New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
August 11, 2014
08:06 EDTNVIVInvivo Therapeutics receives notice of allowance from USPTO
InVivo Therapeutics Holdings Corp. announced that it has received a Notice of Allowance from the United States Patent and Trademark Office for U.S. Patent Application No. 14/177,888, titled “Methods and Compositions for the Treatment of Open and Closed Wound Spinal Cord Injuries”. The application covers InVivo’s Neuro-Spinal Scaffold, which is currently being studied in a pilot clinical trial, and its Neuro-Spinal Scaffold combined with stem cells, which is being developed for the treatment of chronic spinal cord injury. InVivo is the exclusive licensee of this intellectual property for spinal cord injury and other indications through a license with Boston Children’s Hospital and the Massachusetts Institute of Technology. A notice of allowance from the USPTO is a written notification that a patent application has cleared internal review and is pending issuance.
News For NVIV From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
December 16, 2014
08:01 EDTNVIVInvivo Therapeutics announces FDA approval to expedite pilot trial enrollment
InVivo Therapeutics Holdings announced approval by the U.S. FDA for an expedited enrollment plan for the company’s ongoing pilot trial of its investigational Neuro-Spinal Scaffold in patients with acute spinal cord injury. Under the new plan, barring significant safety issues, InVivo will submit two months of safety data to the FDA for the first subject enrolled in October, and will then open enrollment for the second subject in mid-January. Upon enrollment of the second subject, InVivo will submit to the FDA one month of safety data for that subject together with the previous subject’s data; concurrent enrollment for the remaining three subjects will then begin. There will be no additional mandatory holds between enrollment of the final three subjects. This differs from the previous plan, which required a mandatory three-month hold between sequential enrollment of each of the five subjects. This is the company’s first clinical study of its investigational degradable polymer Neuro-Spinal Scaffold. The IDE pilot study has been approved by the FDA and is intended to capture preliminary safety and effectiveness data of the Neuro-Spinal Scaffold in five subjects with acute thoracic spinal cord injury. InVivo then expects to conduct a pivotal study to obtain FDA approval to commence commercialization under a Humanitarian Device Exemption.

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use