Update on TOMAC device (new treatment... - Restless Legs Syn...

Restless Legs Syndrome

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Update on TOMAC device (new treatment for RLS)

grassgree profile image
14 Replies

I wrote to Noctrix Health about the newly approved RLS device and got a quick reply;

Thank you for interest in Noctrix Health and our exciting breakthrough technology. We are dedicated to providing the best care for those suffering with RLS.

The FDA has recently allowed us to start marketing and distributing our wearable medical device that is intended to reduce symptoms of primary moderate-severe Restless Legs Syndrome and to improve sleep quality in adults refractory to medications.

With the FDA granting us the ability to start distributing our product, we are currently building up our inventory to support demand and will provide updates on the availability of the product to patients and physicians.

We expect to start a limited launch of product release in certain U.S. geographies later this summer. We greatly appreciate your patience as we continue to work to make our technology available to those that need it most. We have added you to our list of patients to stay in contact with as new developments arise and as our Noctrix product becomes more available. Please let us know at any time if you would like us to remove you from this list.

To answer your questions about insurance coverage and program applications, we are in the process of creating a FAQ document to answer your questions. You are added to the patient mailing list and will get an update once that FAQ document is completed.

Thank you again for your interest and please feel free to reach out to us with any questions. We look forward to hearing from you.

Sincerely,

Noctrix Team

If you'd like to get on their mailing list, email info@noctrixhealth.com. I'll post again when I get news from them.

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grassgree profile image
grassgree
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14 Replies
ChrisColumbus profile image
ChrisColumbus

Thanks for pursuing this! I'm tempted to ask them the question about their plans - if any - internationally, but with them only at the stage of a 'limited launch of product release in certain U.S. geographies later this summer' I'm not holding my breath for a UK launch!

grassgree profile image
grassgree in reply toChrisColumbus

Well, Noctrix is a start-up company with less than 25 employees. But if the device is showing potential, they'll be getting inquiries from larger companies with deeper pockets. They wouldn't have ramped up production before getting FDA approval. And now that they have approval, they have to find new manufacturers that can follow their specs and churn out the stuff in bulk. But things could change quickly. Maybe some big company will buy them out.

TheDoDahMan profile image
TheDoDahMan

If this thing works 100% for all patients, they'll get offers of 10 grand per device! But I hadn't heard of it - how is it used?

grassgree profile image
grassgree in reply toTheDoDahMan

It's a new device that's worn just below the knees at night to "electrically activate the peroneal nerves bilaterally to produce tonic, sustained muscle activation that is compatible with sleep to suppress symptoms of RLS." Read more in an older post titled "Newly approved treatment for RLS." The clinical trial showed no adverse effects and "statistically significant" improvement of symptoms. Interestingly, Dr. B at Stanford wrote that it had "tremendous potential." We'll need to wait and see what happens in the real world.

TheDoDahMan profile image
TheDoDahMan

Thanks for the info. As I'm a patient of Dr. B, you've got me emotionally surfing on that "tremendous potential" quote. Miracles don't abide by a schedule - they can happen at any time.

grassgree profile image
grassgree in reply toTheDoDahMan

Maybe you'll be in line for the first wave of users! Drop him a line.

TheDoDahMan profile image
TheDoDahMan

I'm signing up as we speak.

grassgree profile image
grassgree in reply toTheDoDahMan

Let us know if you get one.

TheDoDahMan profile image
TheDoDahMan in reply tograssgree

Actually, I can't find a place to sign up on their website. But if anyone wants a little bump in optimism, google "noctrix health" to learn about a group of scientists who are hip to what RLS is all about, and dedicated to building a device that eliminates the symptoms. The FDA awarded them a "Breakthrough Device Designation" for the product they are manufacturing.

grassgree profile image
grassgree in reply toTheDoDahMan

To be added to their mailing list, email info@noctrix.com. I got a quick reply. A couple of days.

TheDoDahMan profile image
TheDoDahMan in reply tograssgree

Just sent the email. Thanx!

BBGGG profile image
BBGGG

I also wrote and this was their response:

Thank you for your interest in Noctrix Health and our exciting breakthrough technology. We are dedicated to providing the best care for those suffering with RLS.

The FDA has recently allowed us to start marketing and distributing our wearable medical device that is intended to reduce symptoms of primary moderate-severe Restless Legs Syndrome and to improve sleep quality in adults refractory to medications.

With the FDA granting us the ability to start distributing our product, we are currently building up our inventory to support demand and will provide updates on the availability of the product to patients and physicians.

We expect to start a limited launch of product release in certain U.S. geographies later this summer. We greatly appreciate your patience as we continue to work to make our technology available to those that need it most. We have added you to our list of patients to stay in contact with as new developments arise and as our Noctrix product becomes more available. Please let us know at any time if you would like us to remove you from this list.

Additionally, 2 requests:

1. Would you be willing to share your cell so we can contact you via cell or text as well? If yes, please feel free to share your cell number via a reply to this email and I will add your number to the list. If not, your email address should work fine.

2. Would you be willing to share the state you live in? This way we can inform you of the closest physician once we begin our Limited Launch.

Thank you again for your interest and please feel free to reach out to us with any questions. We look forward to hearing from you.

I am enclosing a patient brochure.

Sincerely,

Lisa Armstrong

Clinical Research Coordinator

lisa@noctrixhealth.com

415 - 680 - 8984

grassgree profile image
grassgree in reply toBBGGG

Thank you for posting! This is good news.

Hope61 profile image
Hope61

Wow all I got was this ; and that was two weeks ago

Currently, the controlled release states are California, Missouri, and Massachusetts.

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