Member- Aug 28, 2019
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Yes, but did he tell them that he'd had it for years?
What does a calm day mean exactly? Did his tinnitus go back to normal after the treatment?Lenire — Bimodal Stimulation Treatment by Neuromod
- Thread starter Tinnitus Talk
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What does a calm day mean exactly? Did his tinnitus go back to normal after the treatment?
G
GoatSheep
Guest
I don't think he'd lie about it. I don't know the details of his treatment. In the Research News section there is a thread on the University of Michigan device. I'd go post over there and ask him yourself. I don't think he has the option to direct message turned on but if you quote him or @ him he will probably respond.Yes, but did he tell them that he'd had it for years?
Gonna have to agree to disagree on this on the basis of: If a tree falls in the forest, does it make a sound?
In other words, if she never ships a product, should we beatify her as a saint?
Vaporware is vaporware. I will gladly beatify her if and when her device hits the market, no sooner.
The other thing to remember, and correct me if I'm wrong, is that the total number of test subjects she's used has been tiny compared to Neuromod. So if she's so big on crossing Ts and dotting Is with her research, why is that? She's had more than enough time to try this device out on thousands of people. She also is still focused on somatic tinnitus, which isn't what most of us have. When asked if it will work on non-somatic, she says it may. Why doesn't she know already? That's not exactly due diligence.
- Aug 28, 2019
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- May 9, 2017
- 929
- Tinnitus Since
- 2013
- Cause of Tinnitus
- Noise-induced
"This so-called "somatosensory tinnitus" or "somatic tinnitus" occurs in up to two thirds of humans with tinnitus:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4895692/
I wouldn't read too much into the criteria from Shore's trial. You have to set criteria for scientific research and peer review. It doesn't necessarily mean it won't work outside that criteria. You just have to establish a baseline. I was only posting that to show the somatic requirement for her trials. She herself said she wasn't sure if it would treat non-somatic tinnitus, but it could as the studies and trials progressed.
It's because unfortunately we're social tribal creatures and things tend to devolve into team X vs. team Y flag-waving and popularity contests.
I love the way you put it. This just keeps making me think of this crazy idea I keep having... Raiding the University of Michigan Area 51 style and get some real answers.
Irish medtech company closes €8m capital raise
Neuromod Devices, a company that focuses on non-invasive nerve technology, has closed an €8m capital raise, comprising of equity investment and venture-debt.
The funds will be used to accelerate the commercialisation in Europe of its Lenire tinnitus (the perception of noise or ringing in the ears) treatment device, to scale up manufacturing, and to progress its regulatory strategy in the United States.
This financing round was led by existing investors Fountain Healthcare Partners and Moffett Investment Holdings, with venture-debt provided by new investors Kreos Capital and Silicon Valley Bank.
Dr Ross O'Neill, CEO of Neuromod, said: "This investment will allow us to ramp-up the manufacturing of our Lenire tinnitus treatment product, ensuring it will be more widely available for many underserved patients suffering with tinnitus across Europe.
We will also build on European commercialisation through a regulatory submission to the FDA to make way for a launch in the United States".
The company recently opened its first Centre of Excellence specialising in neuromodulation and tinnitus at the Hermitage Medical Clinic in Dublin.
The first facility to offer treatment with Lenire outside of Ireland will be in Hannover, Germany which will open before the end of the year.
Additional locations throughout Europe have been identified and will become operational during the course of 2020, the company said.
Founded in 2010, Neuromod is a spin-out from Maynooth University.
Neuromod Devices, a company that focuses on non-invasive nerve technology, has closed an €8m capital raise, comprising of equity investment and venture-debt.
The funds will be used to accelerate the commercialisation in Europe of its Lenire tinnitus (the perception of noise or ringing in the ears) treatment device, to scale up manufacturing, and to progress its regulatory strategy in the United States.
This financing round was led by existing investors Fountain Healthcare Partners and Moffett Investment Holdings, with venture-debt provided by new investors Kreos Capital and Silicon Valley Bank.
Dr Ross O'Neill, CEO of Neuromod, said: "This investment will allow us to ramp-up the manufacturing of our Lenire tinnitus treatment product, ensuring it will be more widely available for many underserved patients suffering with tinnitus across Europe.
We will also build on European commercialisation through a regulatory submission to the FDA to make way for a launch in the United States".
The company recently opened its first Centre of Excellence specialising in neuromodulation and tinnitus at the Hermitage Medical Clinic in Dublin.
The first facility to offer treatment with Lenire outside of Ireland will be in Hannover, Germany which will open before the end of the year.
Additional locations throughout Europe have been identified and will become operational during the course of 2020, the company said.
Founded in 2010, Neuromod is a spin-out from Maynooth University.
Neuromod will be stationed in Hannover, Germany, by the end of 2019.
Recent article about growing success of Neuromod company:
Neuromod Successfully Closes €8 Million Capital Raise
Recent article about growing success of Neuromod company:
Neuromod Successfully Closes €8 Million Capital Raise
- Proceeds to accelerate ongoing European commercialisation, manufacturing scale-up and US regulatory strategy
- Fountain Healthcare Partners, a major investor, led the financing round with participation from another existing investor, Moffett Investment Holdings
- Venture-debt investors Kreos Capital and Silicon Valley Bank also participated in the capital raise
- May 9, 2017
- 929
- Tinnitus Since
- 2013
- Cause of Tinnitus
- Noise-induced
As someone from the north of Germany, I'm so happy to hear it's going to be in Hannover!
- Aug 3, 2019
- 30
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- 1/1/15
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- Working aircraft on tarmacs
This article is definitely interesting, most investor groups don't like to lose money so they vet the heck out of potential cash cow corps before they commit. Perhaps there is a great number of participants ringing the bell of success stories...
Based on the wording of the press release I am thinking it might start showing up in the US in early 2021. It all depends on when FDA approval would happen but it just sounds to me like that might take most of 2020, especially if they want to use as much newly gathered patient data from early adopters as possible to plead their case. Good news for EU residents in the interim, though.
Any idea where it will be in Hannover?
It's a 3.5h drive from me. I could drive there and back in one day.
There is the renowned university and hearing center "Medizinische Hochschule Hannover" where ENT Prof. Lenarz is the Director:
https://www.mh-hannover.de/18057.html
But they concentrate mostly on surgeries like Cochlear Implants.
But I doubt it will be that center, so I expect some ENT office.
To the Germans: any ideas who it might be?
It's a 3.5h drive from me. I could drive there and back in one day.
There is the renowned university and hearing center "Medizinische Hochschule Hannover" where ENT Prof. Lenarz is the Director:
https://www.mh-hannover.de/18057.html
But they concentrate mostly on surgeries like Cochlear Implants.
But I doubt it will be that center, so I expect some ENT office.
To the Germans: any ideas who it might be?
It's going to be 2020. It's mainly up the the FDA but device approval doesn't usually take too long with them. Neuromod already has it submitted to the FDA, they're just waiting for approval.
They want in the US market ASAP.
- Sep 17, 2017
- 230
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- 2017
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- Medical mistake
I think that could only happen if everything goes like clockwork. Given that the initial Lenire office opened months after their initial guidance I would pad estimates by six months.
Did they? They keep on talking about "US regulatory strategy", which (to me) sounds like it wasn't submitted yet.
G
GoatSheep
Guest
Just kind of a random thought...
It's interesting the VA is now paying for Levo. I think the thread with the article said something about a 5 year contract. Seems like Vets will be getting fucked over in that case if the government is offering coverage for a habituation device. I doubt they would offer coverage for an actual improvement device simultaneously. Because obviously who would take the habituation device.
And also Levo is like $6000 somebody said. Neuromod would be substantially cheaper to cover.
Company behind Levo is supposedly U.S. Vet owned.
Just seems interesting with Lenire on the horizon this is how things would play out.
What do you guys think?
https://www.prnewswire.com/news-rel...-system-for-tinnitus-treatment-300801922.html
They need decent trial data to get past the FDA. So depends when they finally get their TENT-A1 trial past peer review.
They were only 3 months behind their initial launch (target was Q1 2019, it was a little over 3 months late), I think 2021 is pretty extreme. Latest it's going to be is mid 2020. No way in hell is it taking longer than that IMO.
If it does I might just go pick up the Michigan device if it's available by then.
Actually one of the Lenire users, @Redknight, has reported that he asked about it and they said they are already working with the FDA.
- Feb 11, 2019
- 801
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- 01/2014
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- Headcold/Flu
Very insightful point, Sytex75:
That is 8.7 million dollars, and I imagine the investors would say "We are not going to commit this kind of money if this device won't do anything and no one will buy it."
It also shows how valuable this forum is; I and others reported how useless Desyncra and other ACRN therapies were, so that potential candidates were alerted to real life outcomes.
The investors have to know how may thousands of tinnitus sufferers tune into this site for unpropagandized information, and how Lenire had better manifest some sort of potential; otherwise if the full majority of early reports are bluntly negative, this will sink the whole venture.
You are quite correct Agrajag: my Primary Care Physician said that these trial reviews must be plenary and thoroughly convincing. (Recall examples of outright failures, such as that major drug companies' submission for an alleged Viagra/Aphrodisiac for women).
However, if Desyncra could receive FDA approval, I would assume that it would be the proverbial slam dunk for Lenire.
It now appears that this device will be available before Dr. Shore's.
Let's just wait to see if the extreme need for this device ASAP (since no other treatment exists) influences the FDA to give it first and foremost direct consideration.
That is 8.7 million dollars, and I imagine the investors would say "We are not going to commit this kind of money if this device won't do anything and no one will buy it."
It also shows how valuable this forum is; I and others reported how useless Desyncra and other ACRN therapies were, so that potential candidates were alerted to real life outcomes.
The investors have to know how may thousands of tinnitus sufferers tune into this site for unpropagandized information, and how Lenire had better manifest some sort of potential; otherwise if the full majority of early reports are bluntly negative, this will sink the whole venture.
You are quite correct Agrajag: my Primary Care Physician said that these trial reviews must be plenary and thoroughly convincing. (Recall examples of outright failures, such as that major drug companies' submission for an alleged Viagra/Aphrodisiac for women).
However, if Desyncra could receive FDA approval, I would assume that it would be the proverbial slam dunk for Lenire.
It now appears that this device will be available before Dr. Shore's.
Let's just wait to see if the extreme need for this device ASAP (since no other treatment exists) influences the FDA to give it first and foremost direct consideration.
Hmm... Last time a member was so sure of the future she bet her bewbs on it (and lost) only to not follow through on said bewbs.
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