Nice joke, no way it's costing $1000/injection... more like 100 bucks.
Also how about we have a huge party right now to celebrate our cure while we're at it.
Frequency Therapeutics — Hearing Loss Regeneration
- Thread starter RB2014
- Start date
Also how about we have a huge party right now to celebrate our cure while we're at it.
It gets excreted into the perilymph, I think it is primarily traveling through the endolymph before that point but I know that wasn't the focus of your question:
Anyway, I'm not sure the exact mechanics but I presume it would involve lack of cell signaling to the LGR5+ support cells that would normally indicate the presence of a healthy hair cell. Whereas normal cell signaling from a healthy hair cell would block the support cell from being activated (similar to the way only damaged intestinal cells replenish), a lack of this signal presumably allows it.
Whatever the exact mechanism, LGR5+ cells in the intestine know where to replenish the cell supply. And that "knowing" has to come from cell signaling, which is likely similar to what's going on in the cochlea.
I'd probably have to look into the small intestine more to try to find this answer as far as what molecules are involved but they haven't had a problem with supernummery cells so their method must rely on some kind of barrier like this to activating support cells surrounding healthy hair cells.
Edit: I found this which talks about stem cells having increasing responsiveness with tissue injury in the olfactory system:
"As recently proposed for olfactory neural SCs,48 quiescent SCs may represent a reserve population activated upon tissue damage, living side-by-side with cycling SCs that under normal conditions maintain homeostasis. Such a situation may exist in the HF, where Lgr5+ve SCs appear to represent SC populations more ready to respond to stimulating signals than their quiescent bulge neighbors."
Which suggests there is indeed a signal given by damaged tissue but wasn't specific about what it is.
Taken from:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2665733/
Many jurisdictions fully cover approved meds for people on disability, so FX-322 should be free for them.
Member- Feb 14, 2020
- 1,630
- Tinnitus Since
- 1-2019
- Cause of Tinnitus
- 20+ Years of Live Music, Motorcycles, and Power Tools
Thanks for the reply.
So, based on my crude understanding... as FX-322 passes through the IHC/OHC/LGR5+ support cells...
If an LGR5+ cell is receiving a "normal" signal from an accompanying "healthy" IHC/OHC, it will not react to FX-322 passing through. Therefore the FX-322 will continue on...
If an LGR5+ cell is receiving either a "Damaged" or "No Cell" signal from the IHC/OHC; when FX-322 passes through, the LGR5+ support cell will "Activate" the division process and create a new IHC/OHC. In doing so, I assume it "consumes" the FX-322 as part of the signaling process?
- Feb 19, 2020
- 65
- Tinnitus Since
- 11/2017
- Cause of Tinnitus
- Jet Engines, Concert
I was thinking the reverse. Intact cells have a signal that prevents regeneration.
- Feb 14, 2020
- 1,630
- Tinnitus Since
- 1-2019
- Cause of Tinnitus
- 20+ Years of Live Music, Motorcycles, and Power Tools
I think what's most interesting about this is his comments that the cell production has a 'limiting effect' ... so at some point the progenitors do stop responding to the drug once a certain upper threshold of IHC/OHC is reached.
Perhaps the population of regenerated cells needs to reach that ceiling from each dose to allow the next dose to penetrate/flow more deeply into the cochlea?
What I find most interesting is how the limit is ABOVE the normal population. So, anyone care to speculate what happens to these cells when they're overpopulated? Do we get 2 cells attached to one nerve or do they just hang out there with no connection?
If FX-322 and/or any other hearing drug is successful, and if FX-322 does treat in the hearing aid frequency ranges, then there is a very strong chance that certain governments would fund this. However, what happens in certain countries like Australia is that the decision to fund is often limited to certain criteria. Therefore this might mean that the majority may need to privately pay for FX-322 even though it would be funded free of charge to certain cohorts in the community like the pensioners.
The bigger question to ask would be whether governments that subsidise the costs of medicines broadly would do so with FX-322. There are many treatments which provide good and also very necessary benefits to people like the vaccines for typhoid and hepatitis B that are fully private vaccines and therefore these are not covered by the governments in any way.
What I wouldn't be surprised to see the governments do with these regenerative hearing medicines is arrange a deal with Frequency Therapeutics whereby the government agrees to purchase a mass quantity of FX-322 at a reduced rate. This will benefit private patients too because it will mean that they can purchase FX-322 at a much lower rate when compared to the prices charged by Frequency Therapeutics elsewhere. This has been very successfully negotiated with other medicines like the flu vaccine and meningococcal vaccine which are taken up en masse in Australia. Thus you will often see these medicines sold at much lower prices when compared to other parts of the world like America. For example the flu vaccine in America is often 3 or 4 times the price than it currently is in Australia, all because the government was able to arrange a win win deal for both customers and also the pharma company.
My audiogram is normal at 2000 Hz, 6000 Hz and 8000 Hz.
4000 Hz is 45 dB.
And the tinnitus at that frequency is terrible.
Can FX-322 act at 4000 Hz after multiple injections?
Does the molecule come down to 4000 Hz?
On slide 28, it only reaches up to 6500 Hz.
Is 6500 Hz an estimate from the phase 1/2 results?
https://investors.frequencytx.com/static-files/6d161090-16f5-49f4-9606-8caceb5a88a1
4000 Hz is 45 dB.
And the tinnitus at that frequency is terrible.
Can FX-322 act at 4000 Hz after multiple injections?
Does the molecule come down to 4000 Hz?
On slide 28, it only reaches up to 6500 Hz.
Is 6500 Hz an estimate from the phase 1/2 results?
https://investors.frequencytx.com/static-files/6d161090-16f5-49f4-9606-8caceb5a88a1
That part of the video was describing cells in culture. LeBel said in the Tinnitus Talk Podcast they didn't get supernummery cells in intact cochleas.
If that happens, maybe some non-US folks on here can "adopt an American" for a month to make it more affordable to them.
- Feb 14, 2020
- 1,630
- Tinnitus Since
- 1-2019
- Cause of Tinnitus
- 20+ Years of Live Music, Motorcycles, and Power Tools
Oh you can be sure us Americans are going to pay a premium for this. I'd expect the VA to be the big buyer early to treat soldiers/veterans. Outside of that occupational insurance providers may be big on negotiating deals for affected workers.
Everyone else on commercial insurance will probably depend on provider. Unless the QOL score improves significantly, then they might start looking at reimbursement.
The hope is more injections will lead to greater penetrance. And that's what will be answered in 2Q of 2021.
Love to LOL, but unfortunately that treatment discount price scheme seems to only apply to Australian citizens and so unfortunately I could not help you then
.I absolutely agree that certain groups like Veterans and Department of Defense would be very willing to buy this treatment because it is simply the same thing as what they are doing now too. The only difference will be that they are funding regenerative hearing medicine.
I think the Frequency Therapeutics staff member working on pricing will also probably be looking at assessing and instigating these sort of pricing deals. The fact is that Frequency Therapeutics knows that they can make money from these types of arrangements and shift things away from the current treatment providers. There are also other associated benefits with regenerative hearing medicine, such as the fact that there wouldn't be the need to fund repeated treatment for example. Essentially this then means that Department of Defense reduces their expense while Frequency Therapeutics can consequently increase their FX-322 sales numbers.
I have no clue about insurance in America, however I have happened to read that even if FX-322 is successful, there is a high chance that the insurance will not cover it at all, as it is not something that they cover now and that they will try and avoid paying out where possible.
Probably worth noting once more that there are ongoing trials and research into tinnitus and hearing loss that the Department of Defense is funding. I could be wrong, however this indicates to me that the Department of Defense is fully focused on regenerative hearing treatments now that they think that this could be actually achievable. Hence this tends to support the theory that there will almost certainly end up being a positive uptake from Department of Defense for any such treatments and thus there is a potentially beneficial market there then.
One thing for sure in the United States is that military and police recruits and those ending their careers or returning from the battlefield will assuredly receive complimentary FX-322 if their audiogram indicates hearing loss.
Private insurance companies will most likely offer plans that would cover FX-322, but it would be a premium plan at an optimal price. Many standard plans would potentially pay a percentage of the cost much like dental insurance often does.
Private insurance companies will most likely offer plans that would cover FX-322, but it would be a premium plan at an optimal price. Many standard plans would potentially pay a percentage of the cost much like dental insurance often does.
Is this true???? Anyone have a link? I haven't read this anywhere. I was under the impression that people that are profound no longer qualify for FX-322. I have been holding out on a CI just in case...
Yes, the doctor's office would charge $13,000 for my hearing aids. They are the most powerful Starkey ones you can buy. Keep in mind I am -110 dB at 2 kHz and above. Now you know why I don't get excited over 10 dB... They were only allowed to bill the insurance company half that though because of their agreement with them. I paid $1,200 because we spent $4,800 in medical costs out of $6,500 for our deductible for the year. If not for my family having medical issues this year, I would have had to come up with the entire $6,500 and that's with my standard insurance. I usually buy them at Costco. They charge around $3,000 for a pair of hearing aids the last time I checked.
- Jan 16, 2020
- 453
- Tinnitus Since
- 1992
- Cause of Tinnitus
- noise? infection? negative stress? other?
Great to hear all this good news. This is almost like a party atmosphere. So much doom and gloom with the re-surging COVID-19 pandemic.
But a word of caution.
When I got my tinnitus first I was going around to all these different therapists and doctors. Then finally I stumbled upon one that helped quite a bit but didn't cure me. That was TRT. Shock & horror all sides. Well it helped me to live with it. Others it didn't help.
I think that perhaps this FX-322 might help a lot of people, but not all.
I used to have this ritual or ceremony with each new therapy that I tried out. I would stand outside the new doctor's office and ask myself:
"Do I really think that this is going to help?"
"What will things be like when I'm three months older and three thousands poorer?"
Well there's always Otonomy or Hough Ear Institute as a backup.
Synapses? Outer hair cells? Inner hair cells?
But a word of caution.
When I got my tinnitus first I was going around to all these different therapists and doctors. Then finally I stumbled upon one that helped quite a bit but didn't cure me. That was TRT. Shock & horror all sides. Well it helped me to live with it. Others it didn't help.
I think that perhaps this FX-322 might help a lot of people, but not all.
I used to have this ritual or ceremony with each new therapy that I tried out. I would stand outside the new doctor's office and ask myself:
"Do I really think that this is going to help?"
"What will things be like when I'm three months older and three thousands poorer?"
Well there's always Otonomy or Hough Ear Institute as a backup.
Synapses? Outer hair cells? Inner hair cells?
- Jan 16, 2020
- 453
- Tinnitus Since
- 1992
- Cause of Tinnitus
- noise? infection? negative stress? other?
Regenerative medicine looks like opening some Pandora's box. Why stop at fixing people's hearing? There's vision, there's heart and lungs... libido too. It opens up a wide vista. Of course just like exploring the atom there will be dangers and misuse too.Love to LOL, but unfortunately that treatment discount price scheme seems to only apply to Australian citizens and so unfortunately I could not help you then
I absolutely agree that certain groups like Veterans and Department of Defense would be very willing to buy this treatment because it is simply the same thing as what they are doing now too. The only difference will be that they are funding regenerative hearing medicine.
I think the Frequency Therapeutics staff member working on pricing will also probably be looking at assessing and instigating these sort of pricing deals. The fact is that Frequency Therapeutics knows that they can make money from these types of arrangements and shift things away from the current treatment providers. There are also other associated benefits with regenerative hearing medicine, such as the fact that there wouldn't be the need to fund repeated treatment for example. Essentially this then means that Department of Defense reduces their expense while Frequency Therapeutics can consequently increase their FX-322 sales numbers.
I have no clue about insurance in America, however I have happened to read that even if FX-322 is successful, there is a high chance that the insurance will not cover it at all, as it is not something that they cover now and that they will try and avoid paying out where possible.
Probably worth noting once more that there are ongoing trials and research into tinnitus and hearing loss that the Department of Defense is funding. I could be wrong, however this indicates to me that the Department of Defense is fully focused on regenerative hearing treatments now that they think that this could be actually achievable. Hence this tends to support the theory that there will almost certainly end up being a positive uptake from Department of Defense for any such treatments and thus there is a potentially beneficial market there then.
- Sep 21, 2016
- 1,051
- Tinnitus Since
- 2011 - T, 2016- H, relapsed 2019
- Cause of Tinnitus
- noise-induced
Frequency Therapeutics plan on using their progenitor cell activation technology for other indications too, for instance alopecia and multiple sclerosis.
I think Frequency Therapeutics deals with hearing loss first because it is an unmet need which hasn't been done before and also has a high demand. The same could also be said for Multiple Sclerosis which is why they are starting to work on it next. It should also be mentioned that hearing loss is probably the most beneficial industry to work on as a new company first cause it will probably obtain the biggest financial windfall if successful. Subsequently this will mean that Frequency Therapeutics could set their operations up for the future.
From what I understand Frequency Therapeutics is working with a number of areas of the body which will be treated with their PCA treatments. I also think that the reason that Frequency Therapeutics has not worked with other areas like heart medication for example is that there tends to be many medicines which work well to treat heart issues already.
I like his comment about getting treatment now if you have hearing loss. The longer you wait, the longer you deprive yourself of auditory input. It also might put you in a better position when something comes out that restores hearing.
I've often wondered when the "last generation" will be. There's a lot of investment going into life extension. Some think we'll transfer our consciousness into computers, but as someone who programs computers that seems completely bonkers. It's much more likely that we'll find ways to replace body parts that wear out (either by regrowing them or replacing them with machinery). I think the only limit will be how long the brain can last - and if it too, can benefit from regenerative medicine.
Anyway, this is completely off topic, but my mind kind of went on a detour when I read your comment
.
[Inserting the obligatory "assuming FX-322 is successful"], I doubt insurance would cover it for tinnitus, at least in the first few years. Frequency Therapeutics' application is for hearing loss, not tinnitus, so if it's effective for tinnitus, that's great, but off label and not covered. Frequency Therapeutics could follow up with a tinnitus trial that, if approved, could lead to insurance reimbursements, but that would be down the road.
- Feb 14, 2020
- 1,630
- Tinnitus Since
- 1-2019
- Cause of Tinnitus
- 20+ Years of Live Music, Motorcycles, and Power Tools
Tinnitus is a symptom of hearing loss, whether it's NIHL / SSNHL; both of which FX-322 is intended to treat.
This is why Frequency Therapeutics is measuring the high-frequency response AND the HHI / QOL survey of patients in the Phase 2A. If a correlation is made between restoring high-frequency hearing and improvements in HHI/QOL, the insurance companies will likely cover it. This same correlation may be made between TFI improvement / QOL / and restored HF hearing.
So, they don't really need a tinnitus trial. They just need ENTs/Audiologists get with the 21st century and measure the ENTIRE hearing range possible.
An ENT submitting a pre-approval for FX-322 for a patient that complains of hearing loss (and tinnitus), and shows it on an audiogram would be covered; provided the insurance company accepts that it provides a long-term improvement in QOL.
Tinnitus is a symptom. Hearing loss is still the underlying condition, regardless of frequency.
I have read all the previous posts but have not found when the FX-322 will be available on the market.
Does anyone know an approximate date?
Does anyone know an approximate date?
Good point, and I hope you're right!
...hoping 1) extended audiograms become more readily available, and 2) insurance companies honor them as indicative of hearing loss in the absence of explicit FDA approval for tinnitus.
Bottom line is that we don't know. They are starting phase 3 in Q2 of 2021 which may take 1-1.5 years, so probably late 2022 to early 2023.
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