Clinipace Brings Strategic Level of Global Regulatory and Development Experience to Novel Therapy Trial
Nexstim, a Finland-based compant involved with image-guided transcranial magnetic stimulation, has selected Clinipace Worldwide to manage the US-based clinical trial for the Navigated Brain Therapy System.
Nexstim launched a novel NBT device in 2012 for the treatment of brain injury and disease using repetitive transcranial magnetic stimulation (rTMS). The company reports that initial results show promise in helping stroke patients regain lost motor control, and that the NBT System also enables personalized non-drug treatment for people suffering from major depressive disorder (clinical depression).
Though the NBT System meets the requirements of the European Medical Devices Directive (MDD) and has been CE marked, the NBT System and therapeutic use for stroke and depression are not cleared indications in the US.
Read the full release here.
Unlock Commercial Growth through Data-Driven Patient and HCP Insights
May 2nd 2025Leveraging data-driven patient and healthcare provider (HCP) insights, including social drivers of health (SDOH), is essential for life sciences companies to continuously improve patient engagement and commercial success. Mark Rodgers, AVP of Commercial Analytics at Inovalon, discusses how identifying treatment milestones, assessing HCP performance, and segmenting patient populations using SDOH data can drive targeted strategies that improve healthcare outcomes and market access
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
FDA Approves Nipocalimab for the Treatment of Generalized Myasthenia Gravis
April 30th 2025Approval is based on results from the pivotal Vivacity-MG3 trial in which IMAAVY (nipocalimab-aahu) demonstrated superior disease control throughout 24 weeks when compared to placebo plus standard of care.