Helius Medical Technologies, Inc. - HSDT STOCK NEWS

Helius Medical Technologies announced that its subsidiary has received FDA marketing authorization for the Portable Neuromodulation Stimulator (PoNS™). This device is the first of its kind cleared in the U.S. for treating gait deficits due to mild-to-moderate symptoms from multiple sclerosis (MS).

The PoNS device is intended for patients over 22 years, used alongside therapeutic exercises. Helius aims to commercialize this treatment in early 2022 and is pursuing Medicare reimbursement options.

Helius Medical Technologies (Nasdaq:HSDT) announced its participation in the Investor Summit Group’s Q1 Virtual Summit from March 23-25, 2021. Management will present on March 23 at 2:00 p.m. Eastern Time. A live audio webcast will be available for registered participants. Helius focuses on neurological wellness, aiming to develop non-invasive technologies that enhance the brain's healing capabilities. Its first product, the Portable Neuromodulation Stimulator (PoNS™), is authorized in Canada for treating gait deficits due to multiple sclerosis and chronic balance deficits due to mild traumatic brain injury.

Helius Medical Technologies (Nasdaq:HSDT) has announced the appointment of Sherrie Perkins to its Board of Directors, effective March 15, 2021. Perkins brings over 20 years of healthcare industry experience, particularly in neuromodulation, which is expected to enhance Helius’ market development efforts. She has previously held significant roles at LivaNova, PLC and Cyberonics, contributing to their commercial and marketing strategies. Helius focuses on neurological wellness and aims to advance therapies such as the Portable Neuromodulation Stimulator (PoNS™), currently under FDA review for classification.

Helius Medical Technologies (Nasdaq:HSDT) reported Q4 and full-year 2020 financial results, showing revenue of $191,000 for Q4, up from $152,000 in Q4 2019, but down to $0.7 million for the full year from $1.5 million in 2019. Operating losses improved to $3 million in Q4 from $5.6 million a year prior, while net losses narrowed to $2.5 million. The company closed private placements totaling $12.8 million, expected to fund operations into Q1 2022. Helius aims for FDA clearance of its PoNS device and increased its Canadian clinic network to 31.

Helius Medical Technologies (HSDT) has closed an underwritten public offering, raising approximately $11.0 million. This includes the exercise of the underwriter’s over-allotment option, with units priced at $14.82 each. Each unit comprises one share of common stock and a warrant for an additional 0.5 shares at an exercise price of $16.302, expiring five years after issuance. A total of 744,936 shares and 372,468 warrants were issued. The offering was conducted under registration statements effective as of January 27, 2021.

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.