I've only heard their product is dated and technology is similar to old MDT and ANS equipment. Leads had stylette that exited tip and already one other programmer recall. No MRI rating, not even 1.5. But aside from these things, it's absolutely a kick ass system!!! Just ask both customers in the US that are using.
Algovita has had higher trial phase success rates than industry average. This was explained in the Q3 earnings call. The recall with the stylette was due to the improper manufacturing of only 2 (TWO) units. They caused no harm and were fixed. No other units have this problem nor will they ever again. Nuvectra applied for full body MRI and in the Q3 earnings call the company was extremely confident they will get approval. The issue as to why the unit is not MRI compatible only lies in the government's sloth-like movement towards testing... tests done by the company proved successful, now it's just a waiting game. I hear every once in a while that the 'system user interface is dated'... Yet I have relatives who have had both the MDT and the BSX system and neither system had full color display (caveat - some units newer units may have this by now, I don't know), nor such wide range of programmability.
http://investors.nuvectramed.com/phoenix.zhtml?c=254292&p=irol-irhome I couldn't find much of what you claim in writing in their investor deck. The FDA really cares about the kinds of claims that companies make regarding their products, like "higher trial phase success rates than industry average" and "no other units have this problem nor will they ever again" and "the issue as to why the unit is not MRI compatible only lies in the government's sloth-like movement towards testing."
You linked me their investors page which doesn't have their earnings calls on it. Go look at the earnings transcripts. You are correct about the FDA being worried about companies making claims. The Piper Jaffrays analyst had to pry all of this information out of management in the Q&A. Even then, management were extremely cautious in answering, but they gave the tell-tale signs. Forgive me if I don't have the quotes in front of me but the question regarding trial success went something like: Piper Jaffrey analyst: So what kind of success rates are we seeing and what percentage of trials are translating to permanent implants? MGMT: Just think about the industry average trial to permanent ratio...something like 66%. We compare that number to Algovita's results and we are more than pleased. We are extremely excited about our results, but we cannot legally disclose this at the time. Then in the Q3 earnings call, Piper Jaffrey asked management to flesh out the details on the recall. Management explained that there were two units that were made in a certain way, they were the only two units made that way, they caused no damage to the patient, and that there are quality control checks to ensure that all units manufactured in the future would not mess up in this way. And finally, as far as my claim about waiting on the government was because management said in the Q3 call that their submissions were made, there's nothing they can do but wait, and that there are rigorous tests that can take a long time to start, run, complete, and respond to.
Bottom right of the page that I linked does have the Nuvectra January 2017 Investor Presentation. There is no information in the investor presentation about the specific claims you're making. There are no earnings calls transcripts available: http://www.nasdaq.com/symbol/nvtr/call-transcripts
The transcripts get deleted from the web after awhile(30days?). One can probably find it somewhere on the web. I heard the comments and understand it to be true. Management is at a Leerink conference tomorrow at 11:00 which will be broadcast on the website.
Right, the claims I made were from the Q and A with the Piper Jaffrey's analyst for the past two quarterly earnings conference calls., not in the investors presentation. I'm sure the transcripts are somewhere on the web but I cannot find them right now. If they are, someone post them and you can get exact quotes.
Yes, 85% is fantastic. compare to an industry average of 66%-75%. Also a correction above: all tests have been completed for the MRI compatibility and management will be submitting that data immediately, which will have a 180 review period. But once full body MRI is granted, the grant will be retroactive and all implanted units will be MRI compatible. MRI compatibility is a big deal breaker for many physicians, so once the submission and grant gets done with, its all downhill cruising for the sales reps.
Thanks-I heard the Leerink presentation and thought the contents were extremely encouraging. Great leads, small yet powerful IPG and easy to use patient, clinical devices combined with (potentially) better efficacy will get traction in the market. Education of the docs. and salespeople penetrating accounts I would think takes a good 6 months, maybe a year?
Every legit, prospective, multicenter study (North, Kumar, Kapural, Sunburst) has had a >80% trial success rate. So even if the Nuvectra trial success claims are true (which there is no proof of), it's nothing to crow about.
Who is saying this? Can you reference a study or news article, or are you just going off what you have learned from all of the unbiased geniuses on Cafepharma?
I have read countless articles and spoken to many neurosurgeons. EVERYONE stated 66%-75% except one outlier at 60%. 85% is off the charts and if you know anything about SCS you know I'm correct.
I know enough about stim to know that it's pretty easy to manipulate trial success rates by cherry-picking patients which patients are included in the analysis. Until these numbers are confirmed by a third party, they don't mean shit.
