Under the terms of the warrants, InVivo has the right to call for early exercise because NVIV shares have traded above $2.80 per share for 20 consecutive days, which occurred yesterday.
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The Cambridge, Mass.-based company said it is gearing up for safety studies in 5 patients over 15 months, and is shooting for Institutional Review Board (IRB) approval at Massachusetts General Hospital.
The designation means the InVivo scaffold can seek expedited approval from the FDA for a pivotal trial of the device. HUD-based exemptions cover devices aimed at treating rare diseases and health problems, so-called "orphan" conditions.
InVivo Therapeutics (OTC:NVIV) hopes to begin testing in humans in an open-label safety and efficacy study now that it’s updated its submission for an investigational device exemption submission for its spinal cord injury treatment.
InVivo filed the original investigational device exemption application in July 2011, but has yet to be approved.