PoNS Device - being tested in Australia

[Eliza-Jane]

I am still reading The Brain's Way of Healing by Norman Doidge. The PoNS device sits on the tongue. It assists in balance and motor skills. It was created in America and underwent preliminary testing in Melbourne last year.

I found this on FAQ Norman Doidge website.

"I’m interested in the PoNS device, in Chapter 7 of The Brain’s Way of Healing. The PoNS is a device that neuromodulates and resets the brain, and which has helped people traumatic brain injury, Multiple Sclerosis, Parkinson’s disease, Stroke, some pain problems, and other brain and balance difficulties. When will it be available?

PoNS UPDATE, January, 2018. Information on availability of the PoNS will now be through the manufacturer of the device, Helius Medical Technologies. In brief, some good news is that the final patients in the studies required for FDA approval finished their treatment in May and July 2017. The two studies which are the necessary prerequisites for FDA approval have now been completed, and a final package with the results, is currently being prepared by Helius for FDA submission. But the PoNS can not be made available to the public until FDA approval comes through. The latest guestitimate we have heard is that it could take until the end of 2018 for the FDA to release its decision. This may seem confusing, because the PoNS was available to patients who were in the well-known studies (for instance, the U.S. Military study of its use for treating traumatic brain injury and the Montreal Neurological Institute study for use for Multiple Sclerosis patients). But now that the studies are complete, the PoNS cannot be available to anyone until approved by the FDA. We know this is frustrating for those hoping to get access to a PoNS, and who had hoped it would be available by now, but this pace is not unusual in approval of new cutting-edge devices. Other news is that there is a migration of PoNS development activity to Helius. Because the PoNS studies have been completed, the Tactile Communication and Neurorehabilitation Lab that opened in 1992 and developed the PoNS and many other inventions, has been closed and the three scientists who invented the PoNS, Yuri Danilov, PhD, Kurt Kaczmarek, PhD and Mitch Tyler PhD, are now consulting for Helius on how to refine it. The TCNL lab website still has 50 research papers related to the PoNS posted on it, here. "

I guess now we watch this spot.

[aspergerian13]

Important update. Thank you.

[nourilo]

Thanks for the update. It would be great if it becomes available in 2018. Keep us posted...

[pad10]

things are moving along on PoNS...this was tested for TBIs (not pd) so I dont know if it will be available for PWP...does anyone know? will it have to go through FDA approval for each disease it could treat?

Helius Medical Technologies Submits Request for FDA 510(k) Clearance of the PoNS™ Device

NEWTOWN, PA., September 4, 2018 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (NASDAQ:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that the Company has submitted a request to the U.S. Food and Drug Administration (“FDA”) for de novo classification and 510(k) clearance of the Portable Neuromodulation Stimulator (PoNS™) device.

“Helius is excited to announce the submission of our request for de novo classification and 510(k) clearance of the PoNS device for the treatment of chronic balance deficit due to mild- to moderate-traumatic brain injury,” said Philippe Deschamps, Helius’ President, CEO and Chairman. “This important milestone is the result of many years of hard work from the Helius team, and it brings us one step closer to making our novel PoNS Treatment available for U.S. patients who suffer from the potentially disabling effects of TBI-related chronic balance disorder.”

The Company’s request for de novo classification and 510(k) clearance is supported by clinical data from two double-blind, randomized, controlled trials demonstrating the PoNS device’s safety and efficacy, with combined enrollment of 163 patients. It is also informed by feedback provided by FDA during pre-submission meetings that focused on the Company’s trial designs, clinical data and design verification testing.

Mr. Deschamps continued: “Looking ahead, the Company is focused on laying the groundwork for the commercial launch of our PoNS Treatment following FDA clearance and pursuing regulatory clearances in Canada, Australia, Europe.

Here is an explanation of what an FDA 510(k) is.....

”devicewatch.org/reg/510k.shtml

[sandra111]

Здравствуйте, я здесь новенькая.Я тренируюсь на машине с февраля 2018 года.У меня хороший баланс.Он был хорош.Он не помогает всем.Это было хуже.Я ходила к доктору Константини вчера.Эта машина помогает при рассеянном склерозе. В полиции, не все. Я готов. Если я знаю.

[BrentonDavis]

Where or when can testing be done on people such as me? I suffered brain Injury which impaired my vision and would love to try anything to help correct it

[Eliza-Jane]

I don't know which country you live in. In Australia the Royal Melbourne Hospital undertook a trial. You could contact them. Helius Medical Technologies is dealing with the device but I'm not sure where they are. I know it has been used in Canada. Best spend some time on Google. Good luck, I'm sure you will find it.

[BrentonDavis in reply to Eliza-Jane]

Lol sorry. In australia

[Jezsab in reply to BrentonDavis]

Hi Brenton. Apparently approval is being sought to fast track PoNS through the Therapeutic Goods Administration in aust. I have been in touch with the Prof who led the RMH trial and she advises she doesn’t have any further involvement since the past clinical trial so no point contacting RMH. I am making further enquiries through some networks here to try and find out more. Approval definite in Canada and Helius is setting up clinics in Canada for delivery of the training to patients. They have two clinics already, one more planned in first half of 2019 and hope to have 20 across Canada. Demand is high across the world so our best bet is to find out more about the australian connection.

[curio21 in reply to Jezsab]

Hi Jezsab,

Have you had any luck in tracking down any PoNS connections in Australia.....who to contact?