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4 hours ago, nikki_gargin said:No its what they said! In a interview. Not conclusions I made myself.
they want the OTC product out end of this year or next yearto fund the alopecia drug from profits. Its their business plan. Search birchbiomed on google videos.
I did watch the video. Let's see if they truly follow their business plan.
Hi Everyone! Again lol. Thanks for answering my questions.
So as far as I know, Sunogel is actually a Class 3 device and they should be done with Pre-Clinical trials by September. I wouldn't expect a public announcement or anything because they aren't required to publish anything until a year after the study. Although you could go to the government clinical trials website and the results would be published much sooner there.
As far as FS2, they did state that they are trying to get a product out as little as a year because they want to get their over the counter cream to fund their studies on alopecia patients.
Obviously there are many new and exciting products that do take time get out on the market. I emailed the marketing director of FS2 and waiting to hear about the results of Phase 2 which ended in June/July.
I would encourage others to keep bringing new information and reaching out to those companies. I realize it can be completely frustrating when they give very little information because of "company policy", but I'm optimistic.
In the meantime, if you want to donate $1, I'm trying to raise money for Sunogel. Call it silly, but moving towards something is better than staying in place.
I don't think moolah is an issue for all these companies, really. Also, though helpful in and of itself, hundred thousand dollars isn't a lot relatively/in this context. Especially if it gets divided amongst various startups. So keep your money in your pocket or use it to buy yourself some drinks or a good meal or something. I'm sure that's what the startups/companies would tell us as well.
1. I just talked to Susan Elliot from Birch Bio Med and she said that they are STILL doing Phase II trials and hope to be concluded with them by the end of next month.
2. Do you think if one had the Sunogel hydrogel made and then used it on themselves that there are significant health risks?
CAN EVERYONE PLEASE BUG THESE COMPANIES? SUNOGEL ESPECIALLY...
They are the most promising and honestly I just think they are having trouble with their scale up process because it's easy to make a non toxic product in a controlled environment and to scale up they have to guarantee that nothing toxic goes out to the public. HOW LONG WILL IT TAKE FOR THEIR APPROVAL AS A CLASS 3 DEVICE?
6 minutes ago, Lip121212 said:CAN EVERYONE PLEASE BUG THESE COMPANIES? SUNOGEL ESPECIALLY...
They are the most promising and honestly I just think they are having trouble with their scale up process because it's easy to make a non toxic product in a controlled environment and to scale up they have to guarantee that nothing toxic goes out to the public. HOW LONG WILL IT TAKE FOR THEIR APPROVAL AS A CLASS 3 DEVICE?
Patience is key for now. You may be distressed by your scars currently but you are not alone.
19 minutes ago, Lip121212 said:I'm serious though. How long does it take for a medical device company to get approval?
I dont think it takes that long. Dr Sun believes in his product so I am sure he is doing what he can to get funding. Problem might be that companies want to buy his patent which he most likely doesnt want to sell.
38 minutes ago, nikki_gargin said:I dont think it takes that long. Dr Sun believes in his product so I am sure he is doing what he can to get funding. Problem might be that companies want to buy his patent which he most likely doesnt want to sell.
I literally talked to him a couple days ago and he said they are working on their GMP's. Which is Good Manufacturing Processes, where they make sure reproducibility, cleanliness etc...My friend who is a chemist said that this is a really challenging part because when companies do a scale up process it's hard to maintain quality and that each batch is the same... Like how long does it take from them applying for an IDE to clinical trials?
12 hours ago, Lip121212 said:I literally talked to him a couple days ago and he said they are working on their GMP's. Which is Good Manufacturing Processes, where they make sure reproducibility, cleanliness etc...My friend who is a chemist said that this is a really challenging part because when companies do a scale up process it's hard to maintain quality and that each batch is the same... Like how long does it take from them applying for an IDE to clinical trials?
In that case then its reasonable to assume once he has sorted the GMP then clinical trials will follow before he can go to market. Patience it might be 5 or so years before its even being trialed. Who knows.
4 hours ago, nikki_gargin said:In that case then its reasonable to assume once he has sorted the GMP then clinical trials will follow before he can go to market. Patience it might be 5 or so years before its even being trialed. Who knows.
I doubt it would be 5 years to start trials since they are only set to have their pre clinicals concluded by Sept 2019.
Correct me if I'm wrong, but it seems the problem is twofold. First, the cutaneous tissue has to corrected by removing the scar tissue and regenerating the original epidermal and dermal structures. This appears to be something that Sunogel could do in theory. However, the problem of the subcutaneous tissue remains. We need something that will permanently address the fat loss beneath the skin that results from inflammation. I suppose HA fillers would accomplish this, but they require constant upkeep.
So really, it seems that we need some sort of stem cell treatment that selectively increases the fat beneath the scar as well. But like I said, HA fillers will help address this issue.
Another thing that has me concerned is the sericin hydrogel team claims their product is better than Sunogel's, but their results are lackluster and leave what I consider to be an obvious scar. I'll attach a picture. So maybe we'll just have to wait for more advanced stem cell treatments in the coming decade?
3 hours ago, PTAA said:Correct me if I'm wrong, but it seems the problem is twofold. First, the cutaneous tissue has to corrected by removing the scar tissue and regenerating the original epidermal and dermal structures. This appears to be something that Sunogel could do in theory. However, the problem of the subcutaneous tissue remains. We need something that will permanently address the fat loss beneath the skin that results from inflammation. I suppose HA fillers would accomplish this, but they require constant upkeep.
So really, it seems that we need some sort of stem cell treatment that selectively increases the fat beneath the scar as well. But like I said, HA fillers will help address this issue.
Another thing that has me concerned is the sericin hydrogel team claims their product is better than Sunogel's, but their results are lackluster and leave what I consider to be an obvious scar. I'll attach a picture. So maybe we'll just have to wait for more advanced stem cell treatments in the coming decade?
Fat grafting to replace fat. Already available.
I do think combination of fat grafting and microcoring will be a good step forward for those with reasonable expectations and the right kind of scars. Obviously if the whole area is scarred it will not work but patches of scar it technically will improve it by removing some of the tissue. But the skin had a mad capacity to stretch like this picture amazes me. This is serial excision and look how much the skin has had to stretch, but it doesn™t look weird. So microcoring is a big maybe, just not in the way some people tell you on here it works.
I think that we need a few more years before we actually see something that eliminates scars or at least reduces their appearance significantly. This new science is at its beginning stages and many researchers are working on it. Takes time to test new discoveries and many years for commercialization. Hand, leg and face transplants are at the beginning stages. The only way scarless healing can be achieved is if somehow, researchers found a way to reprogram stem cells to regenerate a new complete organ from scratch instead of our bodies replacing it with scar tissue. We are many years away. Just having a product out there that can reduce hypertrophic scars by 50% like FS2 or OLX101 would be welcomed.
On 7/27/2019 at 2:18 PM, nikki_gargin said:Sigh. Microcoring is scarless healing by wound contraction in a micro injury that size. It is scarless because of technique and size of injury which can contract for direct closure. That is why it is advertised as an anti aging device FIRST! Cytellis the company launching this product state this on their website that it gets rid of excess skin, its a percentage loss hence the tightening of facial skin they advertise! Although they are in clinical trials for application on scaring so it may work by contracting your scars till invisiable ( pull together normal skin) but it will NOT get that tissue to regenerate NEW skin.
I have uploaded a diagram from their website that shows you how it works.
quote: Based on the pioneering work of leading researchers in the fields of dermatology and plastic surgery, Cytrellis has created an entirely new technology which is the first and only procedure to eliminate skin without surgery. Not just rejuvenate skin, but actually eliminate unwanted tissue without the risks and downtime associated with more invasive surgical techniques.
notice elimate skin not regenerate.
Assuming all that is true and scarless, nobody has answered me how micro coring removes "ALL" of the scar and is not improvement! And how high the price will be for those improvement sessions. Also nobody has shown me they have a decide that selectively targets the scar areas and avoids coring out intact skin! What a waste of many sessions and normal skin getting cored out, leaving the rest of the scar!
On 7/27/2019 at 2:47 PM, MyBeautifulScars said:Don't jump to conclusions just yet. I don't believe FS2 will be available in a year's time. It takes 10 years for the product to reach the shelves as an over the counter product. I don't believe a prescription will be necessary for this. FS2 will not work for atrophic scars which are basically facial acne scars. But it should work on hypertrophic or keloid scars if all goes well.
You confuse the hell out of me. Didn't you used to say FS2 was a reasonable product to follow currently with clinical trials in the current year? If all these things come out in 10 years, why are we waiting now? Do we not have things to do in a decade and maybe come back in 10 years to discuss it, whether it's worth getting or not?
Speaking of that, I'm going back to hibernation. You guys argue on...
4 hours ago, Lip121212 said:You guys...literally Sunogel is obviously the most promising for ANY scar. In my opinion at least. I will literally venmo one of you to talk to Dr. Sun and see when he thinks they will begin their clinical trials. I've already bothered him way too much and feel annoying.
I know it is promising, but only if you want to dream about it...
oh god this is sad
posting after long time....
everyone here on this thread want there scar to vanish and get a perfect skin...through last couple of months things got tough for me
earlier i wanted scarless healing for my chicken poxscar and AMVC scar ...but from last some months acne kicked in and started scarring me....i am now scarred with pox scar ,amvc scar and now in last 3 to 4 months acne and its scars ..i started accutanr but my hairfall started...so i stopped it
sad to think that its 2019 7 months gone and we didnt got still which give us scarless healing...
I talked to Dr. Sun today and he told me on LinkedIn and he said definitely "less than 3 years"
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