Tissuse Interview, Ask Your Questions Here!

[GotHair?]

Germany is actually ver quick in terms of offering treatments

Can you back that up?
Cos' this study tells differently:

Another determinant of the concept to market period is the time it takes the regulatory agencies to conduct their reviews. It is commonly asserted that FDA processes are significantly slower than those of the EMA, and that FDA processes should be loosened to facilitate drug approval and equalize drug availability in Europe and the United States. Closer examination shows that, in fact, drug review times are significantly shorter at the FDA than the EMA. One study demonstrated that for similar drugs, the median times of initial reviews were 303 and 366 days, respectively, and for full reviews was 322 days compared with 366 days, respectively (21). For drugs that were brought to market in both the United States and EU, 63.7% were brought to market first in the United States, and were available a median of 90 days sooner.

LINK: http://www.sciencedirect.com/science/article/pii/S2452302X16300638

That said they do say that a drug can go through national proccess :

National process

Each EU state can have its own procedures for approving drugs that fall outside of those required to undergo the centralized process.

Mutual recognition
Drugs approved in one EU state via that state's national process can obtain marketing authorization in another EU member state.

However it has been mentioned that it has only been propositioned to cut out phase 3 for fast approval for important treatments which Japan and USA already did. SO this is still probably true for Germany.
And if we go further for Germany it self they have their own set of problems:

http://www.ft.com/cms/s/2/d458d470-4696-11e1-89a8-00144feabdc0.html?ft_site=falcon&desktop=true

Germany has long been considered a “free price” market but that officially came to an end 1 January 2011, when a law known as AMNOG required that companies introducing new drugs submit a cost-benefit dossier to G-BA, which is the ultimate decision-maker in German healthcare. G-BA in turn can consult with the Institute for Quality and Efficacy in Health Care (IQWiG) to assess “patient-related benefit.” IQWiG focuses on evidence-based medicine and patient outcomes in terms of morbidity, mortality and quality of life.

 

[GotHair?]

what if no drug is to be approved but an organoid made from one's own cells?
are the phases and everything the same?

simply put: what if you cut out a tiny piece of skin, dissect it in the petri dish and let the cells divide one time to reach twice as many cells and then put everything back into the patient?
does such a thing really need a complex approval?

Well it seems EMA does have conditional market approval:

EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended conditional approval for Zalmoxis. Conditional approval is one of the Agency’s main mechanisms to facilitate earlier access by patients to medicines that fulfill unmet medical needs. Conditional approval allows EMA to recommend a medicine for marketing authorisation before the availability of confirmatory clinical trial data, if the benefits of making this medicine available to patients immediately outweigh the risks inherent in the lack of comprehensive data.

However it seems this applies only to life threatening diseases.
As stated here:

Medicines for human use are eligible if they belong to at least one of these categories:

• aimed at treating, preventing or diagnosing seriously debilitating or life-threatening diseases;
• intended for use in emergency situations (also less comprehensive pharmaceutical and non-clinical data may be accepted for such products);
• designated as orphan medicines. (very rare disease)

Conditional marketing authorisations may be granted if the CHMP finds that all the following requirements are met:

• the benefit-risk balance of the product is positive;
• it is likely that the applicant will be able to provide comprehensive data;
• unmet medical needs will be fulfilled;
• the benefit to public health of the medicinal product's immediate availability on the market outweighs the risks due to need for further data.

So it seems to me they will still need 3 Phases. Of course there is constant talk for improvement and expansion of conditional approval process.

 

[H]

i don't think so. let's say tsuji comes out in 2020 with a commercial treatment. of course the first 1 or 2 years there will be limited access and higher cost. for me personally, i don't give a damn about cost. it will definitely not cost more than 100k anyway (maybe 50k in the beginning). but for now, i would spend 100k without thinking twice, if it brings back a full head of hair. not because i have enough money (i don't even have 100k at the moment), but i would just take a bank loan and that's it. it's just money which you can pay back over many years. getting back hair is much more important and can't come soon enough.
and i believe many people would do the same.

availibility will quickly be ramped up once the world gets to know that a real freakin cure exists in japan. they will be overrun by requests and forced to ramp up their capabilities and open multiple clinics.

How much has fue come down in price since ARTAS and the whole shebang was introduced? I'm going to go out on a limb here and say not exponentially and they certainly haven't been cut in half and these are mediocre results compared to what hair multiplication in theory can do. Id at least give these guys a break since they at least are trying and they have as much plausiability as most other company's we are looking at right now unless somebody's got a complete Norwood reversal picture follicas got hiding around all we have from them is a cool website and picture of boxes, we haven't seen anything for Loreal yet, and Riken has not made any big announcements as of late about culturing. I like Tsuji a lot but 2019 is a while to go to see if this is going to work so I'm staying neutral in excitement.

you have mentioned that in an earlier post too, but there's no proof, is it?

Is their proof that they do?

I know everyone is railing on about the cost of Tsujis method but I mean when it becomes available you'll be left with a choice. You either pay and get your hair back or you don't. For some it will be money well spent, for others it will be money well saved...

Lol 100k would be a lot to fork out for many many a man with male pattern baldness. Guess these sites won't change much it just won't be waiting on a cure anymore it'll be waiting on an affordable version of a cure. Btw I know i can't say for sure it will be 100k but I can't justify in my mind a cheaper price. Think of fue on 20000 ( some will definitely need more for full density and advanced stage alopecia) grafts on fue procedure at $8 a graft... ya its getting all six digity to me.

 

[thomps1523]

If a treatment is able to pass both phase 1, and phase 2 in Japan are companies able to submit that information to the FDA for immediate approval in the United States? I'm curious if maybe the FDA has different requirements for their phase testing, so tests run in phases in other countries can't transfer over, or can they? Anyone have any idea?

 

[That Guy]

If a treatment is able to pass both phase 1, and phase 2 in Japan are companies able to submit that information to the FDA for immediate approval in the United States? I'm curious if maybe the FDA has different requirements for their phase testing, so tests run in phases in other countries can't transfer over, or can they? Anyone have any idea?

The best answer I think you'll get here is "Maybe"

I've looked it up on both Canadian and American FDA sites and foreign data on a variety of things is accepted, but there are so many f*****g stipulations I can't even throw an accurate guess out as to whether or not that'd be a yes or no. Like, there are literally hundreds of pages regarding these things and none of them give a clear-cut answer we're looking for.

However, Japan does seem to accept foreign data on cellular therapies — as evidenced by Shiseido's licensing of RepliCel's tech and beginning a Phase II.

 

[H]

If a treatment is able to pass both phase 1, and phase 2 in Japan are companies able to submit that information to the FDA for immediate approval in the United States? I'm curious if maybe the FDA has different requirements for their phase testing, so tests run in phases in other countries can't transfer over, or can they? Anyone have any idea?

The fda does accept foreign trial information however its just meet the same requirements as 21 CFR Part 312.

 

[thomps1523]

The fda does accept foreign trial information however its just meet the same requirements as 21 CFR Part 312.

Is there any link showing this? I'm curious if requirements differ enough to require at least something when transferring clinical data.

 

[H]

Is there any link showing this? I'm curious if requirements differ enough to require at least something when transferring clinical data.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=312 I think you'll be able to find what you need here.

Also makes you wonder how fast L'oreal can get their market abroad and I haven't even heard anything about them since the initial announcement nothing in their site nor Poietis's.

 

[inham123]

How much has fue come down in price since ARTAS and the whole shebang was introduced?

Clinics which have bought ARTAS don't use them. Everyone is doing manual (not even motorized) FUE. Prices for top doctors aren't dropping cause of demand. It's much cheaper to start a clinic in Turkey or India cause of labor costs.

There's were the FUE cost comes from, it requires more labor. Hence why FUT is cheaper too.

But I do think hair cloning will be expensive.

 

[H]

Clinics which have bought ARTAS don't use them. Everyone is doing manual (not even motorized) FUE. Prices for top doctors aren't dropping cause of demand. It's much cheaper to start a clinic in Turkey or India cause of labor costs.

There's were the FUE cost comes from, it requires more labor. Hence why FUT is cheaper too.

But I do think hair cloning will be expensive.

Interesting why don't they use ARTAS?

 

[inham123]

It's inferior, both the donor area and the extracted grafts are damaged too much.

 

[H]

It's inferior, both the donor area and the extracted grafts are damaged too much.

Extraction is the problem then but implantation wise it works well?

 

[H]

artas robot is one of the most useless developments in hair transplant business. it was always just a fancy gadget which was a good promotion for some transplant docs. it looked like the future to some customers. but the reality is different, even more so when hair multiplication arrives. this will render those robots obsolete.
for the recipient implantation the robot wasn't used anyway. it was only used to extract hairs from the donor area, but a skilled FUE Doctor could do it much better with thinner extraction needles. the robot just saved 2 or 3 hours of extraction work, depending on how much hairs to transplant. imagine how many transplants a Doctor must do to justify the costs of the device. the robot was developed at a time where everybody already knew that the longterm endgame is hair multiplication which would make the robot useless. so the developers knew they have a time frame of a few years (maybe max. 10 years) to convince docs to buy that useless monster. some stupid docs however weren't smart enough to see the fail and bought one. who cares.

If you want a hair multiplication therapy widely available and affordable it will have to be automated and so I'm pretty interested in the first attempt at a robot developed for hair transplants I care.

 

[That Guy]

If you want a hair multiplication therapy widely available and affordable it will have to be automated and so I'm pretty interested in the first attempt at a robot developed for hair transplants I care.

I disagree.

If anything, all the automation will be a driving factor in the inevitable cost of Tsuji and it's not necessary to automate the crap out of cell culturing.

This treatment, as it says on their website, could be administered by a one-man team.

TissUse and Follica are very smart business wise in the sense that a couple of proprietary devices at most is all that a dermatologist would require to administer the treatment — it puts a sizeable dent in the company's operating costs, which also benefits the consumer.

 

[H]

I disagree.

If anything, all the automation will be a driving factor in the inevitable cost of Tsuji and it's not necessary to automate the crap out of cell culturing.

This treatment, as it says on their website, could be administered by a one-man team.

TissUse and Follica are very smart business wise in the sense that a couple of proprietary devices at most is all that a dermatologist would require to administer the treatment — it puts a sizeable dent in the company's operating costs, which also benefits the consumer.

I guess in my mind I was thinking of them manually implanting neopapilla one at a time which seems unreasonable and would take forever. The average fue takes 8 hours I can only imagine how long something like this would take whilst implanting 10 fold neopapilla. Perhaps they'll develop some type of punch to administer a couple thousand at a time and then do the hairline themselves for a more natural look?

 

[baldboys]

I guess in my mind I was thinking of them manually implanting neopapilla one at a time which seems unreasonable and would take forever. The average fue takes 8 hours I can only imagine how long something like this would take whilst implanting 10 fold neopapilla. Perhaps they'll develop some type of punch to administer a couple thousand at a time and then do the hairline themselves for a more natural look?

How would they manually implant a cell?

 

[mr_robot]

Tsuji cell culturing will definitely be automated and it won't be hugely expensive. What may be expensive is the development of an injection device that will used to inject the cells, however I doubt it will be hugely complicated.

Currently an FUE proceedure is as such:

Extract the donor follicle units with a punch.
Seperate follicle units that contain more than follicle.
Create thousands of slits in the scalp.
Place each folicle into the slit with tweazers.

This is all highly labour intensive. Tsuji will most likely be able to be injected directly into the scalp so in terms of labour will be much easier and therefore cheaper than an transplant. However Riken will initially charge very high prices to surgeons in order to recover their R&D costs and supply will be very limited but once the infrastructure is in place there is no reason it could not be same price as todays transpants.

 

[hanginginthewire]

I thought Tsuji was hair multiplication? Wouldn't the (multiplied) hairs be implanted in just the exact same manner as a regular transplant? I'm not sure what you mean by "injected directly into the scalp"? That sounds like Replicel? Sorry for my ignorance, just want to make sure I understand.

 

[That Guy]

Tsuji cell culturing will definitely be automated and it won't be hugely expensive. What may be expensive is the development of an injection device that will used to inject the cells, however I doubt it will be hugely complicated.

Currently an FUE proceedure is as such:

Extract the donor follicle units with a punch.
Seperate follicle units that contain more than follicle.
Create thousands of slits in the scalp.
Place each folicle into the slit with tweazers.

This is all highly labour intensive. Tsuji will most likely be able to be injected directly into the scalp so in terms of labour will be much easier and therefore cheaper than an transplant. However Riken will initially charge very high prices to surgeons in order to recover their R&D costs and supply will be very limited but once the infrastructure is in place there is no reason it could not be same price as todays transpants.

Yes, but the Tsuji process looks like this:

• Build cell-culturing facilities

• Build machines

• Hire staff and maintenance personnel as required.

• Ship cells to (and from) facility and transplant surgeons who don't get out of bed for less than 4k.

It's not just the R&D costs they will have to recoup, it's the costs of building, maintenance and what not and the treatment is applied by transplant surgeons who will want to milk it for all it's worth like they always do. An FUE, Follica or other proposed methods of hair multiplication could be done in the same office with just a handheld device and some culturing gear in the back.

 

[mr_robot]

Yes, but the Tsuji process looks like this:

• Build cell-culturing facilities

• Build machines

• Hire staff and maintenance personnel as required.

• Ship cells to (and from) facility and transplant surgeons who don't get out of bed for less than 4k.

It's not just the R&D costs they will have to recoup, it's the costs of building, maintenance and what not and the treatment is applied by transplant surgeons who will want to milk it for all it's worth like they always do. An FUE, Follica or other proposed methods of hair multiplication could be done in the same office with just a handheld device and some culturing gear in the back.

All those costs become reasonable over time once the R&D is paid for and production is ramped up. The initial higher cost will always reflect the costs in bring the product to market. The fact is in terms of surgeon time you're probably looking at 1/4th time taken per follicle compared to FUE and the surgeons fee is the lions share of any treatment.

Follica is not hair multiplication and is crude compared compared with Tsuji and until they display evidence to the contrary will not get you the density or control over the final result. Any other proposed methods are just that, proposed, they don't exist yet.

 

[That Guy]

All those costs become reasonable over time once the R&D is paid for and production is ramped up. The initial higher cost will always reflect the costs in bring the product to market. The fact is in terms of surgeon time you're probably looking at 1/4th time taken per follicle compared to FUE and the surgeons fee is the lions share of any treatment.

Follica is not hair multiplication and is crude compared compared with Tsuji and until they display evidence to the contrary will not get you the density or control over the final result. Any other proposed methods are just that, proposed, they don't exist yet.

I didn't say Follica was hair multiplication.

Also, I don't agree that it's "crude" compared to Tsuji. There is more than enough precedence to indicate that, with mastery of the technique, normal density should definitely be possible.

I'll get lynched for saying this, but to be completely honest, a treatment like Follica would in many ways be ideal for the average consumer. You go to a dermatologist, they don't have to take any chunks out of your head, you go home and keep with up the at-home regime, can start and stop and at any time and it's a much more viable solution for people with DUPA or APKH and it will be much easier to get such a treatment approved worldwide in a timely manner.

Any other proposed methods are just that, proposed, they don't exist yet.

Neither does Tsuji's.

 

[H]

How would they manually implant a cell?

A papilla isn't one cell.

 

[H]

I'll get lynched for saying this, but to be completely honest, a treatment like Follica would in many ways be ideal for the average consumer

I would agree with that. It seems their goal is a more in home oriented method so it should be fairly easy to use and way less expensive then any hm transplantation procedure making it more accessible to the masses. I do however agree jo-achim and see a big setback being the density it provides. I don't see someone who is slick bald or has bald areas applying this and 6 to 8 months later having a full mane, maybe in time with enough tweaks to the formula it could who knows. The hair made by follicas method would also need maintenance which if it did give a full head of hair most of us wouldn't/shouldnt give a damn but ideally the thought of having your head reloaded with resistant follicles to a nw0 via multiplication is the most interesting at least to me. I hope they all work out and work out soon.