Neuros Medical has obtained an investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to begin a pivotal clinical trial, designed to evaluate the safety and efficacy of Altius implantable generator in treating chronic pain in amputees.
The Altius system consists of an electrode and a generator, it uses Neuros Medical’s patented electrical nerve block technology to deliver high-frequency stimulation to the peripheral nervous system to block chronic pain.
The prospective, randomised, controlled pivotal clinical trial will enrol 130 patients at 15 institutions in the US.
Results from the pivotal trial will be used to support a future pre-market approval (PMA) application in the US for the Altius system.
Neuros Medical chief scientific officer Dr Zi-Ping Fang said: "Receiving the IDE approval from the FDA to move forward with our pivotal study is an important milestone in the development of our technology."
Recently, the company reported the results of its long-term pilot study, which focused on treating amputees suffering from chronic pain.
In the study, seven out of nine subjects using an external generator reported a significant pain reduction observed for up to 12 months of evaluation.
In addition, more than 50% of the study participants stopped their narcotic pain medication use during the study.
Participants enrolled in the long-term pilot study will now be able to use the implantable generator.
Neuros Medical president and CEO Jon J Snyder said: "We look forward to executing the next steps in the pivotal study process with the eventual goal of receiving approval to market the Altius System to provide long-term pain relief to those suffering from chronic amputation pain."
Neuros Medical’s patented platform technology, Electrical Nerve Block, helps eliminate chronic pain in a variety of conditions including amputation pain, post-surgical pain, migraine, and trigeminal neuralgia.
According to GlobalData estimates, neurostimulation devices market in the US was valued at $1.82bn in 2012 and is expected to grow at a CAGR of 9.2% to reach a value of $3.39bn by 2019.