device with per-patient consumables, and demonstrates continued execution of our global regulatory and development strategy," stated Christopher J. Calhoun, Chief Executive Officer for Cytori. "While we do not intend to immediately commercialize this device, we view the clearance as a critical milestone in our development of related cell processing systems."
In January 2006, Cytori received European regulatory clearance (CE Mark) on a similar next generation system that processes cells from a patient's own adipose tissue in about an hour. This system will be used in the Company's European cardiovascular trials and is currently in use in an investigator-initiated clinical study in Japan to evaluate stem and regenerative cells for reconstructive surgery following a partial mastectomy.

It was part of Cytori´s strategy of getting REPLICATE approvals of all MODULAR parts of Celution. What was missing here was the Adipose tissue digesting part with Celase, for which they already had 510K approval. The to do was to combine those 2 "modules" and you have Celution.

CBER tripped Cytori in early 2007 and the rest we know- or at least -we both know. You probably remember the -The Celution Saga- article I wrote about this catastrophe which was very much liked at LinkedIn.

When I have certainty of the way forward, I will re-issue them on this page, since I have the horrifying past of Cytori pretty well documented and will provide access to the information to newbies if of course, it is still relevant.

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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:
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