PoNS Tongue Stimulator, Designed to Ease Neuroplasticity, Recommended for ISO Certification

PoNS Tongue Stimulator, Designed to Ease Neuroplasticity, Recommended for ISO Certification

Helius Medical Technologies‘s Portable Neuromodulation Stimulator (PoNS), a device being developed to treat neuroplasticity in people with multiple sclerosis (MS) and other neurological diseases, has been recommended for ISO 13485 certification, an international standard of quality management for medical devices, after a positive evaluation by Lloyd’s Register Quality Assurance Limited (LRQA).

This certification defines quality management system requirements for manufacturers of medical devices to ensure they meet both user and regulatory demands.

PoNS is a non-invasive device that allows the delivery of neurostimulation through the tongue. The device, developed by scientists at the University of Wisconsin-Madison Tactile Communication and Neurorehabilitation Laboratory (TCNL), is based on the concept that the tongue is a natural, direct way to stimulate the brain, as it is rich in nerve fibers and connected by two major cranial nerves to the brainstem. PoNS is being developed as a therapy for the treatment of chronic neurological symptoms of trauma or disease, including MS.

LRQA, an independent provider of business assurance services, including management system certification, determining that a company meets the criteria for ISO 13485 certification. Such certification constitutes a regulatory landmark in the commercialization process.

“The ISO 13485 certification illustrates our commitment to quality, our ability to reach milestones required for product commercialization and, above all, our dedication to seeing PoNS™ Therapy through to approval,” Joyce LaViscount, CFO/COO of Helius, a wholly owned subsidiary of NeuroHabilitation, said in a press release.

Helius soon plans to apply for a CE (Conformité Européenne) Mark, a certification granted to products that meet the European Union’s health, safety, and environmental standards, for PoNS, and for similar approval in the United States with the U.S. Food and Drug Administration (FDA). The company will also apply for licensing in Canada and Australia.

In June, Helius reported positive results in a pilot efficacy study demonstrating the benefits of a combination of the PoNS device with physical therapy in patients with advanced MS. The therapeutic combination was assessed in six patients with Expanded Disability Status Scale (EDSS) scores of 6.5 to 7.5 (EDSS score range is 0–10). Patients used the PoNS device and physical therapy for six months to target balance, postural stability, and walking movement or gait. As reported by Multiple Sclerosis News Today, the treatment was seen to improve the patients’ quality of life, as well as physical and cognitive abilities.

PoNS’ efficacy is currently being assessed in a clinical (NCT02158494) in patients with balance disorder as a result of a traumatic brain injury.

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20 comments

  1. Joe Malfara says:

    I would love to part of your trials
    I am also buying shares in the company
    I was looking into stem cell treatment, but now I will not have to

  2. Teresa says:

    Am very Much interested in trying this device to help me with ms symptoms. Please contact me with info on how to obtain the device or to be put into some kind of trial. Thank you

  3. Christine anderson says:

    please tell me where I can get the pons machine. I have Parkinson. please send me information. thank you

  4. Jason Murray says:

    Hello, I am very interested in trying the pons device for m.s., I have primary progressive/relapsing remitting for 9 years now and am desperate for relief. Please keep me posted on any news or trials. Thank you.

  5. Jenny Mister says:

    I researched this and it looks like they are doing pons clinical trials in about five places in the US. But it looks like these trials are for traumatic brain injuries ONLY. Canada is doing the MS studies. I think wherever the company is located will treat anyone.

  6. Regina Adams says:

    My 23 year old daughter has primary progressive MS. Can you send us information on how she might obtain use of a PoNS device?

  7. Debbie O'Rourke says:

    I was diagnosed with Ms back in 2015. I’m following the updates on the trials with great interest. I hope all goes well with them and the fda can pass it soon. Living with the hope all sufferers will soon be able to use it.

  8. Shamim Colon says:

    Hi!
    I’m interested in this device for my son who has cerebral palsy. When will it be available and where can I get it?

  9. Marcy says:

    My son has balance/gait issues related to mild CP. Using this device in conjunction with his intensive physical therapy would appear to be a game changer. Where and when will it be available?

  10. Leanna Crist says:

    I would be thrilled to be a part of any study group for the Pons device. I’ve had MS for 16 years and it has progressed to a point of being house bound. How do any of us find a doctor who can help?

  11. Carol Ryan says:

    Having just spent 48 hours with our grown up daughter while she rocked in pain from the continuing debilitating migraines which are not happening more often. Please where or how do we access the PoNs trails/system. We are in Australia but of course if no one here represents you we or she will come to you. I haven’t been able to put down ‘The Brains way of healing itself’ book for months, then of course, not by accident as is often the way, was with her during the latest monster. Thank you.

  12. Marlene R. Champagne says:

    Very anxious for my daughter to try this as well. Our neurologist and neurological physiotherapist both eager to try. After a catastrophic M.S. attack she has recovered to the point where she just needs help with balance and mobility. She wants a chance to resume her previous life.

  13. Susan Hadrits says:

    I have lived with MS for 34 years. I have been in the secondary progressive stage for about 10 years. I am interested in joining a trial for PoNS to see if it would help someone who has had MS for so long. I am still able to walk with a cane and use a wheelchair for longer distances.

  14. Ann McIntyre says:

    I have had MS since 1980. I am slowly loosing the ability to walk. I would like to be in a trial. please contact me…. I also have a “noisy brain”, deaf in right ear, tinnitus, balance issues.

  15. zahira hagemann says:

    i have parkinson disease and i am very interested in the pons device
    please let me know when and where it will be available.

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