HM: A question about direction

News2

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A question about direction: Some guys on this forum (nervx?) have suggested that the direction of hairgrowth is no longer an issue. Where did you hear this? I have read some interviews with Dr. Ken Washenik, and the most recent one in which he addressed this issue was from May 5th, 2004:
HairSite: Do you think if follicles based hair transplant still has a role to play when cell based hair multiplication becomes available?

Dr. Washenik: Yes, I do. I expect the first few generations of cell based hair multiplication may not have great predicability and consistency as far as the results are concerned. Traditional follicles based hair transplant will still be necessary for balding areas that require absolute predictability and consistency, eg: the hairline.
How can they be certain that direction is no longer an issue? I mean: To my knowledge ARI have not yet started testing their product on humans.

And another question about direction: Would you guys have an HM procedure done even if you knew that the direction wasn't gonna be perfect?
 

nervx

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I think that hairsite interview(which is from the podcast if im not mistaken) was actually done months before the posted date(during winter). It's about 2 years old and a lot has happened since then.

Washenik did an interview about 8-10 months back for a british newspaper where he briefly mentions direction/multiplication factor and so on. I don't remember the exact qoute but it was something along the lines that problems that plagued hm in the past have been solved or greatly improved upon. ARI filed a bunch of patents around this time as well, one which was to help hair growth direction. They've also mentioned they wouldn't move into fda testing if the procedure isn't cosmetically acceptable and since they are doing the trials now it's safe to say they got something working.

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HM YAY!
 

News2

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Thank you for this.
I really can't wait for HM to hit the market, but I'll only have it done if I'm convinced that the results will be cosmetically satisfying. (
 

TAINTED-MEAT

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have they started phase 2 testing yet?
 

News2

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I'm not sure they have started phase 1 yet, let alone phase 2.
 

Rob_x_22

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CAN U imagine a world were everyone has perfect hair ... i guess people will have to find something else to nitpick about huh ?
 

CCS

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how much will they cost? i just need to fill in the hair within an inch from myface. i guess that does not make me a condidate for hm. but that does mean i can get FUE and then put HM in each of the holes in back. no, now that I already have a fine line scar, i might as well just keep taking from teh same place. But where to put the HM hair. hmmm.
 

powersam

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i think the last update by nervex was that they had completed phase 1 - the safety trial.
 

kblah

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Any idea why the phase 2 trails seem to be taking forever to begin? I remember at the start of this year they were talking about starting shortly and the company line hasn't changed since.

With direction I've heard some people talking about a non toxic bio-degradable hydrogel as a potential direction aiding device, but thats nothing official.
 

News2

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i think the last update by nervex was that they had completed phase 1 - the safety trial.

Any idea why the phase 2 trails seem to be taking forever to begin?

That's Intercytex's product you're thinking of. To my knowledge ARI have not started testing theirs yet. (I might be wrong.)
I also want to know why Intercytex haven't started phase II trials yet. Back in May there was an interview with Paul Kemp, the owner (?) of the company, and he said that phase II trials would begin “by the end of the monthâ€￾. It's nearly August now, and the trials have not yet begun.
 

DaSand

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I really want this to come out soon. I'm hoping to participate in Trial III if they are going to do it.
 

nervx

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News2 said:
I'm not sure they have started phase 1 yet, let alone phase 2.

Rumor has it ari is already a long way into phase 1 but is keeping quiet about their progress. They wont comment on their status either, likely due to competition.

Intercytex is currently moving into phase 2 and once passed they will go to market.


how much will they cost?
Less than a hair transplant. 8-10k has been mentioned, although the price isn't final.

Any idea why the phase 2 trails seem to be taking forever to begin?
Yeah intercytex said they were starting phase 2 then didn't. They haven't mentioned why. However they have just finished phase 1 of their skin care product so it's possible they wanted to finish that before starting phase 2 of the hm trials. Whatever the case lets hope they get moving again.
 

News2

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Rumor has it ari is already a long way into phase 1 but is keeping quiet about their progress.
Where do you hear these things???
Wouldn't it be great if they had already completed all trials and had kept quiet about it? :p

Intercytex is currently moving into phase 2 and once passed they will go to market.
Can they do that? I mean: Are there no legal requirements for phase III trials?
Is that why they changed their timeline and now want to launch their product in 2008 (rather than 2010)?
 

nervx

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Wouldn't it be great if they had already completed all trials and had kept quiet about it?

It's a nice fantasy but it wont happen.... stupid reality.

Can they do that? I mean: Are there no legal requirements for phase III trials?
Is that why they changed their timeline and now want to launch their product in 2008 (rather than 2010)?

regulation reguirements are different all over the world. They can release it after phase II in the UK but will still likely have to finish all three for north american release. Japan also has very slack requirements, you can put a new drug/product on the market in less than a year there.

ARI has always aimed for 2008
Intercytex said 09/10 originally but thanks to skipping trial III and competition from ari im guessing that's why they're now saying it could be 2008.
 

kblah

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Some questions aimed mainly at Nervx but anyone who can answer these it would be appreciated. About Intercytex....

I noticed that they are waiting for the MHRA in the UK that the procedure is unregulated. Can you fill in what exactly that means and what sort of timeline you'd expect from the MHRA to take in deciding on this. Possibly even your own opinion and the effect that a regulated/unregulated procedure means on the release.

And how definate are you that Intercytex are probably going to skip phase 3 and head straight to commercialisation, at least in the UK. I can see how they might want to jump into the market before Aderans can attempt competition in various parts of the world, but are you sure :p

Finally I've read that http://www.puramatrix.com/products#att may have something to do with direction on some forum, can't remember exactly. I haven't had a good look through yet, but what are your thoughts on that.

Thanks
 

News2

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I noticed that they are waiting for the MHRA in the UK that the procedure is unregulated. Can you fill in what exactly that means and what sort of timeline you'd expect from the MHRA to take in deciding on this.

Someone from this forum (DaSand) sent them an e-mail, and he posted their reply on here (-> “Read Intercytex's patent application hereâ€￾). Here's the relevant quote:

We are involved with the FDA and the other regulatory agencies in the world. What they are trying to decide at the moment is how cell therapy products should be regulated and the jury is out at the moment. This will impact on the nature of the trials we conduct and when the products get to market.

This is kind of interesting, because just a few months earlier (in April) they sent someone else the following e--mail:

It is hard to predict exactly, but here goes:
Phase II trials might be completed in 2007
Phase III trials might be completed in 2008
Regulatory approval processes might be completed in 2009
ICX-TRC may be on the market in 2010.

Something must have happened, otherwise they wouldn't have decided to skip phase III trials. Maybe ARI's product is further advanced than they're letting on, and they're beginning to feel the competition???

I can see how they might want to jump into the market before Aderans can attempt competition in various parts of the world

I can see that as well. However, it is a risky strategy. On the one hand they might make a lot of money if they are the first to have an HM product on the market, but on the other hand there is a reason why it is more common to have three separate trials: Just imagine what would happen if something DID go wrong and their product triggered some kind of disease (which could have been prevented with proper testing). They would be bankrupt before you can say “HMâ€￾. They would have massive lawsuits on their hands, and no-one would even think about having their procedure done. (I know, this is a slim chance, and I also know that they have successfully completed their saftey trials, but this is surely something they have thought about when they decided to skip phase III trials.) On the other hand: If they really DID decide to skip phase III trials, they must have a lot of confidence in their product.
 
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