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Helius Medical Technologies, Inc. (symbol: HSDT) is a pioneering neurotechnology company headquartered in Newtown, Pennsylvania, dedicated to developing, licensing, and acquiring non-invasive technologies for the treatment of symptoms caused by neurological diseases or trauma. The company’s flagship product, the Portable Neuromodulation Stimulator (PoNS®), is a novel medical device approved in Canada for the treatment of chronic balance deficits due to mild-to-moderate traumatic brain injury (mTBI) and gait deficits related to multiple sclerosis (MS). The PoNS® device works by delivering gentle electrical stimulation to the tongue's surface, which helps improve balance and gait through enhanced neuromodulation.
Recently, Helius Medical Technologies has achieved significant milestones, including expanding its clinical development program in collaboration with renowned institutions like the Shepherd Center and Brooks Rehabilitation. This expansion aims to further validate PoNS®'s efficacy for treating gait and balance deficits in chronic stroke survivors, highlighting the company’s commitment to broadening therapeutic applications.
In terms of partnerships, Helius has secured a meaningful collaboration with Lovell Government Services to introduce the PoNS® device to the U.S. Department of Veterans Affairs (VA) and other federal healthcare providers. This partnership aims to enhance the quality of life for veterans suffering from MS by providing access to innovative treatments. Real-world studies have shown that PoNS® Therapy can lead to clinically meaningful improvements in gait for all MS patients after 14 weeks of therapy.
Financially, Helius Medical Technologies is focusing on securing widespread reimbursement for the PoNS® device. The company recently received its first third-party reimbursement from a major insurance carrier, a crucial step towards establishing market pricing and expanding access. This follows the Centers for Medicare & Medicaid Services’ (CMS) establishment of unique Healthcare Common Procedure Coding System (HCPCS) codes for the PoNS® components.
Additionally, the PoNS® device is now available for purchase via the VA’s Federal Supply Schedule (FSS) and the GSA Advantage marketplace, ensuring quicker access for veterans and federal employees. The inclusion of PoNS® in these platforms underscores its potential as a game-changing therapy for those affected by neurological conditions, promoting neuroplasticity and improving patients' lives.
For more information about the PoNS® or Helius Medical Technologies, please visit www.heliusmedical.com.
Helius Medical Technologies (Nasdaq:HSDT) has completed site participation enrollment for its stroke registrational program in the U.S., incorporating top neurorehabilitation centers such as REHABOLOGYM, Neurology Center of New England, and MGH Institute of Health Professions. The program aims to evaluate the efficacy of PoNS Therapy® on gait and balance in chronic stroke survivors. Additionally, a supporting study has commenced in Canada to aid in Canadian reimbursement and U.S. approval processes. Helius plans to enroll at least 30 patients by Q3 2024 in the U.S. study, with an FDA submission expected in 2025.
The Canadian study, led by Neuro-Concept Rehabilitation Center, aims to enroll 60 subjects by the end of 2024. This multi-center research trial leverages PoNS Therapy's potential to induce neuroplasticity, thereby improving stroke recovery outcomes.
Helius Medical Technologies (Nasdaq: HSDT), a neurotech company, announced its participation in the Spring MicroCap Rodeo Conference on June 6, 2024, in NYC. CEO Dane Andreeff will discuss key topics including the pursuit of U.S. FDA authorization for its Portable Neuromodulation Stimulator (PoNS) device for stroke patients, and a partnership with Lovell Government Services to provide PoNS to federal healthcare systems like the VA and DoD. Helius has also received a preliminary determination for reimbursement from the CMS for the PoNS mouthpiece and controller, with a final price decision expected on October 1, 2024. The presentation will be webcast live and management will be available for one-on-one meetings with approved investors.
Helius Medical Technologies announced that it secured its first third-party reimbursement for its Portable Neuromodulation Stimulator (PoNS) device from a major insurance carrier. The reimbursement rate is set at $23,900, slightly below the list price due to a 7% rebate. This milestone follows the Centers for Medicare & Medicaid Services’ (CMS) establishment of unique codes for the PoNS mouthpiece and controller. Helius is actively negotiating with additional third-party payers and assisting multiple sclerosis (MS) patients in submitting claims. The reimbursed rate is broken down to $16,554 for the controller and $7,347 for the mouthpiece.
Helius Medical Technologies (NASDAQ: HSDT) will exhibit at the 2024 CMSC Annual Meeting, highlighting significant advancements in making their Portable Neuromodulation Stimulator (PoNS) more accessible for individuals with multiple sclerosis (MS). Over the past year, Helius has focused on increasing accessibility and reimbursement for PoNS therapy, a non-implantable, orally applied electrical stimulation therapy that improves gait in MS patients when combined with physical exercise. Key milestones include the assignment of HCPCS codes by the Centers for Medicare & Medicaid Services (CMS) in March, a partnership with Lovell Government Services in April to provide PoNS to the VA and federal healthcare providers, and training a critical mass of physical therapists to ensure broad availability of the therapy. The CMS's final decision on pricing will be effective October 1, 2024. These efforts aim to remove barriers for MS patients, enabling them to benefit from PoNS therapy.
Helius Medical Technologies has announced that its Portable Neuromodulation Stimulator (PoNS®) device has been approved for inclusion on the Veterans Affairs (VA) Federal Supply Schedule (FSS) and General Services Administration (GSA) Advantage contracts. This approval allows U.S. veterans and federal employees access to the PoNS® device for treating gait and balance impairments associated with multiple sclerosis (MS). Priced at $23,843.72 for the device and $7,344.97 for the mouthpiece, the PoNS® device is now available for purchase through the VA's FSS Medical Equipment and Surgical Contract and the GSA Advantage online catalog.
The VA estimates that 55,000 to 70,000 U.S. veterans live with MS. The PoNS® device is designed to induce neuroplasticity, aiding in the modification and adaptation of brain activity. Helius's partnership with Lovell Government Services aims to streamline the availability of this therapy through federal healthcare systems.
Helius Medical Technologies (Nasdaq: HSDT) reported its Q1 2024 financial results. Revenue rose to $135,000 from $111,000 in Q1 2023, driven by higher product sales in the U.S. and Canada. Operating loss decreased to $3.4 million, down from $3.8 million in the prior year. Net loss remained stable at $2.5 million, with a net loss per share improving to $3.08, compared to $4.42 previously. The company successfully closed a $6.4 million public offering, netting $5.6 million. Helius received HCPCS codes for its PoNS device, with final reimbursement rates to be determined by October 1, 2024. The company expanded its stroke registrational program and partnered with Lovell Government Services to access federal healthcare systems.
Helius Medical Technologies, Inc. will release its first quarter 2024 financial results on May 13, 2024. The company, focused on innovative neuromodulation therapies, will discuss progress and plans for U.S. commercialization of PoNS® during a conference call hosted by its executives.
Helius Medical Technologies, Inc. announced the pricing of a $6.4 million public offering involving shares of Common Stock and Pre-Funded Warrants. The offering is expected to close on May 9, 2024, with net proceeds going towards operations and general corporate purposes.
Helius Medical Technologies, Inc., a neurotech company, announced the Centers for Medicare & Medicaid Services preliminary Medicare payment determinations for the PoNS Controller and Mouthpiece, with a public meeting scheduled for May 29, 2024. CMS proposed pricing based on cash pay rates, with the PoNS Mouthpiece capped at $3,075.53 and the PoNS Controller at $1,206.53. Helius plans to present at the meeting to advocate for higher reimbursement rates, intending to expand reimbursement and achieve positive cash flow.
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