Frequency Therapeutics — Hearing Loss Regeneration

[FGG]

What they're printing here is a working tool. It can't break or splinter. And it has to be really, really small. Hopefully it's easier than it sounds, but it really doesn't sound very easy.

"The microneedle shaft has the thickness of a human hair, and the microneedle tip has a radius less than 1% of a human hair's thickness."

Is there a direct unimpeded line from the eardrum to the round window membrane? I guess there must be. How else would they do it?

I was more picturing something like this: they print your anatomy, then they fit it perfectly to one of the (let's say 10 or so) sizes they have, then they use that.

 

[JohnAdams]

I was more picturing something like this: they print your anatomy, then they fit it perfectly to one of the (let's say 10 or so) sizes they have, then they use that.

To get the anatomical shape wouldn't they need a CT or MRI scan?

 

[FGG]

To get the anatomical shape wouldn't they need a CT or MRI scan?

Yes.

 

[Coleoptere]

... and a steady hand!

 

[JohnAdams]

Yes.

Sounds dangerous. No pun intended.

 

[Pre55ure]

... and a steady hand!

I would assume that there are devices that could help with this. My mother had ablation done on her heart a few years back (to stop atrial fibrillation) and I'm pretty sure the doc wasn't just going freehand.

Precision seems like the part that medicine has down pretty well.

 

[d'Wooluf]

I was more picturing something like this: they print your anatomy, then they fit it perfectly to one of the (let's say 10 or so) sizes they have, then they use that.

How about this then? Patient is immobilised, scanned (3D), technician marks the entry and exit points (round window membrane) on the scan, data is fed back to a linked robotic arm which is fitted with the correct needle which applies the needle with robotic precision. The patient doesn't move during this time.

For those inquiring minds who need to know...

RWM in a normal ear is a thin, semitransparent and nearly circular membrane with a diameter of about 1.8 mm. The average thickness of a normal adult RWM was reported as 70 µm by Goycoolea et al [4] and Sahni et al.

I agree with Pre55ure. I doubt they're doing this by hand!

 

[FGG]

How about this then? Patient is immobilised, scanned (3D), technician marks the entry and exit points (round window membrane) on the scan, data is fed back to a linked robotic arm which is fitted with the correct needle which applies the needle with robotic precision. The patient doesn't move during this time.

For those inquiring minds who need to know...

RWM in a normal ear is a thin, semitransparent and nearly circular membrane with a diameter of about 1.8 mm. The average thickness of a normal adult RWM was reported as 70 µm by Goycoolea et al [4] and Sahni et al.

I agree with Pre55ure. I doubt they're doing this by hand!

I'm sure robots could be used for greater precision but it could also be done by hand/feel like they do for epidural.

With an epidural, you know you hit the right spot when you feel the needle pop through (and then you test the negative pressure with a drop of saline). Could this not be done with the Round Window? I'm really not sure but seems possible. The part the ENT holds would be thicker than the hair diameter that goes into the RW, obviously.

Who am I kidding? They can bill whatever they want for this. Probably a robot arm.

 

[JohnAdams]

Assuming that the screening day proceeds the dosing day and calculating that 210 days from October 10th 2019 is May 7th 2020, then it is safe to say that they will know if this is a treatment or a cure for tinnitus by then.

 

[JohnAdams]

Is there a direct unimpeded line from the eardrum to the round window membrane?

No.

 

[ChrisBoyMonkey]

I'm sure robots could be used for greater precision but it could also be done by hand/feel like they do for epidural.

With an epidural, you know you hit the right spot when you feel the needle pop through (and then you test the negative pressure with a drop of saline). Could this not be done with the Round Window? I'm really not sure but seems possible. The part the ENT holds would be thicker than the hair diameter that goes into the RW, obviously.

Who am I kidding? They can bill whatever they want for this. Probably a robot arm.

Maybe something like this could help;

https://phys.org/news/2019-12-tiny-magnetic-particles-enable-material.amp

 

[mrbrightside614]

Maybe something like this could help;

https://phys.org/news/2019-12-tiny-magnetic-particles-enable-material.amp

All of these advances in nanoparticle and magnetic technologies are great, but I feel we would be at the mercy of our nearby ENT's. Their choice of procedure would probably rely on the (by comparison) archaic methods of IT administration. I'd hedge my bets on steady hands and precision over these highly specialized methodologies. It would take a proven, vastly superior technology with fairly simple applications to coax the medical field out of the Stone Age here.

 

[JohnAdams]

All of these advances in nanoparticle and magnetic technologies are great, but I feel we would be at the mercy of our nearby ENT's. Their choice of procedure would probably rely on the (by comparison) archaic methods of IT administration. I'd hedge my bets on steady hands and precision over these highly specialized methodologies. It would take a proven, vastly superior technology with fairly simple applications to coax the medical field out of the Stone Age here.

Or hopefully we won't need RWM injections and they can just up the dose to get a better effect.

 

[MRItechssuck]

You all probably saw this already.

https://www.businesswire.com/news/h...peutics-Business-Updates-Reports-Quarter-2019

Revenue was $24.2 million for the third quarter of 2019. The Company had no revenue in the comparable period of 2018. In accordance with the Company's revenue recognition policy, the $80.0 million upfront payment received from Astellas under the license and collaboration agreement in July 2019 is being recognized as revenue over the period from the execution of the agreement until Frequency meets its obligation to complete a Phase 2a clinical trial for FX-322.

 

[JohnAdams]

nearby ENT's

Traveling to a clinic trained in this would be 100% reasonable if affordable.

 

[mrbrightside614]

Traveling to a clinic trained in this would be 100% reasonable if affordable.

I feel like information dissemination is a huge barrier here. Would have to go by hearsay and personal testimonials. I've developed a savage distrust of almost all western medicine doctors, and while I don't have much experience with eastern medicine, it generally sounds like hocus pocus.

 

[Mathieulh]

Traveling to a clinic trained in this would be 100% reasonable if affordable.

Not if it gets like Neuromod and it's over one year waiting list.

 

[JohnAdams]

Not if it gets like Neuromod and it's over one year waiting list.

I disagree.

 

[JohnAdams]

it generally sounds like hocus pocus.

ABRACADABRA!

 

[patorjk]

The stock is up almost 20% today, it makes me wonder if there are people who know things that we don't. I've only ever followed 2 other biotechs (Auris Medical and Otonomy), so I'm not sure what's normal for these types of companies. I never saw either of those two spike 20% in a single day for seemingly no reason though.

Will there be no new significant info from Frequency until its topline data is in?

 

[JohnAdams]

The stock is up almost 20% today, it makes me wonder if there are people who know things that we don't.

OF COURSE!!!!

 

[FGG]

The stock is up almost 20% today, it makes me wonder if there are people who know things that we don't. I've only ever followed 2 other biotechs (Auris Medical and Otonomy), so I'm not sure what's normal for these types of companies. I never saw either of those two spike 20% in a single day for seemingly no reason though.

Will there be no new significant info from Frequency until its topline data is in?

The CEO just acquired 96,361 shares. I'm sure that was seen as a very bullish sign.

 

[patorjk]

The CEO just acquired 96,361 shares. I'm sure that was seen as a very bullish sign.

Wow, that means the CEO invested around $1.6M (assuming they bought it around $17 a share), that is a really interesting sign...

Edit: Looks like it was an exercise of stock options. I'm not sure exactly how they work, so disregard what I said here.

 

[mrbrightside614]

The stock is up almost 20% today, it makes me wonder if there are people who know things that we don't. I've only ever followed 2 other biotechs (Auris Medical and Otonomy), so I'm not sure what's normal for these types of companies. I never saw either of those two spike 20% in a single day for seemingly no reason though.

Will there be no new significant info from Frequency until its topline data is in?

Can we then say that this treatment is likely to restore damage above 8 kHz (even though testing only measures up to this level)? Feeling like this is my life support lately.

I realize I'm asking a question that is completely impossible to know. But this looks like a good sign.

 

[Pre55ure]

Can we then say that this treatment is likely to restore damage above 8 kHz (even though testing only measures up to this level)?

It seems very likely. Did you watch the video posted a few pages back, showing the speech in noise tests? It was some pretty impressive gains. I would love to see an audiogram up to 16 kHz or so, my understanding is that based on where they are injecting it, high frequencies will be most affected, with diminishing returns down the frequency spectrum.

I will be super happy if FX-322 is successful, but I'm unfortunately waiting for the next bus, as my hearing loss starts at about 1.5 kHz and massively drops off below that.

 

[JohnAdams]

It seems very likely. Did you watch the video posted a few pages back, showing the speech in noise tests? It was some pretty impressive gains. I would love to see an audiogram up to 16 kHz or so, my understanding is that based on where they are injecting it, high frequencies will be most affected, with diminishing returns down the frequency spectrum.

I will be super happy if FX-322 is successful, but I'm unfortunately waiting for the next bus, as my hearing loss starts at about 1.5 kHz and massively drops off below that.

Just remember that they are upping the dose now and the previous dose was relatively small. A larger dose could have a dramatically different effect. We can only wait and see. Sorry about your hearing loss.

 

[d'Wooluf]

I will be super happy if FX-322 is successful, but I'm unfortunately waiting for the next bus, as my hearing loss starts at about 1.5 kHz and massively drops off below that.

I'm waiting for the bus after yours.

 

[Born To Slay]

Any chance FX-322 will benefit hyperacusis patients as well?

 

[JohnAdams]

Any chance FX-322 will benefit hyperacusis patients as well?

The current trial is not measuring that.

Is there a chance? Sure. The mathematical concept of chance dictates there is a chance one of us will find the cure, even if it is 1:10000000000000000. That's still a chance.

 

[RingingBrother]

Any chance FX-322 will benefit hyperacusis patients as well?

Does that come from having too many hair cells?