subslover
9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
10月前
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
10月前
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
1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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