Global CRO Clinipace has agreed to manage clinical trials for Nexstim as the Finnish devicemaker works toward FDA approval for its neurostimulation therapy.
Nexstim manufactures what it calls a Navigated Brain Stimulation system, designed to deliver MRI-guided magnetic stimulation to the brain, thereby treating injury and disease. The device, already cleared in Europe, has shown promise helping stroke patients regain motor control and relieving symptoms of major depressive disorder, according to Nexstim, but the company is yet to secure FDA approval.
That's where Clinipace comes in, as the CRO has signed on to manage Nexstim's U.S.-based clinical program.
"Clearly, new treatments such as Nexstim's NBT System are urgently needed," Clinipace CEO Jeff Williams said in a statement. "However, the development of novel therapies has been traditionally hindered by challenges in conducting clinical research," and Williams believes his company's end-to-end eClinical platform can steer Nexstim through the complicated regulatory environment laid out for brain-stimulating technologies.
Meanwhile, Clinipace is still in the midst of integrating its latest acquisition after closing a deal for Hong Kong CRO Choice Pharma last month. The company isn't planning any layoffs or closures with the merger, and once the deal is done the CRO will employ more than 640 people in 30 countries while maintaining its headquarters in Research Triangle Park, NC.
The Choice deal is Clinipace's 5th acquisition in as many years, following buyouts of Paragon Biomedical, PFC Pharma, Regulus Pharmaceutical and Worldwide Clinical Research.
- read the announcement