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TOPIC: Cytori Presents Thermal Burn Data at the 2015 Amer

Cytori Presents Thermal Burn Data at the 2015 Amer 23 Mar 2015 07:12 #3920

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SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics, Inc.(CYTX) will present data from two preclinical studies describing safety and efficacy of ADRCs for treatment of thermal burn injuries at the Annual Meeting of the American Burn Association (ABA) in Chicago on April 21-24, 2015. This research, funded by the contract with the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services, was part of the package of data submitted to the US Government as part of the In-Process Review meeting that led to the execution of the current contract option valued at $14.1 million, and part of Cytori’s $106 million BARDA contract framework.

The first presentation will describe the use of Cytori Cell Therapy in combination with a widely used skin substitute in a full thickness burn injury model. Data to be presented show increased wound vascularity and maturation in wounds treated with Cytori Cell Therapy. The second presentation will describe a novel model of full thickness thermal burn injury with concomitant radiation exposure. Data to be presented demonstrate that delivery of Cytori Cell Therapy accelerates wound re-epithelialization in this context. These data will form the basis of an Investigational Device Exemption (IDE) package to be submitted to FDA for a proposed clinical trial using Cytori Cell Therapy in thermal burn injury.

“These are encouraging data that support the advancement of Cytori Cell Therapy to accelerate wound healing in severe burn patients,” said Dr. Tenenhaus, a plastic surgeon from UCSD Burn Center who specializes in reconstructive surgery for burns and other traumatic injuries. Dr. Marc Hedrick, President and CEO of Cytori commented: “We remain focused on continuing execution of key deliverables under our BARDA contract and believe that, when coupled with ongoing research and development activities, the data to be presented at ABA will support an FDA IDE approval and unlocking of the next BARDA milestone, which includes $8.3 million in clinical trial funding. We look forward to their full publication in the scientific literature in the near future.”

The treatment of thermal burns remains a critical underserved medical need. Despite standard of care primarily consisting of dressings, skin grafts and skin substitutes, patients frequently suffer from pain, scarring, skin contracture and reduced range of motion. Autologous cell therapies such as those offered by Cytori have the potential to improve the quality and rate of wound healing and reduce scarring.

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. In a mass casualty event, the Government Accountability Office reports that as many as 10,000 patients could require thermal burn care. 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.

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Cytori Presents Thermal Burn Data at the 2015 Amer 23 Mar 2015 07:42 #3921

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Fas,

This is a good example of Cytori withholding clinical data from the stockholders. You have always asserted they had a lot more data to share.

Cytori's web page displays an employee who was burned as a young child when she fell into scalding hot water in a bathtub. Look at her right arm. Stem cell therapy has been remarkable in improving her mobility and wound appearance. Not to guess her age, but these treatments were decades after the initial wound. We are about to see data from immediate treatments on burn wounds (a branding iron on a large animal: goat or cow, I can't remember). The results were impressive enough to gain approval to move forward to the next step under the BARDA contract.

I expect the audience to stand and cheer!
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Cytori Presents Thermal Burn Data at the 2015 Amer 23 Mar 2015 08:39 #3922

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This is a good example of Cytori withholding clinical data from the stockholders. You have always asserted they had a lot more data to share.


Well, Lesley Kelly is really not such a good example, since her case was presented at the Annual Meeting in August 2012 I believe. But than again AFTER Cytori received SPECIFIC approval for radiation, burn, trauma and diabetic wound healing in Europe. That certainly was not by solely treating Lesley. She simply was an odd case, since she was a nurse and saw the power of ADRCs whilst being a small part of RESTORE.

Personally I am getting more frustrated all the time (despite Cytori doing better) after reading the 10K. There is hardly any info on translational medicine any longer. It seems Hedrick is cutting all information flow, except the core apps having focus.

I think thats very sad, so we have to simply rely on Okyanos and hopefully more upcoming clinics with freedom of speech and information. cytori is becoming a closed shop.

Anyway- Lesley´s story you referred to:

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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:

Cytori Presents Thermal Burn Data at the 2015 Amer 23 Mar 2015 08:46 #3923

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Actually, I was referring to the Barda data. This data is owned by Cytori and has been kept close to the vest. Finally, it will be revealed to the public and I hope the pictures are graphic to really drive home how well the cells work. When the human trials begin and doctors see how well they work, I hope they scream from the mountaintop to end the trial and treat everyone with the cells. Hedrick has told me that will not happen. In my opinion, the FDA has no compassion. We will see. Hedrick guided toward years when mentioning the Barda contract.

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Cytori Presents Thermal Burn Data at the 2015 Amer 23 Mar 2015 09:04 #3924

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I hope the pictures are graphic to really drive home how well the cells work


I see- IR Cytori remains a mystery- thats why this page. :cool:

For newbees - a study was done in Naples on local wounds treatment (so not systemic by injecting intramuscular), which study you can pick up on this page and read my commentary...

Link to article: Good news from Naples

an example:

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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:
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