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Friday, June 18, 2021

Inside Scoop on Invivo Therapeutics Holdings Corp (OTCMKTS:NVIV)

Invivo Therapeutics Holdings Corp (OTCMKTS:NVIV) continues its upward drive on accelerating volume since its lows of $0.4651 in November of last year. Recently surpassing $3 on record breaking volume NVIV has transformed itself from illiquid to one of the top traded stocks on the entire exchange.

The move comes as NVIV 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.

On February 23 NVIV said that Froedtert & the Medical College of Wisconsin (MCW) Froedtert Hospital in Milwaukee, WI has been added as a clinical site in the company’s ongoing IDE pilot study of its Neuro-Spinal Scaffold in patients with acute spinal cord injury (SCI). Froedtert Hospital houses the only adult Level 1 trauma center in eastern Wisconsin and receives referred spinal cord injury patients from Wisconsin, northern Illinois, and northern Michigan. Shekar Kurpad, MD, PhD, professor of neurosurgery at MCW and director of the Spinal Cord Injury Center and Spine Surgery Fellowship at Froedtert Hospital, has been named Principal Investigator at the site.

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. We will be updating on NVIV when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with NVIV.

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Disclosure: we hold no position in NVIV either long or short and we have not been compensated for this article.

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