subslover
2月前
Helius Medical Technologies, Inc. Announces Strong Enrollment of its Stroke Pivotal Study Exceeding Initial Target
--128 enrolled participants, as of December 31, 2024, exceeds initial target of 90 participants--
--150 maximum participant enrollment projected by end of January--
--The stroke registrational program is intended to demonstrate the safety and effectiveness of the novel Portable Neuromodulation Stimulator (PoNS®) for improving balance and gait deficits in stroke survivors--
--On track for FDA submission for stroke authorization in the second quarter of 2025--
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 it has completed and far exceeded the initial target enrollment for its stroke registrational program. With 128 participants randomized to-date the program is on track to reach the maximum enrollment target of 150 participants by the end of January 2025.
“Gait and balance deficits are the most frequently occurring disability in stroke patients and represent the largest market opportunity for PoNS Therapy®,” said Dane Andreeff, Helius Medical President and Chief Executive Officer. “We are excited for the opportunity to make PoNS available to the over 7 million patients in the U.S. living with disability from stroke as we remain on target to achieve FDA authorization for stroke in 2025.”
In 2021, the U.S. Food and Drug Administration granted Breakthrough Designation for PoNS in stroke. Helius has designed and implemented the stroke registrational program to establish the effects of cranial-nerve non-invasive neuromodulation (“CN-NINM”), delivered using PoNS Therapy, on gait and balance in chronic stroke survivors to support an FDA submission to expand the PoNS device indication to this patient population. The registrational studies also aim at establishing PoNS efficacy on decreasing risk of falling and maintaining the therapeutic effect post-treatment.
“Completing enrollment of our registrational program’s studies is a significant step toward providing stroke patients with a new therapeutic tool to improve their mobility. We have shown PoNS is effective in treating gait deficits for MS patients and we are excited to reinforce similar therapeutic benefits to address a dire medical need in this patient population,” said Antonella Favit-Van Pelt, M.D., Ph.D., Helius Chief Medical Officer. “Our ability to enroll this study in a timely manner highlights providers’ interest in PoNS Therapy and demonstrates patients’ demand for impactful rehabilitation therapies. With maximum target enrollment expected by the end of the month, we are tracking to our goal to submit for stroke authorization in the second quarter of 2025.”
In March 2023, the FDA endorsed the stroke registrational program which originally included two initial studies. The first was an investigator-initiated randomized placebo-controlled trial (MUSC-RCT) in approximately 60 subjects, led by Dr. Steven Kautz at the Medical University of South Carolina (MUSC) and Dr. Mark Bowden at Brooks Rehabilitation. The second study was a company-sponsored open-label study (HMI-OLS), in approximately 30 subjects. In May 2024, Helius added a third company-sponsored randomized placebo-controlled trial (HMI-RCT) across five sites in Canada and the U.S. All three studies shared the same design and endpoints, including primary outcomes on gait and balance improvement, as well as key secondary endpoints with Type 1 error of reduced risk of falling and maintenance of effect at 12 weeks post-treatment.
Enrollment of the stroke registrational studies started at MUSC for the MUSC-RCT in August 2023 and, at Brooks Rehabilitation, in August 2024. In June 2024, Helius started enrollment of the HMI-OLS at five U.S. Centers of Excellence for Neurorehabilitation including Shepherd Center, MGH-IHP, REHABOLOGYM, Brooks Rehabilitation and New England Neurological Center. Enrollment continued, with the HMI-RCT, in July 2024 at Neuro-Concept Rehabilitation Center, Neuphysio, Synaptic Health, Bergin Motion in Canada and REHABOLOGYM in the U.S.
“By December 31, 2024, we have reached our goal and exceeded our previously communicated target enrollment of 90 subjects, by randomizing 128 participants across the three registrational programs’ studies and we expect to reach our full enrollment of 150 participants in the next couple of weeks. Achieving and exceeding enrollment rate of approximately 5 participants per site per month in such a short timeframe, significantly outperforming the enrollment benchmark for stroke-related medical device studies, is a monumental achievement for Helius,” Dr. Favit-Van Pelt continued. “We are grateful to all our investigators for their extraordinary contribution and dedication to make PoNS Therapy available to stroke patients.”
About the PoNS Device and PoNS Therapy
The Portable Neuromodulation Stimulator (“PoNS”) is an innovative, non-implantable, orally applied therapy that delivers neurostimulation through a mouthpiece connected to a controller while it’s used, primarily at home, with physical rehabilitation exercise, to improve balance and gait. The PoNS device, which delivers mild electrical impulses to the tongue, is indicated for use in the United States as a short-term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (“MS”) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only.
PoNS has shown effectiveness in treating gait or balance and a significant reduction in the risk of falling in stroke patients in Canada, where it received authorization for sale in three indications: (i) for use as a short-term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from stroke and is to be used in conjunction with physical therapy; (ii) for use as a short-term treatment (14 weeks) of chronic balance deficit due to mild-to-moderate traumatic brain injury (“mmTBI”) and is to be used in conjunction with physical therapy; and (iii) for use as a short-term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS and is to be used in conjunction with physical therapy. PoNS is also authorized for sale in Australia for shor
Invest-in-America
2月前
HSDT: See ME recently, below, deploying HSDT's disruptive, revolutionary, new "Portable Neuromodulation Stimulator System"!!! (It's guranteed to staff-off, "Early-Onset-Old-Timers-Disease", as well as help prevent HAIR LOSS, to boot!!!)
Invest-in-America
3月前
HSDT: CONGRATS!! (However, regarding your comment, "when the officer ran back and picked the child up
did the child say my phone?", on you "X" homepage --- you have to understand that such a PHONE for such a little GIRL represents her entire UNIVERSE of friends, pals, Homegirls, parents, relatives, fun sights, fun sounds, ad infinitum, to the core of her BEING, Bro!!! Even as an ATHEIST, I know that TRUTH!!! How about YOU??????? (HA-HA-HA!!!)
subslover
12月前
Helius Medical Technologies, Inc. Announces Partnership with Lovell® Government Services to Expand Reach of PoNS Therapy™
-- 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.
“Through their Multiple Sclerosis Centers of Excellence, the VA is dedicated to maximizing the quality of life for veterans suffering from MS, and we are thrilled to partner with Lovell to expand the reach of our innovative PoNS device. In a study of real-world results, after 14 weeks of PoNS Therapy, 100% of MS patients experienced a clinically meaningful improvement in gait. More than 28,000 cases of MS are reported to the VA annually, making PoNS a potential game changer for veterans and their families,” said Dane Andreeff, President and Chief Executive Officer of Helius.
“As the largest integrated healthcare system in the U.S., the VA provides services to veterans with MS from the time of diagnosis through the rest of their lives. Veterans have given their best to our country and should have access to the most innovative and effective resources available. Lovell is proud to introduce this important product to the VA and other federal healthcare providers,” said Chris Lovell, Major, USMC (Ret.), CEO of Lovell Government Services.
“Recently, Helius highlighted the real-life story of Kevin Byrne, a retired U.S. veteran who’s been suffering from MS since 1999. Gait difficulties had taken away his most valued treasure, quality adventures with his 13-year-old daughter, but PoNS Therapy helped him improve his walking by increasing speed, endurance, and distance. After treatment with PoNS, he was able to take his daughter to New York City, where they enjoyed walking the streets and seeing Broadway shows, experiences he thought were lost forever. 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.
subslover
1年前
Helius Medical Technologies, Inc. Secures HCPCS Codes for Portable Neuromodulation Stimulator (PoNS®) Mouthpiece and Controller
-- Significant step toward reimbursement for the only medical device approved in the U.S. for treatment of gait deficit due to multiple sclerosis (“MS”) --
-- Proceeds from recent stock issuances through the Company’s At-The-Market (“ATM”) program extends cash runway into the third quarter 2024 --
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.
“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. We believe there is a reasonable likelihood that at the public meetings this summer CMS will determine a reimbursement amount for each of the PoNS controller and mouthpiece to take effect on October 1, 2024,” stated Helius’ President and Chief Executive Officer, Dane Andreeff.
“As we pursue widespread reimbursement for PoNS Therapy, we have continued to manage our cash burn. With the recently announced $1.5 million of net proceeds from the sale of shares of our common stock under our ATM program at an average share price of $9.17 per share, our cash runway has been extended into the third quarter of this year. Once we establish reimbursement for PoNS, we believe we will be able to expand reimbursement across third-party payers and have a pathway to positive cash flow as we continue to pursue authorization for stroke in the U.S.,” concluded Andreeff.
PoNS is indicated for use in the United States as a short-term treatment of gait deficit due to mild-to-moderate symptoms from MS and is to be used as an adjunct to a supervised therapeutic exercise program. The Company is also seeking marketing authorization under PoNS’s breakthrough designation for stroke in the United States, where over five million stroke survivors are affected by walking and balance disability. In Canada, PoNS is authorized to treat balance impairment due to MS, stroke and mild-to-moderate traumatic brain injury.
About Helius Medical Technologies, Inc.
subslover
1年前
Helius Medical Technologies, Inc. Announces Alignment with FDA on Registrational Program for Treatment of Stroke Patients
-- Studies uses Portable Neuromodulation Stimulator (PoNS®) to evaluate cranial-nerve non-invasive neuromodulation for gait/balance deficits in stroke patients --
-- Interaction with FDA on clinical program feasibility streamlines cost and timeline and leverages trials with the Medical University of South Carolina and Brooks Rehabilitation --
-- Studies and real-world evidence results will be submitted for regulatory authorization under PoNS’s breakthrough designation for stroke --
-- Regulatory submission for stroke and marketing authorization expected in 2025 --
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.
“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. “This development plan, which leverages early study results and real-world evidence from Canada, allows us to streamline the size, timeline, and cost of the registrational program and positions Helius on the best course toward potential FDA authorization under PoNS’s breakthrough designation for stroke.”
When evaluated in a real-world evidence (RWE) database analysis of Canadian stroke patients with gait or balance deficit, PoNS Therapy demonstrated a significant and clinically meaningful improvement in gait, averaging a 6.74-point improvement in the functional gait assessment (FGA) score over a 14-wk treatment period (95% CI: 4.85 to 8.63). Before starting PoNS Therapy, over 93% of patients were considered at risk of falling, as determined by an FGA
dinogreeves
2年前
They don't have much in the books, they are going to do it soon, they only had 8.5 million as of the end of June and each quarter goes by 3.5 million dollars negative in the books and 250,000 dollars in sales, that is nothing, yes true that they don't have any debt, but what else do they have to show for other that 250,000 dollars in sales, that is not enough to cover expenses. 15-20 is the target to get out, anything more than that you are asking for trouble.
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