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TOPIC: FDA Approval to start RELIEF

FDA Approval to start RELIEF 10 Apr 2017 06:21 #9114

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Cytori Receives U.S. FDA Approval for Burn Clinical Trial Related to BARDA Contract

Apr 10, 2017
SAN DIEGO, April 10, 2017 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (NASDAQ:CYTX) today announced that the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) for a pilot clinical trial to evaluate Cytori Cell Therapy™ in patients with thermal burn injury. This trial, named the RELIEF trial, is a continuation of Cytori’s ongoing research and development efforts under its contract with the Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services.
The RELIEF trial will assess safety and feasibility of intravenous delivery of Cytori Cell Therapy™ as an adjunct to usual care in patients with thermal burn injuries covering between 20% and 50% of their body surface area. The trial is approved to enroll up to 30 patients in up to 10 U.S. sites. Initiation of RELIEF is dependent upon execution of a contract option by BARDA to provide the necessary funds.
“This announcement is yet another milestone achieved as BARDA and Cytori continue to move this technology forward through the development process, from preclinical to clinical implementation,” said Dr. Marc Hedrick, President and Chief Executive Officer of Cytori. “Approval of RELIEF is a major step towards the ultimate goal of making this technology available to our citizens as a national countermeasure against burn injuries potentially including those complicated by radiation exposure.”
The current healthcare system is ill-prepared for large numbers of patients requiring simultaneous treatment for thermal burns, particularly those complicated by radiation exposure. Current standard of care consists of dressings, skin grafts and skin substitutes. Despite these treatments, patients with severe burns commonly suffer from prolonged pain, aggressive scarring, skin contracture and reduced range of motion. Cellular therapeutics such as those offered by Cytori may have the potential not only to improve the quality and rate of wound healing and reduce scarring but also to be deployable in a cost effective manner, even in mass casualty situations.
According to the American Burn Association, there were approximately 450,000 burn injuries in 2013 that required medical treatment in the United States, with approximately 40,000 requiring hospitalization. According to a report from the Government Accountability Office, as many as 10,000 patients could require thermal burn care in a mass casualty event. The limited number of specialist surgeons and burn centers in the U.S. creates a public health need for a burn wound therapy that can be quickly and broadly applied by non-specialist medical personnel following such an event.
The RELIEF Trial is designed as a prospective, open-label, parallel group, usual care controlled, multi-center randomized (2:1, active: usual care alone) safety and feasibility study targeting thermal burns. Subjects will have at least one deep partial or full thickness burn wound that is to be autografted with a meshed split thickness skin graft (STSG). Subjects randomized to Cytori Cell Therapy will undergo small volume fat harvest (100 to 150 mL) during scheduled burn surgery followed by intravenous delivery of Cytori Cell Therapy. Subjects randomized to usual care will not undergo a fat harvesting procedure.

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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:

FDA Approval to start RELIEF 10 Apr 2017 06:35 #9115

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Thanks FAS,

What is your opinion regarding this development?

Best
Sahin

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FDA Approval to start RELIEF 10 Apr 2017 07:10 #9116

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If I understand this correctly, all 30 patients will get the usual standard of care. With 10 sites involved, each site will treat 3 patients. Two will get the stem cell IV and the third will not. After multiple time periods, an assessment of how each participant healed will determine the effectiveness of the stem cells. This is a pilot trial mainly to determine the safety of IV injection with some view toward the healing power.

Barda has never moved the stock price for very long. I am surprised at the pre-market volume and the price movement from an announcement that was totally expected. Barda has not yet officially awarded the next stage of the contract. I think this trial is supposed to cost around $8 million. The next trial is supposed to cost $40 million, but that could be revised to whatever the FDA and Barda think the size needs to be.

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FDA Approval to start RELIEF 10 Apr 2017 08:32 #9117

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DOV wrote: If I understand this correctly, all 30 patients will get the usual standard of care. With 10 sites involved, each site will treat 3 patients. Two will get the stem cell IV and the third will not. After multiple time periods, an assessment of how each participant healed will determine the effectiveness of the stem cells. This is a pilot trial mainly to determine the safety of IV injection with some view toward the healing power.


Agree- the word "adjunct" says it all. An adjunct therapy is another treatment together with the standard of care or primary therapy.
Anybody who has seen the pictures from the Akita trial and paper or the Naples foot ulcer results, which are all related and I would even say, more difficult treatments than burn patients will know and recognize this will in due course be a homerun. It needs however a lot of time and a lot of patience as with anything with the FDA. So way beyond 2020.

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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:

FDA Approval to start RELIEF 10 Apr 2017 11:21 #9118

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After less than 3 hours trading, more than half of the float has been turned over. The owners of Cytori shares appear to be traders??

Anyway- plenty of opportunity for Cowens to make some money for CYTX and Lincoln could do the same. Its time to start to track the share count a bit, since partner deals - as usual- will not happen until the tech has been proven solidly and the high demands by Hedrick and BOD appear more realistic for folks not wearing a Cytori-badge. :whistle:

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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:

FDA Approval to start RELIEF 10 Apr 2017 12:10 #9119

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I think Tiago is raising money today, as DOV had commented before (last time when the PPS crossed $ 2).

The sudden stock price spike has created a big gap and I am sure Hedge may have something to say soon.

Great move today!

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FDA Approval to start RELIEF 10 Apr 2017 14:24 #9120

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A large portion of the volume today appears to be the ATM and the LPC deals at work. While this might be keeping the lid on a further intraday rally, I view this as a positive as it should allow Cytori to represent a much stronger cash position in their negotiations with partners.

STAR results coming soon, Azaya partnerships alluded to/promised, BARDA funding announcement pending, not to mention the possibilities of success in Japan and Europe. Lots of juice to add to this rally when these items materialize.

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FDA Approval to start RELIEF 11 Apr 2017 05:08 #9125

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Well putting aside all of yesterdays mysterious action, at least this is a real trial with a real control group vs the BS lactated ringers only as a control.

I guess if there is one issue is it is certainly geared to the current burn market over what would be expected in a mass casualty event. No one will be doing 10,000 grafts.

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