Associated tags: Health technology, DSM-IV codes, HSDT, Pons, Patient, Helios, Gait, MS, Multiple sclerosis, Pharmaceutical industry, Tongue, Sale
Locations: NEWTOWN, PA, US, PT, MS, CANADA
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Security (finance) 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.
Key Points:
- 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 offering is expected to close on or about May 9, 2024, subject to customary closing conditions.
- The Company intends to use the net proceeds from this offering for funding operations, working capital and other general corporate purposes.
- Craig-Hallum Capital Group LLC is acting as the sole placement agent for the offering.
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 that the Centers for Medicare & Medicaid Services (CMS) posted proposed Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) fee schedule payment rates for the PoNS Controller and Mouthpiece to be discussed at the bi-annual Healthcare Common Procedure Coding System (HCPCS) Public Meeting, scheduled for May 29, 2024.
Key Points:
- For the PoNS Mouthpiece (HCPCS code A4594), CMS based pricing on the cash pay price of $4,500, resulting in a total capped payment of $3,075.53.
- For the PoNS Controller (HCPCS Code A4593), CMS preliminarily set pricing by mapping reimbursement to existing code E0745, (Neuromuscular stimulator, electronic shock unit), resulting in a total capped fee of $1,206.53.
- “CMS’s preliminary determination of reimbursement for both the PoNS Controller and Mouthpiece is a significant win for Helius,” stated Helius’ President and Chief Executive Officer, Dane Andreeff.
- The Company cannot provide any assurance that these rates will be finalized and adopted in their current amounts, or at all.
Retrieved on:
Wednesday, April 24, 2024
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Stroke,
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Shepherd Center,
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Spinal cord,
Helios,
Multiple sclerosis,
MBA,
Management of multiple sclerosis,
Pharmaceutical industry 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.
Key Points:
- Participating to the Company-sponsored single-arm study, Shepherd Center joins Brooks Rehabilitation as a third clinical site to the overall registrational program.
- “Shepherd Center has been a valuable partner to Helius for almost two years.
- We are delighted Dr. Yochelson has agreed to contribute to the implementation of our stroke registrational program and undertake the study at Shepherd Center,” said Antonella Favit-Van Pelt, M.D., Ph.D., Helius' Chief Medical Officer.
- “Shepherd Center’s earlier involvement with the MS program is a testament to the strength of our clinical program.
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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.
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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.
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.
Key Points:
- 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.
- Dane C. Andreeff, President and Chief Executive Officer, and Jeffrey S. Mathiesen, Chief Financial Officer will host a conference call to discuss the results and provide an expanded business update regarding Helius’ progress and plans surrounding the U.S. commercialization of PoNS® as follows:
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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.
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:
Key Points:
- 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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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.
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