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Cytori´s Technology- Celution, IP etc etc
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TOPIC: CTX2 Release

CTX2 Release 01 Jun 2017 06:32 #9395

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FAS and others

Finally, CTX2 is ready for shipment, following BARDA IDE approval.

The BARDA IDE and phase 1 are very important, leading to CTX2 release and secondary Raynald's. With CTX2 and Iv dosing, secondary Raynaud's can be treated in a physician's office at low cost. Celution's consumables will take the center stage, just like inks over printers. Great job done and great strategy forward.

I think nano regenerative medicine may some day excite all of us.

On Cytori Instagram, you can see the entire company's staff standing in front of the new office complex under construction. Harris is also getting a new office in Tokyo {flowers at the entrance}.

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CTX2 Release 01 Jun 2017 07:37 #9396

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franshei wrote: FAS and others

Finally, CTX2 is ready for shipment, following BARDA IDE approval.


Thanks Franshei- the announcement from today..

Cytori to Introduce Next-Generation Celution® Technology

Jun 01, 2017
SAN DIEGO, June 01, 2017 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (NASDAQ:CYTX) ("Cytori" or the "Company"), today announced plans to introduce its next-generation Celution® technology. The technology is available for pre-orders effective June 1st, 2017 with first product shipments anticipated to begin in Q3.
The next-generation Celution® technology incorporates new hardware and enhanced software that substantially improves performance and maintains compliance with evolving global medical device and cell therapy standards. Cytori will offer the new technology through chargeable upgrades to its existing global Celution® user base (where available) and as a standard feature set for Celution® Systems purchased by new customers.
“Cytori continues to evolve its technology platforms as it simultaneously advances its clinical programs,” said John Harris, Vice President and General Manager of Cell Therapy. “This new technology, partially supported through our BARDA contract, will be the cornerstone of our U.S. RELIEF clinical trial for thermal burn injuries and potential U.S. FDA PMA submission for Habeo™ Cell Therapy for scleroderma-associated hand dysfunction.”
This next-generation technology builds on nearly a decade of market experience, thousands of single-use procedure sets sold, numerous clinical trials and our most recent research and development activities.
“This announcement marks the most significant new evolution of our cell therapy technology in years,” said Russ Havranek, Vice President, Global Marketing at Cytori. “This enhanced product offering should immediately resonate with our current installed base in a variety of countries and potential new customers interested in clinical cell therapy for reconstructive, aesthetic and orthopedic conditions.”

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CTX2 Release 01 Jun 2017 08:18 #9397

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It all sounds good that the CTX2 will be used in RELIEF and the Habeo trial, but the commercial relevance evades me a bit.

They "rounded up" Celutions in Europe to diminish competition of say "plastic surgery" Celutions to treat Scleroderma at dumping prices. Japan is more secure for such action, but there the same applies really.

Will Deeside get something to do for China? I doubt it.

DOV can you get some clarification on this when you have time? Not urgent at all though.:bye:

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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:

CTX2 Release 01 Jun 2017 08:28 #9398

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FAS

I think with CTX2, the Lorem agreement will be renegotiated. It is more to Lorem's advantages. The Deeside plant may now geered up for EU and China.

Just my thoughts.

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CTX2 Release 01 Jun 2017 09:08 #9399

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Certainly nice to see this advancement.
Along with Fas' comments....isn't this going to effect sales in Japan as the CTX2 is so much cheaper...last I heard they were considering 10-15K per unit ? Of course it may also broaden adoption there.
In USA I was always assuming it would be the CTX2 and should make Habeo roll out easier. You know, I am still not clear on the point, does Cytori plan to "place" the units in the 40 sites for scleroderma or sell them. Anyone ?

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CTX2 Release 01 Jun 2017 09:35 #9400

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Hedge

I personally think CXT2 is not replacing celution 800 entirely. CXT2 is very much like a tablet vs celution 800, a laptop or a desk top tower, which should be used in more compicated medical procedure.

From what understand celution 800 is selling about $ 200,000 each in Japan - I am sure Harris is giving a lot of discount to about $ 100,000. I think for OA treatments/complicated surgery in Japan, routine uses in US scleroderma centers, frequent cardio uses at Okyano, etc, celution 800 maybe preferred. For warfare combats, plastic surgery, secondary Raynaud's (early stages leading to systemic scleroderma), CTX2 maybe preferred.

I personally think CTX2 would open up the company revenue channels, at a critical time when the US FDA regenerative medicine law/regs will be started in mid 2017.
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CTX2 Release 01 Jun 2017 09:57 #9401

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Thanks franshei !
BTW...agree the 800 was about 200K but no one is really paying that.

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CTX2 Release 01 Jun 2017 10:38 #9402

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Hedge Wrote:

CTX2 is so much cheaper...last I heard they were considering 10-15K per unit


Hedge my man, don't you think that 10-15k is a really low number for a medical device as sophisticated as the cellution? Damned CPAP machines are a couple of grand?? I would think 25-35K is more in line with the degree of technology purported to be contained in the new cellution device.

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CTX2 Release 01 Jun 2017 10:58 #9403

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myownhedgefund wrote: Certainly nice to see this advancement.
In USA I was always assuming it would be the CTX2 and should make Habeo roll out easier. You know, I am still not clear on the point, does Cytori plan to "place" the units in the 40 sites for scleroderma or sell them. Anyone ?


I do think Harris was rather clear at the CC - that is, they will have sales representatives (and NOT Celutions) deployed. Oh well- maybe -after reading this stuff again, it was not all that clear after all. My conclusion though is, that X salesrepresentatives will have a Celution at their disposal, although its not clear who will utilize the equipment. Typical Cytori clearness.

Pending STAR data, Cytori intends to file for an FDA PMA approval as soon as possible. Our technology will be regulated as a Class III medical device. This would position HABEO Cell Therapy as one of the first FDA-approved cell therapies and offer health care providers with an unlabeled treatment option to potentially improve hand function in patients with scleroderma.

The EU pilot trial data thus far have shown safety, feasibility and up to 3 years of clinical benefit in published and presented data. As previously mentioned, we feel the market in the U.S. is comprised of approximately 50,000 patients suffering from scleroderma, and over 90% of those patients have hand involvement. There is nothing approved in the U.S., and first- and second-line therapies to treat scleroderma-related hand dysfunction are not effective or well-tolerated. Third-line therapy used off-label are very expensive despite being poorly tolerated and provide only limited symptomatic relief.

Our market estimations indicate that there is an opportunity to achieve peak annual worldwide sales of $600 million with this product. Our experience with the STAR trial has confirmed the viability of the procedure in various health care facility settings. HABEO is uniquely focused on treating hand dysfunction, a major source of disability and socioeconomic impact for these patients. Pending positive STAR trial data, we anticipate potential approval approximately a year after PMA filing.

Our overarching commercial strategy is to take HABEO direct in the U.S. and look for partnerships outside of the U.S. Market research and validation activities are largely completed. Some of the key completed activities include: in-depth interviews with a number of U.S. and EU payers, hospital administrators, physicians, KOLs and patients to analyze and understand the scleroderma patient population, current treatments, unmet needs and the patient journey, and of course, the reimbursement landscape and potential pathways.

We have further tested these -- with these key stakeholders the HABEO target product profile, annual pricing models and market potential, product adoption, reimbursement coding strategy and the clinical evidence portfolio in support of coverage. HABEO Cell Therapy pricing is anticipated to be similar of those biologic therapies when launched that were targeted to hand dysfunction in rheumatic or inflammatory disease.

Working with the STAR principal investigators and specialty societies for plastic surgery, rheumatology and hand surgery, Cytori has already submitted an application to the AMA for Category III CPT codes that would cover the comprehensive procedure. We anticipate these Category III CPT codes may be published in January of 2018 followed -- or following up CPT coding and activities are also planned post data.

The activities that we have planned for Q3 and Q4 include: health economics evaluation, a burden of illness study, payer budget impact, cost-effectiveness analysis with leading experts, and expansion of our existing relationship with patients in rare disease advocates on national, regional and local levels.

Based on our experience in treating over 100 patients in our pilot and pivotal trials, rapid enrollment in our U.S. trial and the understanding of the referral pattern, market evaluation results and coupled with our long-standing commercial experience in Japan with this technology, our U.S. go-to-market strategy is as follows: we anticipate deploying a highly-focused, specialty sales force and key specialists concentrated in high-population centers of the U.S., with immediate coverage of the approximately 40 scleroderma centers of excellence. Note that nearly half of these centers have already successfully used our technology, understand how to establish the internal referral process, and most importantly, have already implemented the simple bedside procedure as a part of the STAR trial. These STAR trial sites will serve as our beachhead for our commercialization activities surrounding our planned launch. Our plan is to place a solution system at each one of these centers and provide procedural support to the facility.

We will be able to broaden our outreach to the remaining centers of excellence in the U.S., and ultimately, the EU. This center of excellence approach, which is a manageable number, will position Cytori to address the needs of the majority of the market and then our -- and then we will extend our outreach to the rest of the rheumatology community.

In conclusion, our focus is on preparing for 2 key product launches: one, HABEO, with peak worldwide annual revenue estimated to be $600 million, and we're on track with the key commercial preparation activities; and two, ATI-0918 via a partner in Europe. The current annual market for this product is in excess of $300 million and forecasted to grow. Partner outreach is ongoing in 2017. Concurrently, we will continue to focus commercial efforts in Japan to both increase the number of active systems and drive continued utilization growth.

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CTX2 Release 01 Jun 2017 14:47 #9404

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fatboy...could be...obviously the higher the better...I am going back a bit on that figure.

fas...it was in there:
***Our plan is to place a solution system at each one of these centers and provide procedural support to the facility.***
Of course we still don't know if "place" means a sale or its free. It kinda hints a free to me, but we just don't know from the quote.

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CTX2 Release 01 Jun 2017 15:09 #9405

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Hedge,

If BARDA ponied up $14 million then free is not exactly an apt description...

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CTX2 Release 01 Jun 2017 15:31 #9406

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fatboy
I was referring to what the scleroderma centers will pay, if anything in the response part to Fas' comments.
Yes, I do agree however, that BARDA is paying a pretty penny for a 30 patient trial.
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