Helius Medical Technologies Announces Key Updates on CMS Reimbursement and Clinical Programs for PoNS Device’
Helius Medical Technologies, Inc. a neurotech company focused on developing non-implantable and wearable devices for neurological health, has made significant strides in its push to garner broader acceptance and reimbursement for its pioneering Portable Neuromodulation Stimulator (PoNS) device. Recent announcements reveal critical updates that impact the landscape of how this therapeutic device will be utilized and covered financially.
Reimbursement Determination Developments’
As part of the ongoing efforts to widen the accessibility and affordability of its PoNS device, Helius recently announced notable updates following its engagement with the Centers for Medicare & Medicaid Services (CMS). Of primary importance is the reimbursement payment determination for the PoNS Mouthpiece, assigned HCPCS code A4594. The reimbursement has been set at $2,963.30 for lump sum payment. However, Helius Medical Technologies expressed its intention to challenge this determination, seeking adjustments that would better reflect the value and innovation that the PoNS device brings to the field of neurorehabilitation.
Conversely, the national reimbursement payment determination for the PoNS Controller, a crucial component of the device, has been deferred to the next reimbursement cycle. This deferred ruling signals additional deliberation is needed to set an appropriate reimbursement level, signifying the complexity involved in evaluating advanced neurological rehabilitation tools such as the PoNS.
Securing Future Viability through HCPCS Codes and Financial Strategy’
Previously, Helius successfully secured HCPCS codes for both the PoNS Mouthpiece and Controller, marking a significant achievement towards establishing the PoNS as the only medical device approved in the United States for treating gait deficit due to multiple sclerosis (MS). This regulatory milestone highlights the device’s unique position in the market and potentiates increasing therapeutic usage, offering a novel solution for patients suffering from MS-related mobility issues.
In bolstering its operational strategy, Helius has employed a pragmatic financial approach to ensure continued innovation and market penetration. The cash runway has been significantly extended into the third quarter of 2024, thanks to proceeds from recent stock issuances via the company’s At-The-Market (ATM) program. This financial security enables the company to maintain its focus on advancing clinical and reimbursement journeys without the immediate pressure of liquidity constraints.
Expansion of Clinical Trials for PoNS in Stroke Rehabilitation’
Helius’s determination to expand the utility of PoNS is further exemplified in its clinical program focused on stroke rehabilitation. The company announced the expansion of its stroke research initiatives with the inclusion of Brooks Rehabilitation Hospital, which now serves as a second site for the registrational program in stroke. This expansion increases the participant count to 100 patients, aiming to explore and validate the utility of cranial-nerve non-invasive neuromodulation for addressing gait and balance deficits in stroke survivors.
This study represents a critical step in diversifying the therapeutic applications of PoNS, potentially broadening its impact to other neurological disorders beyond MS. By assessing the PoNS device’s efficacy in this new cohort, Helius aims to contribute substantial evidence that may prompt wider acceptance and integration of the device in neurorehabilitation protocols.
Conclusion’
Through strategic regulatory engagements, fiscal foresight, and continued clinical initiatives, Helius Medical Technologies is steadfast in its mission to enhance neurological rehabilitation. Updates in CMS reimbursement determinations, along with the expansion of its clinical programs, underline Helius’s commitment to transforming care paradigms and improving outcomes for individuals with neurological impairments.
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