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TOPIC: Tom´s answers on Raccoon´s Questions Mail

Tom´s answers on Raccoon´s Questions Mail 28 Mar 2013 04:34 #346

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As already assumed, life has been hectic in SD following the FDA decision- a gentle reminder mailed last night received immediate attention by Tom. Thanks Tom very much appreciated!
So here you go :cool:

1. In view of available device tool claims (slide-Practice of Medicine) can any certified specialist in the EU now start a practice/clinic offering say vascular and wound healing therapies on an elective basis and Cytori is allowed to sell anything required by this specialist? Are there barriers in promotion or advertising?

a. Technically, this is possible with certain constraints on how it would be marketed. For example, the approval does not allow a claim to be made that this will “cure” a condition, rather that it may be applied in a specified circumstance. Practically, there other factors to be considered such as the extent of government healthcare, start-up costs for such a clinic, dynamics of the medical community in a certain country. Bottom line is that the most tangible impact in Europe is these approvals may facilitate IRB-approved studies and clinical series.

2. You have mentioned that RESTORE I & II could lead to approval for breast reconstruction (Class 3?) in Japan. In general, can clinics carried out abroad- say in UK, be used for claim applications in Japan and US in the future i.e. leveraging of clinical data?

a. In depends on whether the use abroad was part of a trial, what the design of that trial was, and whether we would have access to the data. To what degree it could support Cytori in the U.S. is tough to tell. The most likely scenario is that it could be used to support initiation of a trial, but we ultimately we would want to control the design of a pilot and approval study. Our focus as of this moment is on ATHENA and BARDA. As we gain approval from the FDA to begin studies in other indications we’ll provide details on that at such time. For competitive reasons we want to be careful with how much we share with regard to our clinical development strategies.


3. Relating to the latter- last year the soft tissue claims in the EU were extended with facial wasting. Can the data leading up to this claim be used for an orphan status HDE approval for Parry Romberg disease in the US? What is the status for this application? Has it been discussed with the FDA so far?

a. Our focus as of this moment in the US is ATHENA and BARDA. Again, as we gain approval from the FDA to begin studies in other indications, we’ll provide details on that. For competitive reasons we want to be careful with how much we share with regard to our path to approvals in Europe and what we are thinking in regard to a US strategy.

4. Considering that Canada and Australia are part of the Commonwealth, is there any additional work to be done beyond filings to achieve the same type of claims as achieved in the EU/UK?
a. I’m not aware that the former commonwealth connection has any relevance to either country’s regulatory process for medical devices or drugs. If you have information to the contrary, please share.

5.The existing CE approvals in soft wound indications appear to address major indications and have specific therapeutic claims (slide). As these indications all have similar methods of action in their treatment how does one apportion indications between potential partners? Is one partner likely to get a major share of the whole block of indications.? Will rights be apportioned on geographic basis?

a. You’ve hit on an important consideration that we have multiple solutions for as it related to prospective partners. Bottom line is we don’t see this as a hindrance to any prospective commercialization pathway that involves Cytori on its own, with a partner, or some combination.

6.Assuming the initial French scleroderma trial on hands and skin proves to be successful, it will be expanded to more serious cases of scleroderma, possibly to cover reimbursement? Is there a framework for pan European trials sponsored by the european state health care authorities (eg european version of NIH) to fund and approve the Celution device for an indication such as scleroderma? If not, is CYTX able to use the data for its own use or in partnership discussions?

a. The current study to be clear is addressing serious forms of the disease. There are various paths to market should the data warrant it be advanced further, including government funds. We can’t speculate at this time to what extent we’ll have access to the data, but this is a site we are close with so we’re optimistic. Let’s see how the data looks and all parties including Cytori will learn more at that time about the next steps.

7.Astellas right of first approval in liver indications just expired and was taken to income. Did they sponsor the work at Kanazawe (Suichi Kaneko)? If they did, what happens with trial data if they decide to not proceed into a partnership agreement? Any status report possible on the progress of talks with Astellas?

a. They did not sponsor the work at Kanazawa. When we have a signed partnership, we’ll publically disclose this information so that all our investors receive it at the same time.

8.You showed an interesting slide at the Shareholders Meeting- Urinary Contenence <image002.jpg>is shown at 1% of patients- i.e. approx. 50. Have some patients been treated in the EU, so that CE Mark can be expected or is this "all Nippon"? What is the size of the investigation announced this month on UI? And on the slide what indications are the yellow and light grey colors- wound healing?
a. We are careful with how much we share on our regulatory strategy for competitive purposes. To the degree there is interest in the investigator-initiated trials, we share your enthusiasm, but please remember that this should be viewed primarily through the lens of the longer-term strategic benefit and the nearer-term revenues. As these therapeutic areas gain greater traction in clinical trials or commercially, we will be in a better position to share more specifics. IN the meantime, with regard to our pipeline, the emphasis today is on ATHENA and BARDA.

9.After the Intravase approval you mentioned that ATHENA data are additionally required to lift Cytori over to the no-option CMI specific therapeutic approval. Shouldnt we be very close to reimbursement also, assuming convincing data are coming from ATHENA?

a. Reimbursement for no-cmi will require more European data.

10. Is there in the UK health care system (NHS), provision for a co-pay pricing structure for breast reconstruction after lumpectomy? ie. NHS pays for the lipofilling procedure, which is already approved (and reimbursible), and the client pays for the Celution processing and consumables? If in case co-pay is possible, could this not supply the additional data (eg. registry trial) to facilitate the total reimbursement for the procedure?

a. I’m not sure how practical or realistic of a process this would be to integrate into an NHS hospital procedure.

11. Last but not least- It would appear that much of the data from translational clinics so far stem from a variety of government agencies or surrogates (universities etc.). What disclosure clauses exist,i.e. what prevents Cytori from sharing the clinical data with shareholders? Things like researcher publication first possibly?. How can this data (from non profit institutions) be utilised by CYTX to progress into reimbursable trials. ie. can they use it in partnership negotiations with big pharma partners?

a. Every customer is unique and it’s based on the region, the study or trial, whether we have access to data, and what data looks like, and whether it’s a core priority for Cytori. What we can share is that once something converts to tangible value to Cytori beyond a customer relationship and revenue, we’ll share the relevant information. Some of the data from wound cases for example was used in part, but not on its own, to secure the BARDA contract. The benefit to Cytori was a fully funded path to market in the US for thermal burns.
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Tom´s answers on Raccoon´s Questions Mail 28 Mar 2013 07:45 #347

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Thanks, as always, Fas !!!!

Biggest standout for me was no option CMI reimbursement for EU would require more "European" data.
That means they wont accept ATHENA data for reimbursement it seems.

Also as expected....much seems in very early stages.

Focus remains....CASH !!!!!!!!!!
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Tom´s answers on Raccoon´s Questions Mail 28 Mar 2013 08:32 #348

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Thanks Fas!! :joy: The answers provided by Tom were more than I've heard in the 4+ years I've been here! I can honestly say I'm more comfortable and excited with Cytori than I've been in a VERY long Time! Asking all the questions and getting some of the answers was more than I expected! :happy: :happy: :happy:

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Tom´s answers on Raccoon´s Questions Mail 28 Mar 2013 08:54 #349

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hedge-
For me, what stands out, is something I have known all along and Tom re-confirmed this again-

For competitive reasons we want to be careful with how much we share


This "secrecy" relates to regulatory accomplishments as well as clinical data- just one example-

Suppose Cytori instead of bringing 4 lines in the earnings announcement early March, issued a "breaking news" announcement over all agencies stating:

After university XXXX having successfully treated 40 patients for urinary incontenence in a sponsored clinical pilot trial in Japan with excellent results- that is all mild incontenence cases had a 100% healing rate, with 70% with more severe case- the Japanese government has granted University XXXX 5 Mio$ to conduct a pivotal trial of 100 patients, which if providing the same results as already shown in the pilot trial will lead to approval and reimbursement of the therapy in Japan. In Japan there are 500.000 new cases of UI every year with males, but primarily females, which in two years could result in significant revenues for this unmet need of over 200 Mio to Cytori


This is the same news-which probably most investors did not take notice of, but which very well could be the case. This basically applies to a whole range of disorders- also in Europe- scleroderma and osteoporosis are BIG things and ultimately if successful each will represent multiples of the present CYTX market cap.

So- what are they afraid of???????????????????????????????????????????????????????

Unfriendly take-over? or ....opinions?

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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:

Tom´s answers on Raccoon´s Questions Mail 28 Mar 2013 09:11 #350

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Hedge, you are right in that cash continues to be the problem for CYTX. Nothing new there! :yawn:

The fact that CMI will not be reimbursable in Europe on the basis of ATHENA is unfortunate but not unexpected. What we should appreciate is that if two SMALL trials (ATHENA & PRECISE) have very good and comparable results then the likelihood of the initial european PRECISE trial being a fluke is negligible. The statistical significance would be comparable to that of a very large trial. If this happens we can hold an auction for this indication and receive enough funds to cover our whole pipeline. A pipeline which as per or host (FAS) is broad beyond belief. :grin:

From Tom's answers we see that they are being very discreet about allowing information about their progress become public knowledge. This is very frustrating but quite understandable as they don't want the competition to know at what level they are. CYTX's strategy with regard disclosure can be compared to a duck gliding over a pond....... it appears to glide very serenely over the water but only because there is a lot of paddling underneath. Todays announcement concerning patents covering renal disease is an example of this.

Lets hope that potential partners start to appreciate the potential of the technology and adjust their pricing models to reflect the valuation figures anticipated by CYTX. The FIRST partner may be the one who gets the best deal even if they may not see it that way initially.......... additional partners (if any) will have to bring exceptional value on top of funds to be considered.

One day we could wake up with a signed Astellas deal. :woohoo: For some it will be out of the blue ...... for others it will simply be late ....... but for all it will be a game changer. There is no way Astellas has not been conducting a lot of trial work over the last two plus years......Liver disease is huge everywhere, especially in JAPAN. For all that, I have not been able to find any mention of it. Looks like everyone is trying to fly under the radar.
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Tom´s answers on Raccoon´s Questions Mail 28 Mar 2013 14:56 #351

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Fas... in your scenario of a final phase trial funded by a government....it does solve the problem of near term cash and this is where the market is focused imho and also has given the short side to again be willing to add pressure in the $2's.

As for a unfriendly take over...maybe CC should have held onto more shares.

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Tom´s answers on Raccoon´s Questions Mail 28 Mar 2013 15:03 #352

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rongside

Appreciate all your points...but its all inter-related with the cash issue partnerships and what still needs to be done

Finally we got some volume the last 15 minutes of trading...otherwise even with todays news...its still very dull here in CYTX

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