Did anyone see this?

[RLSLearner]

NOCTRIX HEALTH SECURES $40 MILLION SERIES C FINANCING TO COMMERCIALIZE NOVEL DEVICE TREATMENT FOR RESTLESS LEGS SYNDROME (RLS)

prnewswire.com/news-release...

PLEASANTON, Calif., Jan. 16, 2024 /PRNewswire/ -- Noctrix Health, Inc. announced today that it has closed a $40M Series C financing round led by Sectoral Asset Management with participation from other new investors Angelini Ventures, ResMed, and Asahi Kasei Corporation with strong support from insiders including OrbiMed and Treo Ventures. This infusion of capital will propel the advancement of Nidra™ Tonic Motor Activation (TOMAC) therapy towards its eagerly anticipated launch in the US market. Nidra™, a revolutionary new device, stands as the first and only approved treatment for drug-refractory Restless Legs Syndrome (RLS), a chronic condition that has debilitating impacts on sleep and quality of life of millions of adults worldwide.

"The strength of Noctrix Health's clinical data combined with the tremendous unmet need underscore the importance of bringing TOMAC therapy to patients with RLS," said Evan Caplan, Principal at OrbiMed. "We have seen how well the team has executed and are excited to continue partnering with them as the company initiates commercialization."

"Treo Ventures is thrilled to continue supporting Noctrix Health. This significant financing will allow the company to reach millions of patients with RLS. TOMAC therapy is a patient-friendly, highly effective, non-pharmacologic innovation for patients unhappy with current solutions who need better treatment options," commented Tracy Pappas, General Partner, Treo Ventures.

Noctrix Health has experienced a banner year in 2023, marked by the FDA marketing authorization of TOMAC therapy, followed by several key publications including a recent study demonstrating TOMAC therapy's efficacy in reducing opioid use in patients with RLS, further reinforcing its potential impact on patient outcomes.

Not sure how this furthers their plans but at least they have money in the bank.

[ChrisColumbus]

Good: should make it available at a better price (currently US$7500 !) and outside of the existing handful of US states.

*But* while the company, medical insurers and patients spend - or prepare to spend - colossal amounts of money are they all absolutely certain that it is really *that* much more effective than the cheap Therapulse? See link:

therapulse.co.uk/

[Madlegs1 in reply to ChrisColumbus]

Indeed!👍

[Joolsg in reply to ChrisColumbus]

Indeed. They seem to be very similar devices, but the price difference is enormous. Also, you need a prescription for the US device, but not for therapulse.A trial comparing the two devices would be useful.

I suspect the US price is hiked up because health insurance will cover the cost.

[ChrisColumbus in reply to Joolsg]

And I suspect that the requirement for a prescription is at least in part an attempt to try to convince US medical insurers to stump up all or at least part of the money: an OTC device is never going to get that level of funding!

[SueJohnson in reply to Joolsg]

But most probably won't or if they do they will raise the cost for the insurance. And I doubt if Medicare nor the Part D insurers will cover it.

[ChrisColumbus in reply to SueJohnson]

RalphWiggam posted "It's not cheap $7500 if insurance doesn't cover it. My insurance did indeed cover a good amount of it"

healthunlocked.com/rlsuk/po...

[SueJohnson in reply to ChrisColumbus]

I saw that, but I still suspect most insurers won't cover it.

[JustVisiting23 in reply to ChrisColumbus]

I don’t mean to be intrusive, but who is your insurer?

[ChrisColumbus in reply to JustVisiting23]

I'm in the UK and have no medical insurance, but the Nidra isn't available here: I was quoting RalphWiggam who's in the US and whose insurance covered a "good part" of the cost. He didn't say who his insurance was with.

[grassgree]

This is good news! Dr. Buchfuhrer is associated with Noctrix Health, and patient results have been very encouraging. Thanks for posting!

[LotteM]

Far too much money for something that in my opinion is not going to be a game changer. At all.

Such money should be spent on finding the cause of RLS: what makes that we have low iron in the substantia nigra in our brains. Sigh. No-one even asks that question….

[RLSLearner in reply to LotteM]

Actually I see lots of research into the cause of RLS. Much of it very 'basic' ie deep into the pathophysiology and it hurts my brain to read. But they tend to be 'plodders' , taking little steps. Like research is a career and not a rush to find a cure. I would like to see big organisations like 23 and me or gut microbiome testers be looking at the differences between people reporting RLS and not. They may find something in their big data. If anyone has any influence at the RLS Foundation maybe make the suggestion.

[ChrisColumbus in reply to RLSLearner]

From the RLS Foundation's Blog:

"Funding priorities for the RLS Foundation’s 2024 grant cycle are:

Neurobiological interaction that elucidates the points of interaction between RLS-relevant neurotransmitters, neuronal pathways and iron deficiency.

Pharmacologic treatments elucidating effects of novel pharmacological approaches on RLS.

Clinical practice that looks to innovations in patient care delivery including, but not limited to, population health programs, technology-enabled healthcare delivery and public health initiatives.

Other research topics to advance the understanding and treatment of RLS."

They are currently offering a US $50,000 research grant, with letters of intent to be submitted by January 26th.

The Foundation "has awarded over $1.9 million in grants for medical research on RLS causes and treatments since 1997", and the American Academy of Sleep Medicine Foundation has supported "more than 300 grants totaling $25.7 million in funding" sleep medicine research since 1998.

And yet here we are...

[SueJohnson in reply to RLSLearner]

You can use 23 and me to check it you have the genes for it but you have to also join 23 and me+. I did and found out I have a genetic disposition for it even though no one in my family nor extended family nor those that came before me had it.

[Simkin]

Very interesting but a huge amount of money. As you say is it so very different to therapulse which I found an enormous help here in the UK.?

[grassgree]

Well I'm going to differ. Development and manufacture of medical devices isn't cheap, requiring years of work from highly specialized workers, with no assurance of success. I don't work for Noctrix Health or know anyone that does, but I am familiar with the process. The most encouraging part is that after two years of clinical study, the participants showed a lasting benefit, even after quitting the device. Symptoms reverted, but not back to where they started. Keep in mind that the study participants were categorized as having refractory RLS; i.e. drug therapies had failed for one reason or another. In 2020 the FDA designated it a "Breakthrough Device." Securing $40 million in venture capital is a huge haul. The device is showing great promise.

The bad news is that Medicare doesn't cover it, "yet." But they are shelling out $26,000 a year for an Alzheimer drug that doesn't work. I use common eye drops that would cost $8,000 a year out of pocket. Finding a way to quit or reduce opioids and recover some quality of life, that is worth $7,500. I can't defend the logic of what insurers decide to cover, especially Medicare, but I have hope.

[ChrisColumbus in reply to grassgree]

So, in the context of US drug charges it doesn't sound quite so crazy.

But potential customers should need convincing that the 'tonic motor activation therapy' used by the Nidra is really a $7500 prescription worth of orders of magnitude more effective than the vibration/'extra corporeal shockwave therapy' used by the UK Therapulse unit - which is available to the US at $90 a pair including delivery. Perhaps it is, but as  Joolsg suggests a comparative trial seems necessary.

(And similarly I don't work for Therapulse or know anyone who does either).

[grassgree in reply to ChrisColumbus]

The devices are different in that the Therapulse works with vibrations, similar to the relief one gets by rubbing something that hurts. The Nidra TOMAC works by stimulating nerve impulses to the brain. Studies showed an ongoing reduction of symptoms over time. To quote from one of their articles; "...long-term TOMAC treatment....could result in neural plasticity at the spinal or brain level that inhibits or reverses RLS pathophysiology." i.e., there is potential for the brain to rewire itself over time.

I'm going to keep my hopes up.

[SueJohnson in reply to ChrisColumbus]

He said if he paid out of pocket. He didn't say what he actually paid, There are some expensive drugs in the US but few that would cost that much after medicare part D or insurance. Of course our insurance before age 65 isn't cheap either.

[ChrisColumbus in reply to SueJohnson]

I understood what she said, and also what RalphWiggam said - insurance paid all or part of the base charges.

In the context of the example of base $8000 before insurance for annual eyedrops, base $7500 before insurance for the Nidra, if its really widely effective, doesn't sound so crazy in a US context.

It still sounds crazy from a UK viewpoint,....

[HipHop1972]

Hi RLSLearner, thanks for the info, all very exciting and much needed jump forward for us all. Can’t wait for this to come on line .

[Jrskyhook32]

how effective is therapulse??

[ChrisColumbus in reply to Jrskyhook32]

I haven't tried it, but as with most things on here, some love it, some say it helps to an extent, some say it doesn't help. But just looking at 74 reviews on an independent review site (i.e. not on the Therapulse site) there are 82% 5 out of 5, 15% 4/5, and 3% - 2 people, one who broke it and one who never received it - 1/5.