3 hours ago, Tano1 said:Good evening everyone. Hope you're all staying warm!I just got off the phone with Dr. Swanson COO and Vice President of PolarityTE and have received some detailed answers. I apologize that the first 2 questions I wasn't able to record because I didn't realize that I couldn't minimize my voice recorder application or else it would pause the recording (thankfully I re-opened it after the second question to check it.) I did however remember his detailed responses on those 2 questions so I will be able to give you accurate information on both. I will also post the questions I asked with exact wording of how I asked them along with Dr. Swanson's responses (omitting the UHs, UMs and throat clearing because I'm a little sick.)
Almost all questions were answered, but unfortunately I couldn't ask them all. We had been speaking for almost half an hour and in the beginning he had told me he did have some free time to discuss some of the questions I had so I kept trying to push to get as many as I could to get answered.
Some questions were merged and/or re-phrased so I believe I was able to word them in such a way that should be able to give you a general answer to your question. Just a couple of questions that couldn't be asked but I think they were at least partially still answered by the other questions I asked.
Give me a couple of hours to get everything posted. I will type out everything here and I may make the audio portion available another day.
Edit: I wasn't able to finish typing the whole interview out since it's getting late for me and it's taking longer than I had expected so I saved what I had and will finish and post it tomorrow as soon as I get the chance. It will be a fairly large post with the 10 questions that I was able to fit in.
Thank you for this! Would you quickly be able to tell us if you were able to learn anything new? Do you still feel
excited after the interview or let down?
27 minutes ago, mjg713 said:Thank you for this! Would you quickly be able to tell us if you were able to learn anything new? Do you still feel
excited after the interview or let down?
I'll answer this quickly because I'm already in bed.
I was able to learn something new from perhaps every question I asked. Some of Dr. Swanson's answers confirmed some of my theories from the past and others gave me some completely new insight.
I am still overall optimistic about PolarityTE and am convinced that it has definitely made an advancement. There are some areas that I see could use improvement, but I also discussed that with Dr. Swanson and will post our discussion along with the questions I asked and its details tomorrow.
5 hours ago, Tano1 said:I'll answer this quickly because I'm already in bed.I was able to learn something new from perhaps every question I asked. Some of Dr. Swanson's answers confirmed some of my theories from the past and others gave me some completely new insight.
I am still overall optimistic about PolarityTE and am convinced that it has definitely made an advancement. There are some areas that I see could use improvement, but I also discussed that with Dr. Swanson and will post our discussion along with the questions I asked and its details tomorrow.
I cant wait for you to tell us what he said, Tano1. I hope "overall optimistic" and "definitely made an advancement" is good news.
11 hours ago, Tano1 said:I'll answer this quickly because I'm already in bed.I was able to learn something new from perhaps every question I asked. Some of Dr. Swanson's answers confirmed some of my theories from the past and others gave me some completely new insight.
I am still overall optimistic about PolarityTE and am convinced that it has definitely made an advancement. There are some areas that I see could use improvement, but I also discussed that with Dr. Swanson and will post our discussion along with the questions I asked and its details tomorrow.
Sharing with us regarding your discussion would be highly appreciated
thanks tano
Interview with Dr. Swanson, M.D. COO and Vice President of PolarityTE
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 PolarityTEs goals and focus and I dont want to take up too much of your time so Ill 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 responseand 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 NOTneed 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 SkinTEs product and so Id 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 itwas 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 containsall 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 its 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 alteredin 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."
9 hours ago, Frasier said:To me it looks very promising. So they are infact working to adress scars like acne scars at the moment! What is the timeline for that?? And what distinguish that treatment from Polaritys treatment today?
Yes and not only are they working to address acne scars and smaller scars in areas like the face, they're making a "derivative product" as Dr. Swanson said, which is basically a similar product to SkinTE or like a branch out method of SkinTE so that it doesn't require such an invasive treatment for skin issues such as those.
He didn't give me a timeline, but you can probably count on that product bypassing any FDA phase trials which means they will be able to release it very quickly once they have perfected it. He hinted that the treatment will probably be as less extreme as their current method of treatment so hopefully they come up with a different way of extracting a skin biopsy or a different way of administering it to the skin defect as well.
5 hours ago, ermete55 said:Tano, tell l me if i understand well: with some cm square of skin is possible to expand the tissue and cure the 10% of the body?
Yes that's correct.
If they take a few sq cm of skin assuming he meant 2 sq cm (which is about the size of your thumb nail), then they can treat 10% of the entirety of skin you have in your entire body from head to toe.
Thank you Tano. That was very kind of you. I want to cry as well (tears of relief that this suffering might one day be over).
I have some sort of hope again for my future. To just think it might one day happen I have so much hope.
I've been an ass to many of you lately because I was so afraid of this failing. But it sounds like a miracle. A miracle I can believe in.
20 minutes ago, Rez77 said:You know what this makes me realize? That if they're successful other tissues can be regenerated as well such as periodontal tissue and maybe even teeth themselves. The future may be so bright.
How about margin? Doesnt change the facts that it is there
thanks for some very interesting insights.
my prognosis: in 2027 acne scarring will still be treated with lasers, fillers and all that inadequate stuff that is known by today. and this thread will still be there and ppl there will see the next big thing coming..
it's only human to react in that way: the miracle has to be at hand.. within reach. then we can believe in it. bc we want to believe in it.
serious, fat deficient acne scarring is not curable with current or proposed methods. learning to accept ourrselves with flaws, that's the real challenge we must go through.
don't let it fck u up.