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, which filed for HUD approval in late 2012, said the designation is for treating "recent complete spinal cord injury (no motor or sensory function) that does not involve penetrating injury or complete severing of the spinal cord," according to a press release.
"The company expects the device to be regulated and distributed under a humanitarian device exemption pending the results of a clinical trial for which InVivo also currently has a submission under review by the FDA," according to the release. "The trial will be conducted to determine that the device does not pose an unreasonable or significant risk of illness or injury, and that the probable benefit to health outweighs the risk of injury or illness from its use."
"HUD designation is important not only for speed-to-market, but it represents a benchmark in InVivo’s commitment to patients with [spinal cord injury]," CEO Frank Reynolds said in prepared remarks. "We are pleased that the FDA has recognized ‘orphan’ status for this condition and acknowledges the urgent demand for new treatment options for SCI. We’ve built out the team and the facility to manufacture products for human studies, and we’re ready to go.
"We intend to leverage our platform to further develop treatments for chronic SCI, and expect 2013 to be a springboard year for our stakeholders as we have multiple 510(k) products targeted for market entry by the end of 2014," Reynolds added. "Our work in 2013 will be marked by clinical SCI data and by developing treatments for additional neurotrauma conditions in the arms and legs while we engage the FDA on multiple products."
Last month, Cambridge-Mass.-based InVivo said it had updated its submission for an investigational device exemption for its spinal cord injury treatment. InVivo filed the original investigational device exemption application in July 2011.
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