InVivo Therapeutics, a developer of groundbreaking technologies for the treatment of spinal cord injuries (NYSE:SCI) and other neurotrauma conditions, announced that it has pursued a Humanitarian Use Device (NYSE:HUD) designation for its biopolymer scaffolding product by filing a request with the U.S. Food and Drug Administration (FDA). The company is currently in works with the FDA to finalize the approval process and begin clinical trial of the scaffolding acute SCI in early 2013.
Humanitarian Use Devices, commonly referred to as HUDs, are developed to treat rare diseases or conditions. InVivo seeks to obtain this designation for its biopolymer scaffolding for use in the treatment of complete function spinal cord injuries that do not involve penetrating injury or the complete severing of the spinal cord.
InVivo met with the FDA in April 2012 to discuss the requirements for obtaining HUD designation and the potential for the device to be regulated and distributed under a Humanitarian Device Exemption (HDE). Obtaining both a HUD and HDE designation would enable the company to commercialize the devices in the United States faster than the Pre-Market (NYSEARCA:PMA) approval process.
"The HUD/HDE provision provides a pathway for obtaining market approval from FDA for medical devices that may help people with rare diseases or conditions that otherwise would be remain unmet," said InVivo Director of Regulatory Affairs Jack Bonasera. "InVivo is confident that the results of well designed pre-clinical studies will satisfy the primary HDE requirements in this type of devastating injury where no motor or sensory function is present below the level of neurological injury."
"HUD designation is not only important for speed-to-market but also represents a benchmark in InVivo's commitment to patients with spinal cord injuries and other neurotrauma conditions. Our GMP team is ready to go, and our clean room is humming. We expect 2013 to be a breakout year for InVivo stakeholders as we advance additional products into the FDA process," stated Frank Reynolds, InVivo Chief Executive Officer.
InVivo has stated that it expects to receive further feedback from the FDA on the HUD request in January 2013.
For more information on InVivo, visit invivotherapeutics.com
Please see disclaimer on the QualityStocks website: disclaimer.qualitystocks.net