InVivo Therapeutics Receives Humanitarian Use Device Designation for Spinal Cord Injury Treatment
CAMBRIDGE, Mass. (April 4, 2013) – InVivo Therapeutics Holdings Corp. (NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI) and other neurotrauma conditions, today announced that the Company has received approval for its request filed with the U.S. Food and Drug Administration (FDA) for Humanitarian Use Device (HUD) designation for its biopolymer scaffolding product.
HUD designation covers devices that treat rare, ‘orphan’ diseases or conditions. InVivo has received designation for the use of its biopolymer scaffolding for the treatment of recent complete spinal cord injury (no motor or sensory function) that does not involve penetrating injury or complete severing of the spinal cord.
Historically, companies that have received ‘orphan’ status have been able to expedite commercialization, bringing products to market several years faster than other regulatory paths would have allowed. The Company expects the device to be regulated and distributed under a Humanitarian Device Exemption (HDE) pending the results of a clinical trial for which InVivo also currently has a submission under review by the FDA. 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 SCI,” said Frank Reynolds, InVivo Chief Executive Officer. “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,” continued Reynolds. “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.”