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Cytori Therapeutics, Inc. Message Board

  • wall_street_titan wall_street_titan Mar 13, 2014 2:49 PM Flag

    HOW BARDA Thinks about Burns in a Nuclear Event

    I think most will find encouragement by going through this:

    fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM334225.pdf

    As Marc Hedrick said, they are not to keen on stockpiling treatments that end up expired and unused. Thus the beauty of the Celution model.

    WSY

    Sentiment: Strong Buy

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    • BARDA approval chances just keep getting better. Now a bill has been put forward in congress (and get this, its bipartisan), to promote regenerative medicine. HHS is BARDA's parent. That increases my view of BARDA approval odds to 88%:

      "While regenerative medicine is already in use to treat wounds, cartilage defects, and diabetic foot ulcers, these successes are potentially just the beginning. Regenerative medicine holds the promise of treating many costly diseases and injuries, such as those sustained by soldiers in battle, while reducing health spending and promoting economic growth. However, more research into the basic science of regenerative medicine is needed. A Department of Health and Human Services (HHS) report recommended that the United States develop a national regenerative medicine strategy in order to take full advantage of regenerative medicine's potential and advance the development of these innovative treatments and cures.

      To achieve these objectives, the Regenerative Medicine Promotion Act would require the Government Accountability Office to issue a report identifying all ongoing federal programs and activities regarding regenerative medicine. The bill would also require the Secretary of HHS to establish a Regenerative Medicine Coordinating Council comprised of Cabinet secretaries, agency heads, researchers, experts, and advocates to develop and maintain a national strategy for the promotion of regenerative medicine research and development. The Council would be tasked with identifying priorities and sources of funding for research into regenerative medicine and recommending policies to overcome barriers in research and product development."

      WST

      Sentiment: Strong Buy

    • As far as we are concern with vested interest in CYTX, we should think highly regarding our technologies in the framework of BARDA.

      However, in my search re BARDA's priorities, new antibiotics without multi-drug resistance and technologies for used in a chemical and biochemical warfares (such as employment of anthrax, etc) appear to have higher ranking for funding. BARDA pays AMGEN multimiilion dollars for their drugs for treating neutropenia, etc. Another area with high priority is technologies used against cyberattacks. Nuclear warfares have lower priorities, as people may consider these to be unlikely events.

    • Marc Hedrick - President
      That's true. Let me give you a little color, Steve. So when going into this discussion with BARDA, I heard a lot about stockpiling and kind of new several companies, whose core relationship with BARDA was built around stockpiling big orders and then renewing that.

      I think BARDA felt burned because of that, it wasn't a great economic model for the government, particularly now looking back on it, 10-plus years after 9/11. What they are looking for is new more innovative, more cost-effective models, by which they can partner with companies and get technology available for the public, if they need it.

      What they like about ours is kind of one deployment opportunity, where we build it, we take it to market for a variety of things. It's pre-deployed, it's out there. They don't have to stockpile and it's in the market. Doctors are pre-trained using it.

      So when the worst happens, a switch can be flipped, and immediately patients can go through a variety of different types of care facilities and be treated in a seamless way. They like that model. It makes total sense to us. Our technology is perfect for that. And I think that's a lot of what's driving their interest.

      Sentiment: Strong Buy

    • Following excerpted from the above conference certainly seems to play to the Celution Product BARDA is evaluating and Cytori business model opportunity:
      DR. MANNING: So that's a great question. You know, what's the value proposition? What we can do at BARDA is we can underwrite, or at least partially underwrite the cost of R&D. So if we can do that successfully, we've created, hopefully, a product that is competitive in the burn marketplace. Now, we agree, that's not a huge market. But at least the R&D cost has been defrayed and you're now in a sales mode.
      What we also hope, and it depends on the product, is that the products can be used for other things, other skin problems beyond just burns, okay? And so, that would be very attractive to us because that would then widen the clinical utilization of the product and allow us to leverage even more.
      But you're right. At a minimum, you've entered the burn market as a competitive player. And we realize that isn't for everyone. There's still not an incredible billion dollar market out there necessarily. But the best we can do right now is to support R&D, support that next generation, and hopefully create products that are competitive.
      Jim?
      DR. JENG: Jim Jeng. I wanted to add to your commentary, Ron. Burns is indeed a very, very small market. I'm Jim Jeng. I'm one of the burn surgeons in Washington, D.C.
      But as industry looks at this problem from a financial point of view, it would really be enlightening and inspiring for industry to realize that the wound care, the chronic wound market is a gargantuan market with huge financial implications and that the cross-talk, like Dr. Manning referred to, with burn care products -- you know, and you think burn care products -- as a wound care market is 80% overlap, and there is your cash cow in the private sector business world.

    • Guess what big announcement Cytori made the day after that conference?

      WST

      Sentiment: Strong Buy

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