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TOPIC: Note on EMEA Scleroderma MAP Program

Note on EMEA Scleroderma MAP Program 02 Feb 2016 06:15 #6160

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This investor note is intended to provide our investors further detail about our recently announced Managed Access Program of Cytori’s ECCS-50 cell therapy for Scleroderma patients in Europe, the Middle East, and Africa (EMEA). Please recall that last month, Cytori announced that it entered into an agreement with Idis Managed Access, part of Clinigen Group plc (“Idis”), to establish a program in select countries across EMEA for patients with impaired hand function due to scleroderma. Initially, we will focus on select countries within these regions and expand over time.

For context, the name ‘Managed Access Program’ is actually analogous to other terms often seen for similar programs such as: named patient, special access, expanded access, early access, early use, compassionate use, single patient IND, treatment IND, special therapeutic, and cohort supply. The names used vary by biopharmaceutical company, country, program, and regulatory area. Cytori plans to use ‘MAP’ as an umbrella term for this program moving forward. We believe that establishing a MAP at this time is justified based on scleroderma being a rare disease, the favorable risk-benefit profile reported by the 12-patient, open-label SCLERADEC-I clinical study results, two pivotal trials currently enrolling, and clear unmet patient needs and proven demand for ECCS-50 throughout EMEA.

As previously communicated, Cytori is currently enrolling patients in the STAR and SCLERADEC-II clinical trials in the U.S. and France, respectively, where patients may receive ECCS-50 therapy for scleroderma of the hand. Over the past several months, Cytori has received numerous requests from patients seeking access to ECCS-50, but who are unable to participate in the aforementioned trials, generally due to a lack of geographic proximity to a site. Our MAP will help address this unmet demand in EMEA and provide those in need with early access to the unlicensed medicine, ECCS-50.

Beyond the humanitarian benefit of helping patients in desperate need of new therapies for scleroderma, there are a number of other more practical reasons to develop and implement a MAP. Cytori’s goal with its MAP is to, first and foremost, provide access to patients who can benefit from the therapy. In addition, we receive certain secondary benefits such as increasing awareness of and facilitating a positive experience with Cytori Cell TherapyTM among healthcare providers in advance of commercialization. Another benefit includes tracking and collecting key program data and documentation which will provide valuable insight regarding the demand for and use of Cytori Cell TherapyTM.

Country specific regulations dictate the mechanisms for patient access which are largely determined by the regulatory status of the drug. In most countries, patient access to ECCS-50 will be provided on an ‘individual’ patient basis where the physician will make an application to their Competent Authority in each country on a patient-by-patient basis. However, in select countries regulations for globally unlicensed drugs such as ECCS-50 will require the implementation of a ‘cohort/group’ program where Cytori and Idis together will need to make an application to and receive approval from their Competent Authority prior to program initiation.

In most countries, ‘funding’ for unlicensed drugs prior to commercial availability within a MAP is permissible and is generally intended to approximate the ultimate reimbursed price for the drug. While revenue in the form of funding for the treatment is not the primary rationale for the MAP, it is a potential benefit. In France, for example, one type of MAP is called a ‘nominative’ Temporary Use Authorization (ATU), governed by specific legislation. Funding for a drug as part of an ATU is typically derived as >90% from government, hospital, and insurer sources and <10% from the patient. Outside of Europe, the funding is mostly derived from the patient. However, there are some markets where regulations mandate unlicensed products be provided free of charge if the product is globally unlicensed or will not allow access at all until first approval (e.g. European Medicines Agency conditional marketing authorization) is gained.

Our plan is to steadily expand the MAP prior to formal reimbursement approval and then, once approval is obtained, gradually eliminate the program in each country. As there are so few effective therapeutic options with favorable safety profiles for these patients with this significant disability, we are hopeful many physicians and patients may choose to take advantage of this program. The launch of the ECCS-50 MAP is consistent with and supportive of Cytori’s Mission, Vision and Values. Furthermore, the MAP is an integral part of our strategy to bring niche cell therapy indications rapidly to market and make Cytori not only a technology leader, but also a profitable enterprise in the near-term. Cytori is committed to keeping you apprised of progress made with its ECCS-50 MAP and provide more details into our overall plan to achieve our corporate goals over the coming months.

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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:

Note on EMEA Scleroderma MAP Program 02 Feb 2016 07:48 #6165

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the MAP is an integral part of our strategy to bring niche cell therapy indications rapidly to market and make Cytori not only a technology leader, but also a profitable enterprise in the near-term.

I had advised them to identify a few similar orphan drugs out of the 73 Idis has marketed and report the revenues from them. More specifically, how many patients were treated in the first and second years for these similar drugs. I have no idea what to put into my spreadsheet for revenue from the Idis partnership. The statement above suggests reaching profitability in the near-term. To me, that means this year so Hedrick will now have to qualify what he means by near-term. I suspect he means in the next few years.

Hedge, my spreadsheet has $1,250,000 for 2016 and $5,000,000 for 2017 specific to IDIS. Total guess! BTW, Jason Kolbert has $57 million in revenue for this year and $205 million for next year. Kolbert is setting Cytori up for failure while Hedrick and Girao are lowballing everything in an effort to exceed expectations. That is all the more reason for publishing an income forecast on this web site. The next one will be after the 2015 results and the guidance for 2016 has been released.
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Note on EMEA Scleroderma MAP Program 02 Feb 2016 10:02 #6166

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My read on PROFITABLE in the NEAR TERM is: not necessarily MAP related.
I think there is a broader hidden meaning.

1. As FAS indicated, warrant removal and its impact on the March earning report.

2. Japan renewed sales and marketing efforts.

3. Possible Lorem's possible purchasing obligations.

4. Increased revenue from Karastem, etc.

5. If the OA interim analysis is positive, this can lead to some financial rewards (such as some kind of partnership and some upfront payment).

6. Maybe Celactive is for real, coming to CYTX with a deal and money.

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Note on EMEA Scleroderma MAP Program 02 Feb 2016 11:26 #6167

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DOV
I would add although everyone should know JK's predictions are a joke he has every intension on being in on the next Cytori raise.

franshei
***I think there is a broader hidden meaning.***

I slight rewrite:
Management statements are broadly meaningless.
Especially when it comes sales revenues.

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Note on EMEA Scleroderma MAP Program 02 Feb 2016 11:34 #6168

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This company is a roller-coaster of happenings!!

I think I'm going to go to FIVERR and pay a dozen people $5 per letter and have them write all those money hungry Congress / Senate members about the immediate need for Cytori's device.

Joking aside, Hedrick & Co. need to bust their hump and make something happen. Despite the $0.18 share price, there's a lot on the Cytori plate and any one of these things can bring a partner.

BARDA, scleroderma 3, OA results, and yes, maybe even China.

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Note on EMEA Scleroderma MAP Program 02 Feb 2016 13:03 #6169

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FAS

This PR appears to be professionally written (well written).

I think this (as well other information) was presented during the NASDAQ hearing on the 21st. Without much specifics (real numbers) to back up words like "leadership", "profitable in the near term", people cannot make a more favorable ruling.

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