Search Results for: node/InVivo

InVivo expects to raise $10.4M from early warrants call

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Massachusetts-based spinal devices maker InVivo Therapeutics (OTC:NVIV) announced an early call for exercise of warrants issued in 2010, expecting to raise $10.4 million.

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.

Invivo starts first human trial for spinal cord scaffold

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InVivo Therapeutics (OTC:NVIV) said the FDA has given the company the green light to begin the first human clinical studies of its bioploymer scaffold, which treats traumatic spinal cord injury.

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.

InVivo Therapeutics’ spinal cord scaffold wins FDA nod

InVivo Therapeutics

InVivo Therapeutics (OTC:NVIV) said the FDA deemed its biopolymer scaffold, designed to treat spinal cord injuries, to be a humanitarian use device.

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 updates bid for FDA OK of spinal trauma treatment

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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.