Movers and SHAKERS
Helius Medical Technologies (HSDT)(HSM:CA)
FDA Breakthrough Device Designation for Stroke
Helius Medical Technologies is a neurotech company focused on neurological wellness. The Company’s purpose is to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. The Company’s first commercial product is the Portable Neuromodulation Stimulator (PoNSTM). For more information, visit www.heliusmedical.com.
Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.
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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 ...
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.