***BARDA putting their stock in Cytori because the machines can be rapidly deployed and pre positioned. ***
Sure, and which machines would those be ? The desktop version quietly went away. We have lost exclusivity to the magic sauce. Relentless delays as BARDA humors and/or request changes to the protocol. First there was lipo with injjections, lipo with a spray, nope IV is the way to go...No instead of lipo BARDA wants to be able to excise a chunk of fat and run it through Celution. Lets not forget the low hurdle Cytori was using for trials back then....now they will be up against SOC, if they survive that is. What a waste of time and tax payer $.
Other than the contract, thank you Tommy Thompson, Cytori no longer as any advantage whatsoever imho.
Even the approved ones will still have to fight for a market.
I still hold that its smaller than many who have opined on the subject think.
This regmed wound healing ship has sailed and Cytori is way back in the distance taking on water. PolarityTE, Vericel and now this new spray on product are already out there to some extent. There are probably more. But Don't worry, nanoencapsulation of stem cells will be the savior!!
Approval is a positive in that it confirms the feasibility of regenerative medicine in the wound care space. Spray on cells were known to us for quite some time and we had seen photos and videos of successfully treated burn wounds. However I would not entirely count out CYTX from the burn/wound space just yet.
A major drawback with Recell is: RECELL® are contraindicated for treatment of infected wounds...
[color=]''During the pivotal trial, the patient donor skin required to be harvested to treat burn sites with the RECELL System was 32 percent less than the amount harvested to treat burn sites with the standard of care (p<0.001). Despite the statistically significant reduction in donor skin required to treat with the RECELL System, burn sites treated with the RECELL ''System achieved definitive closure comparable to the burn sites treated with standard of care. At eight weeks post treatment, 92 percent of the burn sites treated with the RECELL System achieved complete healing versus 85 percent for the sites treated with the standard of care, demonstrating non-inferiority.''[/color]
Avita/Recell was non inferior - key benefit is smaller skin graft requirement, not quicker healing time or greater ability to treat intractible wounds.
CYTX is a potential winner (not necessarily financially), if it can improve on the standard of care through its systemic application. There may well be a case for using both treaments for large and hard to treat burns concurrently. Also lets not forget that BARDA is specifically developing Celution to also treat radiation burns.
As for which machine is used ........... how about the one that IS being used?
Hedge, which trial are you referring to with regard SOC?
The BARDA funded burn trial that has just started is for larger wounds, deep wounds, and with a least 3 wounds per participant being treated.
It should be noted that it IS randomised against standard of care.
With the CTX2 program scratched and the Celution 700/800 now upgraded to CTX-1 the numbers for systems to be employed (in revenue terms) in case RELIEF and the whole BARDA program works out, would change pretty dramatically.
It was conveyed that the CTX1 would cost around 10-15.000$ per unit. Without knowing the price BARDA would have to pay for deploying CTX-1 - it is likely to be in the 200-400K $ range per unit, which is quite a change and BARDA is obviously aware since they approved the protocol for RELIEF.
From the last CC:
There are a couple of other related items I would like to also point out at this time. A substantial upgrade in our core Celution system called now CTX-1 is currently being used in the U.S. RELIEF trial and will be made available commercially based on the outcome of the planned up classification of our Celution technology from Class I to Class III registration, which is currently under evaluation by MHLW in Japan.
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.
New Regmef Burn Treatment APPROVED
27 Sep 2018 13:11 #12275