Minerva vs NovaSure

Quote






anonymous said:
"by the brilliant folks that brought Novasure to market"

You tried to build a better mousetrap and it's not impressive. Brilliant! And never did you expand your minds to solve other problems--you just latched onto the tit of the woman then decided to go to bottle-feeding.

Pure genius.

Dude and Minerva women, you guys figured out a new way to steam-clean the uterus without (hopefully) wrecking other organs permanently. It's all heat and steam--both of you clowns. Your Star Trek "argon" bs "plasma" nonsense woos investors but not doctors. You make steam, asshole. Cook endometrium. There's no calculus involved. It's not really "novel" at all and the AE reports support that.

If you had such a firm grip with such a solid product with such top-notch results then you wouldn't be expending a serious sum to try to discredit a non-threatening (low-value) retro report, would you?

You're screwed.
Click to expand...

Minerva does not use steam. Like at all. The amazing nonsense that the H reps run around with lol. Sell on the merits of your own product. Stop talking about Minerva. Stop handing out books saying “look doc, don’t even bother trying Minerva, look at these doctors here (all of them are paid consultants of Hologic), this is real world experience, none of them like Minerva, see! It’s not worth your time”

94% Success and 72% amenorrhea, in a randomized controlled multicenter FDA study

Novasure could never touch those numbers. Everything else you see and hear is just nonsense and misdirection
 






Wow. This is the mega brainwash rep again. Peer reviewed is a term loosely thrown around by evil empire members like yourself.

This most recent “peer reviewed” study is proof of why throwing out marketing words conflict with scientific endpoints and audited third party clinical data.

No one gives a crap about being the largest.( by the way I am personally) Let this sink in, you are no longer the best ablation on the market. Your resection doesn’t have cautery, see the pattern in surgical?

You have rode the wave without new innovation and now you’re paying the price. Better efficacy and better outcomes will be the reason you are no longer the leader in women’s health( surgical specifically)

As i review your ignorant post i have to let you know that you are are such a brainswashed moron you can’t even speak without independent thought. Saying something is “trusted” is a marketing term.
anonymous said:
I disagree.

HOLX is the largest women's health company in the world. What they sell touches damn near every aspect of an OB/GYN's practice. Novasure has over 80 peer reviewed studies.

Minerva is a startup who is completely out of cash and taking on debt now.


It looks to me like Minerva is throwing their Hail Mary and hoping that if they make enough noise, they can discredit one of their own lead physicians as well as the company that is one of the most trusted names in Women's health. They should have sold when they had the chance, rather than being greedy and watching as the wheels come off.
Click to expand...
 






"94% Success and 72% amenorrhea, in a randomized controlled multicenter FDA study"

Your success rate is believable. Your amenorrhea rate would be called exceedingly optimistic in the p.c. world but because this is the real world, we'll call it what it really is--completely fraudulent. A woman with spotting or light bleeding, or even normal menses if she changed her product often would show up as amenorrheic with your 1940s assay that has a minimum quantitation limit of 2.5 mL blood per tampon/pad. That's a lot of blood that could easily be (ie was) missed and therefore miscategorized as "not detected".

How did your techs handle products with visible blood that registered below detection/quantitation, because you know they existed? Probably a whole lot of them. Guessing red stained but "no 'quantifiable' blood" went into the amenorrhea pile, no? That'll bring 50 up to 70% real quickly.

Are you saying that 72% of women didn't even need to bother sending in products for measurement because they had no bleeding whatsoever?!? Wow! Was that in the paper....? I don't remember reading that but it must be true! So only 28% of your cohort needed to ship in their sanitary products for evaluation? Cool.

Success rate? Sure. Believable. Cool.

Amenorrhea rate? Modern fiction.
 






anonymous said:
"94% Success and 72% amenorrhea, in a randomized controlled multicenter FDA study"

Your success rate is believable. Your amenorrhea rate would be called exceedingly optimistic in the p.c. world but because this is the real world, we'll call it what it really is--completely fraudulent. A woman with spotting or light bleeding, or even normal menses if she changed her product often would show up as amenorrheic with your 1940s assay that has a minimum quantitation limit of 2.5 mL blood per tampon/pad. That's a lot of blood that could easily be (ie was) missed and therefore miscategorized as "not detected".

How did your techs handle products with visible blood that registered below detection/quantitation, because you know they existed? Probably a whole lot of them. Guessing red stained but "no 'quantifiable' blood" went into the amenorrhea pile, no? That'll bring 50 up to 70% real quickly.

Are you saying that 72% of women didn't even need to bother sending in products for measurement because they had no bleeding whatsoever?!? Wow! Was that in the paper....? I don't remember reading that but it must be true! So only 28% of your cohort needed to ship in their sanitary products for evaluation? Cool.

Success rate? Sure. Believable. Cool.

Amenorrhea rate? Modern fiction.
Click to expand...

My God, do you have any common sense or ability to think for yourself, or do you really just blindly believe what ever koolaid spin your management feeds you? what you speak of is just utter nonsense. Aside from the fact that the Pivotal FDA study, utilizing the much more subjective PLAC scoring system, rated the Minerva at a 66% amenorrhea (what say you about that?), the FDA RCT utilizing the much more objective AH corroborated the same statistical analysis with 72%. You are an idiot if you think the AH test is being done in a lab setting from the 1940's. Its 2018. You believe that patients in this trial who have spotting or 2.5ml of bleeding are not sending in the pads? because they cannot tell if there is blood on the pad or not? how and why? what you speak of makes absolutly no sense. you are unethically muddying the water, distracting and confusing doctors, creating chaos and it is an absolute disgrace to all sales reps. you are the reason why reps get a bad name in this biz. Please literally go fuck yourself.

Oh, and dont forget that this was an FDA study and they defined the parameters. It was not Minerva leadership that decided to utilize the obscenely expensive AH in the protocol. This was established by the FDA. AH is considered the "Gold standard" in quantifying blood loss. And amenorrhea is simple to figure out- its no bleeding- not even a single drop. You want us and everyone else to believe that patients in an FDA clinical study cant determine when they are bleeding or not, or that modern laboratories cant find it either? and your quoting a study from the 1940's- and the FDA is all unaware of this? you are a shame.

meanwhile, you run around with a marketing produced retrospective survey, conducted in the most questionable fashion, rejected by the major reputable publications, which proclaims Novasure 97%(!!!) effective and superior to Minerva (lol). and you flood the market with this garbage and do a complete disservice to all your customers and all the many patients out there.

This is the garbage that is out there ladies and gentlemen. Hologic sales force, you should be ashamed of yourselves.
 






anonymous said:
ive posted numerous time in this back and forth and quite frankly, I’m ready to find out the truth. We will see,but this thread is now pointless, we will find out which company lied to their reps, doctors, and ultimately lose integrity. Our customers are sick of it, hopefully this brings a much needed conclusion.
Click to expand...

Both companies are liars. The gynecologists are ignorant to listen to the BS that these companies publish. Pay a consultant and he will come up with the erroneous stats you desire.
 












anonymous said:
My God, do you have any common sense or ability to think for yourself, or do you really just blindly believe what ever koolaid spin your management feeds you? what you speak of is just utter nonsense. Aside from the fact that the Pivotal FDA study, utilizing the much more subjective PLAC scoring system, rated the Minerva at a 66% amenorrhea (what say you about that?), the FDA RCT utilizing the much more objective AH corroborated the same statistical analysis with 72%. You are an idiot if you think the AH test is being done in a lab setting from the 1940's. Its 2018. You believe that patients in this trial who have spotting or 2.5ml of bleeding are not sending in the pads? because they cannot tell if there is blood on the pad or not? how and why? what you speak of makes absolutly no sense. you are unethically muddying the water, distracting and confusing doctors, creating chaos and it is an absolute disgrace to all sales reps. you are the reason why reps get a bad name in this biz. Please literally go fuck yourself.

Oh, and dont forget that this was an FDA study and they defined the parameters. It was not Minerva leadership that decided to utilize the obscenely expensive AH in the protocol. This was established by the FDA. AH is considered the "Gold standard" in quantifying blood loss. And amenorrhea is simple to figure out- its no bleeding- not even a single drop. You want us and everyone else to believe that patients in an FDA clinical study cant determine when they are bleeding or not, or that modern laboratories cant find it either? and your quoting a study from the 1940's- and the FDA is all unaware of this? you are a shame.

meanwhile, you run around with a marketing produced retrospective survey, conducted in the most questionable fashion, rejected by the major reputable publications, which proclaims Novasure 97%(!!!) effective and superior to Minerva (lol). and you flood the market with this garbage and do a complete disservice to all your customers and all the many patients out there.

This is the garbage that is out there ladies and gentlemen. Hologic sales force, you should be ashamed of yourselves.
Click to expand...

You forgot to mention that the definition of "amenorrhea" in both Minerva studies is "not one drop".
 


















anonymous said:
"The real issue is the Hologic then changed the study, which the original submission described how the 2-3 month post procedure bleeding scores were known at the time of enrollment, by removing this information and then stating that "No subject's post-procedure bleeding status was reviewed, queried, nor known at enrollment, in either study arm." They realized no one would publish it the previous way, and lied, misled, what ever you want to call it, in order to get their headlines.

They did not anticipate the original study submission to be in the hands of people who have the balls to stand up and call them out finally on their bullshit."

Now here's where you're fucked: the study, and the cohort, never changed. Their first report (go ahead and put it online so you have another lawsuit) contains the exact same enrollment criteria, primary efficacy outcome (amenorrhea at or beyond,not before, minimum of 3M follow-up), and no women's results were ever omitted in the paper's evolution. Jackass. This was basically a patient-reported satisfaction report, but early drafts contained limited physician-charted "bleeding status" data--because only 2/3 or women returned for follow-up at a median of <30 days post-procedure, and less than half of them had any bleeding status recorded (this was a "hey, how're you feeling" visit), the data was of limited utility or meaningfulness. The authors appreciated that valid reviewer comment, so those incomplete data were omitted and this was patient-only. The EXACT same cohort, without a single omission, but it's a survey so it had a 100% response (not participation) rate.

Asswipe Clapper's trying to distort reality saying that the cohort changed after (less than half) of women's "2-3 month" bleeding status was used to select subjects. That is a joke. And that is precisely why Dove Press/Taylor Francis parent company--both of their legal teams--are laughing at your pathetic efforts to denigrate a solid study. Limitations? Yes, of course, like any study (e.g., using heme alkaline assay to confirm amenorrhea--doesn't work; not anymore). But the facts are the facts, whether you like them or not.

Otherwise your frantic efforts would have resulted in that paper being retracted instead of simply delayed by your nonsense.

Now we will argue in Letters-to-the-editor, which I'm drooling waiting for because I'm going to tear you a new asshole.

You are a lying, deceitful man who tried to denigrate completely the reputations of 4 excellent surgeons, and good men (collateral damage to you, asswipe), and it's didn't work.

Your ruse was exposed and you are pathetic.

You don't matter anymore.
Click to expand...
 






To quote another anyomous user on another Hologic topic chain:

"Strange...I thought Novasure efficacy was 91 percent reduction in periods in the brochures?

Shockingly, it’s now 77.7%. Good luck with that. I doubt any doctors or patients would feel they were lied to in anyway..."

The link below on Hologic's own website lists the FDA approved numbers for success rate at 77.7% and amenorrhea at 36% (Same information is found in their IFU and has always been there and remain unchanged). Additional data from peer-reviewed literature is presented on this webpage as well. However, it seems that this additional data was not up to the FDA's standard or never submitted for consideration, as the FDA approved numbers remain much lower.

http://www.novasure.com/hcp/novasure-procedure-data

http://www.novasure.com/hcp/novasure-procedure-data
 






anonymous said:
To quote another anyomous user on another Hologic topic chain:

"Strange...I thought Novasure efficacy was 91 percent reduction in periods in the brochures?

Shockingly, it’s now 77.7%. Good luck with that. I doubt any doctors or patients would feel they were lied to in anyway..."

The link below on Hologic's own website lists the FDA approved numbers for success rate at 77.7% and amenorrhea at 36% (Same information is found in their IFU and has always been there and remain unchanged). Additional data from peer-reviewed literature is presented on this webpage as well. However, it seems that this additional data was not up to the FDA's standard or never submitted for consideration, as the FDA approved numbers remain much lower.

http://www.novasure.com/hcp/novasure-procedure-data

http://www.novasure.com/hcp/novasure-procedure-data
Click to expand...

Wow great post!!

Dear Minerva reps,

On behalf of my naughty Novasure colleagues around the globe:

As fast as you possibly can, please visit every OBGYN in your territory and tell them that their decision to use Novasure- based on the massive stack of favorable evidence- is clinically unfounded because every time one of their buddies across the USA conducted a study using Novasure, they forgot to submit it to the FDA for revised labeling. Since the FDA didn’t revise the labeling, the data from those trials is invalid. They’ll really appreciate that.

Seriously, your docs will be so relieved that you brought that to light, that they will convert to Minerva on the spot! They NEVER do anything that falls even marginally outside the FDA’s approved manufacturer labeling for the benefit of their patients, and simply can’t rely on their clinical experience to make treatment decisions. If the IFU doesn’t say it, they can’t do it!! They will thank you endlessly!

If you can, please start with my territory.
 






anonymous said:
To quote another anyomous user on another Hologic topic chain:

"Strange...I thought Novasure efficacy was 91 percent reduction in periods in the brochures?

Shockingly, it’s now 77.7%. Good luck with that. I doubt any doctors or patients would feel they were lied to in anyway..."

The link below on Hologic's own website lists the FDA approved numbers for success rate at 77.7% and amenorrhea at 36% (Same information is found in their IFU and has always been there and remain unchanged). Additional data from peer-reviewed literature is presented on this webpage as well. However, it seems that this additional data was not up to the FDA's standard or never submitted for consideration, as the FDA approved numbers remain much lower.

http://www.novasure.com/hcp/novasure-procedure-data

http://www.novasure.com/hcp/novasure-procedure-data
Click to expand...

I don't have anything at stake here as I don't work for HOLX or Minerva. But whoever posted this clearly does not understand how things work, and frankly if you went around saying this to docs they would realize how inexperienced you are and you would lose all credibility moving forward. This is an honest response in attempt to help you and I'm not using any sarcasm.

Any company can tout whatever stats they want in a brochure, on a website, etc as long as they cite the source. Typically FDA claims are only used for a short period of time until things like peer-reviewed studies are conducted and released. The results from studies used during FDA-approval are often much better than what was reported in the FDA initial filing. This actually happened frequently in the breast imaging business of Hologic when 3D mammography was released and very large studies from around the world were producing results significantly better than what Hologic submitted to the FDA. It is not realistic, or necessary, for a company to request that those studies be sent back to the FDA so an FDA filing can be updated with revised info. It is up to the customer (the physician, hospital, etc) to look at studies that are presented to them and determine if they feel the study is relevant (size, manner it was conducted, etc) and impactful (results).

You would be making a huge mistake if you tried to take the route of "this was not up to the FDA's standard.." to a physician or anyone in hospital leadership. It's just not how the process works. Your argument would likely get completely turned around against you - I have no idea how long NovaSure has been FDA approved, but let's say it was 15 years ago. And let's say the study size to get FDA approval and provide the stats you reference of 77.7% etc. was 10,000 patients. Well, over the course of 15 years since FDA approval, what if there have been 50+ peer-reviewed studies all across the world that span over 100,000 patients in very reliable study parameters (the studies are trusted)... and now the results show an average of 90% (12.3% better than FDA data)? So now you have a significantly larger sample size, international audience of patients, different physicians across the globe, all getting better results than what was reported. I'd certainly argue that's the actual effectiveness of the device.

I'd find a new angle if I were you.
 






^^^^Sorry, a sentence in my post above didn't make any sense^^^

Here's what I said: The results from studies used during FDA-approval are often much better than what was reported in the FDA initial filing.

Here's what I was trying to say: The results from studies conducted in the years following FDA approval are often much better than what was reported in the initial FDA filing.
 












anonymous said:
that wasn’t the question posed you loser.

Is Novasure now forced to tell patients and doctors it’s 77.7 success or 91%?

Thanks for the kool aid rant.
Click to expand...

You can't be serious. First of all, the name of the company is Hologic, not Novasure. So it would be Hologic telling patients, not Novasure. And if you read the actual response you're attempting to make fun of, you'll understand why Hologic reps can easily say with confidence 91% and state the sources and studies for those numbers. Or maybe you aren't smart enough to interpret what I wrote which (would make sense given the selling angle you appear to be trying to take). Sure would be hard to compete against you....
 












anonymous said:
I don't have anything at stake here as I don't work for HOLX or Minerva. But whoever posted this clearly does not understand how things work, and frankly if you went around saying this to docs they would realize how inexperienced you are and you would lose all credibility moving forward. This is an honest response in attempt to help you and I'm not using any sarcasm.

Any company can tout whatever stats they want in a brochure, on a website, etc as long as they cite the source. Typically FDA claims are only used for a short period of time until things like peer-reviewed studies are conducted and released. The results from studies used during FDA-approval are often much better than what was reported in the FDA initial filing. This actually happened frequently in the breast imaging business of Hologic when 3D mammography was released and very large studies from around the world were producing results significantly better than what Hologic submitted to the FDA. It is not realistic, or necessary, for a company to request that those studies be sent back to the FDA so an FDA filing can be updated with revised info. It is up to the customer (the physician, hospital, etc) to look at studies that are presented to them and determine if they feel the study is relevant (size, manner it was conducted, etc) and impactful (results).

You would be making a huge mistake if you tried to take the route of "this was not up to the FDA's standard.." to a physician or anyone in hospital leadership. It's just not how the process works. Your argument would likely get completely turned around against you - I have no idea how long NovaSure has been FDA approved, but let's say it was 15 years ago. And let's say the study size to get FDA approval and provide the stats you reference of 77.7% etc. was 10,000 patients. Well, over the course of 15 years since FDA approval, what if there have been 50+ peer-reviewed studies all across the world that span over 100,000 patients in very reliable study parameters (the studies are trusted)... and now the results show an average of 90% (12.3% better than FDA data)? So now you have a significantly larger sample size, international audience of patients, different physicians across the globe, all getting better results than what was reported. I'd certainly argue that's the actual effectiveness of the device.

I'd find a new angle if I were you.
Click to expand...


This guy is wrong on so many levels its not even funny. who r u trying to fool? probably your own salesforce. cant wait for the inevitable purge of this toxic regime. hologic is cruising for a 9 figure fine for all of these misleading sales tactics. soon enough.
 






anonymous said:
This guy is wrong on so many levels its not even funny. who r u trying to fool? probably your own salesforce. cant wait for the inevitable purge of this toxic regime. hologic is cruising for a 9 figure fine for all of these misleading sales tactics. soon enough.
Click to expand...

Ok, then provide me with specifics of where I’m wrong. I don’t work for either company. I honesty don’t care either way what happens here. Im an ex HOLX investor who purchased when RC was CEO and stock was under $20 and purged all of my shares at $43 so I’m all good. I’ve progressed upwards through med device companies and very familiar with legal, regulatory and compliance policies and what goes into FDA submissions and approvals.

Since I’m “wrong on so many levels” I’m sure you will be able to give me specific examples from all of your expertise. The more specific, the better.
 






Top Bottom
Back
Quote