Pons

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

Retrieved on: 
Wednesday, April 3, 2024
Diagnosis, Department of Defence, Service-Disabled Veteran-Owned Small Business, Gait, USMC, RET, SBA, Walking, Patient, HSDT, Quality of life, Small business, Pons, Pharmaceutical industry

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.

Key Points: 
  • In a study of real-world results, after 14 weeks of PoNS Therapy, 100% of MS patients experienced a clinically meaningful improvement in gait.
  • Veterans have given their best to our country and should have access to the most innovative and effective resources available.
  • “Recently, Helius highlighted the real-life story of Kevin Byrne, a retired U.S. veteran who’s been suffering from MS since 1999.
  • While clinical results have demonstrated the effectiveness of PoNS Therapy, it’s firsthand accounts like Captain Byrne’s that are the most gratifying,” concluded Andreeff.

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

Retrieved on: 
Thursday, March 28, 2024
Research, HCPCS, Gait, Patient, Operating cost, Stroke, Sale, Acquisition, HSDT, Andreyev, Social services, ATM, Pons, Medicare, FDA, CMS, PTAP, Food, Video game

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.

Key Points: 
  • Gross profit for the fourth quarter of 2023 was $44 thousand, compared to gross profit of $132 thousand in the fourth quarter of 2022.
  • Operating loss for the fourth quarter of 2023 decreased to a loss of $2.2 million, compared to an operating loss of $2.7 million in the fourth quarter of 2022.
  • Net loss was $1.0 million for the fourth quarter of 2023, compared to a net loss of $4.9 million in the fourth quarter of 2022.
  • The basic and diluted net loss per share for the fourth quarter 2023 was $1.47, compared to net loss per share of $8.66 in the fourth quarter 2022.

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

Retrieved on: 
Tuesday, March 12, 2024
Gait, Walking, Patient, Stroke, Rehabilitation, HSDT, Doctor of Philosophy, Survivor, Medical school, MUSC, Pons, Pharmaceutical industry

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.

Key Points: 
  • -- 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.
  • Under the direction of Mark Bowden, PT, PhD, Brooks Rehabilitation (“Brooks Rehabilitation”) will be the first site to enroll patients.
  • Brooks Rehabilitation is already a participant site to the Company’s ongoing investigator-initiated, placebo-controlled study in stroke, led by Dr. Steven Kautz at the Medical University of South Carolina (“MUSC”).
  • “PoNS Therapy has the potential to meaningfully improve the lives of over five million stroke patients affected by walking and balance disability.

Genco Shipping & Trading Rejects George Economou Nominees

Retrieved on: 
Tuesday, March 5, 2024
Annual general meeting, Transport, Growth, GNK, Pons, Pāramitā, Security (finance)

As part of its review process, our Nominating and Corporate Governance Committee interviewed both nominees and determined that they respectively are not additive to our Board’s existing skills and expertise or lack sufficient experience in shipping and related industries.

Key Points: 
  • As part of its review process, our Nominating and Corporate Governance Committee interviewed both nominees and determined that they respectively are not additive to our Board’s existing skills and expertise or lack sufficient experience in shipping and related industries.
  • Our Board already possesses significant, essential experience for Genco, including experience in shipping, fleet management and commercial and technical management, capital allocation management, financial reporting and M&A.
  • To that end, the Board is focused on our Comprehensive Value Strategy to drive value through drybulk shipping market cycles.
  • The Board will continue to take actions it believes are in the best interest of the Company and all its shareholders.

Helius Medical Technologies, Inc. Secures HCPCS Codes for Portable Neuromodulation Stimulator (PoNS®) Mouthpiece and Controller

Retrieved on: 
Monday, March 4, 2024
Level 2, Survivor, CMS, Helios, ATM, Sale, Stroke, Multiple sclerosis, Pons, Medicare, HSDT, Walking, DSM-IV codes, HCPCS, Health insurance

NEWTOWN, Pa., March 04, 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 Centers for Medicare & Medicaid Services (“CMS”) has assigned Healthcare Common Procedure Coding System (“HCPCS”) Level II codes A4593, “Neuromodulation stimulator system, adjunct to rehabilitation therapy regime” to describe the PoNS controller and A4594, “Neuromodulation stimulator system, adjunct to rehabilitation therapy regime, mouthpiece each” to describe the PoNS mouthpiece. The new HCPCS codes will be effective April 1, 2024.

Key Points: 
  • The new HCPCS codes will be effective April 1, 2024.
  • “PoNS Therapy® is life-changing for people who suffer gait impairment due to MS and we’re pleased that CMS understood the benefits of this innovative treatment by establishing HCPCS codes for both the PoNS mouthpiece and controller.
  • This marks a critical reimbursement and access milestone and provides Helius the ability to begin negotiating reimbursement with third-party payers using these unique HCPCS codes.
  • In Canada, PoNS is authorized to treat balance impairment due to MS, stroke and mild-to-moderate traumatic brain injury.

Biodexa Announces Positive Top Line Phase I Clinical Trial Results for Diffuse Midline Glioma and Provides R&D Update

Retrieved on: 
Friday, February 23, 2024
Type 1, DMG, NCT, CED, Neuro-Oncology (journal), Pons, Safety, Convection, Patient, Survival, Columbia University, Pharmaceutical industry

Nine patients were treated in the study (30 M group, n=3; 60 M group, n=4; 90 M group (optimal dose), n=2).

Key Points: 
  • Nine patients were treated in the study (30 M group, n=3; 60 M group, n=4; 90 M group (optimal dose), n=2).
  • Although the study was not powered to reliably demonstrate efficacy, median overall survival (OS) of patients in the study was 16.5 months.
  • This compares favourably with median survival rate in a cohort of 316 cases of 10.0 months (Jansen et al, 2015.
  • The results of the experiment were inconclusive in that they did not correlate with the results previously seen in in vitro and in vivo studies of tolimidone.

Jefferson County (Fla.) School District K-2nd Grade Students Using Age of Learning’s My Math Academy and My Reading Academy Experienced Significant Increases in Assessment Scores

Retrieved on: 
Thursday, February 29, 2024
Primary, Secondary, Education, Technology, Software, Other Education, Internet, Santa Cruz, Zambales, Student, ESSA, STAR (software), ABCmouse.com Early Learning Academy, Pons, Age, FAST, Research, Partnership, Tutoring

Using My Reading Academy was related to statistically significant increases in 2nd grade students’ assessment scores, after controlling for students’ fall scores and their grade levels.

Key Points: 
  • Using My Reading Academy was related to statistically significant increases in 2nd grade students’ assessment scores, after controlling for students’ fall scores and their grade levels.
  • STAR Math assessment results showed that students using My Math Academy for an average of 12 hours reached levels equivalent to the next grade in math.
  • All educators reported that My Math Academy and My Reading Academy had a positive impact on their students’ math and reading skills.
  • The Jefferson County School District continues to use My Math Academy and My Reading Academy in the current 2023-24 school year.

Helius Medical Technologies, Inc. Announces Alignment with FDA on Registrational Program for Treatment of Stroke Patients

Retrieved on: 
Tuesday, February 6, 2024
Medical school, HSDT, Gait, Patient, Pons, FDA, Falling, RWE, Food, Helios, FGA, Risk, Stroke, Medical device

NEWTOWN, Pa., Feb. 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, announced today that it has concluded its interaction with the U.S. Food and Drug Administration (“FDA”) on optimizing the development plan for its stroke program which aims to evaluate the effects of cranial-nerve non-invasive neuromodulation (“CN-NINM”) delivered using PoNS Therapy® on gait and dynamic balance in chronic stroke survivors. Helius’ registrational program includes two controlled studies. The clinical program will leverage a randomized, controlled, double blinded investigator-initiated trial (“IIT”), led by Dr. Steven Kautz at the Medical University of South Carolina (“MUSC”) and a Company-sponsored study to enroll approximately 100 subjects. Dr. Kautz’s IIT began enrollment of 60 participants in September 2023 with the collaboration of Dr. Mark Bowden at Brooks Rehabilitation as a second site.

Key Points: 
  • “Vetting the registrational program and design of our clinical studies with the FDA is an important milestone for Helius and meeting the agency’s expectations will give us the most efficient path to delivering PoNS Therapy to stroke patients,” said Dr. Antonella Favit-Van Pelt, Helius’ Chief Medical Officer.
  • Across all stroke patients in the database, 69.2% of patients experienced at least a 5-point FGA improvement, which is larger than the 4.2-point minimal detectable change usually seen in stroke patients.
  • “One of our chief objectives is to optimize access to PoNS Therapy for stroke patients suffering from gait and balance deficit in North America.
  • PoNS received breakthrough designations in both multiple sclerosis and stroke in the United States, potentially benefiting, with a new indication, an estimated 90% of stroke patients who are covered by Medicare.

Helius Booth and Special Event at APTA Combined Sections Meeting Will Highlight Physical Therapists’ Ability to Customize PoNS Therapy® to Improve Gait in People with MS

Retrieved on: 
Monday, February 5, 2024
Therapy, Multiple sclerosis, CSM, HSDT, Gait, Patient, Section, Pons, Physical therapy, DPT, Management of multiple sclerosis, Exposition, APTA, Nursing

CSM attendees can register for the after-hours event at booth 7074 or online at https://forms.gle/FEqwwRZpJj38aJRW9 .

Key Points: 
  • CSM attendees can register for the after-hours event at booth 7074 or online at https://forms.gle/FEqwwRZpJj38aJRW9 .
  • Helius’ appearance at the conference follows the first full year PoNS was available to MS patients in the United States, during which Helius’ engagement with physical therapists grew remarkably.
  • These topics will carry over to the after-hours event, held from 5-6:30 p.m. on February 16 at booth 7074.
  • “PoNS Therapy gives physical therapists a powerful new tool to counter some of the life-changing effects of MS, and we look forward to speaking with physical therapists about PoNS and highlighting its therapeutic potential.”

Helius Medical Technologies, Inc. Announces Further Expansion of Stroke Clinical Program with the Addition of Brooks Rehabilitation Hospital

Retrieved on: 
Thursday, January 11, 2024
Pons, Helios, Patient, Multiple sclerosis, MUSC, Medical school, Gait, HSDT, Partnership, Walking, Stroke, Survivor, Rehabilitation, Doctor of Philosophy

NEWTOWN, Pa., Jan. 11, 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 the registrational program with the addition of Brooks Rehabilitation Hospital (“Brooks Rehabilitation”). The program, structured on the basis of encouraging results from an early trial as well as real-world evidence from Canada, where PoNS is already authorized for treatment of stroke, focuses on establishing the effects of cranial-nerve non-invasive neuromodulation (“CN-NINM”), delivered using PoNS Therapy™, on gait and dynamic balance in chronic stroke survivors. Brooks Rehabilitation will participate as an adjunct site, under the direction of Dr. Mark Bowden, PT, PhD, Vice President of Clinical Integration and Research, to the ongoing investigator-initiated, placebo-controlled study in stroke, led by Dr. Steven Kautz at the Medical University of South Carolina (“MUSC”). Dr. Bowden will also take part in additional clinical activities that, when combined with the randomized controlled study, aim to bring the total number of subjects enrolled in the clinical program to approximately 100.

Key Points: 
  • Dr. Bowden will also take part in additional clinical activities that, when combined with the randomized controlled study, aim to bring the total number of subjects enrolled in the clinical program to approximately 100.
  • “The participation of Brooks Rehabilitation marks an important step in the implementation of our clinical program under breakthrough designation for stroke.
  • Dr. Bowden, with his longstanding leadership and contribution to the field of neurorehabilitation for stroke, brings the expertise needed to execute our registrational program.
  • Starting in January 2024, Dr. Bowden anticipates enrolling approximately 40 participants to the development program at Brooks Rehabilitation and expects full enrollment by the end of the year.