But i already have the scars ? ... so how would that be of benefit ?
The idea is to remove the scarred tissue to create a new wound bed that would then have the hydrogel applied to it. The hydrogel would then enhance the body's healing process to allow for complete regeneration.
So, you would need to have the scars removed (through excision or some other means) and then the hydrogel would be applied like it was in the paper.
"The U.S. wound care market has been estimated at as much as $21 billion annually. And while many large companies dominate, Davis says there is room in niche markets, such as the treatment of diabetic ulcers. “The key is pricing the product right,” he says, “And we think we can do that.”"
If they have to compete on price, in niche markets, then their hydrogel can't outperform existing wound care products.
"Eventually, the startup plans to look at developing stem cell-based products for wound healing, gearing up toward a broader focus on tissue engineering."
This wouldn't be necessary if their hydrogel worked as miraculously as some have relentlessly stated.
“Sharon already has been working with the clinicians at Johns Hopkins Hospital in the burn unit,” says Davis, “So we are very encouraged, even though we know we have many regulatory hurdles.”
It's likely effective enough to commercialize due to low manufacturing costs. Regulatory hurdles wouldn't be a problem if clinical results were remarkable.
I'll grant you that at times the tenor of the article isn't best (at least in terms of our ultimate hopes about the product) but you are drawing too far reaching conclusions based on what was said.
First, even if it does outperform existing wound care products that does not mean it would immediately envelope the market and dominate. A friend of mine is in medical sales and they're getting new products all the time, but most hospitals just auto-order product. So when he comes in to tell them about the countless things available that showed improved healing (he's specifically in the hard to heal wound care market, diabetic ulcers etc.) the doctors are resistant to change from a product they know what to expect from. Not to mention, corruption is quite pervasive in the medical industry and who knows what doctors might be getting in return for sticking with a specific product.
Second, as seabs pointed out, the original intent of Gerecht's lab with this research was to utilize stem cells for neo-vascularization. The dextran hydrogel blew them away with the results it got alone. But if you look at the lab's site you'll see several research papers published since the one concerning the hydrogel that are using stem cells to achieve their goals. And from an investment stand point, it's just smart to diversify what you can offer.
Third, the FDA doesn't work that way. The thalidomide tragedy in 1959 brought about sweeping reform and increased regulatory practices for the agency. Only in spectacular situations where it serves the public's best interest (e.g. a plague) to forgo these regulations do drugs and/or devices come onto the market without following the procedures outlined by the FDA. Take the HIV/AIDS epidemic of the 80s for example. Several other countries were rolling out all sorts of different kinds of treatments but the FDA (as noble as their intentions might have been) squashed most other products in favor of AZT and even sent it through a battery of trials. And in that case we're talking about a much more dire need than a device that can completely regenerate skin tissue.
Lastly, these quotes are from the investor, not the researchers scientists. Let's say that he knows for a fact right now that it completely regenerates human skin. What would be the benefit of him announcing that to the world prior to it being improved and, most importantly, prior to him commercializing it for profit? There wouldn't be any benefit and in fact it would probably be harmful to his bottom line. Think of the swarms of investors that would pile into Gerecht's office offering up a much better deal than Gemstone Therapeutics could possibly provide.
Now, none of this is to say I'm 100% convinced that the hydrogel will work, just that nothing I've read so far makes me definitively believe the opposite is true either. An article like that is fun to dissect and try to infer some greater meaning from but at the end of the day it's really only the published papers that matter.
I won't expect stem cell therapy will be available for skin repair soon...
The biomaterials will still play the leading role in the next generation.
The only person who know the dextran hydrogel well is Dr Sun, but he is no longer in the team or works on this any more.
I therefore won't expect too much !
Agreed on stem cells. They face a much tougher road in terms of FDA regulations.
However, I don't understand why you think Sun no longer working there has any impact on the success of the device. I've talked to Sun directly and he still thinks highly of the hydrogel and has continued his work in the field in his new position at Columbia University. He only left JHU because funding ran out for his position there. So there isn't anything to glean from that in regards to the efficacy of the hydrogel.
that's what I know. You may want to ask him again...