Futura Medical Share Discussion Threads

[pdt] 18/4/2023 12:31

Here it is on the Boots site;



Just bought some shares, should be good newsflow over the next six months.

[lbo] 18/4/2023 12:24

The irony of the multi-ID rampers calling Flexiseq gel a ˜Russian scam'. Which by that definition means Eroxon is a English AIM market scam! LOLLook how money has been lost trying to market that drug free gel that is rubbed in for another indication pain also known to respond to placebos!https://rusletter.com/articles/anatoly_chubais_spent__311_million_on_a_non-existent_ointmenthttps://www.asa.org.uk/rulings/pro-bono-bio-entrepreneur-ltd-a17-400871.htmlFlexiseq was a certified Class IIb medical device. We understood that the device certification was granted by a body within the European Member States that had been designated to carry out conformity assessments under the Medical Device Directive.I wonder how much money and take to build Eroxo 'into a long term, profitable and trusted brand'? Especially when it still has no enforceable patent!?https://futuramedical.com/media/2187/admission_doc.pdfThe royalty and the royalty advance may be reduced by such amount (if any) as is agreed or determined by an expert to be fair and reasonable if: (i) any patent application does not proceed to grant or any patent rights are determined to be unenforceable or are revoked or lapse; or (ii) an event occurs which in LRC reasonable opinion adversely affects the commercial viability of the licence agreement or the margins on sales of the Product; or (iii) a competing product is offeredhttps://markets.ft.com/data/announce/full?dockey=1323-13804525-55DPU4H7LEJOV56K9EVP0241BN‘Futura does not have the marketing or regulatory resources to support the day-to-day requirements in a growing compliance-driven medical device market’˜the immediate potential for substantial royalties is low in the absence of a large global brand 'carrier' to take the product forwardâ€

[lbo] 18/4/2023 11:33

And its still funnier how Petroc the proven ramper and liar's defence is always Med3000/Eroxon is somehow above the consistent case law and substantiation principles applied by the FTC, the ASA and the courts! Doesn't he actually realise how stupid that actually sounds! Again he is just a proven ramper trying to pretend low class medical devices like Med3000/Eroxon can make any unsubstantiated claims they want. And why would the regulatory bodies like the ASA or FTC have anything yet to say about FUM or MED3000? Its not on sale yet in the UK and has not even been registered as a medical device yet in the USA. Just more rubbish from Petroc a proven multi-ID ramper trying to pump FUM shares. Because the real reality is he made such a bad investment decision to buy into the 'placebo gel frenzy' and now needs to get other to buy in so he can sell out before the market realises they will never be able to sell enough placebo male arousal gel with no enforceable patent to justify the current Futura Market Cap!

[haroldthegreat] 18/4/2023 10:33

With generic Viagra available at a lower price I would have thought a price point of 19.99 would have been better . There are large numbers of people that cannot take viagra because of interactions so if this is effective it will sell well . If on open display will be shoplifters favourite !
Boots loss our gain . I hope Boots have not been given sole distribution rights . We need widest distribution !

[joestalin] 18/4/2023 10:21

SP up 10% already.

MED3000 is the first pan-European topical treatment for ED available without the need of a doctor's prescription and available over the counter.

James Barder, Chief Executive Officer of Futura Medical said: "We are pleased to confirm that Eroxon is available in the UK from today. This is a significant milestone for the Company as our distribution partners continue to increase the availability of Eroxon® across different markets. ED is a growing problem and we believe that today's announcement will be welcomed by many men suffering from ED for whom current front-line treatments for ED are unsuitable."

LBO, I feel your pain. LOL.

[lbo] 18/4/2023 09:59

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.https://simplywall.st/stocks/gb/pharmaceuticals-biotech/aim-fum/futura-medical-shares/news/we-think-futura-medical-lonfum-needs-to-drive-business-growt˜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 sighthttps://www.arnoldporter.com/-/media/files/perspectives/publications/2021/09/trends-and-developments.pdfIn 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 FDCAFutura 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 deviceThat ‘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!https://www.healthnewsreview.org/toolkit/tips-for-understanding-studies/medical-devices/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 OKJournalists 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 devicesNinety-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 routeFor 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.

[lbo] 18/4/2023 09:51

Amazing how arousal gels already on the market contain the same ingredients as Eroxon!








water-based warming gel Ingredients Stimulant Gel Aqua, Glycerin, Propylene Glycol, Alcohol Denat, Carbomer

[lbo] 18/4/2023 09:47

LOL

Pity its not happy enforceable patent day for a placebo medical device gel that has to be massaged in to get an effect and is made of alcohol, water, glycol and carbomer!

When is that day coming ‘soon’?

I suspect the day of reckoning will arrive before it does!



‘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

[petroc] 18/4/2023 09:42

Happy Eroxon Day, LiarBO! May this date henceforth remind you each year of what a buffoon you were, spending 6 years of your pathetic existence trying to bash this stock with your non-stop lies and misinformation! Hahahahahahahaha!

[broomrigg] 18/4/2023 09:41

FDA approval due this quarter.... = 1 pound +.

[lbo] 18/4/2023 08:32

So none of the Eroxon studies were adequately placebo controlled. Yet still they are marketing Eroxon as ‘Clinically Proven’?


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] 18/4/2023 08:21

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[suresure] 18/4/2023 08:10

Essential research.

[neo26] 18/4/2023 07:53

Hoping for a good day today..

[downyr] 18/4/2023 07:51

It's been a very long time to get to this stage

[neo26] 18/4/2023 07:46

Might use my boots vouchers to help the cause.. :))Finally fum in commercial phase.