“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.”
In short
Spinal device company InVivo Therapeutics Holdings Corp. has announced that the Company has filed a request with the U.S. FDA for Humanitarian Use Device (HUD) designation for its biopolymer scaffolding product. InVivo is currently working with the FDA on the final steps to seek approval to begin a clinical trial of the scaffolding in acute SCI in early 2013.
Background
InVivo uses polymers as a platform technology to develop treatments to improve function in individuals paralysed from traumatic spinal cord injuries.
Devices eligible for HUD designation are by definition allowed onto the market in order to treat rare diseases or conditions. In this case, InVivo has requested the designation for the use of its biopolymer scaffolding in the treatment of complete functional spinal cord injuries that do not involve penetrating injury or the complete severing of the spinal cord.
An HUD designation and a subsequent approved Humanitarian Device Exemption (HDE) would clearly enable InVivo to commercialise the devices in the United States faster than the Pre-Market (PMA) approval process. Indeed the Company expects to receive feedback from the FDA on the HUD request in January 2013.
InVivo Director of Regulatory Affairs Jack Bonasera said; “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. 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.”
Frank Reynolds, InVivo Chief Executive Officer stated; “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”.
Source: InVivo Therapeutics Holdings Corporation, Business Wire
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published: December 18, 2012 in: Regulatory, Spine, Technology