CMSC’s 38th Annual Meeting runs from
“From the beginning, we have prioritized getting PoNS to as many people with MS and gait deficit as possible. We have been actively meeting and negotiating with insurers and others with the goal of increasing accessibility even before PoNS was commercially available,” said Helius Chief Executive Officer
Helius’s ability to make PoNS more accessible reflects three significant recent events:
- In March, the
Centers for Medicare & Medicaid Services (CMS) assigned Healthcare Common Procedure Coding System (HCPCS) codes covering the PoNS controller and mouthpiece, an important milestone in obtaining reimbursement through Medicare. Following public meetings held at the end of May, CMS will make its final decision on pricing, which will be effectiveOctober 1, 2024 . - In April, Helius partnered with Lovell Government Services to make PoNS available to the
U.S. Department of Veterans Affairs (VA) – the largest integrated healthcare system inthe United States , and home to a network ofMultiple Sclerosis Centers of Excellence – theU.S. Department of Defense , and other federal healthcare providers. - Helius also has trained a critical mass of physical therapists, who design the customized exercise regimens that are an integral part of PoNS Therapy®. Having more physical therapists on the ground around the country, including the 10 states where MS is most prevalent, makes it easier for people with MS to access a partner near their home.
“Each of these achievements represents a win in terms of facilitating access to a technology that makes a meaningful difference in their fight against this common but devastating symptom of MS,” Andreeff said. “Taken together, they represent important progress in removing barriers that keep people with MS from walking better and doing the things they enjoy most. Removing those barriers and helping more people benefit from PoNS has been our goal since the start.”
About
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 and 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
PoNS has shown effectiveness in treating gait or balance and a significant reduction in the risk of falling in stroke patients in
Cautionary Disclaimer Statement
Certain statements in this news release are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the
There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those expressed or implied by such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include uncertainties associated with the Company’s capital requirements to achieve its business objectives, availability of funds, the Company’s ability to find additional sources of funding, manufacturing, labor shortage and supply chain risks, including risks related to manufacturing delays, the Company’s ability to obtain national Medicare insurance coverage and to obtain a reimbursement code, the Company’s ability to continue to build internal commercial infrastructure, secure state distribution licenses, market awareness of the PoNS device, future clinical trials and the clinical development process, the product development process and the FDA regulatory submission review and approval process, other development activities, ongoing government regulation, and other risks detailed from time to time in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended
The reader is cautioned not to place undue reliance on any forward-looking statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to update the reasons why actual results could differ from such statements except to the extent required by law.
Investor Relations Contact
T: 212-452-2793
E: lwilson@insitecony.com
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