Helius Medical Technologies filed a 510(k) submission to the FDA seeking expanded indication for its PoNS device to treat gait and balance deficits in chronic stroke patients, based on clinical trials demonstrating statistically significant improvements in functional gait assessment.

Helius Medical Technologies, Inc. announced the pricing of its public offering of 2,768,600 shares of Class A common stock and warrants to purchase up to 2,768,600 shares of common stock at a combined public offering price of $3.27 per share and accompanying warrants. The offering is expected to raise gross proceeds of $9.1 million.

Helius Medical Technologies has exceeded its initial enrollment target for its stroke registrational program, with 128 participants enrolled as of December 31, 2024. The company expects to reach the maximum enrollment of 150 participants by the end of January 2025 and is on track to submit for FDA authorization for the PoNS device in the stroke indication in the second quarter of 2025.

Helius Medical Technologies, a neurotech company, announced its plans to participate in The ThinkEquity Conference on October 30, 2024, where management will present and hold one-on-one investor meetings.

Helius Medical Technologies announced updates on reimbursement determinations from CMS for its PoNS device. CMS set the reimbursement rate for the PoNS Mouthpiece at $2,963.30, which Helius plans to challenge. CMS deferred the final determination for the PoNS Controller to the next cycle.

-- Inclusion of the top neurorehabilitation centers REHABOLOGYM, Neurology Center of New England, and MGH Institute of Health Professions completes site participation enrollment for the U.S. registrational program in stroke -- -- In Canada, an additional study on the use of Portable Neuromodulation Stimulator (PoNS®) Therapy to treat stroke has started to support Canadian reimbursement and U.S. approval for stroke --

NEWTOWN, Pa., May 10, 2024 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (NASDAQ: HSDT) (“Helius” or the “Company”), a neurotech company focused on delivering a novel therapeutic neuromodulation approach for balance and gait deficits, today announced that the Company will release its first quarter 2024 financial results on Monday, May 13, 2024, after the market closes.

Nevro (NVRO) delivered earnings and revenue surprises of 31.37% and 3.56%, respectively, for the quarter ended March 2024. Do the numbers hold clues to what lies ahead for the stock?

NEWTOWN, Pa., May 06, 2024 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq: HSDT) (“Helius” or the “Company”), a neurotech company focused on delivering a novel therapeutic neuromodulation approach for balance and gait deficits, today announced the pricing of a public offering of 804,999 shares of its Class A common stock (“Common Stock”) and 2,047,222 Pre-Funded Warrants, each to purchase one share of Common Stock, together with accompanying Series A and Series B warrants to purchase up to an aggregate of 5,704,442 shares of Common Stock. The public offering price per share of Common Stock and accompanying Series A and Series B warrants is $2.25 and the public offering price per Pre-Funded Warrant and accompanying Series A and Series B warrant is $2.249, resulting in gross proceeds of approximately $6.4 million before deducting the placement agent's fees and other estimated offering expenses. The Series A warrants to purchase up to an aggregate of 2,852,221 shares of Common Stock will have an exercise price of $2.25 per share, will be exercisable immediately following the date of issuance and will expire five years from the original issuance date. The Series B warrants to purchase up to an aggregate of 2,852,221 shares of Common Stock will have an exercise price of $2.25 per share, will be exercisable immediately following the date of issuance and will expire twelve months from the original issuance date.

AxoGen (AXGN) delivered earnings and revenue surprises of 40% and 1.60%, respectively, for the quarter ended March 2024. Do the numbers hold clues to what lies ahead for the stock?

-- Helius Medical and Shepherd Center partner on a study that aims at rehabilitating walking mobility in people recovering from stroke ---- Shepherd Center, a top neurorehabilitation hospital, is the third site in Helius’ U.S. registrational program for Portable Neuromodulation Stimulator (PoNS®) in stroke ---- The single-arm study will evaluate PoNS in treating gait and balance deficits in chronic stroke survivors ---- Regulatory submission seeking marketing authorization for stroke expected in 2025-- NEWTOWN, Pa., April 24, 2024 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the “Company”), a neurotech company focused on delivering a novel therapeutic neuromodulation approach for balance and gait deficits, today announced the expansion of its clinical development program for the broadening of the labeling of its marketed PoNS device to include patients recovering from stroke with the participation of Shepherd Center, under the direction of Michael Yochelson, M.D., MBA, FAAN, FAAPMR, Chief Medical Officer. Participating to the Company-sponsored single-arm study, Shepherd Center joins Brooks Rehabilitation as a third clinical site to the overall registrational program. As one of the nation’s top neurorehabilitation hospitals, Shepherd Center is known for its innovation, patient outcomes exceeding the national average, and expertise in providing world-class clinical care for people experiencing the most complex conditions, including stroke, spinal cord and brain injuries, multi-trauma, traumatic amputations, multiple sclerosis, and pain.

-- Lovell is an approved supplier to the U.S. Department of Veterans Affairs (VA) and Department of Defense (DoD) ---- Over 28,000 cases of multiple sclerosis (MS) are reported to the VA annually -- NEWTOWN, Pa., April 03, 2024 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the “Company”), a neurotech company focused on delivering a novel therapeutic neuromodulation approach for balance and gait deficits, today announced it has partnered with Lovell Government Services (“Lovell”), an SBA-certified Service Disabled Veteran Owned Small Business (“SDVOSB”), to make the Company’s Portable Neuromodulation Stimulator (“PoNS®”) device available to federal healthcare systems. PoNS is indicated in the U.S. for use as a short-term treatment of gait deficit in adults with mild-to-moderate symptoms from MS when used in conjunction with physical therapy.