QualityStocks News - InVivo Therapeutics Holdings Closer to Commencing Human Study for Treatment of Spinal Cord Injuries

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Following discussions with FDA, InVivo expects to begin human clinical trials for biopolymer scaffolding to treat spinal cord injuries.

QualityStocks would like to highlight InVivo Therapeutics Holdings Corp., a publicly traded company focused on utilizing polymers as a platform technology to develop treatments to improve function in individuals paralyzed as a result of traumatic spinal cord injury. The company was founded in 2005 on the basis of proprietary technology co-invented by Robert Langer, ScD. Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who is affiliated with Massachusetts General Hospital.

In the company’s news last week,

InVivo Therapeutics Holdings detailed results of its meeting with the U.S. Food and Drug Administration (FDA) for discussion of the investigational device exemption (IDE) previously filed for InVivo’s biopolymer scaffolding for the treatment of acute spinal cord injuries.

Before InVivo can advance to human clinical studies, the FDA must approve the company’s IDE filing, for which the FDA has agreed to an open dialogue as the application moves toward gaining approval.

Following the meeting, the company said it anticipates that the biopolymer scaffolding device will be regulated under the humanitarian use device/humanitarian device exemption (HUD/HDE) pathway.

“This is a significant step for all patients waiting for first in-man data using biomaterials for spinal cord injuries,” Frank Reynolds, InVivo’s CEO stated in the press release. “We are pleased that our core team of multidisciplinary scientists, led by my partner, Bob Langer, has had the opportunity to meet with the FDA to discuss our platform technology.

“We are encouraged by the communication we have had with the FDA to this point, and pending approval of the IDE, we expect the clinical trial for our treatment of acute spinal cord injuries to commence during the second half of 2012.”

InVivo later this year plans to submit hydrogel-based applications to the FDA for the treatments of SCI and chronic pain. The company also intends to leverage its acute SCI treatments to expand to chronically injured patients.

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Forward-Looking Statement:
This release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. Risks and uncertainties applicable to the company and its business could cause the company's actual results to differ materially from those indicated in any forward-looking statements.

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