Futura Medical Share Discussion Threads

[lbo] 12/4/2023 18:20

Funny how Petroc the proven ramper and liar reacts when being caught out lying and scamming again. His defence is always med3000/Eroxon is above the law and substantiation principles applied by the FTC, the ASA and the courts! Doesn't he realise how transparent and nonsensical that sounds, a proven ramper and trying to pretend low class medical devices can make any claims they want. And why would he regulatory bodies like the ASA or FTC have anything yet to say about FUM or MED3000? Its not for sale yet in the UK and has not been registered as a medical device yet in the USA. He's a total fool and a scammer trying to ramp FUM stock, because he made such bad investment decision to buy into the ‘placebo gel frenzy’ and now needs to sell out before the market realises it will never sell enough to justify the current Futura Market Cap.petroc - 23 Nov 2022 - 18:00:42 - 14168 of 14546I won't care, of course, because I'll have moved on,'So yes the multi-iD ramper claims are a breach of the CAP code and are deliberately misleading.Medical device claims that breach CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 Medicines, medical devices‘Because the trial was not placebo-controlled’˜had not provided adequate evidence to support the claim ‘clinically proven’ ˜concluded that the claim had not been substantiated and was misleading’https://www.asa.org.uk/rulings/actegy-ltd-g20-1053158-actegy-ltd.htmlAssessmentUpheldThe ASA noted that the product appeared to meet the requirements of the Medical Device Directive (MDD) but understood that the MDD did not harmonise EU law relating the advertising of medical devices, which was subject to Directive 2005/29/EC on unfair business to consumer commercial practices (including advertising) generally (Unfair commercial practices directive - UCPD). That meant that advertisers must still meet the requirements of the CAP Code, which reflected the provisions of UCPD. Under the CAP and BCAP Codes, medical claims could be made for CE-marked medical devices provided they complied with other requirements of the Codes, including those relating to substantiation.CE certification in itself does not constitute evidence for medical efficacy claims, and advertisers need to ensure that they hold evidence for such claims.There was no statistically significant difference between the outcomes for the treatment group (patients using the Aerosure device) and the control group (using an inactive sham device). The study was accordingly not adequate evidence of the efficacyhttps://pocketdentistry.com/asa-ruling-on-orthoaccel-technologies-inc-ta-acceledent/Because the trial was not placebo-controlled, we considered AcceleDent had not provided adequate evidence to support the claim AcceleDent, is also clinically proven to reduce the pain and discomfort associated with braces and aligners by up to 71%. We concluded that the claim had not been substantiated and was misleading.On that point the claim breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 Medicines, medical devices, health-related products and beauty products.https://www.asa.org.uk/rulings/actegy-ltd-g20-1053158-actegy-ltd.htmlAssessmentUpheldThe ASA noted that the product appeared to meet the requirements of the Medical Device Directive (MDD) but understood that the MDD did not harmonise EU law relating the advertising of medical devices, which was subject to Directive 2005/29/EC on unfair business to consumer commercial practices (including advertising) generally (Unfair commercial practices directive - UCPD). That meant that advertisers must still meet the requirements of the CAP Code, which reflected the provisions of UCPD. Under the CAP and BCAP Codes, medical claims could be made for CE-marked medical devices provided they complied with other requirements of the Codes, including those relating to substantiation.CE certification in itself does not constitute evidence for medical efficacy claims, and advertisers need to ensure that they hold evidence for such claims.There was no statistically significant difference between the outcomes for the treatment group (patients using the Aerosure device) and the control group (using an inactive sham device). The study was accordingly not adequate evidence of the efficacy

[lbo] 12/4/2023 14:32

So Petroc where is the enforceable patent you said ‘FACTS’ coming soon?

petroc - 21 Jan 2022 - 18:03:42 - 10541 of 10710

What is not to love Eroxon /MED3000 - HERE ARE THE FACTS

- Patent application in progress using patent lawyers - COMING SOON


Yet over a year later and no patent! Another one of Petrocs lies exposed! Because its all based on ‘bias and fraud’ by a group of connected multi-ID rampers around basically trying to give more credence by false and misleading posts on bulletin boards and social media to what is effectively an arousal gel with no evidence form any direct efficacy blinded comparison study to claim otherwise and with no enforceable patent on something that already exists in the market and is well described in the literature! The only thing burying the rampers is they can never provide any real non deficient evidence to substantiate any of their false and misleading claims.



The Company has conducted initial literature and in vitro based research that has shown the cooling from the evaporation of these specific combinations of solvents




Voltarol Emugel vehicle is made of the same ‘evaporate cooling’ ingredients as in Eroxon

carbomer,
isopropyl alcohol,
propylene glycol,
water



‘TPR100 gave similar results to the gold standard, Voltarol 2% gel’



The cooling effect of a topically applied product can be evaluated using a validated handheld thermal imaging system. When the gel matrix is destroyed after application to the skin, the bound water and alcohol evaporates and a measurable cooling-effect results. Consumer satisfaction with a topical product is based on subjective criteria such as how the product feels and how it is perceived on the skin. Therefore, appropriate questionnaires are of major importance for cosmetic products to assess the subjective perception not only of soothing and cooling effects but also of moisturizing properties and fragrance.



A key element of Futura Medicals strategy is to reduce development risk through using well characterised existing agents that are reformulated with its proprietary DermaSys technology to create new products. This means intellectual property protection is limited to use patents for the individual products and umbrella patents for the technology. There is a risk that some claims will either be challenged in future (eg on the grounds of non-obviousness or existence of prior art) and/or that another technology may be employed to achieve a similar effect

[lbo] 12/4/2023 14:28

LOL

More like the rampers trying to bury the truth its all based on a steaming pile of placebo gel ‘form of fraud’ ‘swindle’

Take out the GTN enhancer drug and what’s left!? A lubricant gel with some placebo effects!



PLO = Placebo (identical gel to MED2005 but without the active pharmaceutical ingredient glyceryl trinitrate)




After Phase III Failure, UK Firm Pushes Placebo to Treat Erectile Dysfunction



GlaxoSmithKline unexpectedly handed back the development rights to Futura’s erectile dysfunction gel

“We are not going to progress on this particular compound for normal commercial reasons which we do not wish to go into,” GSK said.

benefit from the gel’s dual action as an penile enhancer and a lubricant

[lbo] 12/4/2023 13:03

So you do now give credence to everything Mr Barder says? And yes five more years has passed but the same still applies! And if anything its even more overvalued and delivered even less! ROFLMAO

The rampers are now so desperate to get out themselves before yet another fundraising. Then when that money runs out yet again and the revenues yet again fail to materialise from a medical device placebo gel with no enforceable patent to justify that in their own words the ‘company is massively overvalued if you go by concrete results’

mikethebike4 - 11 Apr 2018 - 14:35:10 - 4072 of 11141

Having had similar waffling, 'smoke-screen' answers from Mr Barder over the years which have turned out to end in exactly nothing I am loathe to give any credence to virtually everything he says

mikethebike4 - 11 Apr 2018 - 15:58:28 - 4091 of 11141

Company is massively over valued if you go by 'concrete' results !

mikethebike4 - 11 Apr 2018 - 15:14:56 - 4082 of 11141

I only try and bring some sort of balance into the equation to help the gullible not get carried away with fanciful future projections.
I would like nothing better than to be proved wrong about Mr Barder (our CEO since 2001) and to sale away into the sunset grasping 5 times as many £s in my fist as I paid for the shares
Unfortunately for people like J7J, Mr Barder has been through this advisors process before - with CSD500 - and look where we've got in 17 years - sales of the product did not even equal the money we paid him to be our CEO for 2017 !

mikethebike4 - 06 Dec 2017 - 10:32:27 - 3468 of 10591

"A couple of decent deals and will be back off to the races."
Do you have any idea of how long shareholders have been using these words

mikethebike4 - 23 Mar 2017 - 09:52:33 - 2560 of 10591

As someone who has been invested for many years and who attended an AGM years ago and complained to Barder about the very slow progress, I am very frustrated.
All the time the Board are drawing good salaries off the backs of shareholders money they have very little incentive to get off their backsides and get 'selling' - thats what running a company is all about at the end of the day!

mikethebike4 - 24 Feb 2020 - 09:11:58 - 7290 of 9713

why should it be any different this time when you've still got the same useless lot running the show

mikethebike4 - 07 Jan 2019 - 11:22:52 - 4692 of 9641

I repeat I very much hope you are right - no one would be happier than me if you are - however I stupidly (in hindsight) bought in when everything looked really rosy - we were told there were loads of 'distributors' all 'champing at the bit to get selling a wonderful industry disruptive product (which it still is incidentally) once the 2 year shelf-life problem was fixed. This was despite the fact that the Holland/Belgium distributor was quite happy and successful selling them with the original 18 months shelf-life
And where are we now years later - one tiny distributor from which Futura receives a total sales income only just about covering Mr Barders employment remuneration
I just hope this MED/TPR situation is not just a repeat of CSD. As to why I don't just sell up, well my shareholding is worth such a tiny proportion of what I paid for it I might just as well hang on in the hope that new shareholders getting in now are luckier than I was and I can get some of my money back - I think what we need is Mr Barders retirement - that should give the share price a kick

[lbo] 12/4/2023 12:33

Funny how Petroc the proven ramper and liar reacts when being caught out lying and scamming again. His defence is always med3000/Eroxon is above the law and substantiation principles applied by the FTC, the ASA and the courts! Doesn't he realise how transparent and nonsensical that sounds, a proven ramper and trying to pretend low class medical devices can make any claims they want. And why would he regulatory bodies like the ASA or FTC have anything yet to say about FUM or MED3000? Its not for sale yet in the UK and has not been registered as a medical device yet in the USA. He's a total fool and a scammer trying to ramp FUM stock, because he made such bad investment decision to buy into the ‘placebo gel frenzy’ and now needs to sell out before the market realises it will never sell enough to justify the current Futura Market Cap.

petroc - 23 Nov 2022 - 18:00:42 - 14168 of 14546

I won't care, of course, because I'll have moved on,'


So yes the multi-iD ramper claims are a breach of the CAP code and are deliberately misleading.

Medical device claims that breach CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 Medicines, medical devices

‘Because the trial was not placebo-controlled’

˜had not provided adequate evidence to support the claim ‘clinically proven’ ˜concluded that the claim had not been substantiated and was misleading’




Assessment

Upheld

The ASA noted that the product appeared to meet the requirements of the Medical Device Directive (MDD) but understood that the MDD did not harmonise EU law relating the advertising of medical devices, which was subject to Directive 2005/29/EC on unfair business to consumer commercial practices (including advertising) generally (Unfair commercial practices directive - UCPD). That meant that advertisers must still meet the requirements of the CAP Code, which reflected the provisions of UCPD. Under the CAP and BCAP Codes, medical claims could be made for CE-marked medical devices provided they complied with other requirements of the Codes, including those relating to substantiation.

CE certification in itself does not constitute evidence for medical efficacy claims, and advertisers need to ensure that they hold evidence for such claims.

There was no statistically significant difference between the outcomes for the treatment group (patients using the Aerosure device) and the control group (using an inactive sham device). The study was accordingly not adequate evidence of the efficacy




Because the trial was not placebo-controlled, we considered AcceleDent had not provided adequate evidence to support the claim AcceleDent, is also clinically proven to reduce the pain and discomfort associated with braces and aligners by up to 71%. We concluded that the claim had not been substantiated and was misleading.

On that point the claim breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 Medicines, medical devices, health-related products and beauty products.



Assessment

Upheld

The ASA noted that the product appeared to meet the requirements of the Medical Device Directive (MDD) but understood that the MDD did not harmonise EU law relating the advertising of medical devices, which was subject to Directive 2005/29/EC on unfair business to consumer commercial practices (including advertising) generally (Unfair commercial practices directive - UCPD). That meant that advertisers must still meet the requirements of the CAP Code, which reflected the provisions of UCPD. Under the CAP and BCAP Codes, medical claims could be made for CE-marked medical devices provided they complied with other requirements of the Codes, including those relating to substantiation.

CE certification in itself does not constitute evidence for medical efficacy claims, and advertisers need to ensure that they hold evidence for such claims.

There was no statistically significant difference between the outcomes for the treatment group (patients using the Aerosure device) and the control group (using an inactive sham device). The study was accordingly not adequate evidence of the efficacy

[lbo] 12/4/2023 12:23

JoeStalin - 22 Jan 2018 - 11:16:41 - 3640 of 17304

Only a clown thinks selling a few packs at all makes for a business.


ROFLMAO

The real question is will they do a fundraising before the De Novo medical device registration decision or wait? Either way it doesn’t matter as they still cant substantiate it works any better then an placebo arousal gel would in the same deficient tests.




‘Therefore, from June 2022 it had roughly 13 months of cash runway’

it's fair to say the end of the cash runway is in sight’



In terms of advertising and promotion, for most over-the-counter medical devices, the FDA and FTC exercise joint regulatory authority over product labelling and advertising. The FDA has primary jurisdiction over labelling for all medical devices and advertising for restricted devices (typically Class III), while FTC has primary jurisdiction over advertising of unrestricted medical devices (Class I and most Class II devices). The FDCA prohibits the distribution or receipt in interstate commerce of a misbranded medical device, which includes a device bearing false or misleading labelling. Claims in device labelling, including product websites, that are outside the scope of the device cleared uses can misbrand, and even adulterate the device, another prohibited act under the FDCA

Futura has openly admitted in previous RNS it is exploiting the ‘least burdensome’ pathway for De Novo Medical device registration for Med3000/Eroxon

‘For the few devices subject to a scientific review, the quality standards are flimsy. Randomized controlled trials, the gold standard, are infrequent. Most studies are unblinded, and thus prone to bias. The FDA settles for loosely defined reasonable assurance that a device is safe and effective, versus its higher standard of substantial evidence for drugs, which require studies with comparison groups that didnt receive the same treatment. Thus, data that would never be sufficient to support the approval of a drug can result in the approval of a device used to treat the same condition, potentially diverting patients from effective drugs to less-effective device

That ‘reasonable assurance’ that a device is effective includes just it being a placebo effect as no evidence from any adequately controlled and blinded study exists to substantiate any claims of an effect beyond a placebo gel!




Devices are subject to weaker standards than drugs because they are regulated under a different law. The Medical Device Amendments of 1976 was intended to encourage innovation while allowing for a range of review standards based on risk, according to legal expert Richard A. Merrill. An array of corporate lobbying has since prompted Congress to ease regulations and make it easier for devices to get the FDA OK
Journalists need to scrutinize the claims.
Journalists have a responsibility to report this lack of evidence, but they often dont. Investigative journalist Jeanne Lenzer, who wrote a book about the under-regulated medical device industry, says more dogged reporting is needed: We really dont know what we are getting with many of these devices

Ninety-nine percent of devices never have to provide clinical data, thanks in part to the 2002 Medical Devices User Fee Act, which requires the FDA to use the least burdensome route

For the few devices subject to a scientific review, the quality standards are flimsy. Randomized controlled trials, the gold standard, are infrequent. Most studies are unblinded, and thus prone to bias. The FDA settles for loosely defined reasonable assurance that a device is safe and effective, versus its higher standard of substantial evidence for drugs, which require studies with comparison groups that didnt receive the same treatment. Thus, data that would never be sufficient to support the approval of a drug can result in the approval of a device used to treat the same condition, potentially diverting patients from effective drugs to less-effective devices.

[joestalin] 12/4/2023 12:21

Having a good easter, LBO?

(guffaw)