Scarless Healing

Started by Tom_Mason Tom_Mason

9,310 posts in this topic

27 minutes ago, Sirius Lee said:

But how would this apply to acne scars, particularly if you have extensive acne pits all over your face? Surely, you can't just sand down the entire face before applying their products.
Interview with Dr. Swanson, M.D. COO and Vice President of PolarityTE
 
Note: A reminder that the first 2 questions were unable to be recorded due to me being unaware that minimizing my voice recording application would pause the recording. I can confirm though that the first 2 responses I will lay out to those 2 questions are both accurate information and very similar to the responses he gave me. All the questions are also direct wording from myself.

We introduced ourselves briefly and I asked Dr. Swanson if I could conduct an interview with some detailed questions to help us better understand how SkinTE works to which he replied that it would be fine. 

Tano1: "First off I just want to say it's a pleasure to have the opportunity to speak with you today. 
I just wanted to ask you some questions to help us better understand PolarityTE’s goals and focus and I don’t want to take up too much of your time so I’ll try and be as brief and straightforward as I can."

1.) Tano1: "To start off with my first question concerning the area to be treated, is the full injury/wound excised with all of its skin layers for SkinTE to be applied or how is the wound addressed before the application of SkinTE?"
    
    Dr. Swanson replied with a detailed response on how the process works from the time the skin biopsy is taken to the time SkinTE is produced and administered on the burn/wound. His response was very similar to the video PolarityTE has on their YouTube channel on the part informing of the 3 step process.

    Tano1: "Thank you for your response and addressing the wound itself, can it be excised with all 3 layers of skin as well as partial excisions depending on the wound/injury/defect?"
    
    Dr. Swanson gave me a detailed answer that all 3 layers can be excised whether in wounds, burns or scars for SkinTE to then be applied. He added that partial excisions can be made as well whether the wound just extends to the dermal layer of the skin or even just PART of the dermis.
He went into more detail on how the hypodermis or subcutaneous tissue can be left alone if it's not damaged/injured and made it clear to me that the full dermis does NOT need to be excised if it is not necessary further stating that the lower (reticular) dermis can be left alone while excising the upper (papillary) dermis only if appropriate.
    
2.) Tano1: "A relatively big topic of interest that has been discussed time and time again is over the margins shown in the images of swine pertaining to SkinTE’s product and so I’d like to try and dive a little bit deeper on that and I've seen terms viewing this as "virtually seamless" which is why I'd like to try and go deeper into detail and ask:"

"Is this margin really so small that it can be virtually seamless or rather I should say, indistinguishable to the naked eye?"

    Dr. Swanson responded in detail of how the margin produced is a relatively small line where the edges of the wound meet with SkinTE. He went on to say that as far as the naked eye goes, the team working with SkinTE, had they not have been trained, knew what to look for, and witnessed the regeneration of the skin in swine, would not have been able to distinguish where the wound used to be.
    He went on to say that it was very difficult for them to spot any trace of a margin with the naked eye and they had to look real closely referring me then specifically to the images that we can see on their presentation of the margin. He added that those images were under magnification just to be able to see the actual crease or line of the margin and then added that it is indeed virtually seamless to the naked eye. He then told me that they're very optimistic that this will translate to humans since swine has predictive aspects of skin and healing which are very similar to humans.
    
Note: The questions above were worded nearly exactly as I asked them. The answers are also very accurate and very similar (some parts word for word) of what Dr. Swanson said to me.
Note: The next questions have full audio to them because I checked my voice recording application and realized it paused once I minimized it. It was turned on and left on my screen at this point to make sure it did not pause anymore. The rest of the interview contains all direct words from Dr. Swanson as well now.

3.) Tano1: "We see also that you plan to branch out into cosmetic/scar revisions if successful with burns. Now assuming that SkinTE succeeded in burn wounds (and of course we believe it’s going to), will this be a viable solution for skin conditions and/or defects such as: acne scars, surgical scars, hypo-hyperpigmentation or even damage that has been seen from currently utilized skin and scar treatments? just to name a few."

    Dr. Swanson: "Yea you know, it's hard to give the exact answer on every single one of those indications. Some of those could potentially be addressed with the SkinTE product as it stands today and others we are in the process of developing derivative products using similar technology to address." "It's a lot of nuances to what would be best in each situation, but you know I think that old scars, large scars can certainly be removed and have SkinTE applied to the base of the wound if the provider and patient think that could be beneficial."
        "And, you know, if we're talking about smaller scars like acne scars or fine line scars in sensitive areas like on the face, then those might be things that people would rather address with some derivative products we're developing right now in our research and development department."
        
    Tano1: Oh that's amazing, that's amazing. 
        
4.) Tano1: "Okay so this question now concerns the hair follicles that were regenerated in the full thickness skin because we had some discussion over the functionality of all the skin and its appendages. We read that it did regenerate not just full thickness skin, but all of its appendages as well. So Since hair regeneration is something else that was noted by PolarityTE with plans to be sought out, is this something that will be pursued for those with thinning hair or even those who have gone bald as a result of genetics or injury?"

    Dr. Swanson: "Yea this is definitely a topic of a lot of interest from external parties like yourself as well as internally at Polarity. I think that they were talking about the hair restoration market or trying to regenerate hair of the scalp. That's another product that is in active development now."
       "The SkinTE product itself in those swine studies and as we expect in the human studies and use of the product will regenerate hair in there and terminal hair, but in order to really address the hair restoration market, we want to optimize one of those derivative products over time and know if we will be able to and we're optimistic on that front, but I think that SkinTE as it stands today, needs to be altered in order to really provide those types of patients with a solution to their problem that will be satisfying for them."
    
5.) Tano: "Okay and how soon can we expect PolarityTE to move into the cosmetic/scar market upon entering the market for burns? I believe you guys are already registered through the FDA and I believe correct me if I'm wrong, but its already been released commercially? Of course limited commercial release?"

    Dr. Swanson: "Yea so, yea you're right it's registered with the FDA so it's available for human use for defects of the skin and in that limited market release it's going to be applied to not only burn wounds out of the gate, but there also chronic wounds, smaller wounds like most defects of the face as well as highly larger reconstructive wounds that a variety of providers are going to start using it in."
        "So those are the intial markets going into the intial sort of application that we'll be seeing results in hopefully at the beginning of next year and then in terms of the scar revision market, that's actually quite a broad market in terms of what we're talking about so some scar revisions are actually quite large, so patients who have had large skin grafts or even moderate sized skin grafts that scar over time, that's something that could be addressed with SkinTE, but the scarred area would have to be removed and SkinTE applied."
        "If we're talking about the fine line scars or smaller scars in highly sensitive areas, the same solution could be applied where the scar is removed and SkinTE is applied. If the provider and patient felt it wasn't worth that level of invasive treatment, then those smaller scars might be better addressed by future products in development that we're working on for some potentially hypertrophic, fine line scars that house problems based on where they are. For scar revision we'll be going into that market right out of the gate in the limited market release, but those will be more of the larger scars that patients have developed because of former skin grafts if that makes sense."
        
    Tano1: "Yes, yes wow that's absolutely amazing. Just a couple more questions I have for you Dr. Swanson. I don't want to take up too much of your time. I'm trying to be as brief and straightforward as I can."
    
6.) Tano1: "Regarding the skin biopsy, around how big is the skin sample that will be taken. I know it was said that it would be a small biopsy and then it's expanded using the 3D Platform Technology. So how small would the skin sample be taken, and how much can it be expanded by to sort of get an idea of the size of the wound that can be covered."

    Dr. Swanson: "Yea the size of the harvest will depend on the size of the wound. With that minimum amount that we would ask the provider to send to us which would likely address anything up to 10% of the body and that's to give you" *in-audible* (I think he said hint) "about the size of another extremity and a average size result."
        "We would be asking them to send us a few square centimeters of full thickness skin and then if we were talking about very large wounds like you know, burn wounds that are covering half the body or other types of processes of wounds that large, we would probably ask for another few square centimeters per 10% just kind of in the same proportion."
        "So you know the large majority of wounds will be addressable with that initial small sample of a few square centimeters. As you imagine there aren't many wounds that get bigger than 10% of the body, but when they do, it's not a tremendous amount more of skin that we'll require. When wounds are getting to that size, you also could have a lot of options from where the skin will come. There is no designated area where people are going to take these harvest samples."
        "And we're talking very, very large wounds where sometimes for instance in burn patients, the only viable skin left is often actually the scalp or sort of protected creases like in the armpits or the groin you know, all those areas are fine for the skin to come from."
        
        Tano1: "Oh wow that actually answers another one of my questions which was where the biopsy can be taken from if it could be taken from varying parts of the body so that's great to know."
        
7.) Tano1: "In terms of affordability, how affordable will SkinTE be in comparison to current treatments?"

    Dr. Swanson: "Yea that's a great question and you know our goal has always been (especially coming from the medical and surgical field) was to really try to provide the greatest value we can at the most affordable cost and I think this has actually differentiated us a lot in our approach. We've been combating a lot of people in the industry and advisors and investor communities who think: well, you guys can potentially provide this level of increased value; got to go after that and ask for that increased value and the price of product."
        "And we" *in-audible* (I believe he said: And we whole heartedly ditched that approach) "because we're actually able to produce the product" *in-audible* "so our goal is to be competitive or even lower cost on the current available product options where we think that will not only be providing value on the outcome side, but also delivering at a cost that will be affordable to patients and the healthcare system as a whole."

    Tano1: "That's great. Just a couple more questions for you Dr. Swanson if you'll just bear with me just a little bit longer."
    
8.) Tano1: "Is there a long term plan to make this product available and I guess I should say just any of your incoming research and developments available to other countries? Or I wanna even step a little bit further and maybe even worldwide?"

    Dr. Swanson: "Yea you know right now we are purely focused on the United States and starting this commercial launch here. We're always evaluating potential options internationally and we don't have any definitive plans on that front today meaning that we're going to one country over another next, but we certainly want to bring this as far across the globe as possible and we've been sort of exploring all opportunities to do it whether with sort of partners that are already in that area of the world or trying to think of if it would be more practical for us to do it ourselves just because the manufacturing is highly unique and was designed to a very innovative solution for doing it with an autologous product. So it may be something that we can deploy ourselves than anyone else."
        
    Tano1: "Great and I just have one last question for you."
    
9.) Tano1: "How long of a recovery period is expected when undergoing treatment with SkinTE?"

    Dr. Swanson: "Yea no that's a great question. As a high flying answer to that question I would say the recovery period, and when I say recovery I'm assuming you're referring more to the healing time and rushing of the healing and regeneration."
    
    Tano1: "Yes the actual healing. I know it's different of course you add on the time of your down time."
    
    Dr. Swanson: "You know, it's along the same lines of the healing of any type of graft that's applied where we expect to see a large amount of the healing and regeneration complete within 2-3 months as with any sort of healing process. Final stable results aren't really seen for a year and that's across all tissues in the body with everything that's ever been done in surgery and treatments where you can expect almost 80% of the healing to be accomplished in those first 3 months and then that final 20% of what the stable outcome is going to be happens over the remainder of the year. So it's sort of a fast ramp up to what you're going to see, but that final remodeling and permanent outcome isn't really known for an entire year.
         "In terms of more short term timelines with our product what we found in swine was the day the product is applied, the dressing is applied like a larger skin graft that's usually left on for 5-7 days. You saw in that first 5-7 days almost a water type barrier set in across the wound and then around the 2 week time point was when we would start seeing those hair shafts and follicles regenerating out of the wound."
        "It was over the 2-3 month time that we saw the full thickness skin regeneration expand across the wound."
        
        Tano1: "Wow that is amazing. You know, I actually wanted to fit one more question in I'm sorry. I just wanted to fit one more question in and it's regarding the skin biopsy again because some people they get a little worried about, you know, they feel like they're trading one scar for another or one wound for another."
        
10.) Tano1: "How would the skin biopsy itself be addressed after the skin is taken out? Is it possible to maybe apply the SkinTE product on the biopsy as well or how do you guys go about addressing that?"

    Dr. Swanson: "So where the harvest is taken, the full thickness skin is removed, but that wound is closed with sutures to become a straight line incision so it would be like having any sort of surgical incision that gets closed and heals in a straight line scar. The providers, especially the ones in the initial rollout and limited release and certainly plastic and reconstructive surgeons are very well aware of those sorts of biopsies and harvests in order to hide those straight line scars."
        "It's actually very similar to taking a full thickness skin graft and when you do that, you take those kinds of harvest and grafts from areas where you can hide the straight line scar and it helps avoid I think what you're getting at, but it wouldn't be left open and it wouldn't need the product applied to it if that makes sense. That's one of the major limitations of full thickness skin grafts is since you're taking the full thickness skin, that donor site is not able to regenerate skin the way a split-thickness skin graft does so you have to close it. So you can't take a very large sample and full thickness skin grafts can't be expanded."
        "So even though it results in a better outcome than a split-thickness skin graft, they can't treat very large wounds because they can't be expanded very well and you can't take big heaps. SkinTE potentially can harness the benefits of a full-thickness skin graft in terms of its healing and regeneration of all the layers; maintaining all the hair follicles and shafts and appendages, but as sort of the benefit of the split-thickness skin graft which can be applied to much larger surface areas."
        
        Tano1: "Well this definitely looks to be a truly innovative company and we believe it is. I just wanted to thank you so much Dr. Swanson for taking time out of your day to help us better understand PolarityTE's vision and goals. It really was a pleasure speaking with you. We'll await the future and success of PolarityTE."
De Rerum Natura reacted to this

sorry for my bad english

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9 hours ago, Sirius Lee said:

But how would this apply to acne scars, particularly if you have extensive acne pits all over your face? Surely, you can't just sand down the entire face before applying their products.

JohnRottenSkin's post of the convo Tiano had with Swanson pretty much covers this. As Swanson states, they're working on derivative products for more cosmetic leaning application, but believe SkinTE would work as is but be too invasive for most scars. If you did use SkinTE for acne, I'd imagine the surgeon would want to go piece by piece instead of excising or debriding it all at once. That's speculation on my part of course.

For Sunogel, I'm not sure. Dr. Sun, in conversations with others on this site, has brought up the invasiveness of the procedure but believes it will work in all cases. Sunogel is slightly less invasive because it doesn't need a biopsy site of healthy tissue.

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12 hours ago, JohnRottenSkin said:
Interview with Dr. Swanson, M.D. COO and Vice President of PolarityTE

 Dr. Swanson gave me a detailed answer that all 3 layers can be excised whether in wounds, burns or scars for SkinTE to then be applied. He added that partial excisions can be made as well whether the wound just extends to the dermal layer of the skin or even just PART of the dermis. He went into more detail on how the hypodermis or subcutaneous tissue can be left alone if it's not damaged/injured and made it clear to me that the full dermis does NOT need to be excised if it is not necessary further stating that the lower (reticular) dermis can be left alone while excising the upper (papillary) dermis only if appropriate.

3.) Tano1: "We see also that you plan to branch out into cosmetic/scar revisions if successful with burns. Now assuming that SkinTE succeeded in burn wounds (and of course we believe it’s going to), will this be a viable solution for skin conditions and/or defects such as: acne scars, surgical scars, hypo-hyperpigmentation or even damage that has been seen from currently utilized skin and scar treatments? just to name a few."

    Dr. Swanson: "Yea you know, it's hard to give the exact answer on every single one of those indications. Some of those could potentially be addressed with the SkinTE product as it stands today and others we are in the process of developing derivative products using similar technology to address." "It's a lot of nuances to what would be best in each situation, but you know I think that old scars, large scars can certainly be removed and have SkinTE applied to the base of the wound if the provider and patient think that could be beneficial."

(Note: Bold colored texts above are mine)

Thanks for the transcript. Sounds promising. But it sounds very invasive. This would be especially difficult (if not cumbersome) for acne scar sufferers considering that they would need to literally excise the scars on their face. As I already stated in my previous post, this would be a real challenge if you have a lot of scars all over your face. Also this type of treatment would likely require inpatient care and longer recovery downtime.

 
4 hours ago, golfpanther said:

JohnRottenSkin's post of the convo Tiano had with Swanson pretty much covers this. As Swanson states, they're working on derivative products for more cosmetic leaning application, but believe SkinTE would work as is but be too invasive for most scars. If you did use SkinTE for acne, I'd imagine the surgeon would want to go piece by piece instead of excising or debriding it all at once. That's speculation on my part of course.

For Sunogel, I'm not sure. Dr. Sun, in conversations with others on this site, has brought up the invasiveness of the procedure but believes it will work in all cases. Sunogel is slightly less invasive because it doesn't need a biopsy site of healthy tissue.

I guess it's better than what we have in store at the moment, but it seems to be too invasive--especially for those with a ton of scars. One at a time would be like a death by a 1000 papercuts. Ggrrrr!

There is no life without water. Use it to your advantage.


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22 minutes ago, Sirius Lee said:

(Note: Bold colored texts above are mine)

Thanks for the transcript. Sounds promising. But it sounds very invasive. This would be especially difficult (if not cumbersome) for acne scar sufferers considering that they would need to literally excise the scars on their face. As I already stated in my previous post, this would be a real challenge if you have a lot of scars all over your face. Also this type of treatment would likely require inpatient care and longer recovery downtime.

 
I guess it's better than what we have in store at the moment, but it seems to be too invasive--especially for those with a ton of scars. One at a time would be like a death by a 1000 papercuts. Ggrrrr!

Keep in mind that elsewhere in that transcript Swanson talks about how they're developing derivative products of SkinTE that are more geared for cosmetic applications. They also answer a similar question in the investor call they have posted on their website.

As of now though, even with derivative products it's likely that excision will be necessary to get complete regeneration. A wound bed, as I stated before, is critical in terms of getting the desired results (i.e. regeneration with skin appendages).

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Do you guys think they don't want to treat patients with acne scars with SkinTe because excision to correct acne scars is too invasive? 
That would be really stupid.....I have my scars mainly in my back and I wouldn't mind to get my skin excised in my back, but even in my face I wouldn't care too much if it would get rid of my acne scars forever. 

I just can't accept they don't even attempt to treat acne sufferers with SkinTE :smileys_n_people_31:
I would bet their derivative product purposefully developed for acne scars won't be out for many years....I can't wait that much

Maybe we should try to convince them in some way....like sending emails, calls, gathering firms or whatever. 
We literally could have a cure for our problem and we're denied it.  
And I'd bet the overwhelming majority of acne scars sufferers (even the ones that post on this forum) don't even know a product like SkinTE exist and waste their time and money with useless treatments like lasers, peeling, infini, needling, fillers and whatever....
If all of us send emails to them, they at least should rethink about it. 

Edited by SimpleMutton

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1 hour ago, SimpleMutton said:

Do you guys think they don't want to treat patients with acne scars with SkinTe because excision to correct acne scars is too invasive? 
That would be really stupid.....I have my scars mainly in my back and I wouldn't mind to get my skin excised in my back, but even in my face I wouldn't care too much if it would get rid of my acne scars forever. 

I just can't accept they don't even attempt to treat acne sufferers with SkinTE :smileys_n_people_31:
I would bet their derivative product purposefully developed for acne scars won't be out for many years....I can't wait that much

Maybe we should try to convince them in some way....like sending emails, calls, gathering firms or whatever. 
We literally could have a cure for our problem and we're denied it.  
And I'd bet the overwhelming majority of acne scars sufferers (even the ones that post on this forum) don't even know a product like SkinTE exist and waste their time and money with useless treatments like lasers, peeling, infini, needling, fillers and whatever....
If all of us send emails to them, they at least should rethink about it. 


To be clear, Swanson never said SkinTE couldn't be used on acne scars or other non-burn scars, just that the procedure might be too invasive for most surgeons to perform it. Remember, it's not up to Swanson if it gets used in a certain way or not, it's up to whomever you find to actually do the procedure.

He did say that if the surgeon and patient thought the invasiveness was worth it then he believes, based on the research they've done to this point, it would provide the same regeneration. I'm sure if you look hard enough you could find a surgeon and derm willing to do it if it works in humans.
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we need to wait first results in humans. If we will see margin and "new skin" is good then we can email and phone them and whatever. The turning point is a single succesful treatment by SkinTE. But, there is timeline - 3 months and 12 months to see result.

SimpleMutton reacted to this

sorry for my bad english

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For those who are in the dark, It's a real bitch to get FDA approval in the USA. Most do not even make to the phase 3. Here's a quick rundown:
 

Steps from Test Tube to New Drug Application Review

FDA approval process

 

It takes on average 12 years and over US$350 million to get a new drug from the laboratory onto the pharmacy shelf. Once a company develops a drug, it undergoes around three and a half years of laboratory testing, before an application is made to the U.S. Food and Drug Administration (FDA) to begin testing the drug in humans. Only one in 1000 of the compounds that enter laboratory testing will ever make it to human testing.

If the FDA gives the green light, the "investigative" drug will then enter three phases of clinical trials:

  • Phase 1 uses 20-80 healthy volunteers to establish a drug's safety and profile. (about 1 year) 
  • Phase 2 employs 100-300 patient volunteers to assess the drug's effectiveness. (about 2 years) 
  • Phase 3 involves 1000-3000 patients in clinics and hospitals who are monitored carefully to determine effectiveness and identify adverse reactions. (about 3 years)

Only after successful phase 3 can the drug be released to the public!!!

There is no life without water. Use it to your advantage.


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1 hour ago, Sirius Lee said:

For those who are in the dark, It's a real bitch to get FDA approval in the USA. Most do not even make to the phase 3. Here's a quick rundown:
 

Steps from Test Tube to New Drug Application Review

FDA approval process

 

It takes on average 12 years and over US$350 million to get a new drug from the laboratory onto the pharmacy shelf. Once a company develops a drug, it undergoes around three and a half years of laboratory testing, before an application is made to the U.S. Food and Drug Administration (FDA) to begin testing the drug in humans. Only one in 1000 of the compounds that enter laboratory testing will ever make it to human testing.

If the FDA gives the green light, the "investigative" drug will then enter three phases of clinical trials:

  • Phase 1 uses 20-80 healthy volunteers to establish a drug's safety and profile. (about 1 year) 
  • Phase 2 employs 100-300 patient volunteers to assess the drug's effectiveness. (about 2 years) 
  • Phase 3 involves 1000-3000 patients in clinics and hospitals who are monitored carefully to determine effectiveness and identify adverse reactions. (about 3 years)

Only after successful phase 3 can the drug be released to the public!!!
skinTE is already approved

sorry for my bad english

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Has this article been posted here?

Regeneration of the entire human epidermis using transgenic stem cells
J
unctional epidermolysis bullosa (JEB) is a severe and often lethal genetic disease caused by mutations in genes encoding the basement membrane component laminin-332. Surviving patients with JEB develop chronic wounds to the skin and mucosa, which impair their quality of life and lead to skin cancer. Here we show that autologous transgenic keratinocyte cultures regenerated an entire, fully functional epidermis on a seven-year-old child suffering from a devastating, life- threatening form of JEB. The proviral integration pattern was maintained in vivo and epidermal renewal did not cause any clonal selection. Clonal tracing showed that the human epidermis is sustained not by equipotent progenitors, but by a limited number of long-lived stem cells, detected as holoclones, that can extensively self-renew in vitro and in vivo and produce progenitors that replenish terminally differentiated keratinocytes. This study provides a blueprint that can be applied to other stem cell-mediated combined ex vivo cell and gene therapies.

:smileys_n_people_116:  https://goo.gl/pUe6mP 
 

This major clinical development was based on decades of basic research. The clinical data gathered during 21 months of follow-up after the boy’s treatment have also led to major insights into human skin biology, as discussed in an accompanying News & Views (M. Aragona and C. Blanpain Nature http://dx.doi.org/10.1038/nature24753; 2017). For example, normal regeneration of the epidermis is directed by only a few stem-cell clones that can self-renew.

By their nature, highly personalized treatments using gene therapies and products derived from an individual’s stem cells are likely to be applicable to only a subset of patients. Although the report presents the treatment of one patient, it is a classic case of researchers standing on the shoulders of others. This project, for example, relied on long-term follow-up of a patient treated in 2006, as well as parallel studies that underpinned the development of tools for ex vivo gene therapy and for growing transplantable sheets of epidermis in vitro.  

:smileys_n_people_116:  https://goo.gl/FSRb7Q


  Edited by Sirius Lee

There is no life without water. Use it to your advantage.


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i didnt hear about this articles before, thank you. Check out private chat. I invited you. There are many useful info


sorry for my bad english

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17 hours ago, Sirius Lee said:

For those who are in the dark, It's a real bitch to get FDA approval in the USA. Most do not even make to the phase 3. Here's a quick rundown:
 

Steps from Test Tube to New Drug Application Review

FDA approval process

 

It takes on average 12 years and over US$350 million to get a new drug from the laboratory onto the pharmacy shelf. Once a company develops a drug, it undergoes around three and a half years of laboratory testing, before an application is made to the U.S. Food and Drug Administration (FDA) to begin testing the drug in humans. Only one in 1000 of the compounds that enter laboratory testing will ever make it to human testing.

If the FDA gives the green light, the "investigative" drug will then enter three phases of clinical trials:

  • Phase 1 uses 20-80 healthy volunteers to establish a drug's safety and profile. (about 1 year) 
  • Phase 2 employs 100-300 patient volunteers to assess the drug's effectiveness. (about 2 years) 
  • Phase 3 involves 1000-3000 patients in clinics and hospitals who are monitored carefully to determine effectiveness and identify adverse reactions. (about 3 years)

Only after successful phase 3 can the drug be released to the public!!!

As John stated, SkinTE is already approved and in clinics as I type this. It’s likely already been used on some humans at this point; either as part of the pilot clinical trial or as a product. We just haven’t heard about it because as a publicly traded company they’ll want to release results when it’s most advantageous for them and their shareholders.

Neither Sunogel or SkinTE need to go to phase 3 because they are considered devices. Why? Because nothing is added (ie stem cells, drugs etc) to them that would classify them as a drug.

The other post you made recently  would need phase  3 because they’re putting induced stem cells into the body.

lastly, the FDA recently changed their regulatory process for regenerative medicine to get products to patients faster. Edited by golfpanther

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Dr Speigal a cranial facial reconstructive plastic surgeon says 10 years because he does a lot of cutting and his job is to hide the scarring. He said it will be at least 10 years before something that works will be on the market. I hope they have something on the market faster but like always people release treatments that don't work to get your money.

Edited by nikkigirl

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9 minutes ago, nikkigirl said:

Dr Speigal a cranial facial reconstructive plastic surgeon says 10 years because he does a lot of cutting and his job is to hide the scarring. He said it will be at least 10 years before something that works will be on the market. I hope they have something on the market faster but like always people release treatments that don't work to get your money.

he knows nothing

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50 minutes ago, nikkigirl said:

Dr Speigal a cranial facial reconstructive plastic surgeon says 10 years because he does a lot of cutting and his job is to hide the scarring. He said it will be at least 10 years before something that works will be on the market. I hope they have something on the market faster but like always people release treatments that don't work to get your money.

Thank you for yet another insightful comment.

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On 12/6/2017 at 2:57 PM, nikkigirl said:

Dr Speigal a cranial facial reconstructive plastic surgeon says 10 years because he does a lot of cutting and his job is to hide the scarring. He said it will be at least 10 years before something that works will be on the market. I hope they have something on the market faster but like always people release treatments that don't work to get your money.


He may end up being right, but keep in mind, he's a surgeon and not a scientist/doctor working on scar free healing and regenerative medicine. Those are two dramatically different things.

I'm sure he knows a lot about how to properly perform a surgery to minimize or hide scarring. Does that mean he knows about all the intricacies of wound healing like Dr. Sun or PolarityTE does? No, and he likely doesn't know about the existence of either product because in my experience, a lot of derms and surgeons are too busy focusing on their practice to have time to research disruptive medicine.

Disruptive is the key word for my next point. If either Sunogel or PolarityTE prove to provide complete regeneration with their products this will have major ramifications for someone like Dr. Spiegel. Suddenly, his main calling card and source of business (i.e. the ability to perform surgeries with minimal or mostly hidden scars) is rendered mostly moot. 

Look, I'm not saying that he's making this claim callously. Most likely he's just ignorant to all the research being done because he doesn't have the time to dig into it like a lot of us on this site do or is being cautious about specific timelines. However, keep in mind that products like Sunogel and SkinTE threaten his business. Think about it. Let's say he somehow knew for a fact that a product was coming that provided complete regeneration for wounds. Do you think he'd gush about it? Absolutely not, it would cost him business in the interim because people would just want to wait for the product and then go to the least expensive surgeon (that was still trustworthy and skilled) they could find.

Regenerative medicine is incredibly disruptive and as such there is going to be a lot of misinformation as it picks up steam (the FDA streamlining the process should rapidly accelerate this). This will come from both sides; doctors, surgeons and manufacturers of lesser products feeling threatened by the sea change and "unscrupulous actors" (as the FDA puts it) that seek to use regenerative medicine as a buzz term to get people to fork over tons of money for ineffective treatments.

Nothing about PolarityTE or Sunogel suggests they are the latter to this point. Both are even going through clinical studies even though they don't have to. That's a great sign because it shows they aren't just going with the path of least resistance to make a buck. Edited by golfpanther
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I think the disruptive part is something many people don't realize about these emerging technologies. Going from the current scar revision processes to scarless healing is just like going from the basic brick phone to an iPhone -->even proving that scarless healing is possible will change EVERYTHING --- the scar market will be a small drop in the ocean. Think of the skincare markets, the aging treatment markets, the hair loss markets, even plastic surgery will be affected. Plus companies will start shifting technology towards refining scarless technology rather than stick with what they have. So IF (big IF) this technology proves to work, things will speed up at an exponential pace.

Edited by Raster
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1 hour ago, Raster said:

I think the disruptive part is something many people don't realize about these emerging technologies. Going from the current scar revision processes to scarless healing is just like going from the basic brick phone to an iPhone -->even proving that scarless healing is possible will change EVERYTHING --- the scar market will be a small drop in the ocean. Think of the skincare markets, the aging treatment markets, the hair loss markets, even plastic surgery will be affected. Plus companies will start shifting technology towards refining scarless technology rather than stick with what they have. So IF (big IF) this technology proves to work, things will speed up at an exponential pace.


The real crux of the matter is whether it will be affordable for those who really need the damn thing. 
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There is no life without water. Use it to your advantage.


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14 hours ago, Sirius Lee said:

The real crux of the matter is whether it will be affordable for those who really need the damn thing. 

Yes, this is an issue. Products typically come to market at a price point where most people can't afford it.

However, I do have some hope from what PolarityTE has said about this subject. They seem to understand that there is a balance between profit and actually trying to help people. This could of course all be marketing BS but they've been asked that direct question and have stated they want to keep costs as low as they can so they can help the most people.

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PolarityTE: Investors Beware

Dec. 7.17 | About: PolarityTE, Inc. (COOL)

Summary

PolarityTE’s sole key asset is a patent application that it acquired for a value of $104.7 million.

Common equity holders are exposed to severe potential dilution, given a capital structure that is saddled with convertibles.

PolarityTE has failed to release its full pre-clinical data, and its planned human trials appear delayed.

The entity has been reverse merged several times into a variety of businesses. We believe PolarityTE is the latest in a series of failed story stocks.

We believe the common equity is likely worthless.


:smileys_n_people_116:  https://seekingalpha.com/article/4130500-polarityte-investors-beware



 
  1.  
  2. We are short shares of $COOL and believe the equity is likely worthless

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    We believe $COOL is the latest hype stock in an entity that has been reverse merged into at least 6 different businesses

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    $COOL's sole key asset is a patent application that it purchased from a resident doctor for a value of $104.7 million

     




 

There is no life without water. Use it to your advantage.


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1 hour ago, Sirius Lee said:

PolarityTE: Investors Beware

Dec. 7.17 | About: PolarityTE, Inc. (COOL)
 

Summary

PolarityTE’s sole key asset is a patent application that it acquired for a value of $104.7 million.

Common equity holders are exposed to severe potential dilution, given a capital structure that is saddled with convertibles.

PolarityTE has failed to release its full pre-clinical data, and its planned human trials appear delayed.

The entity has been reverse merged several times into a variety of businesses. We believe PolarityTE is the latest in a series of failed story stocks.

We believe the common equity is likely worthless.


:smileys_n_people_116:  https://seekingalpha.com/article/4130500-polarityte-investors-beware



 
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  2. We are short shares of $COOL and believe the equity is likely worthless

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    $COOL's sole key asset is a patent application that it purchased from a resident doctor for a value of $104.7 million

     




 
Well that's definitely bad news. Let's not give up hope on this company just yet. 

I don't know if this was posted but they are approved for clinical trials. They are expected to release data in 2018.

http://www.nasdaq.com/press-release/polarityte-lead-product-skinte-is-approved-for-use-by-multiple-medical-institutions-20171019-00605

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3 minutes ago, Anonymouz1 said:
Well that's definitely bad news. Let's not give up hope on this company just yet. 

I don't know if this was posted but they are approved for clinical trials. They are expected to release data in 2018.

http://www.nasdaq.com/press-release/polarityte-lead-product-skinte-is-approved-for-use-by-multiple-medical-institutions-20171019-00605

I posted the article in the private chat some of us are on and while it isn't good news, I think it's wise to keep things in perspective. Honestly, most of that stuff revolves around stock valuation and investment, which doesn't affect or indicate the efficacy of the product one bit. It might work, it might not work, but the article's main thrust is to inform their readers about whether they should invest in the company.

To me, there were 2 salient points raised: 1. Why hasn't there been peer reviewed published papers about the swine tests and 2. Why are there no clinical trials listed on clinicaltrials.gov? However, even with this there are explanations beyond, "The sky is falling and it doesn't work!"

First, it could be that since it's already been approved by the FDA and supposedly in 18 burn centers in the US (and ostensibly being used), Lough and Swanson and PolarityTE have decided it's not necessary to spend the time, money and resources on the trial and instead will just use data from clinics to prove the efficacy of the product. I hope this isn't the case, as I'd like at least a small peer-reviewed pilot trial, but I can see this as a reason.

Second, it could just be delayed and not mean much of anything beyond that.

Third, and this is the most optimistic one, they've already used it on patients and it works. At that point, why do the pilot study? This isn't like other devices or drugs that offer marginal/percentage improvement. If it works like it did in pigs then you'll just have completely regenerated skin.

Fourth, in regards to published papers when it comes to the pigs, I have no idea how long it takes to actually get into a journal and I doubt the author of the article does either. In a quick search for papers on pubmed for studies where Lough was an investigator I found one from April 17th, 2017. That is clearly after he left Johns Hopkins and formed PolarityTE so anecdotally, it seems like these things can take a while.

Lastly, I reached out to PolarityTE after reading the article and basically said that I'm very hopeful for the product but also concerned by the lack of a clinical trial and no published papers and asked for an update. To my surprise, I got a response very quickly. They said we could jump on a call for an update as early as tomorrow or next week. I'm going to do and will keep you all posted. My main questions are:

1. Has the pilot clinical trial begun? If so, do you have any results to share? If not, why and when do you estimate it will happen (if they're still pursuing this)?

2. Why haven't there been any published papers in regards to the tests done on pigs?

3. Has the product been used outside of the pilot study and if so can you share any results?

4. Is the plan to still bring SkinTE to a wide market release in the first half of 2018?

That's bout all I have. Any suggestions are welcome, but reference Tiano's convo with them before to make sure we're getting new questions/information.

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14 minutes ago, golfpanther said:

I posted the article in the private chat some of us are on and while it isn't good news, I think it's wise to keep things in perspective. Honestly, most of that stuff revolves around stock valuation and investment, which doesn't affect or indicate the efficacy of the product one bit. It might work, it might not work, but the article's main thrust is to inform their readers about whether they should invest in the company.


Research analysts rarely ever make SHORT recommendations. Unless their plan is to screw with the larger investing community, this would be very rash on their part. It's also worth mentioning that most of the rumors that circulate on Wall Street usually pan out as true in the end. As such, I wouldn't be surprised if these analysts have inside info that we are not aware of just yet.

There is no life without water. Use it to your advantage.


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32 minutes ago, Sirius Lee said:

Research analysts rarely ever make SHORT recommendations. Unless their plan is to screw with the larger investing community, this would be very rash on their part. It's also worth mentioning that most of the rumors that circulate on Wall Street usually pan out as true in the end. As such, I wouldn't be surprised if these analysts have inside info that we are not aware of just yet.
No inside info, you can tweet them (HinderburgResearch)
answer is -  The company stated in June that it: “expects to initiate a human clinical trial...in the third quarter of 2017” Then in October: “clinical application is expected fourth quarter”. We asked for an update (as it’s December) and received no reply yet .

Nothing looks like inside info

sorry for my bad english

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