Welcome, Guest
Username: Password: Remember me
The Company
  • Page:
  • 1

TOPIC: Amended BARDA contract accelerates development

Amended BARDA contract accelerates development 19 Dec 2014 08:07 #2950

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3290
  • Thank you received: 1110
Which is always good- i.e. acceleration :yep:

Cytori and BARDA Amend Contract Option to Accelerate the Advancement of a Thermal Burn Injury Countermeasure
Cytori Therapeutics (CYTX) today announced that the Company and Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services, executed an amendment of a contract option originally signed in August 2014 to fund continued investigation and development of Cytori Cell Therapy™ for use in thermal burn injuries.
The amended option is valued at $14.1 million, an increase of approximately $2 million from its original value of $12.1 million. Upon Investigational Device Exemption (IDE) approval by the FDA, BARDA anticipates providing additional funding to cover costs associated with the completion of a clinical trial, currently estimated at $8.3 million, bringing the combined contract option value up to $22.4 million.
The supplemental funds from this amended contract will be primarily used to support 2015 activities such as verification, testing and validation for delivery and processing of adipose-derived regenerative cells (ADRCs™). Reports generated by the funded activities will be submitted to the FDA as part of an IDE package for a proposed clinical trial using Cytori Cell Therapy in thermal burn injury. The original contract retains two additional options 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 pleased to see that once again, BARDA continues to show strong support and interest in Cytori Cell Therapy for this indication,” said Dr. Marc Hedrick, President and Chief Executive Officer of Cytori.“With these incremental funds, we can expedite the product development and clinical timelines by several months.”
The treatment of thermal burns remains a critical unmet 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.

Please Log in or Create an account to join the conversation.

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:

Amended BARDA contract accelerates development 19 Dec 2014 08:28 #2953

  • franshei
  • franshei's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 788
  • Thank you received: 102
Hedrick will proved to be a better CEO than Calhoun. Looks like he and Girao and the new IR manager (under Girao) are now playing the PR releases strategically.

Regarding this new BARDA money of $ 2 million, Hedrick mentioned in the quarterly CC than a new item in this regard would be coming, yet in the Investors' Conference Call recently, he did not mention this (he stayed within the boundary of 8 K filings).

He talked about the pending 90 patient trial in OA during the third Q CC ($ 3 million; to be originated from Rush-Chicago). Yet Hedrick has not talked much about the OA trial, since the last Q CC. I think he will surprise us again soon with some news.

During the third Q CC, he was saying that he would ask Kesten to look into the cost of doing a US trial on scleroderma (after contacting the FDA). Then beyond the $ 300,000 for doing more EU works in scleroderma, CYTX has suddenly announced initiation of a US pivotal phase 3 trial in this illness, in 2015.

Indeed, Hedrick and Girao appear to do a better job than Calhoun-Saad, giving us more and more positive surprises to fight the shorts. Maybe Sabby is teaching CYTX new tricks.

Please Log in or Create an account to join the conversation.

Amended BARDA contract accelerates development 19 Dec 2014 08:42 #2954

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3290
  • Thank you received: 1110

Maybe Sabby is teaching CYTX new tricks.


You can forget about that. The one person I know who has met Hal Mintz thinks he would not have the capabilities to do that.

Its clear that the news which is filling the pipeline now, is not coming from thin air, but are the result of hard work with a lot of prep work required which with FDA and the likes, absorbs quite some time. :KO:

Anyway- I am glad some folks are happy.

Personally I am deeply disappointed in Hedrick- PERSONAL promises to do certain things (our question list!!) are not fullfilled and in the Q&A chat he ignores all my questions and just answers some easy meaningless stuff.

To me - thats not the way to go. :puke:

:evil: :bang:

Please Log in or Create an account to join the conversation.

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:
  • Page:
  • 1
Time to create page: 0.073 seconds

Copyright Information

Copyright Fas Kuiters © 2016 young-foxes.com. All Rights Reserved.
This page is made with Joomla CMS and its various templates designed by Fas Kuiters with the excellent Themler tool.

 

 

Shared Spreadsheet Links

DOV´s Revised Projections for the Periods 2017 until 2020

Shareble link : HERE

Fas Kuiters Websites