FDA Breakthrough Designation. Yesterday, Helius announced that it received Breakthrough Designation from the U.S. Food and Drug Administration (“FDA”) for its PoNS device with the proposed indication for use as a temporary treatment of dynamic gait and balance deficits due to symptoms from stroke. It is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over. Helius will utilize the Breakthrough Devices Program to facilitate its pursuit of U.S. regulatory clearance for treatment of stroke-induced symptoms.What is Breakthrough Designation? The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review.Another Large Market. It is estimated seven million Americans are living with stroke-related complications, and more than 80% of stroke survivors are estimated to develop gait impairment. Another 795,000 people suffer stroke annually in the U.S. If clearance is obtained, Helius will have treatment options for MS and stroke with gait deficit (and TBI patients in Canada). We believe this broader audience for the PoNS device will help attract doctors and clinics.Maintaining Outperform Rating. HSDT shares sold off following second quarter earnings and we believe present a favorable risk/reward opportunity. We are maintaining our Outperform rating and $20.00 12-month price target on HSDT shares. Through its PoNS device and treatment program, we believe Helius has a first mover advantage in using the tongue for neurostimulation to reduce symptoms of neurological disease or trauma. Read More >>