What does “clinical application” mean? is clinical application the same as FDA trial? How is it possible that they plan for market entry in early 2018? I thought they haven’t even started FDA trials. 2018 is only 2 months away.
Clinical application means they’re using it in a clinical setting. It’s already registered or approved by the FDA. They’re currently using in select locations clinically then doing a larger commercial rollout at the top of next year. It’s already here. No need to wait years. Just a few months to see just how effective it really is.
@mcclane thanks man ! I have been visiting this site for almost a decade, only see empty promises and false hopes but now it feels like I woke up one day and all of a sudden there is a cure for my strip scars. I would be equally thrilled even if you were to tell me it would be 3 years before they roll this out.
Great news but don’t get too excited just yet. As you know , most strip scars are devoid of blood supply. Incidentally, SkinTE also issued the following warning in a press release. From Globenewswire https://globenewswire.com/news-release/2017/10/03/1140038/0/en/PolarityTE-Announces-FDA-Registration-of-Lead-Product-SkinTE.html
"Important Safety Information
Poor general medical condition or any pathology that would limit the blood supply and compromise healing, as well as nonvascular surgical sites, should be considered when selecting patients for SkinTE™, as such conditions may compromise successful outcomes or lead to sub-optimal results."
Good points, HairSite. An idea: treating the areas with VEGF might help improve the micro-circulation.
Another day, another indication of progress and confidence. That’s why these guys feel different to me. With every other company or research team, it’s radio silence for years.
Nothing too major here, but steady progress, staying the course…
The approval of SkinTE by multiple medical institutions’ value analysis committees. So it will be used at multiple medical institutions this year as they aimed for.
Data is planned to be released through multiple channels in the first half of 2018. That’s exciting. That’s what we’re holding out for!
Can we get Dr. Cole here and ask if he can tweak this so that it will work for hair regeneration without having to create a massive wound on my scalp?
@mcclane, I agree that it looks like we will know pretty soon if this procedure can restore hair. However, I would be very surprised if it lives up exactly to the company’s claims about regenerating hair. If it does regenerate hair, I think the hairs will be very fine, thin, and not compatible with the cosmetic requirements that hair loss patients really want and need. I seriously doubt it will come anywhere near regenerating cosmetically useful hair.
My assessment of this procedure, for now, is that it is a move in the right direction in regrowing “full-thickness” tissue with skin appendages, but at the end of the day it will fall far short of its claims.
Interesting that this stock is publicly traded on the NASDAQ (symbol: COOL), and the company as it exists is the product of a reverse-merger with a publicly-traded former gaming company, Megesco Entertainment. I don’t know of any reverse mergers that have resulted in successful companies. Reverse mergers are mostly used as a way for founders to quickly cash in and cash out, and make a bundle of money based on temporary excitement about their stock, rather than having a long-term sustainable product or business model. If they really had a revolutionary product, and they wanted to go public, it seems they would have first proven it clinically, and the investment bankers and venture capital firms would have been lining up at their doorstep to prepare a regular IPO.
It seems there is already a lot of analysis on this company on stock analysis sites like Seeking Alpha –
Can’t find all the articles I was reading last week, but one of them said that there are already a lot of products out there similar to SkinTE, and none of them have measured up to the initial hype.
OT Some say Ted Turner had a pretty successful reverse merger
The exception that proves the rule? I’m sure there are some successes but the vast majority of reverse mergers I’ve seen have been messy disasters.
some more info I’m hopeful
We’ll see soon enough. I’m not saying this isn’t a good product for burn victims, and others who lose skin. The question is will it be useful for restoring hair for people with MPB? I suspect it won’t, because I think the quality and quantity of the hair won’t be what we need.
Yes, it’s important for cells to experience “polarity” to regrow fully-functional skin. That means that the cells have to know which way is “up” and which way is “down”, as they did in the embryo when they were forming skin and other organs for the first time. In the embryo they experienced polarity by way of very complex chemical signaling coming from other cells situated 360 degrees around them, in a 3-dimensional matrix. So they were properly oriented in space, and that’s how they were able to use their genes to grow into properly situated 3-dimensional organs. That’s why, for instance, on your scalp, all the hairs are embedded in the dermis and grow OUT of your scalp, rather than some growing inward or in all different directions.
I suspect that this SkinTE product will solve some of that problem. It will allow the cells to form functional skin with fine hair, maybe even sweat glands, etc. in their proper orientation.
I just don’t think it will be close to perfect. I think this is still a young technology. SkinTE may have polarity on one axis (proximal to distal – that is, inward to outward). But maybe, because it lacks all of the very complicated chemical signaling of the developing embryo and fetus, it won’t have ALL the signaling and polarity it needs on all the axes it needs. My guess is hairs will grow, but they won’t be thick, full, terminal hairs with the appearance and density needed to give a person a full head of hair or fill in bald spots with quality hair.
I may be wrong about this, and we’ll soon see… If I am wrong, then great for all of us – we’ll all be very happy. But I suspect that is as far as this will go for now.
Hi folks, any news on SkinTE? This one also dead???
This update was just last week. Still looking good… Though, still nothing definitive.
I was about to post that article also-seems really positive, given the feedback from doctors. I got some minor scars that I’d like to see vanish so if this product lives up to its hype I’ll definitely get the treatment in the future.
As for hair regeneration, I think if it genuinely regenerates full thickness skin with hair then this really could be our cure for baldness, since it’d simply be a matter of taking a strip of skin where permanent hair grows, implanting it where it’s needed and repeat as necessary. Of course it’s not specifically designed for that purpose but I don’t see why it can’t work.
SkinTE seems to have to most promise for people in our situation (from what I’ve seen so far). We’ll know more probably by mid-year. They’ve used it on burn patients and apparently they’ve had great results. I hope they release the photos, only way to know if it’s legit or hype.