polyphemus, As I mentioned, BSX has a product called Orise Gel for Submucosal GI lifting.. while it does work to "Lift" the lesion etc.. it does NOT harbor hemostat or sealant qualities. AC5-G could be the first minimally invasive, submucosal lifting agent for GI and Colonoscopy procedures that DOES have Hemostat and sealant properties.. this is a major advantage and additional market opportunity.IMO
To your point, yes, AC5-G is a pipeline candidate at this time. But, again, it should be noted that the proof of concept is already proven (ie: Self assembly of the peptides based on (+) and (-) charges or ions). Expanding the label here would NOT be difficult at all. In fact, it was already mentioned that AC5-G may be able to utilize the US 510(K) pathway as well.
(other internal AC5 SURGICAL pipeline products would need a PMA) (I agree with you on that point. However, I do Not believe that ARTH will run a PMA alone. I think they will do this with Partner(s). IMO
when looking at 3DM, I can only encourage you to do some extra digging there. I have done a tremendous amount of due diligence on the topic.
In a previous post, I mentioned that the AC5 pipeline has been well patented and defended against other "Imitators." It is important to point out that ARTH successfully defended their patents in BOTH Japan and Europe..(3DM is a Japanese company...hmmm.) So, just because another company may "claim" to have something, doesn't mean that they do. I would be happy to discuss further if you like..
lastly, as I mentioned before, AC5 can be used as a hemostat and a sealant..(topically and internally). The AC5 is a multi-modal wound care system.. That means it can be used in ALL phases of wound treatment and healing. THIS is what makes it so unique, novel and different from any other marketed products. So, ARTH is not going after just one or two market places... they are going after all of them. AND they will NOT do it alone.. I believe they are looking to secure partnerships(s) that will do the heavy sales lifting.. the question is, what partner wants which piece of the pie? I Believe they will partner BOTH the Dermal Sciences products (Topical) and the Biosurgical (Internal) products along with other pipeline products like AC5-G and the early ophthalmology products.
I believe that "KOL" feedback is being utilized to help bring partnership(s) negotiations to the finish line. IMO
Please do not take my word for it, I encourage everyone to do their homework and form their own conclusions. good luck everyone.
: )
