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TOPIC: Japan Commercial Update

Japan Commercial Update 18 Feb 2016 06:51 #6432

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Press release from Cytori website.

I saw a post on yahoo message board suggesting that someone on this board could perhaps get word to management that these press releases be more widely publicized. I one hundred percent agree!

Best,

Angryharry

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Japan Commercial Update 18 Feb 2016 06:58 #6433

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Japan Commercial Update 18 Feb 2016 07:36 #6437

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Here´s the text:

J

apan Commercial Update
02/18/2016
Dear Investors,

In early February, I presented in detail the rationale and plan for our managed access program (MAP) in Europe, which had been in planning stages during 2015 and may be associated with substantial strategic and financial upside for the company in 2016 and beyond. Similarly, when the new Japanese regenerative medicine regulations were finalized in late 2014, we began an intensive reevaluation of our Japanese operation. I would like to explain in greater detail our plans to further increase utilization and revenue in this important region.
Our primary objective in Japan is to build upon our current base of users to become the leading cell therapy company in the country. To make this a reality, we have been focused on executing three strategic goals.
First, we strengthened and restructured our team in Japan for long-term success. We created a global executive position, Vice President & General Manager - Cell Therapy, and because of the strategic nature of the Japanese market, we decided to base that position in Japan. John Harris was hired to fill that role and started with Cytori in October of last year. John has deep experience in regenerative medicine – prior to starting with Cytori, John was the President & Representative Director of Becton Dickinson’s operations in Japan. BD is well known in the regenerative medicine market and supplies many of the researchers in Japan the instruments and reagents necessary to further regenerative medicine research. John, like most of our team there, is fluent in both Japanese and English and will work closely with Mr. Seijiro Shirahama, who has taken on the role of head of new customer acquisition and Ms. Tomoko Takebayashi who has been promoted to head of customer service.
Second, under John’s leadership, we have developed a strategy that is intended to maximize current opportunities, expand indications and enhance reimbursements and position the company for long-term breakout growth. The Regenerative Medicine Law, enacted in November of 2014, made provisions for utilization of cellular based therapeutics. Celution is approved in Japan as a class I medical device. Shirahama-san and Takebayashi-san have been focused on driving installations of our system and providing support to facilities to comply with the Regenerative Medicine Law. Provider demand for cellular therapeutics is primed for substantial growth and we have seen a significant increase in consumable utilization in Japan due to their efforts.
More specifically, we see three discrete commercial opportunities developing: (1) aesthetic, (2) self-pay medical and (3) support of clinical trials designed to drive approval and reimbursement for specific indications. While each of these segments, are distinct, requiring tailored go-to-market approaches, all three are driving revenue today with our approved products and not reliant on formal government or payer reimbursement. Furthermore, each of these segments support activities that could lead in the future to approved, reimbursable cell therapies. Here is a brief update on each of these three segments:
We continue to see growth in aesthetic utilization of Celution, particularly for face and breast indications, over the past few quarters. In late 2015, Cytori partnered with one of Japan’s largest chains of privately owned beauty clinics to deploy Celution in a growing number of its clinics throughout the country. We have seen significant increases in consumable utilization at this key customer, highlighting a successful business model, and suggesting the opportunity for further growth through new installations and/or new customers in a similar model.
The self-pay medical applications represent opportunities to treat patients with chronic medical conditions prior to full approval and reimbursement of the cellular therapeutic. The elderly population is growing in Japan, and we have seen interest in expanding the use of Cytori technology for the OEM of cellular therapeutics in orthopedic, urologic and other conditions. In late 2015, Cytori has partnered with a few entrepreneurial clinics to drive this application, and initial usage has been encouraging.
Finally, Cytori continues to partner with and support academic centers for investigator initiated translational trials. The most advanced of these trials is the ADRESU trial which is currently enrolling in Japan for male urinary incontinence following radical prostatectomy. This trial, if successful, could support approval and reimbursement for this indication. A number of other such translational trials are in process and we anticipate planning for scleroderma and osteoarthritis of the knee clinical trials in Japan to more fully align the Japan organization with our corporate objectives.
Third, we are increasing our direct interactions with the Japanese Ministry of Health, Labour and Welfare to bring cellular therapeutics to market via both the device approval and regenerative medicine product pathway. We are taking a practical and collaborative approach to the process with the ultimate goal of “on-label” approval for indications currently in development elsewhere in the world such as osteoarthritis and scleroderma.
While this new strategy has only been in place for a few quarters, we are seeing promising early trends. Overall, the number of active systems placed and consumables used give us confidence that we are on the right track. We continue to look forward to steady growth from our Japanese operations, with positive contributions to corporate results.

Sincerely,

Dr. Marc H. Hedrick, President and Chief Executive Officer

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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:

Japan Commercial Update 18 Feb 2016 08:06 #6438

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Fas, this write up as well as that for MAP are professional written- very different style from the past. I suspect they were presented to NASDAQ in the January 21 hearing. So, these are all good intentional plans. I think CYTX plans to have periodic updates (see 2016 Hedrick's JPM presentation slides). China is a big disappointment (Lorem). Hope MAP and Japan will do well.

Clinically, it looks like any future activities will be low cost, while thermal burns will paid by BARDA.

2018 profitability is possible. In the mean time, ATM will remain a profit center.

R/s is unavoidable to shrink the 200 million shares outstanding in line with industrial norm (20 to 50 million shares).

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Japan Commercial Update 18 Feb 2016 08:18 #6439

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franshei wrote:

R/s is unavoidable to shrink the 200 million shares outstanding in line with industrial norm (20 to 50 million shares).



Fran, you can keep repeating and hope the reality will change the way you desire, but the reality is something else... the number of shares means nothing.. .the price is everything, and further dilution's impact must be considered before hand,,, Yes Marc could (and probably would) do a small RS but that would be sold so fast that Marc's jaw will drop.

IF there is any RS it has to be SO BIG to stop the bleeding... HUGE!

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Japan Commercial Update 18 Feb 2016 08:24 #6440

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Franshei --

Do you have concrete evidence (that the rest of us haven't been made privy to) that Lorem is a big disappointment, or are you simply speculating and taking the liberty to spread your speculation without declaring it as such?

I've heard no concrete information that Lorem is not proceeding as agreed.

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Japan Commercial Update 18 Feb 2016 08:50 #6442

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angryharry wrote: Franshei --

Do you have concrete evidence (that the rest of us haven't been made privy to) that Lorem is a big disappointment, or are you simply speculating and taking the liberty to spread your speculation without declaring it as such?

I've heard no concrete information that Lorem is not proceeding as agreed.


Participating on discussion boards is all and ONLY speculation. There is no one user here that is privy to inside knowledge, so all statements are assumed to be speculation and simply a continuation or deducing of prior (non-) events. :whistle:

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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:

Japan Commercial Update 18 Feb 2016 10:12 #6446

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Long winded and nothing to sink ones teeth into.

Why cant Marc quantify the numbers to show growth ?

x number of celutions 2 years ago to number of in use now...same for consumable usage.

He doesn't want to give exact figures, fine, express it in % growth terms from 2 years ago to now.

So far in dollar terms we know it been fairly meaningless even given the suggested lower burn rate for 2015.
Still, potential AND CURRENT investors want to see that a sales ramp is forming !!!!!!!!!!!!!!!!!!!!!!! :bash:

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Japan Commercial Update 18 Feb 2016 11:00 #6447

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Hedge,

I have to agree with you. If the scenario were as rosy as Hedrick wants to portray it then he should be more than willing to provide data supporting his optimism. I don't want to be a naysayer but when you parse the communication for meaningful information you can't help but examine it in the light of previous events. The optimist in me want to believe that the omission of any concrete data is simply due to Hedricks not wanting to complicate the communication. I also welcome the fact that Hedrick published it. Hopefully future statements will contain greater amounts of data to support any progress being made.

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Japan Commercial Update 18 Feb 2016 11:00 #6448

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angry, see my post under heading ctx2.

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Japan Commercial Update 18 Feb 2016 11:07 #6449

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Roth, thanks.

Roth had a recent face to face meeting with Hedrick and Girao. Lorem was brought up.

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Japan Commercial Update 18 Feb 2016 11:48 #6450

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thanks, rothco and franshei.

fatboy and hedge -- i think both your points revert back to the fact that hedrick is just not equipped with the broad ranging experience, wherewithal and thirst to maintain the CEO seat. i don't think he grasps these concepts: the significance of showing numbers, the significance of being a lead salesman (honest, but a salesman nonetheless), etc.

again it was pointed out on yahoo message board that today's positive release did not hit business wire (the press release distribution and regulatory disclosure PR outlet) yet the negatively expressed and negatively interpreted OA release did.

these all seem like amateur mistakes to me. hate to dwell in the past, but spending 10k plus the fee for representation to conduct a hearing with nasdaq, then having that appeal fail, also indicates a lack of experience in such publicly held company matters. these are the things that happen with an inexperienced, lackadaisical CEO.

(all this if we're giving him the credit of giving his best and honest effort)

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Japan Commercial Update 18 Feb 2016 11:51 #6451

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hopefully, he's just giving a prelude to the next earnings call with today's release and will give all the desired numbers on the next earnings call.

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Japan Commercial Update 18 Feb 2016 15:25 #6452

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for my final post on this thread, i'll conclude with this quote:

"if you can't do the little things right, you will never do the big things right."

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