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TOPIC: IDE clinic for BARDA announced

IDE clinic for BARDA announced 19 Aug 2014 07:14 #2037

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So- here is your awaited BARDA announcement. Unlike what most folks will think- i.e. bad, since there is only 20 Mio to "spend", it is actually very good since the FDA apparently will approve an IDE trial and not what probably was anticipated and "calculated" in the higher 56 Mio option an IND trial.

As a reminder for readers of the site- IDE- is a device clinic (IDE = Investigational Device Exemption) - IND a "Investigational New Drug" trial, which normally includes many more patients and therefore is much more costly.

This also means, that market is much closer than some people expect.... :grin: :vegas:

The announcement:

BARDA Executes Contract Option with Cytori for Continued Development of Thermal Burn Injury Counter Measure
Option Valued at $ 12.1 Million plus $ 8.3 Million for FDA Approved IDE Trial

SAN DIEGO, August 19, 2014 – Cytori Therapeutics (NASDAQ: CYTX) and Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services announced the execution of a contract option to fund the continued investigation and development of Cytori Cell Therapy for use in thermal burn injuries. The current extension is valued at approximately $ 12.1 million. Upon IDE approval by the FDA, BARDA anticipates funding to cover costs associated with execution of the clinical trial, currently estimated at approximately $ 8.3 million, bringing the combined value to up to $ 20.4 million.

The execution of this option funds the remaining research and development activities required to enable a pilot clinical trial of Cytori Cell Therapy in thermal burn. It also funds approximately two years of preclinical studies in other burn-related areas that could lead to broadening of the utility of Cytori technology to burn centers and in wound healing more generally. The immediate focus of contract activities is directed at preclinical, clinical and regulatory activities leading to FDA Investigational Device Exemption (IDE) approval for the trial. The contract retains two additional options in the original contract to fund a pivotal clinical trial and additional work in thermal burn complicated by radiation exposure valued at up to $ 45 million and $ 23 million respectively.

“We are honored to be the first technology in the area of thermal burn to have a contract option executed by BARDA,” said Dr. Marc Hedrick, President and Chief Executive Officer of Cytori. “As part of the review and negotiation process, we submitted to BARDA a comprehensive package of preclinical and clinical safety data from our research under this contract as well as data from our U.S. clinical trials. The preclinical data from the initial phase of the project has been very positive and consistent with what we have observed in patients with chronic wounds treated with ADRCs and we anticipate submitting the data for publication later this year. Execution of this contract option allows us to keep national preparedness a top corporate priority and represents a key partner funded pathway to market in parallel with ongoing Cytori-funded activities.”

In September 2012 Cytori was awarded a contract with BARDA for the development of Cytori Cell Therapy for thermal burns combined with radiation injury. The initial base period of the contract covered three contract milestones which were achieved to the government’s satisfaction. These milestones included:

Preclinical studies demonstrating improved healing parameters using Cytori Cell Therapy in a thermal burn model
Preliminary design and development of Cytori’s next generation Celution® System, and
Demonstration of feasibility of obtaining viable, functional regenerative cells from adipose tissue samples from burn patients.

By exercising this option of the contract, originally awarded to Cytori in September 2012, this investment funds research and development activities as to whether ADRCs™ could serve as a valuable medical countermeasure for thermal burns when combined with radiation injury as part of the U.S. government’s national preparedness initiative. This contract is part of BARDA’s national preparedness initiative to prepare for a possible mass casualty event by developing technologies that may address unmet medical needs in the area of bio-defense. In the event of a radiological or nuclear emergency, people are likely to have combined injuries involving trauma, radiation, and thermal burns. In a mass casualty event, healthcare providers will need a variety of effective ways to diagnose and treat the wide range of illnesses and injuries. Cytori’s technology could be effectively pre-deployed at hospitals throughout the U.S., creating a wide network that could be utilized by non-specialist personnel, which would allow for an efficient response to such an event.

The treatment of thermal burns remains a critical unmet medical need. Despite standard of care treatment 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 Cytori Cell Therapy have the potential to improve the quality and rate of wound healing and to reduce scarring. According to the American Burn Association, there were approximately 450,000 burn injuries that required medical treatment in the United States in 2013, 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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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:

IDE clinic for BARDA announced 19 Aug 2014 07:48 #2038

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As part of the review and negotiation process, we submitted to BARDA a comprehensive package of preclinical and clinical safety data from our research under this contract as well as data from our U.S. clinical trials.

This statement is unbelievable.

Why say that if there was not anything else except ATHENA, which is blinded and not finished?????

Or more things in the dark that investors do not know about??????

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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:

IDE clinic for BARDA announced 19 Aug 2014 09:21 #2039

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IDE would make burn market closer but given this seemingly reversal of FDA device thinking with celution can we expect this will apply to ALL applications ?
That makes what BARDA accomplished to date quite valuable !!! :nice:

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IDE clinic for BARDA announced 19 Aug 2014 09:31 #2040

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*** and in wound healing more generally.***

Like this part as well.

#####

Fas, with regards to the unknown burn activities...remember some time back there was a slide durning a presentation that showed a extra study going on the the USA and I questioned what it was or if they were simply counting ATHENA one and ATHENA two as different studies....well we may have our answer in burn treatment.

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IDE clinic for BARDA announced 19 Aug 2014 09:56 #2041

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Old FDA " screw cytori"
New FDA " We love cytori " ( actually it was a shotgun wedding enforced via BARDA via Tommy Thompson) ....this is really the environment we needed .... They'll get some cash, partner or both ... This is BIG IMO.

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IDE clinic for BARDA announced 19 Aug 2014 11:01 #2043

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Do you think it is big enough to raise the pps to a level where those holding warrants will exercise the option to purchase shares, thus adding quite a bit of much needed cash ? I do not hold such warrants, I am long and screwed. Saad has commented to some that he believed the pps would be at such a point. There best be some more news to come if his words are to become reality. It certainly would be a giant step in the right direction. Then again Saad left so perhaps he knew this would not come to pass. :bang:

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IDE clinic for BARDA announced 19 Aug 2014 15:00 #2044

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Boy- did I have a rough day- exiting and successful, but just stress and dog-tired. So just briefly....

Hedge- IDE would make burn market closer but given this seemingly reversal of FDA device thinking with celution can we expect this will apply to ALL applications ?


Just a quote from Hedrick from the last call- now we know that Cytori Cell Therapy will be regulated as a device all over the world. He was talking about Japan- so that implies that yes- in the US CCT is also regulated the device way- all as PMA´s probably.

For the rest- the market action was expected- although I think it was really a bit "over-subdued" :whistle: :puke: :yawn:

On the other hand- Osiris once doubled in value when an agreement was announced between BARDA and Osiris/Genzyme to produce prochymal for stockpiling against ARS. Nothing came of it. Same with Cleveland Labs, when they did NOT get the contract (i.e. halved in value)
Cytori must have an incredible bad reputation on Wallstreet for this to happen. I think changes are necessary.

Hedrick I feel has no clout or respect period. :cry:

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IDE clinic for BARDA announced 19 Aug 2014 15:18 #2045

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I agree regarding Hedrick. Unless he was placed in the position to "clean house" so to speak. Having the Cellution machine classified as a device is definitely a major development. Maybe when the reality is understood wall street will take notice. Hedrick's concept of razor and razor blades is closer than before.

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IDE clinic for BARDA announced 19 Aug 2014 16:56 #2046

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***Hedrick I feel has no clout or respect period***

When you stop the only major trial funded by the company due to adverse events and dont disclose it for two months I would imagine its hard to extend trust to the new and improved openess of CYTX. That said, I believe there is quite a list of other issues of trust, believability and general unknowns.

:really:

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