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TOPIC: Kerastem receives FDA IDE approval for Alopecia

Kerastem receives FDA IDE approval for Alopecia 28 Jul 2015 07:14 #4882

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SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics, Inc. (NASDAQ: CYTX) today announced that Kerastem Technologies, a wholly owned subsidiary of Bimini Technologies, received U.S. Food and Drug Administration (FDA) conditional Investigational Device Exemption (IDE) approval to conduct a clinical trial studying the safety and feasibility of its technology for the treatment of female and early male pattern baldness (androgenic alopecia).

The phase II study, known as the STYLE trial, follows initial clinical work in Europe and Japan. This clinical experience served as a basis for the FDA IDE submission. The data will be presented in September at the 2015 International Society of Hair Restoration Surgery meeting in Chicago. STYLE is a 70 patient controlled trial that is expected to begin enrollment in late 2015 at up to eight (8) centers within the United States. The primary endpoint is safety and tolerability of the treatment and secondary endpoints include change in hair growth and density.

In 2013, Bimini, a private medical technology company, acquired global and exclusive rights to commercialize Cytori Celution® Technology for alopecia and hair related indications. Under the commercial agreement, Bimini will be responsible for all key activities including clinical studies, regulatory approvals, and market development. Bimini will acquire Cytori products at agreed upon transfer pricing and pay Cytori a perpetual royalty on sales.


For more information on the STYLE trial, visit www.kerastem.com or clinicaltrials.gov/ct2/show/NCT02503852?term=Kerastem&rank=1


As indicated the clinic is conditional for something, which was not conveyed, what that was.

It is also an IDE clinic, i.e. a PMA device investigation, normally referred to as a pilot clinic and not a phase 2 to not to mistake it for a "drug" type clinic.

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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:

Kerastem receives FDA IDE approval for Alopecia 28 Jul 2015 07:36 #4883

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The procedure seems to be with ENRICHED fat..


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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:

Kerastem receives FDA IDE approval for Alopecia 28 Jul 2015 09:20 #4886

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Help me out here... didn't these people buy our product for 5-15 Million and walk away (depending on future growth)?

Why are we celebrating this?

A little higher, and shorts will join the party again.

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Kerastem receives FDA IDE approval for Alopecia 28 Jul 2015 09:32 #4887

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I think there are some quiet buying below 50 cents lately. I think quick profit may be made, before meeting the big "gap" again (I know some people do not like the word GAP).

Indeed, this is a SPIKE and it may not last.

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Kerastem receives FDA IDE approval for Alopecia 28 Jul 2015 09:37 #4888

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will be shorted, since this news has nothing to do with us... this is another pump and dump game... wait for the bottom, which will be in the middle of major stock market crash....

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Kerastem receives FDA IDE approval for Alopecia 28 Jul 2015 09:57 #4890

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Just that most gaps get filled franshei.

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Kerastem receives FDA IDE approval for Alopecia 28 Jul 2015 10:05 #4891

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Bimini just bought the exclusive rights to Puregraft. That is marketing and manufacturing.

In respect of Celution apps- and Alopecia is one of them- KeraStem obviously has to buy the Celutions from Cytori and Cytori receives a license fee for every application sold.

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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:

Kerastem receives FDA IDE approval for Alopecia 28 Jul 2015 10:48 #4893

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fas wrote: Bimini just bought the exclusive rights to Puregraft. That is marketing and manufacturing.

In respect of Celution apps- and Alopecia is one of them- KeraStem obviously has to buy the Celutions from Cytori and Cytori receives a license fee for every application sold.


Thanks Fas, but I thought the patent for hair growth belonged to someone else... Been busy doing other things, but I can find it in the next couple of days.

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Kerastem receives FDA IDE approval for Alopecia 28 Jul 2015 11:09 #4895

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Thanks Fas, but I thought the patent for hair growth belonged to someone else... Been busy doing other things, but I can find it in the next couple of days.


I just looked at all "inventor Hedrick" patents and patent applications and surely there is not one in his name regarding alopecia, but also not in respect of hundreds of other disorders (including OA and scleroderma).

I do not think that has too much value anyway, in view of the patents on Celution and an approval is to be obtained on the DEVICE for every single application..
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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:

Kerastem receives FDA IDE approval for Alopecia 28 Jul 2015 11:19 #4896

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Mr Hedge, IMHO PPS going up before earning can be worrisome. Likewise, so called good news may lead to bad news. Let us see how things could turn out this time around.

Last year, before the earning and stockholders' meeting, CYTX released several so called "good" PRs (including an update on Lorem). Bad things have kept on coming after the stockholders' meeting. Remember Hedrick was saying in the stockholders meeting that the company was aware of the poor PPS (about $ 2 or so at the time) and he said the company had a plan to turn things around in 1 to 2 years' time (but not right away). Who would know at the time that the company would be a "going concern" and the PPS would be 30 plus cents in the next 12 months.

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Kerastem receives FDA IDE approval for Alopecia 31 Jul 2015 09:17 #4917

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Gap filled franshei. :whistle:

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