Writer of the article:
Article content material
— Research finds vital enchancment in gait deficit in a number of sclerosis sufferers utilizing translingual neurostimulation (“PoNS Remedy®”) mixed with a therapeutic train program —
— Poster was certainly one of ten rehabilitation analysis shows nominated for the Labe C. Scheinberg Award recognizing the platform or poster, in every therapeutic class, that has the best impression in advancing the care of individuals with MS —
NEWTOWN, Pa., June 06, 2022 (GLOBE NEWSWIRE) — Helius Medical Applied sciences, Inc. (Nasdaq:HSDT) (“Helius” or the “Firm”), a neurotech firm centered on neurological wellness, in the present day introduced {that a} poster detailing the advantages of the Firm’s Transportable Neuromodulation Stimulator (“PoNS”) Remedy mixed with a therapeutic train program was offered on the 2022 Consortium of A number of Sclerosis Facilities (“CMSC”) Annual Assembly held June 1-4, 2022, in Nationwide Harbor, Maryland.
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Article content material
“The CMSC Annual Assembly is an excellent alternative to have interaction with thought leaders and researchers within the MS area. We’re delighted to share the advantages of our modern PoNS gadget and to be a part of the group that’s working to deliver leading edge interventions to enhance gait deficits in sufferers with MS. It’s particularly gratifying that our poster was chosen out of 150 to obtain a prestigious award nomination,” said Antonella Favit-VanPelt, MD, PhD, Chief Medical Officer of Helius.
“Importantly, this newest dataset offers key real-world proof of our remedy’s scientific advantages, which might be seen at two weeks from starting rehabilitation therapy with PoNS. We sit up for persevering with to collect real-world proof by means of our Therapeutic Expertise Program (“TEP”), a multi-center, company-sponsored, open label observational interventional trial to judge the impression of topics’ adherence to PoNS remedy for gait enchancment in MS, in addition to by means of sufferers’ voluntary participation to our upcoming registry program as a part of the just lately introduced Affected person Remedy Entry Program,” concluded Dr. Favit-VanPelt.
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Article content material
Research Conclusions
- On this evaluation of a real-world dataset of sufferers with MS with typically lengthy length of illness, translingual neurostimulation (PoNS Remedy) mixed with a therapeutic train program considerably improved gait deficit at Week 2, the earliest evaluated time level, and at each subsequent time level.
- Gait deficit was assessed by the Useful Gait Evaluation (“FGA”) scale. Imply enhancements in FGA whole scores primarily based on noticed information have been extremely statistically vital in any respect follow-up time factors (paired t-test P<0.0001). Imply enchancment in FGA at Week 14 of PoNS remedy was 4.75 (95% CI: 3.66 to five.84), and the median enchancment was 5 factors with 58.3% of sufferers displaying an enchancment of ≥4 factors, noticeably larger than the minimal detectable change (“MDC”) for older adults, stroke sufferers, and individuals with different neurological illness.
- Evaluation of real-world information pooled with the 2 randomized scientific trials (“RCTs”) demonstrated, in step with the RCT information, that PoNS Remedy is secure and efficient in enhancing gait deficit in people with gentle and average signs from MS. Imply enchancment within the Dynamic Gait Index (DGI) evaluation from baseline to Week 14 was 4.58 (95% CI: 3.62 to five.54) for the pooled RWE and RCT evaluation together with all potential information in any respect weeks. Over 55% of sufferers handled with energetic PoNS remedy skilled ≥4 point-improvement from baseline within the DGI rating.
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Article content material
Poster Particulars
1Helius Medical Applied sciences, Newtown, PA.
2Biomedical Statistical Consulting, Wynnewood, PA.
About Helius Medical Applied sciences, Inc.
Helius Medical Applied sciences is a number one neurotech firm within the medical gadget subject centered on neurologic deficits utilizing non-implantable platform applied sciences that amplify the mind’s capacity to compensate and promotes neuroplasticity, aiming to enhance the lives of individuals coping with neurologic ailments. The Firm’s first business product is the Transportable Neuromodulation Stimulator (PoNS). For extra data, go to www.heliusmedical.com.
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Article content material
Concerning the PoNS System and PoNS Remedy
The Transportable Neuromodulation Stimulator (PoNS) is an modern non-surgical medical gadget, inclusive of a controller and mouthpiece, which delivers electrical stimulation to the floor of the tongue to enhance steadiness and gait. The PoNS gadget is indicated to be used in the US as a short-term therapy of gait deficit on account of mild-to-moderate signs from a number of sclerosis (“MS”) and is for use as an adjunct to a supervised therapeutic train program in sufferers 22 years of age and over by prescription solely. Helius is advancing PoNS post-approval analysis in MS by means of a just lately launched Therapeutic Expertise Program (TEP) designed to companion with neurologists and neurorehabilitation therapists at 10-12 US facilities of excellence, who specific an curiosity in turning into “early adopters” of PoNS remedy.
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Article content material
PoNS can be approved on the market in Canada for 2 indications: (i) to be used as a short-term therapy (14 weeks) of power steadiness deficit on account of mild-to-moderate traumatic mind harm (“mmTBI”) and is for use at the side of bodily remedy; and (ii) to be used as a brief time period therapy (14 weeks) of gait deficit on account of gentle and average signs from MS and is for use at the side of bodily remedy. PoNS can be approved on the market in Australia for brief time period use by healthcare professionals as an adjunct to a therapeutic train program to enhance steadiness and gait.
Cautionary Disclaimer Assertion
Sure statements on this information launch aren’t primarily based on historic information and represent forward-looking statements or forward-looking data throughout the which means of the U.S. Personal Securities Litigation Reform Act of 1995 and Canadian securities legal guidelines. All statements aside from statements of historic reality included on this information launch are forward-looking statements that contain dangers and uncertainties. Ahead-looking statements are sometimes recognized by phrases reminiscent of “imagine,” “count on,” “proceed,” “will,” “objective,” “goal” and related expressions. Such forward-looking statements embody, amongst others, the scope and success of TEP, and price of adoption of PoNS Remedy.
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Article content material
There might be no assurance that such statements will show to be correct and precise outcomes and future occasions might differ materially from these expressed or implied by such statements. Vital components that would trigger precise outcomes to vary materially from the Firm’s expectations embody uncertainties related to the Firm’s capital necessities to attain its enterprise aims, and skill to boost capital, the impression of the COVID-19 pandemic, the Firm’s capacity to coach bodily therapists within the supervision of using the PoNS Remedy, the Firm’s capacity to safe contracts with rehabilitation clinics, the Firm’s capacity to acquire nationwide Medicare protection and to acquire a reimbursement code in order that the PoNS gadget is roofed by Medicare and Medicaid, the Firm’s capacity to construct inside business infrastructure, safe state distribution licenses, construct a business workforce and construct relationships with Key Opinion Leaders, neurology specialists and neurorehabilitation facilities, market consciousness of the PoNS gadget, future scientific trials and the scientific growth course of, manufacturing and provide chain dangers, the product growth course of and FDA regulatory submission assessment and approval course of, different growth actions, ongoing authorities regulation, and different dangers detailed occasionally within the “Danger Components” part of the Firm’s Annual Report on Type 10-Ok for the 12 months ended December 31, 2021, and its different filings with the US Securities and Alternate Fee and the Canadian securities regulators, which might be obtained from both at www.sec.gov or www.sedar.com.
The reader is cautioned to not place undue reliance on any forward-looking assertion. The forward-looking statements contained on this information launch are made as of the date of this information launch and the Firm assumes no obligation to replace any forward-looking assertion or to replace the explanation why precise outcomes might differ from such statements besides to the extent required by regulation.
Investor Relations Contact
Lisa M. Wilson, In-Website Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com
Commercial
Writer of the article:
Article content material
— Research finds vital enchancment in gait deficit in a number of sclerosis sufferers utilizing translingual neurostimulation (“PoNS Remedy®”) mixed with a therapeutic train program —
— Poster was certainly one of ten rehabilitation analysis shows nominated for the Labe C. Scheinberg Award recognizing the platform or poster, in every therapeutic class, that has the best impression in advancing the care of individuals with MS —
NEWTOWN, Pa., June 06, 2022 (GLOBE NEWSWIRE) — Helius Medical Applied sciences, Inc. (Nasdaq:HSDT) (“Helius” or the “Firm”), a neurotech firm centered on neurological wellness, in the present day introduced {that a} poster detailing the advantages of the Firm’s Transportable Neuromodulation Stimulator (“PoNS”) Remedy mixed with a therapeutic train program was offered on the 2022 Consortium of A number of Sclerosis Facilities (“CMSC”) Annual Assembly held June 1-4, 2022, in Nationwide Harbor, Maryland.
Commercial 2
Article content material
“The CMSC Annual Assembly is an excellent alternative to have interaction with thought leaders and researchers within the MS area. We’re delighted to share the advantages of our modern PoNS gadget and to be a part of the group that’s working to deliver leading edge interventions to enhance gait deficits in sufferers with MS. It’s particularly gratifying that our poster was chosen out of 150 to obtain a prestigious award nomination,” said Antonella Favit-VanPelt, MD, PhD, Chief Medical Officer of Helius.
“Importantly, this newest dataset offers key real-world proof of our remedy’s scientific advantages, which might be seen at two weeks from starting rehabilitation therapy with PoNS. We sit up for persevering with to collect real-world proof by means of our Therapeutic Expertise Program (“TEP”), a multi-center, company-sponsored, open label observational interventional trial to judge the impression of topics’ adherence to PoNS remedy for gait enchancment in MS, in addition to by means of sufferers’ voluntary participation to our upcoming registry program as a part of the just lately introduced Affected person Remedy Entry Program,” concluded Dr. Favit-VanPelt.
Commercial 3
Article content material
Research Conclusions
- On this evaluation of a real-world dataset of sufferers with MS with typically lengthy length of illness, translingual neurostimulation (PoNS Remedy) mixed with a therapeutic train program considerably improved gait deficit at Week 2, the earliest evaluated time level, and at each subsequent time level.
- Gait deficit was assessed by the Useful Gait Evaluation (“FGA”) scale. Imply enhancements in FGA whole scores primarily based on noticed information have been extremely statistically vital in any respect follow-up time factors (paired t-test P<0.0001). Imply enchancment in FGA at Week 14 of PoNS remedy was 4.75 (95% CI: 3.66 to five.84), and the median enchancment was 5 factors with 58.3% of sufferers displaying an enchancment of ≥4 factors, noticeably larger than the minimal detectable change (“MDC”) for older adults, stroke sufferers, and individuals with different neurological illness.
- Evaluation of real-world information pooled with the 2 randomized scientific trials (“RCTs”) demonstrated, in step with the RCT information, that PoNS Remedy is secure and efficient in enhancing gait deficit in people with gentle and average signs from MS. Imply enchancment within the Dynamic Gait Index (DGI) evaluation from baseline to Week 14 was 4.58 (95% CI: 3.62 to five.54) for the pooled RWE and RCT evaluation together with all potential information in any respect weeks. Over 55% of sufferers handled with energetic PoNS remedy skilled ≥4 point-improvement from baseline within the DGI rating.
Commercial 4
Article content material
Poster Particulars
1Helius Medical Applied sciences, Newtown, PA.
2Biomedical Statistical Consulting, Wynnewood, PA.
About Helius Medical Applied sciences, Inc.
Helius Medical Applied sciences is a number one neurotech firm within the medical gadget subject centered on neurologic deficits utilizing non-implantable platform applied sciences that amplify the mind’s capacity to compensate and promotes neuroplasticity, aiming to enhance the lives of individuals coping with neurologic ailments. The Firm’s first business product is the Transportable Neuromodulation Stimulator (PoNS). For extra data, go to www.heliusmedical.com.
Commercial 5
Article content material
Concerning the PoNS System and PoNS Remedy
The Transportable Neuromodulation Stimulator (PoNS) is an modern non-surgical medical gadget, inclusive of a controller and mouthpiece, which delivers electrical stimulation to the floor of the tongue to enhance steadiness and gait. The PoNS gadget is indicated to be used in the US as a short-term therapy of gait deficit on account of mild-to-moderate signs from a number of sclerosis (“MS”) and is for use as an adjunct to a supervised therapeutic train program in sufferers 22 years of age and over by prescription solely. Helius is advancing PoNS post-approval analysis in MS by means of a just lately launched Therapeutic Expertise Program (TEP) designed to companion with neurologists and neurorehabilitation therapists at 10-12 US facilities of excellence, who specific an curiosity in turning into “early adopters” of PoNS remedy.
Commercial 6
Article content material
PoNS can be approved on the market in Canada for 2 indications: (i) to be used as a short-term therapy (14 weeks) of power steadiness deficit on account of mild-to-moderate traumatic mind harm (“mmTBI”) and is for use at the side of bodily remedy; and (ii) to be used as a brief time period therapy (14 weeks) of gait deficit on account of gentle and average signs from MS and is for use at the side of bodily remedy. PoNS can be approved on the market in Australia for brief time period use by healthcare professionals as an adjunct to a therapeutic train program to enhance steadiness and gait.
Cautionary Disclaimer Assertion
Sure statements on this information launch aren’t primarily based on historic information and represent forward-looking statements or forward-looking data throughout the which means of the U.S. Personal Securities Litigation Reform Act of 1995 and Canadian securities legal guidelines. All statements aside from statements of historic reality included on this information launch are forward-looking statements that contain dangers and uncertainties. Ahead-looking statements are sometimes recognized by phrases reminiscent of “imagine,” “count on,” “proceed,” “will,” “objective,” “goal” and related expressions. Such forward-looking statements embody, amongst others, the scope and success of TEP, and price of adoption of PoNS Remedy.
Commercial 7
Article content material
There might be no assurance that such statements will show to be correct and precise outcomes and future occasions might differ materially from these expressed or implied by such statements. Vital components that would trigger precise outcomes to vary materially from the Firm’s expectations embody uncertainties related to the Firm’s capital necessities to attain its enterprise aims, and skill to boost capital, the impression of the COVID-19 pandemic, the Firm’s capacity to coach bodily therapists within the supervision of using the PoNS Remedy, the Firm’s capacity to safe contracts with rehabilitation clinics, the Firm’s capacity to acquire nationwide Medicare protection and to acquire a reimbursement code in order that the PoNS gadget is roofed by Medicare and Medicaid, the Firm’s capacity to construct inside business infrastructure, safe state distribution licenses, construct a business workforce and construct relationships with Key Opinion Leaders, neurology specialists and neurorehabilitation facilities, market consciousness of the PoNS gadget, future scientific trials and the scientific growth course of, manufacturing and provide chain dangers, the product growth course of and FDA regulatory submission assessment and approval course of, different growth actions, ongoing authorities regulation, and different dangers detailed occasionally within the “Danger Components” part of the Firm’s Annual Report on Type 10-Ok for the 12 months ended December 31, 2021, and its different filings with the US Securities and Alternate Fee and the Canadian securities regulators, which might be obtained from both at www.sec.gov or www.sedar.com.
The reader is cautioned to not place undue reliance on any forward-looking assertion. The forward-looking statements contained on this information launch are made as of the date of this information launch and the Firm assumes no obligation to replace any forward-looking assertion or to replace the explanation why precise outcomes might differ from such statements besides to the extent required by regulation.
Investor Relations Contact
Lisa M. Wilson, In-Website Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com
Commercial
