Articles from Helius Medical Technologies, Inc.

--Revelation Neuro, Inc. is focused on advancing development of a Non-Implantable Artificial Intelligence (“AI”) Powered BCI Technology--

--Anthem Blue Cross Blue Shield approves claim for PoNS Device at out-of-network adjusted list price--

--PoNS Therapeutic Experience Program (PoNSTEP) study demonstrates durable long-term beneficial effects of PoNS Therapy on gait deficit improvement in people with Multiple Sclerosis--

NEWTOWN, Pa., Jan. 21, 2025 (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 today announced it has entered into agreements with certain holders of its existing warrants exercisable for 4,971,110 shares of its common stock, in the aggregate, to exercise outstanding warrants at a reduced exercise price of $0.751 per share, in exchange for new warrants as described below. The aggregate gross proceeds from the exercise of the existing warrants is expected to total approximately $3.7 million, before deducting financial advisory fees. The exercisability of the new warrants and any resulting issuance of the shares underlying the new warrants are subject to stockholder approval in accordance with Nasdaq rules.

--128 enrolled participants, as of December 31, 2024, exceeds initial target of 90 participants--

Initial order placed with Company’s distributor at contracted price and represents operational implementation through VA Federal Supply Schedule (FSS) Contract

Management to host business update call today at 9:00am ET

NEWTOWN, Pa., Nov. 18, 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 initiated a process, in consultation with its financial and legal advisors, to explore a range of strategic alternatives focused on maximizing stockholder value.  

-- Reimbursement Determination for the PoNS Mouthpiece (HCPCS code A4594) set at $2,963.30 on Lump Sum Payment to be challenged by Helius --

-- Achieves primary endpoint showing a linear relationship between adherence to PoNS Therapy® in Phase 2 and improvement in DGI scores from Phase 1 to end of treatment at week 14 --

NEWTOWN, Pa., Aug. 16, 2024 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq: HSDT) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that, effective August 14, 2024, its independent directors approved equity awards under Helius’ 2021 Inducement Plan, as a material inducement to three individuals entering into employment with the Company. The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4), which also requires a public announcement of equity awards that are not made under a stockholder approved equity plan.

Company to host call at 4:30pm today

NEWTOWN, Pa., Aug. 06, 2024 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (NASDAQHSDT) (“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 second quarter 2024 financial results on Monday, August 12, 2024, after the market closes.

-- 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 --

-- Reimbursement at $23,900, slightly below list price --

Company Will Highlight Major Milestones on Accessibility and Reimbursement Fronts

-- Approval provides U.S. veterans and other U.S. government agency employees who suffer gait and balance impairment due to multiple sclerosis (MS) access to the only portable neurostimulation therapy with the potential to generate neuroplasticity --

Company to host call at 4:30pm today

NEWTOWN, Pa., May 10, 2024 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (NASDAQHSDT) (“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.

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.

-- The Centers for Medicare & Medicaid Services (CMS) released its preliminary Medicare payment determinations for the PoNS Controller and Mouthpiece --

-- 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--

-- 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 --

-- Company to host call at 4:30pm today --

NEWTOWN, Pa., March 15, 2024 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (NASDAQHSDT) (“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 fourth quarter and full year 2023 financial results on Thursday, March 28, 2024, after the market closes.

-- Enrollment of at least ten patients at Brooks Rehabilitation will begin this month ---- Study will evaluate the use of Portable Neuromodulation Stimulator (PoNS®) for gait and balance deficits in chronic stroke survivors ---- Results will support efforts to achieve U.S. authorization under PoNS’s breakthrough designation for stroke --

NEWTOWN, Pa., March 07, 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 Dane Andreeff, President and Chief Executive Officer, and Jeff Mathiesen, Chief Financial Officer, will present at the 36th Annual ROTH Conference, March 17-19, 2024, Laguna Nigel, CA, as follows:

-- Significant step toward reimbursement for the only medical device approved in the U.S. for treatment of gait deficit due to multiple sclerosis (“MS”) --

-- Studies uses Portable Neuromodulation Stimulator (PoNS®) to evaluate cranial-nerve non-invasive neuromodulation for gait/balance deficits in stroke patients --

Event Appearance Caps Year of Growth: PoNS®-Trained PTs Now Found Across the United States

-- Brooks Rehabilitation Hospital adds a second site to the registrational program in stroke, and brings the total number of patients to 100 --

NEWTOWN, Pa., Nov. 30, 2023 (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 Dane Andreeff, President and Chief Executive Officer, will present at the NobleCon 19th Annual Emerging Growth Equity Conference as follows:

-- Cash runway extended into Q2 2024 ---- Company to host call at 4:30pm today --

-- Collaborative project between Pacific Blue Cross and HealthTech Connex designed to reduce long-term disability and improve quality of life for individuals suffering from traumatic brain injury (“TBI”) ---- 56% of study participants who were previously unable to work due to TBI returned to their prior occupations after 14 weeks of PoNS Therapy --

-- Expects to report Q3 revenues in range of $140 - $150 thousand, reflecting the expected decrease in U.S. sales with the conclusion of the Patient Therapy Access Program (PTAP) on June 30, 2023 --

-- PoNS® devices to be provided to a least five sites in five separate administrative regions within Québec ---- Government-funded initiative will evaluate the benefits of PoNS Therapy™ when used by patients who have suffered the effects of stroke --

NEWTOWN, Pa., Oct. 02, 2023 (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 Jeff Mathiesen, Chief Financial Officer, will participate at two upcoming conferences as follows:

-- UPC numbers assigned by Wolters Kluwer Health, provider of trusted clinical technology ---- PoNS system and mouthpiece will be included in pharmacy database utilized by 17 out 20 of the top-grossing pharmacy benefit managers (PBMs) –---- PoNS expected to be one of few products with both pharmacy and device codes, providing dual paths for potential reimbursement --

Company’s First-Ever ANPT Booth Sponsorship Enables Specialists to Learn More about this Breakthrough Technology on Eve of National Physical Therapy Month

-- The study will evaluate the optimal time to use PoNS Therapy™ during a patient’s stroke recovery journey --

-- Presentation to educate on Portable Neuromodulation Stimulator (PoNS®) Therapy, highlighting the differentiation from other neuromodulation technologies, and the science behind its effectiveness, clinical data, safety profile --

NEWTOWN, Pa., Sept. 05, 2023 (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 on August 31, 2023, Helius received formal notice from the Listing Qualifications staff of The Nasdaq Stock Market LLC indicating that Helius has evidenced full compliance with the minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) and otherwise satisfies all other applicable criteria for continued listing on The Nasdaq Capital Market. As a result, the listing matter has been closed.

NEWTOWN, Pa., Aug. 16, 2023 (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, announced today a 1-for-50 reverse split of its Class A common stock, par value $0.001 (“common stock”), effective at 5:00 pm Eastern time today. Beginning on August 17, 2023, the Company’s common stock will trade on The Nasdaq Capital Market on a split adjusted basis.

-- Total Q2 revenue up 115% over prior year; 131% over Q1 2023 -- -- Company to host call at 4:30pm today --

Sixth Center of Excellence added in multi-center, company-sponsored, open label observational interventional trial to evaluate the impact of subjects’ adherence to PoNS Therapy™ for gait improvement in Multiple Sclerosis

NEWTOWN, Pa., Aug. 02, 2023 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (NASDAQHSDT) (“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 second quarter 2023 financial results on Thursday, August 10, 2023, after the market closes.

-- Number of subjects increased from 12 to 60 ---- Portable Neuromodulation Stimulator (PoNS®) will be used to evaluate cranial-nerve non-invasive neuromodulation and dynamic gait/balance in stroke patients --

-- Critical initial step toward US reimbursement --

NEWTOWN, Pa., June 14, 2023 (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 Dane Andreeff, President and Chief Executive Officer, and Jeff Mathiesen, Chief Financial Officer, will present at the Healthcare Virtual Conference Part II, presented by Maxim Group LLC and hosted by M-Vest, on Wednesday, June 21st at 11:30 A.M. ET

NEWTOWN, Pa., May 24, 2023 (GLOBE NEWSWIRE) -- Helius Medical Technologies (Nasdaq:HSDT), a neurotech company focused on delivering a novel therapeutic neuromodulation approach for gait deficits, is excited to announce its participation in the prestigious Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting.  The event, which coincides with the May 30 observance of World MS Day, will take place from May 31 to June 3 at the Gaylord Rockies Resort & Convention Center in Aurora, Colo.  Helius will spotlight its cutting-edge Portable Neuromodulation Stimulator (PoNS®) device, which can improve gait deficit in people living with multiple sclerosis (MS).

NEWTOWN, Pa., May 19, 2023 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq: HSDT) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that, effective May 18, 2023, its independent directors approved an equity award under Helius’ 2021 Inducement Plan, as a material inducement to an individual entering into employment with the Company. The equity award was approved in accordance with Nasdaq Listing Rule 5635(c)(4), which also requires a public announcement of equity awards that are not made under a stockholder approved equity plan.

-- Company to host call at 4:30pm today --

NEWTOWN, Pa., May 04, 2023 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (NASDAQHSDT) (“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 2023 financial results on Thursday, May 11, 2023, after the market closes.

MS, Stroke and mmTBI Cover Broader Set of Indications Across North American Markets

NEWTOWN, Pa., March 23, 2023 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, announced today that its Board of Directors declared a dividend of one one-thousandth of a share of newly designated Series B Preferred Stock, par value $0.001 per share, for each outstanding share of Helius Class A common stock held of record on April 3, 2023. The outstanding shares of Series B Preferred Stock will vote together with the outstanding shares of the Company’s Class A common stock as a single class exclusively with respect to any proposal to adopt an amendment to the Company’s certificate of incorporation to reclassify the outstanding shares of the Company’s Class A common stock into a smaller number of shares of such Class A common stock at a ratio specified in or determined in accordance with the terms of any such amendment, as well as any proposal to adjourn any meeting of stockholders called for the purpose of voting on the foregoing matter, and will not be entitled to vote on any other matter, except to the extent required under the Delaware General Corporation Law. Subject to certain limitations, each outstanding share of Series B Preferred Stock will have 1,000,000 votes per share (or 1,000 votes per one one-thousandth of a share of Series B Preferred Stock).

-- Full year 2022 revenue of $0.8 million, an increase of 51% over 2021 --

-- PoNS already approved in Canada for treatment of chronic balance deficit due to mild-to-moderate traumatic brain injury (TBI) and gait deficit due to mild and moderate symptoms from Multiple Sclerosis (MS) --

NEWTOWN, Pa., March 06, 2023 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (NASDAQHSDT) (“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 fourth quarter and full year 2022 financial results on Thursday, March 9, 2023, after the market closes.

NEWTOWN, Pa., March 02, 2023 (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 Dane Andreeff, President and Chief Executive Officer, and Jeff Mathiesen, Chief Financial Officer, will present at the 35th Annual ROTH Conference, March 12-14, 2023, Laguna Nigel, CA, as follows:

Physical therapists in attendance can enhance their skillset with free on-site PoNS training

-- Q4 2022 revenue projected to range from $275,000 to $285,000 ---- Full year 2022 revenue projected to range from $780,000 to $790,000 ---- Unaudited year end cash balance of $14.5 million --

NEWTOWN, Pa., Jan. 19, 2023 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that Dane Andreeff, President and Chief Executive Officer, and Jeff Mathiesen, Chief Financial Officer, will present at the Virtual Q1 Investor Summit Microcap Event, as follows:

-- Fifth Center of Excellence added in multi-center, company-sponsored, open label observational interventional trial to evaluate the impact of subjects’ adherence to PoNS® therapy for gait improvement in Multiple Sclerosis --

PTAP Lowers the Cost of PoNS Therapy™ for Qualified Americans

New Partnership with UpScript Provides Access to Care, Delivers PoNS Devices to Doorsteps

NEWTOWN, Pa., Dec. 30, 2022 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq: HSDT) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that, effective December 27, 2022, its independent directors approved an equity award under Helius’ 2021 Inducement Plan, as a material inducement to an individual entering into employment with the Company. The equity award was approved in accordance with Nasdaq Listing Rule 5635(c)(4), which also requires a public announcement of equity awards that are not made under a stockholder approved equity plan.

-- Total Q3 revenue up 80% over prior year ---- Cash on hand expected to fund operations through 2023 ---- Company to host call at 8:30am today --

-- Fourth Center of Excellence added in multi-center, company-sponsored, open label observational interventional trial to evaluate impact of subjects’ adherence to PoNS® therapy for gait improvement in Multiple Sclerosis --

-- Third Center of Excellence added in multi-center, company-sponsored, open label observational interventional trial to evaluate the impact of subjects’ adherence to PoNS® therapy for gait improvement in Multiple Sclerosis --

Physical Therapists Who Visit Booth 512 Can Sign Up for Free Online PoNS Therapy™ Training

NEWTOWN, Pa., Nov. 01, 2022 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (NASDAQHSDT) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that the Company will release its third quarter 2022 financial results on Monday, November 14, 2022, before the market opens.

Company Spotlights its Appreciation to Physical Therapists Trained in its Innovative PoNS Therapy™ in Honor of National Physical Therapy Month

NEWTOWN, Pa., Sept. 29, 2022 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that Dane Andreeff, President and Chief Executive Officer, and Jeff Mathiesen, Chief Financial Officer, will present at the ROTH Capital Partners Inaugural Healthcare Opportunities Conference, as follows: