Helius Announces Positive Outcome of the Portable Neuromodulation Stimulator PoNS® Stroke Registrational Program and Upcoming Submission to FDA Under Breakthrough Designation

The primary endpoints for all three studies included improvement of gait and/or balance deficit after 12 weeks of study treatment with two key multiplicity-controlled secondary endpoints assessing risk of falling and 12- week durability of effect. The double-blind randomized clinical trial met the primary endpoint of demonstrating statistically significant greater improvements in gait and/or balance deficit due to stroke with active PoNS Therapy with and without including additional data from an open label ...