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TOPIC: Was CC a Boob for betting on Boobs ?

Was CC a Boob for betting on Boobs ? 08 Mar 2013 12:57 #264

  • rongside
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When the Wired article came out I believed that breast reconstruction was a shoo in for approval AND reimbursement.

www.wired.com/magazine/2010/10/ff_futureofbreasts/

The subsequent positive data from the RESTORE trial and its publication was further confirmation of good things to come. Also positive was the NICE review of lipomodelling:

guidance.nice.org.uk/IPG417

Therefore, for me at least, the news that NICE had not approved reimbursement of the ADRC enhanced lipofilling procedure was an unpleasant surprise. :bash: I should have suspected that the delay in an announcement was not positive. CC gave us the bad news in what was otherwise a good conference call to offset the negative repercussions.

In retrospect one can accuse CC of being a boob in putting so much money in boobs, but this is not fair. The sales effort to support cosmetic augmentation self pay may have been a mistake, but the breast reconstruction after lumpectomy was a valid target and they hit it. We get approval, but they, NICE, block us by requesting additional trial data for cost benefit analysis.

It would appear that financial considerations in times of fiscal crisis have determined that women will not get the treatment they need and deserve. :puke: As per CC they have set an amount of reimbursement that is so little that it does not cover the Celution and surgical procedure costs. Also CC implies that NICE does not want to have more women with lumpectomy seeking treatment ie. maintain the status quo for budget reasons? Having to overcome a situation such as this goes to show how difficult it is to succeed in the Biotech/Pharma space. It also explains why drugs/treatments cost so much to develop.

I would think that CYTX could approach the NHS and suggest a co-pay agreement where patients pay the excess above the NHS payment schedule for the procedure. This could also be undertaken as a registry type trial where the data could be used for cost benefit analysis. It is not possible for CYTX to put more money in this indication at this time, but that does not mean that they cannot keep on pushing this forward.

The NHS is an institution which the British can be proud of. That they cannot fund everything is a given. They should not use requests for more data to delay or derail progress. Co-pay is the way to go.

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Was CC a Boob for betting on Boobs ? 08 Mar 2013 14:04 #265

  • myownhedgefund
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So if CC touted UK breast recon as the event that would make them cash flow positive...this indication alone !!!
When was the denial realized and why was it not reported in a timely manner as a material event ?

Where is Lloyd Dean with this ?

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Was CC a Boob for betting on Boobs ? 08 Mar 2013 16:55 #266

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Just to make sure everybody knows what Rongside and Hedge are talking about-

One area in which we have not had success in is in the process of obtaining nice endorsement of our technology for breast reconstruction in the U.K. Our file submitted last year and subsequently revised was returned to us for further data to better substantiate cost-effectiveness. There were 2 important contributing factors in their decision. One was a significant reduction in the fat grafting payment to the NHS hospitals that negatively affected our cost-effectiveness modeling. Overcoming this issue would require an additional comparative trial with prospective cost-effectiveness data. Secondly, since the vast majority of these patients are not reconstructed today, our treatment could represent additional new cost to the NHS. And in the current austerity mode of the NHS, this would not require -- this would require additional quality-of-life data. And while we strongly believe in the effectiveness, patient quality-of-life benefit and ultimate cost-effectiveness of this treatment, we have not budgeted additional trial work in Europe for 2013. We will update you as the situation changes, but we will continue to sell globally for this indication under our existing claims.


Hedge- I do not recall CC saying that- just something by Saad that only UK (general) could. I dont know- its meaningless to argue about that I think, conference calls are "covered" by forward looking statements- 10K reports are NOT. And I am an expert in those things.

John- yes, I would tend to agree with you. Having a lumpectomy done and the resulting deformity agony doesnt mean breast reconstruction is a life threatening disorder requiring immediate attention. So having the patient kick-in would make sense.
I dont know- I was never that hot about all this- than again- its part of the science and very worthwhile in respect of female psychology.

Just know that there is still a review ongoing at EMPACT -but only covers a limited population.

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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:

Was CC a Boob for betting on Boobs ? 08 Mar 2013 18:28 #267

  • myownhedgefund
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Fas...I understand the forward looking statement aspect and agree...however filing for a reimbursement, then being denied is a material event in my mind and should be reported.
BTW...I do believe CC also stated the cash flow positive aspect of UK breast recon. ...it may have been in a presentation, but it doesnt matter.

I look forward to your comments Sunday :)

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Was CC a Boob for betting on Boobs ? 09 Mar 2013 09:05 #268

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Yes- when one considers all that has been said and sofar has not materialized, these "small" things really do not matter all that much. :bash:
Anyway- I think I will postpone my article until next week- I definitely want to review the regulatory part of the 10K before I write ANYTHING.

And so far as you have also noticed- it has not been released yet. :yawn:

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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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