CAMBRIDGE, Mass. (December 14, 2012) - InVivo Therapeutics Holdings Corp. (NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI) and other neurotrauma conditions, today announced that the Company has filed a request with the U.S. Food and Drug Administration (FDA) for Humanitarian Use Device (HUD) designation for its biopolymer scaffolding product. InVivo is currently working with the FDA on the final steps to seek approval to begin a clinical trial of the scaffolding in acute SCI in early 2013.
Devices eligible for HUD designation are developed to treat rare diseases or conditions. InVivo has requested designation for the use of its biopolymer scaffolding in the treatment of complete functional spinal cord injuries that do not involve penetrating injury or the complete severing of the spinal cord.
The request comes after an April 2012 meeting in which InVivo and the FDA discussed the requirements for the HUD designation and the potential for the device to be regulated and distributed under a Humanitarian Device Exemption (HDE). An HUD designation and a subsequent approved Humanitarian Device Exemption (HDE) would enable InVivo to commercialize the devices in the United States faster than the Pre-Market (PMA) approval process.
Said InVivo Director of Regulatory Affairs Jack Bonasera, “The HUD/HDE provision provides a pathway for obtaining market approval from FDA for medical devices that may help people with rare diseases or conditions that otherwise would be remain unmet. InVivo is confident that the results of well designed pre-clinical studies will satisfy the primary HDE requirements in this type of devastating injury where no motor or sensory function is present below the level of neurological injury.”
“HUD designation is not only important for speed-to-market but also represents a benchmark in InVivo’s commitment to patients with spinal cord injuries and other neurotrauma conditions. Our GMP team is ready to go, and our clean room is humming. We expect 2013 to be a breakout year for InVivo stakeholders as we advance additional products into the FDA process,” said Frank Reynolds, InVivo Chief Executive Officer.
The Company expects to receive feedback from the FDA on the HUD request in January 2013.
Once an IND is submitted the FDA has 30 days to either approve or return for more supporting data from the company.
With all the pre submittal time and effort put into this submittal I'm assuming in about 30 days we will get the approval to commence Phase I trial. Sure hope so.
Hi, you said IND. I wonder if it is the same for the HDE? And, I agree it will probably be approved, but it would be nice to know what is "plan B" if it doesn't. Fix objections and re-submit? They should have it all covered by now, so I can imagine mostly buys coming over the next 30 days. Back into the $2-s.
"InVivo has requested designation for the use of its biopolymer scaffolding in the treatment of complete functional spinal cord injuries that do not involve penetrating injury or the complete severing of the spinal cord. "
They originally indicated the first trial would be in penetrating injuries, gunshot, knife etc.
However now it looks to be the much more common non penetrating injuries.
I read this as very good since the penetrating injuries can be a very mixed bag and maybe hard to find perfect candidates whereas non penetratingare much more common and I suspect the better candidates for this treatment, and much faster patient enrollment.
However whereas the penetrating injury already has an open chord so inserting the scaffold would not increase trauma to the chord the non pentrating injury requires an incision into the chord, which creates in some way more injury.
In fact this is one of the advantages of the hydrogell since an injection into the chord is the least intrusive.
I'm assuming all this has been discussed with the FDA and they are on board. This may have been part of why the time to submitting the HUD aplication has taken longer than we expected, although I still think getting lab set up and running was a part of that.
Important find. Thanks for pointing that out, Mr rx. Looks like the Co is still doing it's homework and working closely with the FDA. This attention to detail, and keeping the eye on the ball, may save us a lot of time and trouble.