Question-and-Answer Session
Operator
Thank you. (Operator Instructions)
Your next question comes from the line of Tao Levy with Deutsche Bank. Please proceed.
Tao Levy - Deutsche Bank
Good morning. Tao from Deutsche. Can you hear me?
Sam Lynch
Yes.
Tao Levy - Deutsche Bank
Hey. How you guys doing?
Sam Lynch
Good morning, Tao.
Tao Levy - Deutsche Bank
So just a couple quick questions. One, Sam, have you kind of finalized what the design of your vertebral study is going to look like? How many patients, follow up, etc.?
Sam Lynch
I'm not sure I can use the term completely finalized. We have submitted now our application to begin that study, which of course, includes a definitive protocol. The caveat is, of course, the final protocol design will be dependent upon the final approvals by the different regulatory bodies. So with that caveat, let me just say that the design that we have settled on is kind of, as we have alluded to previously, a 10 patient pilot study in which we would treat two vertebral bodies in each of those patients. One would be treated with GEM OS2 and the other would be a controlled vertebral body that would be treated either with a GEM injection or just no treatment at all. And again, one of those vertebral bodies would be superior to a vertebral body that had a kyphoplasty vertebroplasty performed on it and one of those vertebral bodies would be inferior to the kyphoplasty or vertebroplasty and that would be randomized.
We will look at CT scans as an endpoint, among others, for assessment of changes in bone density over time. And Steve, I believe that we have a nine-month to a year follow up in those patients.
Steven Hirsch
Correct, yes.
Tao Levy - Deutsche Bank
Okay, great. And for those that like to do the nitty gritty math on the GEM OS1 trial enrollments, can you get into a little more detail how patient enrollment has looked, what was looking before the letter, sort of on a per week basis and maybe over the last couple weeks since you did get the letter?
Sam Lynch
Tao, again, rather than talking on a per week basis, you can sort of do the math again. You know that since we last announced the enrollment rate, which was about two months ago, which was 125. It's now at 170 so we've got 45 patients over that two month period of time approximately, so we're averaging about 20 to 25 patients a month.
- To read the full transcript on Seeking Alpha, click here »
