Deltex Medical Share Discussion Threads

[mrc2u] 09/1/2019 13:31

We are expecting a trading update soon. What do they need to have done to show they will not need to raise more cash and can get on with selling the business?Second half last year had sales of £2,993,000; gross profit on consumables of £2,285,000; sundry & net monitor income of £51,000; cash costs of £2,736,000. Adding up last three gives loss before non cash items of £403,000.DEMG say they have reduced costs by £2m annually on an annualised basis so we can expect £1m less in second half: let's say £800,000 in case some of it took time to come through.That would still make £0.4m profit before non-cash on flat sales. So they could 'afford' second half sales to be down around £0.5m to £0.6m and still be cash break even. They really, really ought to do better than that. They claim US is growing and it was only funnies that made first half go back. UK will go backwards no doubt but the absolute value of losses is reducing each time. International seems to wobble around but ought to be somewhere between up a bit and down a bit. So flat seems much more likely than down 20%.Regardless, if full year sales are £4.8m or better, that ought to be cash sorted and share price should correct to more than double today. If H2 sales show a bit of growth, 4p or 5p is on the cards.Anyone agree?Anyone disagree?MrC

[janatha] 02/1/2019 11:31

Happy New Year to one and all!

[schloo] 02/1/2019 09:56

This seems clear. NICE put out a comment that was inconsistent with its previous one and clarified.

NICE plan to put out new guidance after which the old guidance will be withdrawn. The current guidance remains in place until then.

Even if it did split the anaesthetists.

Interesting that they refer to MTG3 as being about cardiac output monitoring rather than DEMG's CardioQ-ODM device, which is what it was in fact about. This just reinforces that NICE wants to look at the evidence for all the technologies and make recommendations accordingly. This can only be good news for Deltex as it has stacks of positive evidence and bad news for the others (Edwards, Pulsion, Lidco, Cheetah) who each also have stacks of evidence, but little or none of it positive.

So, we are looking at new guidance which ought to reconcile the professional splits, should be more widely followed than the current guidance (which, judging by UK sales history is being actively ignored) and ought to confirm DEMG has a huge competitive advantage.

Thanks to Buywell for highlighting a huge upside opportunity.

[buywell3] 02/1/2019 09:07

Wonder what he is doing about this ?



Deltex Medical stated on page 5 line number 123

'' Deltex Medical notes that the scope identifies MTG3 as NICE guidance to be “partially” updated in this guideline whereas the recent potential review of MTG3 led to the statement “NICE has reviewed this guidance and will update MTG3 within the perioperative care guideline. Once this guideline has published, MTG3 will be withdrawn.”


NICE/Developer’s response reply was

''Thank you for your comment.

''MTG3 Cardiac monitoring devices will be withdrawn once this new guideline has published. ''

[chrisdgb] 02/1/2019 08:54

Will be interesting to see how the new guy has been getting on in recent months, happy new year all, let us hope for some light at the end of the tunnel..!?

[buywell3] 22/12/2018 04:44

I wish one and all a Happy Xmas and a Happy New Year

Peace and goodwill to all men , women , gender neutrals , persons of any other persuasions .................. and Alf


I shall return

Early next year with some new info I am just going through re the withdrawal of MTG3 ODM which I will concede has been rather poorly worded/handled by NICE IMO.

[mrc2u] 21/12/2018 18:04

Ooh, do you think Buywell the Terrible has been getting up at 4.00 in the morning to practice his Cossack dancing?

[yump] 21/12/2018 16:43

You guys do realise that Russia has employed people to appear on forums and bulletin boards and to deliberately waste peoples' time, to try to topple our economy don't you ?

The alternative explanation (that half of all forums and bb's are occupied by idiots or people with issues) is too horrific to contemplate.

[schloo] 21/12/2018 16:05

There are no safety concerns. There have been no adverse incidents in over 20 years.

[buywell3] 21/12/2018 15:49

4.3. Safety concerns


When asked whether there are any safety concerns surrounding the use of CardioQ-ODM+, clinical experts reported the following (paraphrased by Cedar below):

 It is quite common to experience erroneous readings, or failure to obtain a reading is quite common (at least 10%; reported to NICE in development of MTG3). It is a serious problem for CardioQ-ODM+.












Review report of MTG3: CardioQ-ODM oesophageal Doppler monitor

Date completed: 15/03/16

see Page 4 of 105

[schloo] 21/12/2018 08:14

Didn't take long and now you are making it up yet again, Buywell.

NICE say they PROPOSE to withdraw the guidance, not the recommendations. The recommendations are to be incorporated in a new piece of guidance. They have not yet withdrawn the guidance and the recommendations will survive such withdrawal. Both guidance and recommendations are current.

You imply that being on the static list is somehow a bad thing for Deltex. Once again, you are making stuff up purely so you can troll. On its medical technologies guidance home page, NICE makes it clear what this really means:

"Static list
We regularly review our medical technologies guidance. If there is no new research or evidence available that would have a material effect on a piece of current guidance, it gets moved to the static list.

If new evidence becomes available, the guidance can be transferred back to the active list for further appraisal."

This is absolutely clear. The guidance is still in force and has not been changed in any way.

None of the new evidence since NICE recommended CardioQ-ODM has had a material effect on the current guidance which stays in place, as do the recommendations. As the biggest ever trial of ODM, the Spanish FEDORA study earlier this year, showed NICE were absolutely spot on in the first place, this seems only sensible.

Your implication that Deltex are being deceitful in still displaying links to the NICE guidance is as idiotic as the other stuff you have been making up. You are a dishonest, pathetic loser trying to make up fake news. Suggest you go into politics.

[buywell3] 21/12/2018 04:03

NICE have published this on May 2017

''We reviewed this guidance in May 2017. We propose to withdraw the guidance and incorporate the recommendations into NICE's guideline on perioperative care.

Readers of the current guidance should be aware that CardioQ-ODM has been superseded by CardioQ-ODM+ and that the analysis on costs and potential savings in the current guidance may be subject to local pathway changes. Further information is in the review proposal and review decision documents.''




But Deltex still have these links on their website ... why ?








NICE have withdrawn their guidance on CardioQ-ODM as of May 2017 so why are the above links still active ?


Nice stated

''MTG3 should be updated in a suitable clinical guideline, and the current guidance transferred to the static list and a statement added to overview page on the website to explain the review of the guidance and that a new version of the technology is available. ''

Paper signed off by: Mark Campbell, Associate Director Date 12 May 2017

above taken from:-

Review Decision

Outcome of review of MTG3: CardioQ-ODM oesophageal doppler monitor

[mrc2u] 20/12/2018 16:47

BuywellNo idea what your point is. Please make it, if you have oneMrC

[buywell3] 20/12/2018 15:45

As these Hemodynamic devices get used in operating rooms and ICU's

I suggest you look at which dept within the NHS funds their purchase and hence the views and opinions of such staff within that dept might impact upon the devices chosen for use.

It might explain why sales in the NHS have slumped



wigwammer19 Dec '18 - 10:48 - 9644 of 9650
0 2 1
It appears Deltex refer to successful multi centre RCT evidence, and lack of evidence for alternatives, while the individual from the RCA fills the page with poorly written, poorly substantiated and poorly thought out opinion. I think Deltex will eventually get there :)

[schloo] 20/12/2018 10:18

So, can we take it that you are no claiming that the probes are dangerous? And that you are no longer claiming that Imacor is relevant?

The third is more difficult to refute because it does actually benefit from having a factual basis. Someone, supposedly on behalf of the Royal College of Anaesthetists, did actually write the poorly argued, semi-literate rant you quoted.

The key point is up front "NICE MTG divided our specialty". Some were supportive, hence the Royal College choosing to focus on ODM in the Academy pamphlet. Some were hostile and, presumably, whoever wrote this particular piece was from that faction.

It is interesting that the only specific article he mentions was an opinion piece that had to be corrected for factual inaccuracies and provoked wide condemnation including from the head of the NICE programme.

However there is no doubt that the NICE guidance was not implemented and that the national roll-out of ODM was a complete fiasco, causing a long track record of Deltex growth in the UK to reverse, and those of us who have been shareholders to take a huge hit. However, investment is about the future and the real question re NICE is what will happen when the guidance is updated.

Deltex has the evidence and it is very strong and shows huge benefit to patients. Competitors, no matter how often they try, can not get evidence of equivalent benefit (if any) and there are simple technological explanations for why not. NICE have, to date, only looked at the Deltex evidence, now they will have to look at all the technologies and this could/should be disastrous for Edwards, Lidco, Pulsion, Cheetah and all and very good news for Deltex. But only if NICE grows the balls to stand up to the flat-earther nonsense opinions of the type you dug out.

In the meantime there is no reason to believe that the current NICE guidance will have any impact on sales although the big Spanish trial may. That trial, incidentally, was published in the Royal College of Anaesthetist's own journal, had a College council member as one of the authors and was accepted for publication when the current President was editor of the journal. Hardly plausible that they agree with your whining chum, is it?

[buywell2] 20/12/2018 04:13

I am going to have a say here as it seems this whole thread is 99% DEMG rampers

Unlike most of you I can read and understand what is being said

schloo19 Dec '18 - 16:49 - 9647 of 9649

3. Far from being anti-ODM, the Royal College of Anaesthetists is on public record as supporting Deltex's technology and the evidence behind it


NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE

Centre for Health Technology Evaluation

Review Decision

Outcome of review of MTG3: CardioQ-ODM oesophageal doppler monitor









Respondent: Royal College of Anaesthetists

Response to proposal: Proposes that new guidance is produced

General

While it is entirely reasonable for NICE to re-examine the evidence for oesophageal Doppler monitoring we encourage the production of new guidance as soon as possible.
NICE MTG3 divided our specialty.

The existing guidance was strongly criticised from within the specialty with a number of cogent points being raised (see Anaesthesia. 2011 Dec; 66(12):1081-3);
whilst other guidelines have promoted it.

There may have been considerable confusion in the interpretation of NICE MTG3 when CQUIN payments, around the time of the Enhanced Recovery Partnership Programme, were linked to mandatory cardiac output monitoring.

This was not helpful as the guidance was no stronger than “consider the use in…”

There is also a strong feeling that in fully implemented enhanced recovery programmes, cardiac output monitoring may be unnecessary in many cases.

Enhanced Recovery is a package of clinical measures with a certain goal; Cardio Q ODM (or is it Q+?) is a specific technology designed simply to estimate cardiac output.

The two things are completely different.

It is entirely possible – with success – to implement enhanced recovery without ever using the ODM.

Doppler monitoring is not integral to enhanced recovery, and although earlier guidance from the DoH implied this, the Doppler was merely used as an example.

Rather, an estimate of cardiac output is integral and there are many ways to estimate cardiac output. More focus in the original guidance should have
been placed on the comparison of the accuracy of the devices in estimating the quantity being measured (i.e., cardiac output).

In other words, simply because trials have shown enhanced recovery programmes improve outcomes, it does not mean that ODM is beneficial.

At most, it means that the information provided by ODM is potentially beneficial when combined with an enhanced recovery approach.

It is essential to separate the accuracy of a technology in measuring
what it purports to measure from the way in which this accurate information is used.

The suggestion that the Doppler element of the Q+ can be regarded in isolation is not supported by any cogent argument.

There is a suggestion that the PPV function is ‘not recommended’ and MTG3 has made the arbitrary decision not to focus on this.

However, the reality is that the function exists and the real question (amenable to further study) is how and to what extent this influences the overall interpretation of the data and hence, patient outcomes.

If PPV was not intended to be integral to the device function, then why incorporate it at all?

These statements come across as both confused and confusing and do not seem a persuasive justification for assessing the Doppler function in isolation.

We have concerns that some phraseology is highly inappropriate, such as, the implication that central line CVC catheters are rarely used.

Can this be substantiated by any evidence?

There is a concern that practitioners may as a result be led to abandoning a technique that is well established and often necessary (e.g., for giving drugs).

We recommend that, if the current guidance should stand then the actual wording of the guidance be highlighted (i.e. Consider for use in…etc.).

In other words, that the general principles of the guidance (i.e. consider cardiac output monitoring in certain patients) be emphasised rather than that a single technology be used.

This is of course, notwithstanding that the words ‘consider for use in’ also mean pari passu ‘consider should not be used in...’.

Furthermore, we advise that new guidance be produced as soon as possible.

There are a number of large multicentre RCTs in elective and emergency surgery patients that will help craft these guidelines that are underway and supported by the College.

The nature of these trials suggests equipoise and their design is consistent with a “consider in...” approach for selected patients in thecontext of local results and guidance.




NICE Response


Thank you for your comments and insights into the changes in the care pathway and the technology with the introduction of the newer version, CardioQ-ODM+.

Your comment supports the view changes in the care pathway and the technology are such that the original guidance cannot be updated.

It is now proposed that MTG3 is transferred to the static list until it is updated as part of a clinical guideline.

Updating the guidance within a new clinical guideline will allow evaluation of
cardiac output monitoring as part of intraoperative fluid optimisation.

A statement has been added to the overview page on the website to explain the review of the guidance and that a new version of the technology is available.

Any new RCT evidence can be considered as part of the development of a suitable clinical guideline.

[mrc2u] 19/12/2018 16:53

A hit, a palpable hit!About time Buywell took himself off to the library with a bottle of port and a pistolHe would have a very small target indeed so suggest multiple bullets

[schloo] 19/12/2018 16:49

Buywell

I followed your advice and did my own research. I actually read the most recent report and note its conclusion:

"The hospital stated that there were no issues with the device at the time of use and that it performed as intended. There were no design, manufacturing, or quality issues with the "evice" which was discarded at the time of use."

Dynamite? More like playdoh. The probes are safe and not dangerous.

To recap today's lessons:

1. IMACOR's device costs ten times as much as Deltex's, does different things and has no evidence yet. Any threat has been made up by you.
2. Deltex probes are not dangerous. You made that up. The evidence you presented shows the complete opposite of what your pathetic trolling suggested.
3. Far from being anti-ODM, the Royal College of Anaesthetists is on public record as supporting Deltex's technology and the evidence behind it

[buywell3] 19/12/2018 15:05

I just put ''deltex maude'' into a google search



the above was in 2011



This is a USA FDA database

MAUDE - Manufacturer and User Facility Device Experience - FDA

The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and ...

MAUDE - FDA

Sep 11, 2018 - MAUDE data represents reports of adverse events involving medical devices. The download data files consist of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. ... MAUDE may not include ...
Now I seem to remember having arguments with folks on here before about the use of probes being inserted into a patients esophagus

IMHO this database is dynamite regarding sales for any medical device manufacturer ... if many adverse events get reported V sales being hit


Currently in 2018 there are more adverse events appearing concerning Deltex

4 records meeting your search criteria returned- Manufacturer: deltex

Report Date From: 11/01/2011 Report Date To: 11/30/2018

Manufacturer .........Brand Name ..............Date Report Received
DELTEX MEDICAL LTD DP6 .....10/06/2018
DELTEX MEDICAL LTD DP240 10/06/2018
DELTEX MEDICAL LTD DOPPLER PROBE 240 HOUR 10/01/2018
DELTEX MEDICAL LIMITED DP6 PROBE 03/12/2013


Could this be why USA sales are falling back ?

dyor

[schloo] 19/12/2018 12:00

Well said, Wigwammer.

Evidence based medicine matters.

In fact that is the title of a document from the Academy of Medical Royal Colleges. See hxxp://www.aomrc.org.uk/wp-content/uploads/2016/05/Evidence_Based_Medicine_Matters_0413.pdf

Guess which one technology the Royal College of Anaesthetists chooses to highlight in it?

Yes: oesophageal Doppler monitoring. And its a literate contribution. And it puts Doppler up there with laparoscopic surgery and finding ways to live with HIV.

Good to see what the grown-ups think.

[wigwammer] 19/12/2018 10:48

It appears Deltex refer to successful multi centre RCT evidence, and lack of evidence for alternatives, while the individual from the RCA fills the page with poorly written, poorly substantiated and poorly thought out opinion. I think Deltex will eventually get there :)

[schloo] 19/12/2018 09:21

Buywell

You say probes "can cause damage to patients". That is untrue. Around 1,000,000 probes have been used over 20+ years and there has NEVER been an incident of patient harm caused by a probe.

By contrast, the attrition rate from placing a predecessor technology, the pulmonary artery catheter, is around 10%. That is a lot more than none in a million, indeed that would have been 100,000 in a million.

Why did you make this up?

We will deal with your other nonsense later.

[buywell3] 18/12/2018 21:15

Probes have problems though as I have pointed out before ... they can cause damage to patients and it seems the Royal College of Anaesthetists don't seem to be a fan as per my post of a few days back

see what they say




I suggest you read 5.7 because things have changed since 2010




Which makes me think that because other manufacturers are now selling Hemodynamic monitoring equipment using probes .... and growing MAUDE evidence seems to show recent problems after 2010

This seems to be the Deltex answer ... which from memory was never properly discussed



''The HD-ICG system is non-invasive making it ideal for monitoring patients in both critical care and surgery who are awake and do not tolerate ODM probes.''

I take it you still hold these maxk

[maxk] 18/12/2018 20:47

The probe bit is kit, anyone can bring a probe to market, but how it works and why it works is the clever bit.

[buywell3] 18/12/2018 20:21

My point is that more esophageal hemodynamic probe using devices are now coming to market

I thought that Deltex had this type of probe protected by their IP ?

Looks like they don't ... will check

Here we go

''In the UK, unregistered design right lasts for up to 15 years in the UK and three years in the European Union. By contrast, a registered design is protected for up to 25 years in the UK, subject to the protection being renewed every five years.''


So it looks like the IP has now lapsed