I can tell you with no reservations that "As evidenced by winning the 2011 Apple Award for Primate SCI Research, from the National Spinal Injury Association" is not quite accurate. It is more accurately for excellence in publishing research.
The award is given by ASIA and NOT by NSCIA ( http://www.asia-spinalinjury.org/awa...pple_award.php ).
Just picky little facts
Frank Reynolds is the guy that co-founded InViVo but he was kicked out and he found PixarBio. Smilar to Steve Jobs when he was kicked out of a company Apple and he founded Pixar. Hope he will be as successful as Steve jobs or even more
All of the news releases on their website is for pain management. Doesn't appear to be a new company attempting to compete with Invivo. Mr. Reynolds is probably still sitting on too much Invivo stock to want to do that anyway.Originally Posted by JAMESRRR
Can anybody shed some light on this?
http://pixarbio.com/portfolio/spinal-cord-injury/
Spinal Cord Injury Treatment
PixarBio CEO and CSO Frank Reynolds conceived, believed, invented, and patented first generation NeuroScaffolds for neuroprotection and regeneration of the spinal cord after traumatic spinal cord injury as Chief Science Officer, CEO and CFO of InVivo Therapeutics Corp (NASD:NVIV)
In 2015, Frank?s first generation NeuroScaffolds during an FDA human study nothing short of a miracle in the first human patents to receive the NeuroScaffolds. Patient reports are phenomenal.
At PixarBio Frank has led the invention of a novel generation of acute and chronic injectable Neuroscaffold?s, NeuroRelease SCI TM.
In 2016, PixarBio applied to the USFDA CDER for Orphan Status approval for NeuroRelease SCI.
We look forward to advancing NR-SCI to market and to a competitive marketplace in SCI with the expectation to raise the bar far above the current state of R&D in the industry.
PixarBio?s Injectable NeuroScaffold TM is the perfect platform to advance from acute neuro-protective spinal cord injury treatment to a regeneration treatment for chronic spinal cord injury
As evidenced by winning the 2011 Apple Award for Primate SCI Research, from the National Spinal Injury Association, and his 2015 Life-time Achievement Awards from National Spinal Injury Association Frank Reynolds lead the spinal cord injury research industry 2005-2015, and from 2016 and beyond he will be out-invented himself with his second, third, fourth and beyond generations of SCI Acute and Chronic SCI inventions.
? 2016 PixarBio
please . . .test what you already know; and give us what you have. we may not be dying, but we certainly are not living either
He just got the approval for injectable version of neuroscaffolds
"Changes at InVivo Therapeutics after I left the company in August of 2013 have permanently limited wide market adoption of my first generation of NeuroScaffolds. PixarBio’s Novel NR-SCI is an injectable self-assembling NeuroScaffold for acute spinal cord injury with clinical studies planned for Late 2018. Our submission to the FDA represents a significant advancement over NVIV’s product. Minimally invasive and patent protected to deliver drugs, biologics and cells, we will lead the spinal cord injury industry forward.”
“This submission to the FDA represents a new phase of SCI industry growth where minimally invasive products for spinal cord injury will fill R&D portfolios. NR-SCI, is a New Drug injected to treat the onset of paralysis after a traumatic spinal cord injury, also known as “the secondary injury.” Up to 90% of patients are NOT paralyzed from their primary injury, but instead they are paralyzed over a 21-day post-injury inflammation process that results in scar tissue formation. We will disrupt scar tissue formation.”
There are actually three different types of scaffolds we're watching that will be in direct competition. One for acute injury and a future chronic treatment with InVivo and the other one that now alludes to a treatment at both stages of SCI with a private company called PixarBio.
If you see from the video with InVivo Inspire Study, it's an acute scaffold being surgically implanted. It is a solid, measured to the lesion cavity and installed after pressure release and the dura is stitched back up. The scaffold is designed to fill the lesion cavity and allow axonal growth to more easily cross. They like the scaffold to be installed very soon after injury. It's in a Phase 3 stage of human trial.
The InVivo NeuralTrails scaffold for chronic that will be in clinical trials real soon seen at the end of the video is an injectable gel specifically designed to encapsulate and provide an ideal environment for holding delicate neural stem cells and allowing them to migrate a bit and form connections. It will be dispensed in a single long line from one side of the lesion to the other to get around the scar already present. Hence the name "trail". They have a patent for the technology but no Phase 1 human trial has been scheduled yet.
The one described at PixarBio Onward Study is a one time injectable gel with the capability to slowly release medications that will supposedly provide neuroprotection and aid regeneration via micoparticles and is biodegradable. They say it will dispense biologics, cells and drugs. They claim the injectable will be used from acute to the chronic injury (I'm not sure what that means exactly). It could mean an acute treatment that works out to the chronic stage with cells making connections into late stage or that they plan a different injectable for each of the two SCI injury phases. They haven't disclosed what stem cells they're specifically talking about. I'm not sure where the injections will take place either. I haven't seen any video on that yet or gotten any detailed information. We should be hearing more information before too long so we can follow along. I'm thinking they will be recruiting acute injuries once they get FDA approval on the orphan status drug but time will tell if they will do an across the board patient population. We'll see later where exactly the (chronic) piece fits in that they have alluded to. I believe for now, they mean to target "acute injury" at the beginning and hope human trials can start in 2018 because they've said “PixarBio ONWARD Study™” to treat acute spinal cord injury,”...
Scaffolds can be confusing and complicated. They are made out many different products and put into the injury site in many different ways at different stages of injury. We won't know a whole lot more on their performance until we're able to see human trial data and do some side by side comparisons on their efficacy. It's an exciting line of research and hopefully there is some success.
Robert Langer has been involved with both companies (InVivo and PixarBio) and hundreds more. He holds an unbelievable amount of patents. The guy is an extraordinary scientist.
PixarBio Corp. is a private company that hopes to become publicly traded this year. Langer is a Co-Founder along with Co-Founder Frank Reynolds.
InVivo (NVIV) is already a publicly traded company. Langer now sits on their Scientific Advisory Board and was a co-founder. Reynolds left the company back in Aug 2013.
Last edited by GRAMMY; 03-28-2016 at 10:56 PM.
Thank you very much GRAMMY. Your explanation above brings so much insight.
Thanks Grammy.
please . . .test what you already know; and give us what you have. we may not be dying, but we certainly are not living either
InVivo Therapeutics: Taking On Spinal-Cord Injury
LINK: Publication Source: Life Science Leader
Patients with thoracic injuries have been in the clinical trial. The company plans to initiate a second study with the Neuro-Spinal Scaffold in mid-2016, this time treating acute cervical SCIs in expanded populations — and again using the HDE path. It may also take the premarket approval (PMA) route for further expansion and acceleration of the scaffold program. A trial designed for PMA approval would allow the company to test the scaffold in all acute SCI patients, even those with incomplete injuries, and it could put the product on the FDA’s Expedited Access Pathway (EAP) for devices, similar to the Breakthrough Therapy Designation on the drug side. With EAP, the FDA could grant a PMA for the device based on a two-phase study — one that meets certain criteria before approval and delivers confirmatory data post-approval.
It appears that InVivo's method will become the standard for acute injuries (complete and incomplete) in the near future. I follow patient #1 and patient #3 on youtube and they are doing well.
Let's hope the rollout gets bigger. The real step may be when they find a cell partner
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