Helius Medical Technologies

Helius Medical Technologies, Inc. is a neurotech company in the medical device industry that focuses on neurological wellness. The firm develops, licenses and acquires non-invasive platform technologies that amplify the brain’s ability to heal itself and reduce symptoms of neurological disease or trauma. It engages in the development of the investigational Portable Neuromodulation Stimulator (PoNS), that delivers neurostimulation via the tongue which has been shown in clinical studies to enhance the effectiveness of physical exercises in people with neurological symptoms from disease or trauma such as mild-to-moderate traumatic brain injury. The company was founded in 2014 and is headquartered in Newtown, PA.

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Helius Medical Technologies reports Q1 revenue, eyes CMS reimbursement boost

Helius Medical Technologies navigated Q1 2024 with a focus on reimbursement, FDA approval, and financial sustainability, supported by financing and market expansion initiatives.
Progress in securing reimbursement, expanding market reach, and addressing demand signals growth potential and market acceptance for the company's products.
Challenges in achieving profitability and executing development plans underscore the importance of timely reimbursement and effective operational strategies.

Helius Medical Technologies navigates revenue challenges with strategic growth initiatives

Helius Medical Technologies faces challenges from program terminations impacting revenue and ongoing operating losses, but maintains a strong cash position with no debt.
Efforts to expand access to PoNS Therapy through strategic partnerships and sales initiatives present growth opportunities in the MS and stroke treatment markets.
The company's financial performance in Q2 2024 reflects a mixed picture of revenue decline, operational losses, and cash stability, with potential for growth pending reimbursement determinations.

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Helius Medical Technologies, Inc. is a neurotech company in the medical device industry that focuses on neurological wellness. The firm develops, licenses and acquires non-invasive platform technologies that amplify the brain’s ability to heal itself and reduce symptoms of neurological disease or trauma. It engages in the development of the investigational portable neuromodulation stimulator, that delivers neurostimulation via the tongue which has been shown in clinical studies to enhance the effectiveness of physical exercises in people with neurological symptoms from disease or trauma such as mild-to-moderate traumatic brain injury. The company was founded in 2014 and is headquartered in Newtown, PA.

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

Helius Announces First Portable Neuromodulation Stimulator (PoNS®) System Sale to the Veterans Affairs (VA) Healthcare System

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 provided updates on its efforts to achieve fair market access for its Portable Neuromodulation Stimulator (PoNS) device and announced plans to host a business update call today at 9:00am ET.

Helius Medical Technologies, Inc. Provides Updates on Efforts to Achieve Fair Market Access for its Portable Neuromodulation Stimulator (PoNS®) Device

NEWTOWN, Pa., Oct. 18, 2024 – PRISM MediaWire – Helius Medical Technologies, Inc.

Helius Medical Technologies, Inc. to Present at the 2024 ThinkEquity Conference

-- Reimbursement Determination for the PoNS Mouthpiece (HCPCS code A4594) set at $2,963.30 on Lump Sum Payment to be challenged by Helius -- -- National Reimbursement Payment Determination from CMS for its PoNS Controller Deferred to the Next Cycle --

Helius Medical Technologies, Inc. Announces Reimbursement Payment Determination Updates from CMS for its Portable Neuromodulation Stimulator (PoNS®) Controller and Mouthpiece

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.

Helius Medical Technologies, Inc. Reports Inducement Grants Under Nasdaq Listing Rule 5635(C)(4)

Helius Medical Technologies, Inc. (NASDAQ:HSDT ) Q2 2024 Results Conference Call August 12, 2024 4:30 PM ET Company Participants Michelle Bilski - IR Dane Andreeff - President and CO Jeff Mathiesen - CFO Conference Call Participants Anthony Vendetti - Maxim Group Operator Good day, and thank you for standing by. Welcome to the Helius Medical Technologies Second Quarter 2024 Earnings Conference Call [Operator Instructions].

Helius Medical Technologies, Inc. (HSDT) Q2 2024 Earnings Call Transcript

NEWTOWN, Pa., Aug. 12, 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 results for the quarter ended June 30, 2024.

Helius Medical Technologies, Inc. Reports Second Quarter 2024 Financial Results

NEWTOWN, Pa., Aug. 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 that the Company will release its second quarter 2024 financial results on Monday, August 12, 2024, after the market closes.

Helius Medical Technologies, Inc. to Release Second Quarter 2024 Financial Results on August 12, 2024

-- 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 --

Helius Medical Technologies, Inc. Completes Site Participation Enrollment for its U.S. Registrational Program in Stroke

NEWTOWN, PA / ACCESSWIRE / May 31, 2024 / 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 it will participate in the Spring MicroCap Rodeo Conference to be held on Thursday, June 6th in NYC. Dane Andreeff, CEO, will attend the conference and plans to discuss: Pursuit of a stroke authorization in the U.S. for its Portable Neuromodulation Stimulator (PoNS®) device with the U.S. Food and Drug Administration (FDA); Helius' partnership with Lovell® Government Services to make PoNS available to federal healthcare systems, including the U.S. Department of Veterans Affairs (VA) and Department of Defense (DoD).

Helius Medical Technologies, Inc. to Present at the Spring MicroCap Rodeo Conference

Company Will Highlight Major Milestones on Accessibility and Reimbursement Fronts Company Will Highlight Major Milestones on Accessibility and Reimbursement Fronts

Helius Medical Technologies to Exhibit at 2024 CMSC Annual Meeting, Marking a Year of Achievements: Making PoNS More Available to People with MS

-- 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 -- NEWTOWN, Pa., May 20, 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 Company's Portable Neuromodulation Stimulator (PoNS®) device has been approved for inclusion on Lovell Government Services' (“Lovell”) Veterans Affairs (VA) Federal Supply Schedule (FSS) and General Services Administration (GSA) Advantage contracts.

Helius Medical Technologies, Inc. Announces PoNS® Is Now Available on the Veterans Affairs (VA) Federal Supply Schedule (FSS) and General Services Administration (GSA) Advantage Contracts

Helius Medical Technologies, Inc. (NASDAQ:HSDT ) Q1 2024 Results Conference Call May 13, 2024 4:30 PM ET Company Participants Michelle Bilski - Investor Relations-In-Site Communications Dane Andreeff - President and Chief Executive Officer Jeff Mathiesen - Chief Financial Officer Conference Call Participants Nicholas Sherwood - Maxim Group Operator Good day, and thank you for standing by. Welcome to the Helius Medical Technologies First Quarter 2024 Earnings Conference Call.

Helius Medical Technologies, Inc. (HSDT) Q1 2024 Earnings Call Transcript

NEWTOWN, Pa., May 13, 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 results for the quarter ended March 31, 2024.

Helius Medical Technologies, Inc. Reports First Quarter 2024 Financial Results

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.

Helius Medical Technologies, Inc. to Release First Quarter 2024 Financial Results on May 13, 2024

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.

Helius Medical Technologies, Inc. Announces Pricing of $6.4 Million Public Offering

Helius Medical Technology (NASDAQ: HSDT ) stock is rocketing higher on Friday alongside heavy trading of the neurotechnology company's shares. This has more than 3.5 million shares of HSDT stock changing hands as of this writing.

Why Is Helius Medical Technology (HSDT) Stock Up 47% Today?

-- 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.

Helius Medical Technologies, Inc. Expands Stroke Clinical Program with Participation of Shepherd Center

Helius Medical Technologies Inc (NASDAQ: HSDT) is up close to 40% in premarket on Wednesday after teaming up with Lovell Government Services. Why is it good news for Helius Medical stock?

Helius Medical stock rallies 40%: explore why

-- 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.

Helius Medical Technologies, Inc. Announces Partnership with Lovell® Government Services to Expand Reach of PoNS Therapy™

Helius Medical Technologies, Inc. (HSDT) Q4 2023 Earnings Call Transcript

-- Company to host call at 4:30pm today -- NEWTOWN, Pa., March 28, 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 results for the quarter and full year ended December 31, 2023.

Helius Medical Technologies, Inc. Reports Fourth Quarter and Full Year 2023 Financial Results

NEWTOWN, Pa., March 15, 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 fourth quarter and full year 2023 financial results on Thursday, March 28, 2024, after the market closes.

Helius Medical Technologies, Inc. to Release Fourth Quarter and Full Year 2023 Financial Results on March 28, 2024

-- 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 12, 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 initiation of an open-label study for its registrational program in stroke. The program was established based on encouraging early trial results as well as real-world evidence from Canada, where PoNS is already authorized for treatment of stroke, and aims to establish the effects of cranial-nerve non-invasive neuromodulation (“CN-NINM”), delivered using PoNS Therapy®, on gait and dynamic balance in chronic stroke survivors.

Helius Medical Technologies, Inc. Initiates Open-Label Study for Registrational Program in 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:

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