Update on TOMAC device (new treatment for RLS)

[grassgree]

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 [e-mail]. I'll post again when I get news from them.

[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 in reply to ChrisColumbus]

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]

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 in reply to TheDoDahMan]

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]

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 in reply to TheDoDahMan]

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

[TheDoDahMan]

I'm signing up as we speak.

[grassgree in reply to TheDoDahMan]

Let us know if you get one.

[TheDoDahMan in reply to grassgree]

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 in reply to TheDoDahMan]

To be added to their mailing list, email [e-mail]. I got a quick reply. A couple of days.

[TheDoDahMan in reply to grassgree]

Just sent the email. Thanx!

[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

[e-mail]

415 - 680 - 8984

[grassgree in reply to BBGGG]

Thank you for posting! This is good news.

[Hope61]

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

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