Invivo Therapeutics Holdings Corp (OTCMKTS:NVIV) is moving up in a hurry. The stock is on their rise after the Company announced approval by the U.S. Food and Drug Administration (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 (about three months after the first subject was enrolled).
NVIV said ”to date, there have been no reported serious safety events with the study’s first subject, and InVivo has been cleared by the Data Safety Monitoring Board (DSMB) to move forward with the study. As specified in the study protocol, the DSMB is a committee of independent clinical research experts charged with examining the safety data accumulated during the trial.”
Invivo Therapeutics Holdings Corp (OTCMKTS:NVIV) is a pioneering biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, ScD. Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, MD, who then was at Boston Children’s Hospital and now is affiliated with Massachusetts General Hospital.
Prior to the recent move up NVIV had been in decline for a while as former CEO Frank Reynolds aggressive selling of his massive position accumulated over years from running the Company. Things between Mr. Reynolds and the Company turned sour sometime in 2013 and as a result the ex CEO ramped up his distribution campaign to close to 100,000 shares per day.
Earlier this year in NVIV’s 10k for 2013 the Company reveals they are suing Mr. Reynolds for breaches of fiduciary duties, breach of contract, conversion, misappropriation of corporate assets, unjust enrichment, and corporate waste. In response, Mr. Reynolds filed a counterclaim against the Company alleging breach of contract and breach of the covenant of good faith and fair dealing, and tortious interference with a contract.
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The recently announced FDA Approval to Expedite Enrollment for Ongoing Pilot Trial 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 (HDE).
Invivo CEO Mark Perrin said, “Over the last calendar year, we have cultivated a collaborative and fruitful relationship with the FDA, and we couldn’t be happier with today’s announcement. Under our new plan, it’s possible to reduce the duration of our pilot trial by up to one year. This, of course, is dependent on patient presentation, but with today’s approval, along with our previously-announced approval of increasing the number of clinical sites up to 20, we are much better positioned to execute and complete this trial in an expedited fashion. Although we cannot predict when subjects will present, we now anticipate full enrollment in the pilot trial in 2015.”
Currently trading at a $117 million market valuation NVIV has an excellent cash position of $17 million in the treasury and is fully funded moving forward. The recently announced FDA Approval to Expedite Enrollment for Ongoing Pilot Trial is a massive step forward for the Company.
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NVIV is a stock that was trading as high as $6 a share several years ago and has a significant gap to fill from current levels. Considering the recent news and just how cheap NVIV is here its little wonder how parabolic the stock is now.
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Disclosure: we hold no position in NVIV either long or short and we have not been compensated for this article.