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TOPIC: CYTX Receives Smal Business Administration Designation

CYTX Receives Smal Business Administration Designation 06 Feb 2017 08:18 #8752

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The newly granted small business status allows Cytori to receive significant financial incentives, fee reductions, and fee waivers for selective FDA medical device regulatory filings. Such designation makes the Company eligible for a substantial reduction in many medical device user fees and a one-time waiver of the user fee for its first premarket approval (PMA) application potentially occurring later in 2017.

"The small business designation will substantially reduce filing fees in 2017 for our planned PMA application for HABEO Cell Therapy, our lead development candidate currently under investigation for use in scleroderma, should our STAR Phase III data support filing of this application," stated Tiago Girao.

See release for full details.

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CYTX Receives Smal Business Administration Designation 06 Feb 2017 08:35 #8753

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Full announcement-

Feb 06, 2017
SAN DIEGO, Feb. 06, 2017 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (NASDAQ:CYTX) announced today that the US Food and Drug Administration (FDA) Division of Industry and Consumer Education (DICE) has granted Small Business status to Cytori Therapeutics for Fiscal Year 2017. The newly granted Small Business status allows Cytori to receive significant financial incentives, fee reductions, and fee waivers for selective FDA medical device regulatory filings. Such designation makes the company eligible for a substantial reduction in many medical device user fees and a one-time waiver of the user fee for its first premarket approval (PMA) application potentially occurring later in 2017.
“Cytori Cell Therapy benefits from being regulated as a device through the PMA process. The small business designation will substantially reduce filing fees in 2017 for our planned PMA application for HABEOTM Cell Therapy, our lead development candidate currently under investigation for use in scleroderma, should our STAR Phase III data support filing of this application,” stated Tiago Girao, VP of Finance and CFO of Cytori Therapeutics.
The STAR trial is a Phase 3, US-based, multi-center (19 sites), randomized, controlled trial of HABEO in 88 patients with hand dysfunction and Raynaud’s phenomenon associated with scleroderma. Enrollment was completed in mid-2016. Data unblinding and analysis will commence once the last enrolled subject has completed their 48-week follow-up visit, anticipated to be in mid-2017.
In the United States, the scleroderma affected population appears to be approximately 184 per million, which would account for a market size of 45,000 scleroderma patients.1 Additionally, in Europe, scleroderma is estimated to have a prevalence between 31 per million and 277 per million which equates to approximately 17,000 to 149,000 scleroderma affected people in the Europe.2

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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:

CYTX Receives Smal Business Administration Designation 06 Feb 2017 09:04 #8754

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Rodney Strong

I went back to listen to Hedrick's 1/19 CC and reread Tiago's recent email.

1. The AZA due should be closed in 2-3 week after 1/19.

2. The AZA-CYTX marriage has to do with a. cell free off the self regenerative medicine (first sentence in Hedrick's CC) and b retreatment of patients (Tiago's email; Hedrick also mentioned this in the 3rd Q call from Tokyo -he said the details will be released in the next several Qs).

Puzzling. But we may soon learn more.

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CYTX Receives Smal Business Administration Designation 06 Feb 2017 10:34 #8755

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1. As Hedge would say, the volume is too low and the gap will probably be filled.

2. I think WST has two good points in his recent messages and I think CYTX is trying to do something about them through this AZA deal (maybe or maybe not).

a. autologous issue;
b. FDA requirement re "onsite manufacturing procedure" (manpower requirement) - I think for the 20 US sclerodemra treatment centers, CYTX can handle the FDA requirement in this niche indication.
I think CYTX has also mentioned that in EU, onsite monitoring is also required - it would be difficult, if there is only one CYTX employee in EU.
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