http://sci.rutgers.edu/forum/showpos...&postcount=727Originally Posted by boda
http://sci.rutgers.edu/forum/showpos...&postcount=727
InVivo Therapeutics Expects to Commence Human Study after
Meeting on IDE Filing for Biopolymer Scaffolding to Treat Spinal Cord
Injuries
CAMBRIDGE, Mass. (April 13, 2012) – InVivo Therapeutics Holdings Corp.
(OTC/BB: NVIV), a developer of groundbreaking technologies for the treatment of
spinal cord injuries (SCI), announced today that it held a meeting with the U.S. Food
and Drug Administration (“FDA”) in which they discussed the Investigational Device
Exemption (“IDE”) application previously filed by InVivo for its biopolymer scaffolding to
treat acute spinal cord injuries.
Following the meeting, the Company is expecting the biopolymer scaffolding device to
be regulated under the Humanitarian Use Device/Humanitarian Device Exemption
(HUD/HDE) pathway. Before human clinical studies can commence, the FDA must
approve the Company’s IDE filing, for which the FDA has agreed to an open dialogue
as part of the final process toward gaining approval. During the FDA meeting, the
Company addressed several points in the FDA’s feedback including the proposed
design and clinical protocol for the study.
“This is a significant step for all patients waiting for first in-man data using biomaterials
for spinal cord injuries,” said Frank Reynolds, InVivo’s Chief Executive Officer. “We are
pleased that our core team of multidisciplinary scientists, led by my partner, Bob
Langer, has had the opportunity to meet with the FDA to discuss our platform
technology. We are encouraged by the communication we have had with the FDA to
this point, and pending approval of the IDE, we expect the clinical trial for our treatment
of acute spinal cord injuries to commence during the second half of 2012.”
Later in 2012, the Company plans to submit hydrogel-based applications to the FDA for
the treatments of SCI and chronic pain. As the industry of cell-based therapies
advances, InVivo also intends to leverage the Company’s acute SCI treatments to
expand to chronically injured patients. InVivo has pioneered a new treatment that uses
a biocompatible polymer-based scaffolding to provide structural support to a damaged
spinal cord in order to spare tissue from scarring while improving recovering and
prognosis after a traumatic SCI. Today, there is no effective treatment for the spinal
cord for paralysis caused by SCIs, and the market potential for acute SCI is estimated
to be over $10 billion.
About InVivo Therapeutics
InVivo Therapeutics Holdings Corp. is focused on utilizing polymers as a platform
technology to develop treatments to improve function in individuals paralyzed as a result
of traumatic spinal cord injury. The Company was founded in 2005 on the basis of
C-5, 6 SCI. Took about 6 months to walk. Walking full time. Without any assistance since Nov. 2003 and will make a full recovery
Marc,
at W2W 2011 the medical director of Invivo Dr. Slokim gave a presentation that was just about acute SCI, so I said I was very disapponted as I was hoping he would have had something to present about chronic SCI since the audience had just people with chronic SCI... he was a little embarassed and then said they had few animals with SCI and they were waiting for them to get to the chronic stage to do chronic studies.
Clearly he was lying, otherwise he would have mention that in the presentation.
The point is that these people think we are all stupid ships who don't have the brain & the balls to ask questions, so they think they can sell us any kind of stinky BS.
About FB if you go to their page https://www.facebook.com/invivotherapeutics look at the comments of their post on april 13. I asked them about chronics and they said by the end of the year they will have something ready to apply for an IND to the FDA. I don't believe it, but in a few months we'll find out if it is true.
IMO InVivo will run out of money before they can finish the trial on acute as to do a trial on acute you need to recute a huge number of patient to prove efficacy wich takes also long time and lots of $.
Just look at Geron how long did they take to recrut just 5 people??
Then consider Mr. Raynolds said that the plan of the company is to put on the market the therapy for acute and then use the profit to develop a therapy for chronix...
C'mon we know that's not going to work out..
Paolo
In God we trust; all others bring data. - Edwards Deming
Dennis Tesolat
www.StemCellsandAtomBombs.blogspot.com
"Change does not roll in on the wheels of inevitability, but comes through continuous struggle. And so we must straighten our backs and work for our freedom."
Martin Luther King
I am pretty sure Mr. Renyolds read lots of books to figure out a way to help himself and others with SCIs. He was a one in a million kinda guy buy getting feeling back for no particular reason. I'm glad he is doing something because he didn't have to do anything.
the video i watched where mr. reynolds told his story about reading books and curing himself was pretty funny stuff...i guess he's supposed to be inspirational...
Reynolds got a HUGE increase in pay when his company went public. He is like 99% of all researchers, he will say anything to keep his company funded.
speaking of this, i just recently learned that i was offered a spot in a clinical trial. and giving the time of my injury, it certainly had to be geron's. but my point here is, i completely dont remember them offering this to me. its said that it was offered and i declined. so the way they are going about recruiting may be the problem. invivo may have a different game plan. idk.
but back on topic, the more i watch these news channel appearances of this guy, the more i cant stand it. i think the guy that claims he was paralyzed and healed himself from reading about it is a straight up liar about it all, including this chronic claim they are making.
i hope i am wrong. id love to know that no one has to live like this any more.
he is trying to make money out of other people's misery
reading books and cured himself as if
why doesn't he sell us the books then..
Btw - did anyone spot any connection between InVivo device and Karolinska Sweden Trial device or it's all coincidence?
www.MiracleofWalk.com
Miracles are not contrary to nature, but only contrary
to what we know about nature
Saint Augustine
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