Polarityte Update (demonstrates The Broad Utility Of This Novel Product Beyond Burn Care)

[Tano1]

It sounds promising.
I thought the area treated is left with minor scarring around the edges, but apparently that is not the case.
Oh, well. All we can do is wait, I guess.

Yes the area treated results in a “margin” which is That virtually seamless scar Dr. Swanson talked about. The biopsy also results in a scar but of course that one will be small as well. Results should be popping up within the next 2 months I think.

 

[That Guy]

Yeah, as time goes on, the more I become skeptical of this company.

Three posters on HLC recently had this conversation on the PolarityTE article and I think they raise some very serious points.

From a poster called "Jonathan":

"In terms of the commentary in the article, if we’re to assume what’s posted is accurate then it is very damning. The dilution, reverse mergers, and series of failed companies is definitely not a good thing. I don’t follow the pharma industry at all, but that level of dilution through convertibles is scary.

I think further research is warranted to look into the company’s claims, as a lot of the article’s concern surrounds a lack of information regarding the company’s intellectual property and the veracity of their claims."

From Michel:

"The lack of information regarding the company’s intellectual property (SkinTE) is what should have concerned us from the getgo.
Nobody knows what the heck SkinTE is, how it works, what it entails. All we have is a couple of pig pictures. That’s all. And that ain’t enough.

In comparison, we know a) that RCH-01 is a cell-based treatment, whereby cells are isolated from the back of a patient’s head, then amplified and injected into thinning or bald areas, b) that RAIN (Follica) is a combinatorial treatment, that entails microneedling(-wounding) and drug application (most probably minoxidil)."

That is an extremely good point. No one knows wtf a "SkinTE" kit contains. We don't REALLY know how it works, or any of that sh*t. By comparison, while some specific details regarding other upcoming treatments are left out of the public eye, we DO still have a pretty solid grasp overall of what exactly the therapy entails.

From Buyer Beware:

"The company still hasn’t disclosed any locations where it is being tested, and the last announcement merely pushed out the supposed release of data until sometime later this year. This looks a lot like the company is trying to “buy time”. In the meantime they are selling hope without hard data."

He/she is completely on the mark that we have no idea where it's being tested. So far, a lot of this is indeed lining up with the idea of it being a "story stock".

Further, they supposedly got FDA clearance under section 361 of the American Public Health Service Act. Thing is, the FDA lets you search its database, but I can't seem to find how to find Polarity (if they are even there). However, they do let you email them to find tissue establishments. This is the Section 361 I mentioned.

I think I'm going to give them an email and see if they have any record of this company. Because if they don't, it means that PolarityTE's news update is bullshit and the company is indeed a farce.

and @Tano1 I don't mean to sound like a dick, but we can't take his word for it even if he has spoke with the doctors. I'm not calling you a liar, but ultimately, what you say happened (without any tangible evidence) is just hearsay and amounts to no better than the whole fiasco the forum had with Beps63 in the Brotzu thread.

These questions have been raised before, but I think these posts on HLC stress the importance of it. Last time, you guys justified it by saying "Oh well, they have a real office and stuff!"

Yeah, so does Herbalife....

Update: I used the FDA's application for searching for Tissue establishments in the USA, registered, pending-approval, inactive, etc. and used all the relevant keywords and nothing regarding Polarity, Telogen Effluvium, or Skin has any record.

You can try your luck, if you want.

 

[Jake lake]

Yeah, as time goes on, the more I become skeptical of this company.

Three posters on HLC recently had this conversation on the PolarityTE article and I think they raise some very serious points.

From a poster called "Jonathan":

"In terms of the commentary in the article, if we’re to assume what’s posted is accurate then it is very damning. The dilution, reverse mergers, and series of failed companies is definitely not a good thing. I don’t follow the pharma industry at all, but that level of dilution through convertibles is scary.

I think further research is warranted to look into the company’s claims, as a lot of the article’s concern surrounds a lack of information regarding the company’s intellectual property and the veracity of their claims."

From Michel:

"The lack of information regarding the company’s intellectual property (SkinTE) is what should have concerned us from the getgo.
Nobody knows what the heck SkinTE is, how it works, what it entails. All we have is a couple of pig pictures. That’s all. And that ain’t enough.

In comparison, we know a) that RCH-01 is a cell-based treatment, whereby cells are isolated from the back of a patient’s head, then amplified and injected into thinning or bald areas, b) that RAIN (Follica) is a combinatorial treatment, that entails microneedling(-wounding) and drug application (most probably minoxidil)."

That is an extremely good point. No one knows wtf a "SkinTE" kit contains. We don't REALLY know how it works, or any of that sh*t. By comparison, while some specific details regarding other upcoming treatments are left out of the public eye, we DO still have a pretty solid grasp overall of what exactly the therapy entails.

From Buyer Beware:

"The company still hasn’t disclosed any locations where it is being tested, and the last announcement merely pushed out the supposed release of data until sometime later this year. This looks a lot like the company is trying to “buy time”. In the meantime they are selling hope without hard data."

He/she is completely on the mark that we have no idea where it's being tested. So far, a lot of this is indeed lining up with the idea of it being a "story stock".

Further, they supposedly got FDA clearance under section 361 of the American Public Health Service Act. Thing is, the FDA lets you search its database, but I can't seem to find how to find Polarity (if they are even there). However, they do let you email them to find tissue establishments. This is the Section 361 I mentioned.

I think I'm going to give them an email and see if they have any record of this company. Because if they don't, it means that PolarityTE's news update is bullshit and the company is indeed a farce.

and @Tano1 I don't mean to sound like a dick, but we can't take his word for it even if he has spoke with the doctors. I'm not calling you a liar, but ultimately, what you say happened (without any tangible evidence) is just hearsay and amounts to no better than the whole fiasco the forum had with Beps63 in the Brotzu thread.

These questions have been raised before, but I think these posts on HLC stress the importance of it. Last time, you guys justified it by saying "Oh well, they have a real office and stuff!"

Yeah, so does Herbalife....

Update: I used the FDA's application for searching for Tissue establishments in the USA, registered, pending-approval, inactive, etc. and used all the relevant keywords and nothing regarding Polarity, Telogen Effluvium, or Skin has any record.

You can try your luck, if you want.

Correct. Myth debunked. Time to wrap up this thread and lock it like Applemets. Up to the next scam!

 

[itsAlright]

Yeah, as time goes on, the more I become skeptical of this company.

Three posters on HLC recently had this conversation on the PolarityTE article and I think they raise some very serious points.

From a poster called "Jonathan":

"In terms of the commentary in the article, if we’re to assume what’s posted is accurate then it is very damning. The dilution, reverse mergers, and series of failed companies is definitely not a good thing. I don’t follow the pharma industry at all, but that level of dilution through convertibles is scary.

I think further research is warranted to look into the company’s claims, as a lot of the article’s concern surrounds a lack of information regarding the company’s intellectual property and the veracity of their claims."

From Michel:

"The lack of information regarding the company’s intellectual property (SkinTE) is what should have concerned us from the getgo.
Nobody knows what the heck SkinTE is, how it works, what it entails. All we have is a couple of pig pictures. That’s all. And that ain’t enough.

In comparison, we know a) that RCH-01 is a cell-based treatment, whereby cells are isolated from the back of a patient’s head, then amplified and injected into thinning or bald areas, b) that RAIN (Follica) is a combinatorial treatment, that entails microneedling(-wounding) and drug application (most probably minoxidil)."

That is an extremely good point. No one knows wtf a "SkinTE" kit contains. We don't REALLY know how it works, or any of that sh*t. By comparison, while some specific details regarding other upcoming treatments are left out of the public eye, we DO still have a pretty solid grasp overall of what exactly the therapy entails.

From Buyer Beware:

"The company still hasn’t disclosed any locations where it is being tested, and the last announcement merely pushed out the supposed release of data until sometime later this year. This looks a lot like the company is trying to “buy time”. In the meantime they are selling hope without hard data."

He/she is completely on the mark that we have no idea where it's being tested. So far, a lot of this is indeed lining up with the idea of it being a "story stock".

Further, they supposedly got FDA clearance under section 361 of the American Public Health Service Act. Thing is, the FDA lets you search its database, but I can't seem to find how to find Polarity (if they are even there). However, they do let you email them to find tissue establishments. This is the Section 361 I mentioned.

I think I'm going to give them an email and see if they have any record of this company. Because if they don't, it means that PolarityTE's news update is bullshit and the company is indeed a farce.

and @Tano1 I don't mean to sound like a dick, but we can't take his word for it even if he has spoke with the doctors. I'm not calling you a liar, but ultimately, what you say happened (without any tangible evidence) is just hearsay and amounts to no better than the whole fiasco the forum had with Beps63 in the Brotzu thread.

These questions have been raised before, but I think these posts on HLC stress the importance of it. Last time, you guys justified it by saying "Oh well, they have a real office and stuff!"

Yeah, so does Herbalife....

Update: I used the FDA's application for searching for Tissue establishments in the USA, registered, pending-approval, inactive, etc. and used all the relevant keywords and nothing regarding Polarity, Telogen Effluvium, or Skin has any record.

You can try your luck, if you want.

I'm not expert on any of this, but few among us are so I'm going to interject with a splash of my hope serum.

1) Regarding the reverse merger situation, I'm not sure I see the problem here. From what I have read, "A reverse takeover or reverse merger takeover (reverse IPO) is the acquisition of a public company by a private company so that the private company can bypass the lengthy and complex process of going public," (https://en.wikipedia.org/wiki/Reverse_takeover).
Would this not just be a quick and effective way to get funding? What is so shocking about the previous failed companies?

2)To address the other issue, the "we don't know what a SkinTE kit is". I'm not sure how detailed we need them to get with this, but they have addressed the basics.

The kit itself is just what they send the patient's processed and unprocessed skin sample in. As to why they don't give the specifics of their method of processing, I'm not a biology guy, haven't taken a course since 10th grade, but I'd assume it has something to do with the patent that lists the inventor as Dr. Denver Lough (CEO of PolarityTE):

https://www.google.com/patents/WO2016089825A1?cl=en

I could be completely off base trying to dive into this (outside my realm and tired), but it seems like the actual product is some kind of "bio-scaffold" with the patient's cells spread throughout in a way that allows the skin/hair/whatever to grow back in the most efficient and least scarring way possible.

From the patent:
"Use of the LGR epithelial stem cells, particularly in conjunction with a formed scaffolding substrate, provides full thickness wounds and or voids in epithelial systems with a stem cell enriched tissue substitute. Moreover, the addition of this minimally polarized functional cell unit (MPFU) to an epithelial system is enhances/improves the status that epithelium which includes the growth, generation or regeneration of hair, glands, secreted anti-microbial peptides, growth factors and analytes generally required to maintain and promote the health and viability of the epithelium and local surrounding tissues elements."

There is a ton of information in that patent about what I would assume is the process behind PolarityTE's products.

3) As to the locations of the testing; it would seem they simply don't want the results of the product's tentative release to be widely publicized and affect funding in case there are any kinks to work out with initial human application.

That said, I'd bet that Johns Hopkins is one of the locations; in this ABC story on PolarityTE, a patient and doctor from Johns Hopkins Burn Center make an appearance and there is a strong connection (CEO and COO both formerly worked at Johns Hopkins).

Also, couldn't we draw some soft conclusions from the locations of those on the Clinical Board of Advisors?

4) Lastly, are we really going to assume that Dr. Denver Lough (CEO) and Dr. Ned Swanson (COO) left residencies at Johns Hopkins voluntarily to start a farcical company so they can make a bunch of cash on a reverse merger? I know student loans are high for doctors, so maybe that's true.. lol

Seriously though the management team, board of directors, and clinical board of advisors are STACKED with MDs and PHDs and ABCDFGs from all over the country (BYU, Johns Hopkins, Texas A&M, USF, Harvard). Color me surprised if all the doctors and research leaders you see listed in the investor presentation are being duped or are purposefully soiling their name for this company.

Thank you though for the skepticism, I'm not being sarcastic when I say it's a really good thing that we have give and take on this forum. I think it is what keeps our expectations healthy and realistic but optimistic.

 

[Tano1]

@That Guy You can put that much to rest at least because I actually have tangible evidence. I recorded most of the phone conversation. Only 2 questions I couldn’t record because my voice recorder stopped when I minimized the app. Good thing I re-opened to check it.

Anyway, I don’t mind sharing the audio clip on the only hair-loss related question (the other 9 were all about skin and cost etc...) I asked him with everyone, but it’s gonna be almost exactly what I’ve already stated here.

My voice portions I wouldn’t even share because I’d rather keep my identity private so I guess you’d just have to take my word on that. Can share all of his responses though for sure. Suits me fine either way if anyone believes me or not. I don’t lose any sleep.

Not sure why the FDA deal doesn’t show up, but I think we’re all aware that they wouldn’t be able to get away with lying about their status with the FDA because they would be involved in serious legal issues and could potentially be shut down entirely. They’d legally have to state that their product has not been evaluated by the FDA. If you go to their site they have a press release that states they registered with the FDA and it was fairly quick too since they didn’t have to go through any phase trials. I’m sure you’ve seen this already but I’ll reference it anyway.

https://www.polarityte.com/news-med...e-announces-fda-registration-of-lead-product-

If you read down below it states they are “not subject to pre-market or approval requirements” which means they do not need phase trials or approval from the FDA to market. They do however have to register with them because of section 361 as you read about does subject them to “post-market regulatory requirements” which means they will be monitored. Again you can choose to believe me or dismiss this, but an e-mail from another forum member of a different forum stated that the FDA would oversee their pilot study so they’ll pretty much be under their supervision which makes sense if they are subject to post-market regulatory requirements. they did say they wanted to conduct their own trials which are currently underway because they wanted to actually prove that this works.

From a different phone conversation also with Dr. Swanson, a member of a different forum informed me that they will be releasing their results from their pilot study (their trials) and the burn centers will have their own option to choose to release results as well if they wish. Their patent is still in the process of being written so it hasn’t been posted. They started with 1 patent, but since then it has split into 5 patents and they hired a full time lawyer to get the wording right to protect their intellectual property.

Also from that forum member’s phone conversation, they decided not to release additional data that they have from their pig studies because they didn’t want to cause confusion with the public and investors because their research was approached from a “product optimization standpoint” which would make me assume that they had shitty results to start out, but were able to optimize the regeneration. Also re-confirmed in his convo that hair loss is being worked on right now for a derivative product.

I’m with you though in that I don’t fully believe they can achieve such dramatic results. This definitely isn’t something comparable to Tsuji. The CEO did leave John Hopkins though which is a very renowned place so take that for what it’s worth.

 

[thomps1523]

So was there a particular person in direct contact with @Admin that set up previous interviews? Seems like there are 2 companies right now everyone would love to get in contact with. @Swoop are you still in touch with him? Maybe you @Roberto_72 ?

 

[itsAlright]

With all the let downs it is good to see that PolarityTE's trials appear to be going well.
https://twitter.com/polarityte?lang=en

This statement in the Form-10K they released is exciting in this age of prolonged release:

"Because we do not expect our product candidates to require time-intensive, costly, multi-phase clinical trials or prior marketing approval or authorization like other therapeutics, biologics and devices, we plan to develop and commercialize several products simultaneously."

The vision of this company is much larger than I realized as well:

"As we believe our innovative platform technology has wide applicability—not only to regenerate multiple human tissues, organs, and composite structures, but also across other complex interacting biological systems (such as the immune system)—we believe that over time we can become a leader in the global regenerative medicine market, which according to Stratistics MRC is expected to exceed $100 billion by 2022."

PolarityTE vs. Replicel 2022

Any speed readers here?

https://ir.polarityte.com/all-sec-filings/content/0001493152-18-001228/form10-k.htm

 

[Iah11]

"Deep Pipeline of Additional Potential Applications. In addition to the regrowth of skin, we believe our platform’s capabilities can be extended across many indications, including bone, cartilage, muscle, blood vessels and neural elements, as well as solid and hollow organ composite tissue systems. For example, we believe there are currently unmet medical needs that can be addressed by the regeneration of cartilage for the treatment of osteoarthritis and facial reconstruction, the regeneration of fat-for-fat transfers during plastic surgery procedures, the regeneration of nerves following traumatic loss, the regeneration of blood vessels for vascular grafts, the regeneration of the urogenital epithelium and submucosa for urethral strictures and bladder reconstruction following tumor removal, the regeneration of liver tissue for liver fibrosis or failure, and the regeneration of bowel tissue to prevent leaking where the bowel is reconnected (prevention of anastomotic leak) or replaced due to excessive loss from trauma, surgery or congenital defects"

seems like a very exciting company in the sense that the technology is already being utilised ( it began to be used commercially in select hospitals in november 2017). Having said that, looking at that document, no mention at all of hair regen/hair transplants being a potential target but in the past they've stated that hair growth is being looked at for an offshoot product so who knows.

the product works by taking skin sample and from that sample creating a 'paste' which is then applied to wounded skin, and it takes on the appearance of normal, healthy skin with hair follicles.

considering the mechanism, i wonder if you could take a strip of skin from the back of head and create a paste to apply on the top of a bald scalp, creating a full head of hair?

and if this genuinely works and i have no reason to believe they're lying, then hair follicle regeneration is already a commercialised/commercialising reality. the issue now is hoping Polarity utilise this tech for the treatment of hair loss!

 

[Iah11]

Also considering their twitter states "SkinTE is now on patients, at multiple centers, within a variety of wound types and indications including acute and chronic wounds, burn wounds, surgical reconstructions and scar revisions", what's stopping a paste formed from hairy skin being applied to a bald scalp? it doesn't seem like the type of wound is important, nor does the wound have to be fresh. is it not possible to forgo the wound or scar replacement and just replace bald skin with hairy skin by applying the paste?

 

[hanginginthewire]

 

[Iah11]

haha, also notice this image from their website from preclinical research. shows regeneration of a full patch of bald hair (from a burn). definitely looks really promising, just don't know when they'll look to commercialise the hair regeneration use.

 

[itsAlright]

It would certainly be "too good to be true" for this company to pull through with a method to treat hair loss. However I believe a regenerative cell treatment for hair loss such as this one is going to be the first to the goal line.

Pharmaceuticals are just too costly and the trials are too time consuming to bring anything to market in the near future.

 

[MrV88]

From Twitter:

PolarityTE

@PolarityTE
·
19h

In preclinical testing, we observed that SkinTE regenerated full-thickness skin complete with all of its layers (epidermis, dermis, hypodermis) and functional appendages, including hair follicles, sweat glands and sebaceous glands. (link: http://bit.ly/2nmv2EX) bit.ly/2nmv2EX $COOL 1/2

 

[Rolandconil]

it's like Follica.

 

[MrV88]

it's like Follica.

View attachment 78108

But it's out and Follica ain't lol...

 

[blvd77]

it's like Follica.

View attachment 78108

follica is in the brotzu category - a monument to delusionality of HairLossTalk.com posters.

 

[blvd77]

about polarity, what exactly is the science between their method? something is fishy here.

 

[itsAlright]

about polarity, what exactly is the science between their method? something is fishy here.

See my post above...

They basically create a "bio-scaffold" for your own cells to regrow/regenerate in an almost scarless and even way.

 

[Tano1]

follica is in the brotzu category - a monument to delusionality of HairLossTalk.com posters.

Follica in a Brotzu category? Get it together son! They created de novo hair follicles through wounding. Even if it’s just 25/cm squared, that’s definitely at least progress. You optimize that to give you double the result, then you have the illusion of a full head of hair already. Better than just maintenance treatments if you ask me.

The science behind SkinTE is that they require a biopsy from anywhere that houses healthy skin and gets expanded by Polarity where it is converted into a paste form. Full thickness graft is taken and the team is able to apply the benefits of a split-thickness graft as well so it’s at least 1 step up from any current treatment for burn victims. This isn’t for head hair right now and as SkinTE stands, it would need to be altered for balding patients to have any satisfactory results. Read the 1st 3 pages of this thread for more info.

Can’t be a pessimist your whole life; otherwise, you’ll be one of the last ones crossing the finish line.

 

[MrV88]

Follica in a Brotzu category? Get it together son! They created de novo hair follicles through wounding. Even if it’s just 25/cm squared, that’s definitely at least progress. You optimize that to give you double the result, then you have the illusion of a full head of hair already. Better than just maintenance treatments if you ask me.

The science behind SkinTE is that they require a biopsy from anywhere that houses healthy skin and gets expanded by Polarity where it is converted into a paste form. Full thickness graft is taken and the team is able to apply the benefits of a split-thickness graft as well so it’s at least 1 step up from any current treatment for burn victims. This isn’t for head hair right now and as SkinTE stands, it would need to be altered for balding patients to have any satisfactory results. Read the 1st 3 pages of this thread for more info.

Can’t be a pessimist your whole life; otherwise, you’ll be one of the last ones crossing the finish line.

He meant that Follica is so far away and sometimes delusional like Brotzu because of the non existent release date non effectiveness