Invivo Therapeutics Holdings Corp (NASDAQ:NVIV) has released an update on the results from it’s INSPIRE study. As per the announcement from the company, the fifth patient enrolled in the study, initially had AIS A spinal cord injury, which had improved to an AIS B incomplete spinal cord injury, over the course of six-months, after the implant. The ASIA impairment scale (AIS) was used to measure the improvements during the study, which runs up to AIS E, depending on the severity of the injury.
NVIV has been making significant progress, in recent days, with respect to its INSPIRE study, based on the Neuro-Spinal Scaffold. Recently, the company was successful in getting a Humanitarian Device Exemption (HDE) modular and shell submission process, approved from the FDA. The HDE review process is conducted in modules, by the FDA.
The modules are assessed one at a time by the regulatory, which then provides timely feedback to the manufacturer, to resolve any shortcomings in the device. Invivo’s HDE modular shell is composed of 3-modules: the preclinical studies module, the manufacturing module and the clinical module. The Neuro-Spinal Scaffold is currently in the initial stage, but is expected to complete the process by 2017.
Approximately 60% of the patients, enrolled in the INSPIRE study; have seen an AIS grade improvement, when assessed over a 6-month period. Fewer than 16% of patients with complete thoracic injuries have an AIS grade improvement, during the same period, as per large natural history databases. The measure of study success was initially placed 25% of the patients experiencing an AIS grade improvement.
The CEO of NVIV, Mark Perrin, stated that the third conversion has brought the company closer to achieving its Objective Performance Criterion. He also added that the company’s goal was to achieve full enrollment, by the end of 2016, in order to become eligible for an HDE in 2017.
Invivo Therapeutics Holdings Corp (NASDAQ:NVIV) had a trade volume of 1.61 million and gained 29.97% during the March 7 session, to reach a close at $9.80.