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TOPIC: The Japan Commercial Update re-visited

The Japan Commercial Update re-visited 29 Jun 2016 13:58 #7349

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With the recent announcement and DOV´s explanations based upon his phone conversation with Hedrick, I think its worth re-visiting the investor note from February- since both IDIS and Japan are the keys to the Inflection Point and should be understood to judge Cytori and its immediate future (i.e the coming 18 months).

Japan Commercial Update

Feb 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 based 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.

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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:

The Japan Commercial Update re-visited 29 Jun 2016 14:15 #7350

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Maybe for the visionaries amongst the crowd here- it is perfectly clear that the Japanese Regenerative Law was designed and made for Shinya Yamanaka et al, which should restore a lot of Japanese superiority in respect of consumer inventions and IP, moving from convenience goods to medical therapies for the aging affluent society of the globe.

However- it becomes more and more clear that iPS cells- like ESCs- are beyond the scope of being controllable. At present there is - to my knowledge- no clinical trial ongoing- the first one being stopped after one (=1) patient.

Leaves the field for adult cell therapy... the only thing working. The PR on Shinzo Abe´s initiative has surely created lots of awareness for regenerative medicine in the land of the rising sun.

I believe Cytori is very well positioned to benefit from all that PR which has been lacking in Europe, but indirectly is also fed by all these illegal clinics in the US.. :yawn: :grin:

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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:

The Japan Commercial Update re-visited 29 Jun 2016 18:39 #7352

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FYI, That iPSC trial has been restarted.

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The Japan Commercial Update re-visited 30 Jun 2016 06:14 #7353

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Wall Street Titan wrote: FYI, That iPSC trial has been restarted.


Yes- they intend to restart in 2017 and are switching to allo to bring down the cost from approx 1Mio$ to a fifth of that or lower... :whistle:

OSAKA -- Four Japanese institutions will collaborate on transplanting tissue grown from induced pluripotent stem cells taken from donors into patients suffering from age-related macular degeneration, a hard-to-cure eye disease.

The initiative, announced Monday, will break new ground in that the cost of transplanting iPS-derived tissue will be significantly reduced by using stocked cells provided by donors, instead of using the patients' own cells as in a previous case involving a sufferer of the same disease.

Under the partnership agreed on May 30, Kyoto University will provide iPS cells resistant to immunological rejection in the treatment and the government-affiliated Riken research institute will grow them into retinal cells. Osaka University and the Kobe City Medical Center General Hospital will implant these cells into patients as early as the first half of 2017.

"We formed a solid tag team between four institutions, which I feel will be a force to be reckoned with," Kyoto University professor Shinya Yamanaka told a news conference Monday.

Clinical research will also run concurrently using tissue grown from the patients' own iPS cells. About 20 candidates in all will receive transplants.

In 2014, Riken performed the world's first transplant of iPS-derived retinal tissue, with a Japanese woman suffering from macular degeneration on the receiving end. But because the patient provided her own iPS cells, costs related to that procedure reportedly climbed to around 100 million yen ($931,000). Using donor iPS cells is expected to drive down costs to a fifth or lower.

A transplant on a second patient was called off after the discovery of a genetic mutation in the patient's iPS cells.


Link to article : HERE

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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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