PoNS Tongue Stimulator, Designed to Ease Neuroplasticity, Recommended for ISO Certification
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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.
Joe Malfara
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
Gary Jeffords
I would interested in being part of your trial with the PoNs device.
I have MS (secondary progressive for 13 years)
Teresa
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
Christine anderson
please tell me where I can get the pons machine. I have Parkinson. please send me information. thank you
frank brooks
where can I buy it.
Judith Williams
I would like to try this as a stroke survivor. I would like to be a part of any trials.
Diane & Bob Paxman
Our 45 year old daughter has been diagnosed with progressive MS, 2 years ago. Can you send us information on how she might obtain use of a PoNs device?
Megan Wilson
I'm very interested in trying this. Being a distance runner for many years and now MS has taking away all of my mobility.
I live in a small town Wallowa, Or.
Jason Murray
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.
John Berg
Jason, I was diagnosed with PPMS in June 2015, which at least explained my peripheral nueropathy after 5 years of tests...and numerous dead-ends. Recently I had the first two infusions of Orevus; supposedly this slows the progression, though I’vs not yet felt any change. Last week my wife brought home a book titled “The Brain’s Way of Healing” by Norman Doidge, M.D. and in particular pages 226 to 249 dealing with results of using the PoNS device for people with Parkinsons and MS. The results seem remarkable, at least enough to stir me to do more online research — which is how I came across your note. I live in the Seattle area, in a state with the highest incidence of MS in the world. I will keep searching for more info on the PoNS device — and hope to gain access to one myself very soon.
Jenny Mister
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.
Regina Adams
My 23 year old daughter has primary progressive MS. Can you send us information on how she might obtain use of a PoNS device?
Debbie O'Rourke
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.
nanci
I don't see how to post my own new comment. The trial would be great.
Shamim Colon
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?
Marcy
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?
Leanna Crist
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?
Carol Ryan
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.
Marlene R. Champagne
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.
nanci
I don't know why I'm having trouble posting this. It is Helius Medical Technologies.
Najiyyah Bowman
I am interested in any trials offered in the NY area. Diagnosed in 2016 with RRMS
Susan Hadrits
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.
Ann McIntyre
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.
Patrick Dent
2005, african American with oacillopsia and SIBO. Severe depression and anxiety. Help me please
zahira hagemann
i have parkinson disease and i am very interested in the pons device
please let me know when and where it will be available.
Ricardo Alvarez
I'm interested in a trial. I am in Florida. Wondering if could fix empty body syndrome by regenrating trigeminal nerve.
Ginny
I would love to be part of a trial study. I have fibromyalgia/chronic fatigue/chronic migraines/ multiple chemical sensitivities. Have tried everything. My sister has Parkinson's - she would also be a good candidate
Kathleen Dates
Im interested in the PoNs trail... Or even purchasing this device!Ive been diagnosed with M. S. an having a hard time with it.I can't work, drive or even a normal life. Life itself is becoming hard to live.
Paul McRae
Could the pons device be used to improve working memory in people?
Lydia Bailey
I am very interested in purchasing the pons device. I watched the program on tv. I'm desperate to help my mother who is now doing physical therapy.
Jen
I am interested in the poNs trial for anorexia nervosa, and chronic anxiety. The Anorexic brain rewires after prolonged restricted eating. I am interested to see if the pons device can help with neurological conditions like depression and anxiety which so many are affected by. Medication is a risky and often deadly treatment option, and the pons device (like meditation) may be a safer way of healing and rebalancing the hypersensitive brain. Anorexia has a high mortality rate and I wonder if this device might help save many bright young lives. I also have a close friend with MS who I am certain would be interested in trialling the pons device.
Audrey Farley
My fiance has MS and he's very depressed.I don't want to see him give up,he wants me to leave him because of his MS and I want I have faith that things will get better,even if not I want leave him because of a disease he never asked for.I saw a you tube video in which Montell Williams is using the PONS device with great results.Please tell us how we can find this device.
Guido Lenzi
please tell me where or In which way I can get the pons machine. I have Parkinson. please send me information. thank you
Jim Conway
I was diagnosed with MS in 1984. My EDSS was recently assessed as being 8.00. I have secondary progressive MS. I live in Sydney Australia. How can I access a PoNs machine?
Kylie
Hey, I have relapsing/remitting ms and it has been getting g worse, I would like to be I the trial if your still doing them.
Thank you
HELEN CONWAY
Hi there, I've had MS for many years but have never used orthodox treatment as I feel it has nothing worthwhile to offer. Would so love to get a PoNS machine. Can you tell me when this will be possible?
Thanks,
Helen
Peter Horniblow
Only recently discovered Ponsi during internet search for help. PPMS FOR 15 YEARS. Has now gone from being a major inconvenience to absolute life changer. Not sure who I am addressing but any information on how to gain access to this new treatment would be tremendously appreciated.
Mildred Galarza
I Have M.S I wake up in so much pain everyday. This illness has broken my spirit. I live in N.Y. I would like to try this device asap.
Meyer
https://heliusmedical.com/
See newsroom and clinicaltrials
Robert Fulton
Hi I am an 82 yr old stroke and heart attack victim. My name is Robert. I am in stroke rehab therapy and seem to be at a plateau in my recovery. I am very much interested in using a PoNS device, I have done much research on your device and feel I would benefit greatly from its use. Look forward to your response. Robert Fulton
tim Stewart
All I have to whine about is a measly TBI induced case of anosmia, but I am highly motivated to try this treatment. Given that our medical system has morphed into the wealthiest and most powerful mob in the world, why in Godfather's name can't they make the PoNS device accessible to us merikans?
Randy LaKing
My friend with MS lives in Toronto and can travel to Montreal for treatment. She has heard that the cost is 30,000 and that Canadian medical does not cover it. Is there a way to get her into a free trial or does the patient have to pay for the trial? What are the costs if this is not correct?
Rick Lowry
Is this legitimate
Kirsty
My youngest boy got sick with flu last year at the age of 4 and in the result he has been left disabled and unable to speak. As a mother I am desperately trying to find little miracles like this to get even the smallest parts of my little boy back but here in the UK we don't have this option. If by chance there are any trials coming up please please keep Blake in mind we would be so very grateful thankyou.
agathocles tsatsoulis
I have PD and I am interested in The PoNS device.Can you inform m about the availability of this device in Greece?
Agathocles Tsatsoulis
Kara
I have SPMS, EDS 6.5. I went to Canada to try this. I only had small improvements in balance, likely attributed to intensive PT required during training with PONS device. I didn't meet anyone at the clinic that was having any big improvements either. Save your time and money. There's a reason that this was not FDA approved. It does little or nothing.
Diane & Bob Paxman of Alberta, Canada
Our 45 year old daughter has been diagnosed with progressive MS, 2 years ago. Can you send us information on how she might obtain use of a PoNs device?