Puretech Health - 2017 Annual Report (2018-04-16)

[Noisette]

Hi ladies and gentlemen,

After a few months, I came here just to say hello with some little news..

That's not really new but we can see that " Follica has completed its clinical-stage development of a next-generation device and drug combination product for androgenetic alopecia, which is currently in an optimisation study. Further phases of pre-clinical testing are also ongoing towards the prioritisation and development of next-generation, proprietary compounds based on Follica’s intellectual property. The Follica RAIN pivotal study is expected to commence following the completion of the optimisation study."

So
1. Development of next generation device and Drug combination product done.
2. Is currently in an optimisation study.
3. Ongoing pre-clinical testing towards the prioritisation and develoment of next generation compounds.
4. Pivotal study following the completion of the ongoing optimisation study.

Source: http://puretechhealth.com/images/investors/PureTech-Health-ARA-2017_optimized-for-printing.pdf

And in February 13th 2018, Follica has obtained a granted patent​

Source: https://patentimages.storage.googleapis.com/be/0a/6b/f3cb333585bc13/USD810280.pdf


May the force be with your scalp

 

[NorwoodGuardian]

So when will it be released?

 

[Kagaho]

Thanks Noisette! Good and updated info

 

[Noisette]

So when will it be released?

Good question. Nobody knows but after their ongoing optimisation study they will enter in the pivotal trial (phase 3). Maybe they are expecting to have a clearance sometime at the end of this year. ( = hypothesis).. (If we take the previous timeline ).

 

[Kagaho]

I really like Puretech Health. Not only because of Follica.

 

[Ikkaku]

Noisette !!!!! <333333

 

[itsAlright]

@Noisette I'm always so impressed with the facts you dig up, when I see one of your posts I know I'll be pleasantly surprised.

Thanks yet again!

 

[Vinc2097]

Hi ladies and gentlemen,

After a few months, I came here just to say hello with some little news..

That's not really new but we can see that " Follica has completed its clinical-stage development of a next-generation device and drug combination product for androgenetic alopecia, which is currently in an optimisation study. Further phases of pre-clinical testing are also ongoing towards the prioritisation and development of next-generation, proprietary compounds based on Follica’s intellectual property. The Follica RAIN pivotal study is expected to commence following the completion of the optimisation study."

So
1. Development of next generation device and Drug combination product done.
2. Is currently in an optimisation study.
3. Ongoing pre-clinical testing towards the prioritisation and develoment of next generation compounds.
4. Pivotal study following the completion of the ongoing optimisation study.

Source: http://puretechhealth.com/images/investors/PureTech-Health-ARA-2017_optimized-for-printing.pdf
View attachment 85787
View attachment 85788

And in February 13th 2018, Follica has obtained a granted patent​

View attachment 85786
View attachment 85789

Source: https://patentimages.storage.googleapis.com/be/0a/6b/f3cb333585bc13/USD810280.pdf


May the force be with your scalp

Hey, great post!! I want to know what is exactly follica. Right now i know its a wounding device + a growth treatment.

But what is the growth treatment.. minoxidil ? I hope not... ! thx

 

[Kagaho]

Hey, great post!! I want to know what is exactly follica. Right now i know its a wounding device + a growth treatment.

But what is the growth treatment.. minoxidil ? I hope not... ! thx

For some time its going to be Minoxidil, mate.

But like Noisette posted they are going to develop their own stuff:

Further phases of pre-clinical testing are also ongoing towards the prioritisation and development of next-generation, proprietary compounds based on Follica’s intellectual property.

 

[wc5269]

Good question. Nobody knows but after their ongoing optimisation study they will enter in the pivotal trial (phase 3). Maybe they are expecting to have a clearance sometime at the end of this year. ( = hypothesis).. (If we take the previous timeline ).

Do you mean clearance to start the study? Because there is no way in hell this is released by the end of the year if they haven't even started recruitment for the phase 3 study. Recruitment -> Approval for a phase 3, a 2 year timeline would be optimistic. So spring of 2020...

 

[itsAlright]

Do you mean clearance to start the study? Because there is no way in hell this is released by the end of the year if they haven't even started recruitment for the phase 3 study. Recruitment -> Approval for a phase 3, a 2 year timeline would be optimistic. So spring of 2020...

Why couldn't the optimization study transition into the pivotal study?

 

[Kagaho]

Do you mean clearance to start the study? Because there is no way in hell this is released by the end of the year if they haven't even started recruitment for the phase 3 study. Recruitment -> Approval for a phase 3, a 2 year timeline would be optimistic. So spring of 2020...

They are at least 1.5 years from releasing something, probably more

 

[wc5269]

Why couldn't the optimization study transition into the pivotal study?

Just a guess because I don't know the details, but I would assume they need more subjects to have the power to prove efficacy. Even if they could, you would guess 1 year for the phase 3 and another 6-12 months for FDA approval.

 

[itsjustsimon]

For some time its going to be Minoxidil, mate.

But like Noisette posted they are going to develop their own stuff:

So they’ve been developing some fancy dermastamp for 12 years? You sure it’s just minoxidil?

 

[wc5269]

So they’ve been developing some fancy dermastamp for 12 years? You sure it’s just minoxidil?

"Further phases of pre-clinical testing are also ongoing towards the prioritisation and development of next-generation, proprietary compounds based on Follica’s intellectual property. "

That means they're at least 5 years away from having anything on the market.

 

[Kagaho]

So they’ve been developing some fancy dermastamp for 12 years? You sure it’s just minoxidil?

They did more than that but the chosen drug at the time didnt achieve what they want

Maybe @Noisette can help us here, but i remember reading minoxidil as their main growth stim. They probably put some other stuff too but i dont think we have many options right now to enhace the effect.

And of course remember that they are doing preclinical testing for a novel drug. But thats gonne take some time boyyo

 

[hanginginthewire]

"Further phases of pre-clinical testing are also ongoing towards the prioritisation and development of next-generation, proprietary compounds based on Follica’s intellectual property. "

That means they're at least 5 years away from having anything on the market.

Whaaaaaaat???!! Noooooo!!!

Don’t these phases have to mean something? You make it sound like after Phase 3 is completed they will be pleased to announce they are entering Phase 4. And then 5. 6....

 

[Vinc2097]

For some time its going to be Minoxidil, mate.

But like Noisette posted they are going to develop their own stuff:

ok thanks, minoxidil sides screw me lol....

 

[That Guy]

Nothin' gets my dick harder than a Noisette post

"Further phases of pre-clinical testing are also ongoing towards the prioritisation and development of next-generation, proprietary compounds based on Follica’s intellectual property. "

That means they're at least 5 years away from having anything on the market.

No it doesn't, f*** lol.

Everyone take a good look at this post. It's a prime example of extracting negative information from a source where none exists and stating this conjecture as a fact.

I seem to recall it even being stated previously that what will hit the market after the pivotal will be (obviously) the first-generation iteration of the treatment. We don't know definitively what compounds they are using at present, but obviously, research will continue to create even better compounds after market release.

It's like you guys don't know that technology is improved upon over time. It's not like they just save up until they have the tech at its most advanced stage. If that's how it worked, we'd still be in the fuckin' stone age.

 

[wc5269]

Nothin' gets my dick harder than a Noisette post



No it doesn't, f*** lol.

Everyone take a good look at this post. It's a prime example of extracting negative information from a source where none exists and stating this conjecture as a fact.

I seem to recall it even being stated previously that what will hit the market after the pivotal will be (obviously) the first-generation iteration of the treatment. We don't know definitively what compounds they are using at present, but obviously, research will continue to create even better compounds after market release.

It's like you guys don't know that technology is improved upon over time. It's not like they just save up until they have the tech at its most advanced stage. If that's how it worked, we'd still be in the fuckin' stone age.

From their website:

"We conducted three clinical studies of patients with androgenetic alopecia, which demonstrated hair follicle neogenesis via biopsy following skin disruption and hair growth through target area hair count. One of these studies demonstrated that skin disruption alone was safe and generates not only new hair follicles and but also terminal (visible, thick) hairs. We are further developing and testing compounds that enhance these effects"

I personally think it's pretty clear that the study is on the device and not a device + novel compound. From what I take from their above statement is that they have done clinical tests on their skin disruption technique, and are in preclinical with their potential compounds. I would genuinely love to be proven wrong, do you have any details to share on these 3 clinical studies that would prove otherwise? I stand by my statement that if their novel compounds for this treatment are still in preclinical, they're ~5 years from market if everything goes right. Maybe you misinterpreted what I said, I'm not saying this device they have in phase 2 is 5 years away, I think it's closer to 2 years away.