Helius Med Technologies Inc Stock Price, News & Analysis

Helius Medical Technologies (Nasdaq:HSDT) announced the pricing of an underwritten public offering, raising approximately $9.6 million before expenses. The offering consists of 647,772 units, each priced at $14.82, and includes one share of common stock along with a warrant for 0.5 shares at an exercise price of $16.302. The closing is expected around February 1, 2021. Ladenburg Thalmann & Co. Inc. is the sole bookrunning manager. The company has also granted underwriters a 45-day option for over-allotments.

Helius Medical Technologies (Nasdaq:HSDT) responded positively to the Centers for Medicare & Medicaid Services' (CMS) new Medicare Coverage of Innovative Technology (MCIT) pathway established on January 12, 2021. This initiative enables national Medicare coverage for FDA-designated breakthrough devices from the date of market authorization for up to four years. Should Helius secure FDA clearance for its Portable Neuromodulation Stimulator (PoNS), immediate coverage for beneficiaries could enhance access for approximately 60 million Medicare enrollees.

Helius Medical Technologies (Nasdaq:HSDT) has announced that it has cured its minimum bid price deficiency, allowing its stock to remain listed on The Nasdaq Capital Market. The scheduled hearing for a non-compliance appeal has been canceled following this compliance confirmation from Nasdaq. Helius focuses on developing non-invasive technologies aimed at neurological wellness, with its first product being the Portable Neuromodulation Stimulator (PoNS™), currently under review by the FDA in the U.S. and the Australian Therapeutic Goods Administration.

Helius Medical Technologies, a neurotech company, will participate in the Noble Capital Markets 17th Annual Small & Microcap Investor Conference on January 19-20, 2021. Management's presentation is scheduled for January 19 at 11:15 a.m. ET. A live audio webcast will be accessible following free registration on the Noble conference website. Helius focuses on developing non-invasive technologies for neurological wellness, including the Portable Neuromodulation Stimulator (PoNS™), currently under FDA review.

Helius Medical Technologies has formally responded to the FDA's request for additional information regarding the de novo classification of its Portable Neuromodulation Stimulator (PoNS™) for treating gait deficits due to Multiple Sclerosis (MS). This response aims to resume the FDA's review process, which was on hold following a previous request from the agency. The company anticipates a decision from the FDA in the first half of the year. Helius previously obtained Breakthrough Designation for PoNS™ in May 2020.

Helius Medical Technologies, Inc. (Nasdaq:HSDT) reported unusual trading activity for its Class A Common Stock on the Toronto Stock Exchange and The Nasdaq Capital Market. The company confirmed it is unaware of any undisclosed material changes impacting its business that could explain the recent trading price increase. In conjunction, Helius has made available an investor presentation in anticipation of its participation in upcoming investor conferences this January, previously announced on January 4, 2021.

Helius Medical Technologies (Nasdaq:HSDT) has announced participation in several virtual investor conferences during January 2021. Key events include:

• The Demy-Colton Digital Medicine and Medtech Showcase from January 11-15, with on-demand access starting January 6th.
• The H.C. Wainwright BioConnect Conference from January 11-14, with presentations available on January 11th.
• The Sidoti Winter 2021 Conference on January 13-14, where management will present on January 13th.
• The ICR Conference from January 11-14, with management presenting on January 14th.

Helius Medical Technologies (HSDT) announced a 1-for-35 reverse stock split effective December 31, 2020, aimed at complying with Nasdaq listing requirements. Consequently, the outstanding shares will decrease from approximately 51.9 million to 1.5 million, while the number of authorized shares remains at 150 million. The common stock will trade on a split-adjusted basis starting January 4, 2021. Shareholders will receive cash for any fractional shares. More details can be found in the definitive proxy statement filed with the SEC.

Helius Medical Technologies (HSDT) reported its Q3 2020 financial results. Revenue was $131K, down from $150K in Q3 2019. Operating loss decreased to $3.7M from $5.7M year-over-year. The company closed a $3.4M private placement to support operations into Q1 2021. Following a leadership change, Helius continues to pursue FDA clearance for its Portable Neuromodulation Stimulator (PoNS) device to treat Multiple Sclerosis symptoms. Authorized clinics for PoNS treatment increased from 7 to 27 in Canada amid ongoing challenges from the COVID-19 pandemic.