Endo, thanks for sharing the fruits of your inquiries!
"An interesting marketing strategy" is an understatement - but is it not probably more a negotiating strategy than marketing? As in: ISRG wants Firefly in the Xi badly enough to make it standard equipment - no longer optional as in the Si. And ISRG certainly would like the more advanced capabilities, they must've discussed a new arrangement. But for whatever reason, ISRG doesn't want the upgrades badly enough to renegotiate with NVDQ, or at least not badly enough to meet Arun's asking price. So Arun in the meantime feels no urgency. The advanced Pinpoint will basically sell itself to surgeons, while Firefly will keep on selling with every Xi, and Arun is willing to sit tight and wait for ISRG to get so many requests that they are forced to come back to NVDQ with an even better offer to get the upgraded Firefly.
Just a theory.
Anyway, I am significantly long on both companies (combined 60% of my portfolio) so I can live with it either way, but I hope ISRG blinks - I believe having a latest and greatest Firefly integrated into the Xi vision system would be a win for both companies.
Tredleon: I'm not disagreeing with your premise that Arun may be out of his league, but I don't think all of the evidence is in yet. I do also hear and understand your frustration with the pace of progress. Also agree it does seem mystifying that they have dropped the breast cancer reconstruction standard of care theme from the updates, along with the seeming lack of progress on overseas marketing. Perhaps the latter is more a function of trying to focus on cracking the US nut first? But again you could be right - are we seeing an apparent inability to juggle multiple balls? If these themes don't appear to be changing by the end of this calendar year, then I will agree that leadership is problematic.
Anyone have thoughts on why NVDQ is being beaten down again right before Tuesday's earnings release? Does someone know something we don't?
My thoughts are that the Lifecell situation is overall going to be a net positive, at least in the intermediate to long term. So I'm treating yesterday and today's drop as another buying opportunity - just picked up another 900 shares.
Endo - The only mentions in the CC were that FDA clearance is still in process for the da Vinci Xi version of Firefly:
"Turning to new products, we’ve received FDA clearance for our Xi Vessel Sealer and are working through the clearance process with Xi Stapler and Xi Firefly in United States and other countries. These advanced technologies are an important step in filling in the Xi offering. Our Xi architecture simplifies implementation and improves performance for our advanced instruments, and we look forward to their introduction around the world. We have submitted our 510-K application for our single-site wristed needle drivers, and are working through the clearance process. Pilot product performance for the wristed needle driver for single-site is compelling. We expect it will add significant capability and efficiencies for single-site surgeons."
And also... "We are currently in the process of obtaining US FDA and international regulatory clearances for the Xi versions of our Stapler and Firefly products"
So we still have no idea when US FDA approval will come - best case is this quarter based on 90-day FDA cycle. Also, will the Xi version of Firefly include the newer Spy/Pinpoint capabilities? If so does this imply a re-negotiated deal with NVDQ?
GSA: It sure looks like Aimago already had plans to go after that "combination device" themselves. So this is looking like a brilliant pre-emptive move by Arun to bolster the IP portfolio and join forces with a potential future competitor still in start-up mode.
Note the quote at the end of the following snippet - I found this in an Aimago press release from 8/26/2013:
' While the principle of ICG / fluorescent based perfusion imaging is in public domain, the now licensed patent applications seek to protect the combination of LDI with ICG / fluorescence imaging into one single imaging device. These patent applications, filed in 2007, are currently in review phases in both the United States and Germany.
Prof. Theo Lasser, head of the EPFL Biomedical Optics Lab and co-founder of Aïmago, has experience with ICG and comments: “We are satisfied to see that Aïmago now has access to the entire IP package. From a clinical perspective, the implemented LDI modality covers the majority of applications related to skin perfusion imaging, while ICG / fluorescence imaging opens the door to deeper tissues and organs – all through one single, highly intuitive instrument.” '
I too learned about NVDQ from reading Fish's and Pezel's posts in the ISRG message boards on IV and Y. Did not pull the trigger on NVDQ until late 2012 at $8.88, and have added on the dips following each of the last two secondary offerings, for an average basis of $13.49 per share. I am also confident NVDQ is something special and I look forward to a long ride! I give full credit and many thanks to Fish, Pezel, Endo and GSA for sharing the compelling investment premise and the continuing tech developments and building momentum/optimism behind this company.
Also, I have been an ISRG shareholder since January 2006 and have added several times since then - needless to say I'm *quite* pleased with the release of the dV Xi platform. I'm confident this begins a whole new growth phase for ISRG, certainly by Q3. And hopefully they will find a way to renegotiate with NVDQ on including the upgraded technology from the new Pinpoint into Firefly (undoubtedly would require more favorable terms for NVDQ).
In any case - from all appearances I will be both a NVDQ and ISRG shareholder for many years to come.
endo - first I'd like to compliment you on your writing. Also, I agree with your take on the increasingly positive fundamentals and news underlying NVDQ. Like you, GSA and vonPezel, I'm convinced there is a long term success story unfolding here that should be very very rewarding to all patient and thoughtful investors. The traders will trade, let them worry about the short term noise.
On to bigger things... have you (or anyone) been to or heard any news out of SAGES? Big show going on, for both NVDQ and ISRG, and things seem strangely quiet. Given the new daVinci Xi (with Firefly compatability) and the expected release of the new version of Pinpoint, I was hoping we might be hearing some hard news released from SAGES (as if Xi wasn't enough), but also hoping for reports of people who visited the booths.
And finally - there is the long-awaited PILLAR II publication hanging out there - I gather there is still no word on that?
Thanks again to you, GSA and VonPezel for sharing your thoughts. Cheers,
@justin.garland: You keep saying "Laso" - do you mean to say "Lasso"? And does "Lasso" mean the same thing as the "V-Loop Circular Catheter Manipulator"? I sure hope so.
We know that STXS has completed their Clinical Trial of Vdrive With V-Loop System, and further that STXS management has stated in their last Conference Call that they intend to submit the 510(k) for this to the FDA in the first quarter of 2014. Hopefully this happens by 3/31 and we see a bump up - followed by another bump up when the approval comes in the 60-90 days you mentioned!
And here's to hoping that your prediction is eventually right: a J&J buyout would be sweet.
Read more: http://www.nasdaq.com/article/stereotaxis-closes-clinical-trial-of-vdrive-with-vloop-system--quick-facts-20140107-00129#ixzz2x0laK0aU
You're correct - ISRG announced in their 4th Quarter CC back on January 22 that they had submitted an application for using Firefly to image the biliary system.
From the ISRG Q4 transcript: "In imaging, we submitted a 510(k) application to expand indications for our Firefly Fluorescence imaging system to use in biliary imaging. We believe this will have application for use in imaging in the common bile duct during Cholecystectomy, and will complement the use of Single-Site."
I agree it's been stuck in this $17-$19 range for too long, although it got there for some good reasons. So is this your breakout starting today? No news that I see.
It does seem we're past the point where QSII should get a little more respect from the market. Since the end of last summer it can't get above the mid-19's without getting slapped back down. About time to see it back in the mid-20's - although actual news and/or positive earnings surprise would be nice.
Still long QSII. GD
farfignugen21. my thanks to you also for the good info.
I have been holding ISRG for 7 years and started a much smaller position in NVDQ about 6 weeks ago (cost basis $8.90/share). My interest was triggered by what ISRG is doing with Firefly, and after studying NVDQ for a while I pulled the trigger on a starter position. So far I am more than encouraged by how the ISRG/NVDQ joint venture appears to be panning out. The recent Corporate Presentation on the NVDQ website is certainly encouraging as well. I believe the future looks bright for this company.
As for the ISRG joint venture: while it's fair to say that the sales to ISRG are not "hugely profitable", they allow NVDQ to leverage the ever-growing ISRG sales/marketing organization. They are providing increasing volume to NVDQ manufacturing and so I surmise help to achieve economies of scale for NVDQ. Also, ISRG is bearing (or sharing?) the cost of conducting a clinical trial and filing the 510k with the FDA for the Biliary indication on Firefly, which can only help NVDQ. And as you said, Firefly's ever-increasing penetration of Robotic procedures provides invaluable exposure and credibility for the technology in all surgical platforms, which hopefully will provide a very profitable "multiplier effect".
Cheers, and good luck to all NVDQ longs,
Yeah, just think of all that growth still to come in Europe and rest of world markets!
And the US still years from saturation (not counting new procedures, new instruments, future da Vinci upgrades and who knows what other new products they are working on or will acquire). It's so tough being a monopoly.
Fish, am I correct in my understanding that they did not include the 2012 R&D tax credit in Q4 results, but they will take the 2012 credit in Q1 2013, so we will see that benefit during the next CC? Thanks!
(And they still had a great Q4 even without it!)
Just listened to the ISRG Q4 Conference Call. According to ISRG they sold 88 Firefly units during the quarter. Also, ISRG announced they have already submitted a 510k with the FDA to expand the Firefly approval to include the Biliary system (for imaging bile ducts during daVinci Cholecystectomy).
Excellent news for NVDQ.
Sorry, but the only ones threatened are the dinosaurs who don't want to learn the newest and least-invasive techniques. They will all "get retired" soon enough.
DaVinci is all about reducing the invasiveness of the surgery, reducing blood loss, pain and recovery time. It reduces the surgeon's hand tremors and fatigue and the physical stress on the surgeon. It improves the surgeon's access, vision and comfort, and improves overall outcomes. Surgeons love the thing!
It is *NOT* about reducing headcount in the Operating Room. It takes a SURGEON to run each robot, sometimes two surgeons, plus a team of assistants.
Procedure growth is running strong at +26% year over year, and ISRG's "Surgeon Listing" keeps growing every week. These are qualified surgeons trained to use DaVinci in specific procedures and who have then performed a sufficient number of those procedures using DaVinci to be certified.
You are incorrect - they do get those reveneus, but some of them (the Biosense Webster royalties) now go to pay off the Cowen debt. Obviously the recurring rev's are not all coming from Biosense royalties.
Once Cowen is paid off then they get "all" of it (to pay off lord knows what other debts...)
Kaminski was supposed to present at the Deutsche Bank Annual Health Care Conference in Boston last Tuesday. Can anyone comment on the following:
1. Was anything posted or published regarding specific content of his Deutsche Bank presentation?
2. Did K add anything substantive in addition to content already included in the Q1 Conf Call?
3. Has Deutsche Bank subsequently (re-)initiated coverage of STXS?
Thanks in advance - GD (a long-suffering Long)
What stock are you talking about?
ARMH is up over 5% for the day and it hit a 52-week high earlier today. It was even just upgraded by the scumbags at Goldman Sachs earlier today.
No one should be surprised by ISRG beating estimates, they always do (with the exception of the '09 crisis). I'd be utterly and completely shocked if they *didn't* beat!
Beating by 10% is asking a lot though... Average estimate is for EPS = 2.10, so ISRG would have to beat that by 21 cents, bringing in EPS = 2.31. Definitely do-able - I sure hope they can pull it off. My guess is more like 2.23. But still, that plus good procedure growth... and hopefully some good news on new product announcements... and this thing should easily be trading back up to 330 by the end of the week.