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Re: SPORT19 post# 3764

Friday, 11/10/2017 1:17:03 PM

Friday, November 10, 2017 1:17:03 PM

Post# of 7900
Typical fluff CC from Transenterix. A few capital market guys....

OR
What indications will they pursue next?





Great, hi, thanks for taking the question. I just had a follow-up on the new approvals for next year. Todd, did you say hernia chole, and if so, when do you think you would expect FDA approval next year. And then can you remind us the number of cases done for these indications in the United States? Thanks.

Todd Pope

Sure. We are planning on filing both hernia and cholecystectomy date in the coming months. And we would expect, I would just say as by way of comparison, our Senhance process was mid-April through mid-October, so six months. So we would expect it to be in line or potentially a little shorter than that for expansion indications. As far as number of those procedures, those are two of the larger procedures done. You know, you combine them together; hernia and gallbladder, and you're up over two million procedures in the United States. And I'll remind you that our initial indication was right at 1.5 million for colorectal and GYN. So we fell like we're going to be in the wide sweet spot in '18 of a great number of procedures that are really going to be interested in a robotic system that gives them some differentiated features and some per-procedure economics that they could actually rationalize using these robots, the Senhance. So we're excited about it. We purposefully have chosen those, and we think those are going to be very beneficial for us.

Glenn Novarro. Thank you. And our next question is a follow-up from Rick Wise with Stifel. Your line is now open.

Rick Wise

Hi, Todd, just a couple of follow-ups here, just to follow-up on Glenn's question about the data and everything. I think you said a hundred cases each for hernia and chole. Is that a lot, will it take a long time to pull that together? And you think FDA is going to accept European or they want U.S. data, just how do we think about that nuance?

Todd Pope

Yes, to clarify, that's a hundred on hernia, and chole we're a combined data, not individual. And I don't think the FDA typically has any problem accepting European data, certainly what we turned in with our first submission that we got approval on October 13. So we feel really good about -- we just feel good that we've got systems placed in multiple countries doing surgery every day across multiple specialties. I think it gives us a real rich clinical experience that we can gather and pull data from, and continue to go into 2018 on our expanded indication strategy.

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