Helius Announces the Submission of Request for FDA 510(k) Clearance of PoNS

Company News

On the 20th of last month, China Medical System Holdings Limited (the “Company”, together with its subsidiaries, the “Group”) released an announcement related to the asset purchase of the Products – the portable neurostimulation devices (whether under the name of PoNS Devices or otherwise) (the “Products”). PoNS is a class II medical device developed for the adjuvant treatment of balance disorders in patients with traumatic brain injury (TBI), stroke, cerebral palsy, etc.

On September 4, 2018, Helius Medical Technologies(“Helius”) announced the submission of its request to the U.S. Food and Drug Administration (FDA) for de novo classification and 510(k) clearance of the PoNS device for the treatment of chronic balance deficit due to mild- to moderate- TBI. For details, please refer to the website of Helius (https://heliusmedical.com/index.php/newsroom/news-release/2018/232-), the contents of which do not form part of this announcement.

The Group will prepare for the regulatory application and other related work of PoNS in China after Helius submits request for FDA 510(k) clearance of it.