Finland-based Nexstim Receives Order from US Therapy Customer for Navigated Brain Therapy System

Nexstim Oyj, a Finnish medical technology company, has received an order from a US therapy customer. The company focuses on improving rehabilitation for stroke patients through noninvasive brain stimulation. Its Navigated Brain Therapy (NBT) System is a device for stroke therapy that targets upper limb motor disability and is under Phase III pivotal clinical trial study in the US. Nexstim's systems are used in over 100 facilities globally for research, therapy, and neurosurgical planning purposes.

Bioxodes Inc., a biotechnology company focused on innovative stroke therapies, has announced positive Phase 2a data for its investigational drug, BIOX-101. The results, published in a clinical trial, demonstrate primary safety and promising efficacy in the treatment of intracerebral hemorrhage (ICH). The study, involving 23 patients, showed a reduction in hematoma size, slower perihematomal edema growth, favorable anti-inflammatory biomarker movement, and an increase in the number of patients achieving functional independence at 90 days compared to standard care. No deaths were reported during the eight-month follow-up period Bioxodes Reports Breakthrough Phase 2a Data for Stroke Drug^[1].

The Data Monitoring Committee has supported advancing the drug to a Phase 2b or Phase 3 efficacy trial, reflecting the potential of BIOX-101 to address a significant unmet medical need. Bioxodes has halted enrollment in the BIRCH Phase 2a trial to accelerate a potentially registrational Phase 2b program and is launching a Series B funding round to support this effort. The company holds Orphan Drug Designation in the U.S. and EU and plans to seek EMA PRIME designation in 2025, followed by FDA Fast Track Bioxodes Reports Breakthrough Phase 2a Data for Stroke Drug^[1].

The trial's results are notable for their early signal in an area with no approved pharmacological therapy. However, the dataset remains exploratory and underpowered for efficacy. The company is positioning BIOX-101 at the intersection of hemostasis-sparing anticoagulation and neuroinflammation, targeting FXIa/FXIIa and neutrophil-mediated pathology where conventional anticoagulants are contraindicated. The next study will require rigorous randomization, blinding, and tight control of time-to-dose to convert this into a registrational path Bioxodes Reports Breakthrough Phase 2a Data for Stroke Drug^[1].

For trial operators, the program will concentrate activity in comprehensive stroke centers with 24/7 activation, rapid CT/MRI workflows, and capacity for serial imaging over 10 days. Key watch items for the Phase 2b design choices include dose and infusion timing, dichotomous versus shift mRS endpoints, inclusion of perihematomal edema as a powered endpoint, stratification for anticoagulated patients and deep versus lobar bleeds, and rules for concomitant surgery. The funding runway and manufacturing scale-up for an acute-care biologic are nontrivial, as is competing for enrollment against other acute stroke studies in an overburdened staffing environment Bioxodes Reports Breakthrough Phase 2a Data for Stroke Drug^[1].

Separately, Nexstim Oyj, a Finnish medical technology company, has received an order from a US therapy customer. The company focuses on improving rehabilitation for stroke patients through noninvasive brain stimulation. Its Navigated Brain Therapy (NBT) System is a device for stroke therapy that targets upper limb motor disability and is under Phase III pivotal clinical trial study in the US. Nexstim's systems are used in over 100 facilities globally for research, therapy, and neurosurgical planning purposes .