I have a couple of questions regarding what Tony said during the most recent 10/27/19 cc - I am not in the healthcare field...so probably asking pretty basic questions -

1. Does anyone know why Tony mentioned schools? Are those schools studying Excellagen? Any sales to schools?

2. Tony mentioned sales have begun in 3 VACs. Anyone know the magnitude of a VAC? Are there thousands of patients who need wound care?

Thank you very much!


Tony Dolisi: Sure. Absolutely. Thank you, gentlemen. And thank you, Joe. So, as of the
end of July, we're still in the manufacturing, and distribution, and the seeding
into the marketplace. The seeding does continue, but it's a little bit more
extensive. We have now completed several of the VAs, including going to
what they call the SACS. So, as opposed to doing individual VACs with the
VA, we've gone through central, and it’s a new process that was put in place
at the VA, and it's for new biologics to come in, if they meet all the criteria. It
sorts of reduces the time that it would take to move towards to a VAC.
But we're in several VACs with the VA--Waco, Temple, Miami, Knoxville,
Bronx, Manhattan, Brooklyn, Philadelphia, Phoenix, and a couple of
additional ones--as well as private institutions, mostly academic... University
of Miami, Mount Sinai, UNC Chapel Hill, UT Southwestern, Brooklyn,
Minnesota, Oklahoma--just several across the country that we've been
working with--Northwell.
So, that process has been going well, we've got three VACs complete at this
point. As I've mentioned in the past, it's a lengthy process, I don't know how
familiar you are or not with the value analysis committees and the process
that takes place, and the wound care and medicine biologics side.
But the first step is to get approved for almost a mini trial where the head of
surgery get to experience utilization with the product, wait for the patients to
come back, whether it'd be weeks or months, do an evaluation, fill out a
massive amount of paperwork done, they're experienced with the product and
how the patients responded, if there are any safety concerns, adverse issues,
and so on and so forth. Then it gets submitted back to the VAC and that
committee reads through all the cases and makes the decision if they want to
move forward.
The process could be anywhere from three to nine months if they move it
through pretty quickly. And we've not had, at this point, any rejections
through that process, and the responses have been quite well.
Once that's all complete, then sales can start--once it goes through the VAC
committee and it gets approved. And again, we've moved through about three
of those where we've completed the process and we've begun sales.